Levonelle One Step 1500 microgram Tablet

Ref: 1280/141116/1/F

(levonorgestrel)

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Levonelle One Step 1500 microgram Tablet but will be called Levonelle One Step throughout this leaflet.

What is in this leaflet

^ What Levonelle One Step is and what it is used for

What you need to know before you take Levonelle One Step ^ How to take Levonelle One Step Possible side effects & How to store Levonelle One Step ^ Contents of the pack and other information

^ What Levonelle One Step is and what is it used for

Levonelle One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Levonelle One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Levonelle One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Levonelle One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonelle One Step, it will not stop you from becoming pregnant.

^ What you need to know before you take Levonelle One Step

Do not use Levonelle One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Levonelle One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Levonelle One Step cannot terminate pregnancy, so Levonelle One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Levonelle One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Levonelle One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

Your doctor may decide that Levonelle One Step is not suitable for you, or that another type of emergency contraception would be better for you.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonelle One Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Levonelle One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Levonelle One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Levonelle One Step from working effectively. If you have used any of the medicines below during the last 4 weeks,

Levonelle One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonelle One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Levonelle One Step” for further advice).

Levonelle One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Levonelle One Step You should only use Levonelle One Step in emergencies and not as a regular method of contraception.

If Levonelle One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Levonelle One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Levonelle One Step will harm a baby that develops in your uterus/womb if you use Levonelle One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Levonelle One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Patient Information Leaflet (continued)

Fertility

Levonelle One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

Driving and using machines

Your Levonelle One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Levonelle One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonelle One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

^ How to take Levonelle One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.

Levonelle One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Levonelle One Step from working properly (see section above "Other medicines and Levonelle One Step”) or if you have used one of these medicines in the past 4 weeks, Levonelle One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonelle One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Levonelle One Step

After you have taken Levonelle One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Levonelle One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Levonelle One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonelle One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Levonelle One Step

After the use of Levonelle One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Levonelle One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

[4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

^ How to store Levonelle One Step

Keep out of the sight and reach of children.

Do not use Levonelle One Step after the expiry date which is stated on the package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

[6    Contents of the pack and other information

What Levonelle One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Levonelle One Step looks like and contents of the pack

Each pack of Levonelle One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Gedeon Richter Plc, Gyomroi ut 19-21, H-1103, Budapest, Hungary and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Levonelle is a registered trademark of Bayer Schering Pharma Aktiengesellschaft.

Revision date: 14/11/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Postinor One Step 1500 microgram Tablet but will be called Postinor One Step throughout this leaflet.

what is in this leaflet

^ What Postinor One Step is and what it is used for

rp What you need to know before you take Postinor One Step

3 How to take Postinor One Step

[4 Possible side effects

[4 How to store Postinor One Step

^ Contents of the pack and other information

^ What Postinor One Step is and what is it used for

Postinor One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Postinor One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Postinor One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Postinor One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Postinor One Step, it will not stop you from becoming pregnant.

What you need to know before you take Postinor One Step

Do not use Postinor One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Postinor One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Postinor One Step cannot terminate pregnancy, so Postinor One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Postinor One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Postinor One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Postinor One Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Postinor One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Postinor One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Postinor One Step from working effectively. If you have used any of the medicines below during the last 4 weeks, Postinor One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Postinor One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Postinor One Step” for further advice).

Postinor One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Postinor One Step You should only use Postinor One Step in emergencies and not as a regular method of contraception.

If Postinor One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Postinor One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Postinor One Step will harm a baby that develops in your uterus/womb if you use Postinor One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Postinor One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Fertility

Postinor One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

(levonorestrel)

Patient Information Leaflet (continued)

Driving and using machines

Your Postinor One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Postinor One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Postinor One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Postinor One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.

Postinor One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Postinor One Step from working properly (see section above "Other medicines and Postinor One Step”) or if you have used one of these medicines in the past 4 weeks, Postinor One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Postinor One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Postinor One Step

After you have taken Postinor One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Postinor One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Postinor One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Postinor One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Postinor One Step

After the use of Postinor One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Postinor One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Postinor One Step

Keep out of the sight and reach of children.

Do not use Postinor One Step after the expiry date which is stated on the package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

Contents of the pack and other information

What Postinor One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Postinor One Step looks like and contents of the pack

Each pack of Postinor One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Gedeon Richter Plc, Gyomroi ut 19-21, H-1103, Budapest, Hungary and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Postinor is a registered trademark of Bayer Schering Pharma Aktiengesellschaft.

Revision date: 14/11/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Levonorgestrel One Step 1500 microgram Tablet but will be called Levonorgestrel One Step throughout this leaflet.

What is in this leaflet

^ What Levonorgestrel One Step is and what it is used for ^ What you need to know before you take Levonorgestrel One Step How to take Levonorgestrel One Step ^ Possible side effects ,5 How to store Levonorgestrel One Step

Contents of the pack and other information

^ What Levonorgestrel One Step is and what is it used for

Levonorgestrel One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Levonorgestrel One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Levonorgestrel One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Levonorgestrel One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonorgestrel One Step, it will not stop you from becoming pregnant.

What you need to know before you take Levonorgestrel One Step

Do not use Levonorgestrel One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Levonorgestrel One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Levonorgestrel One Step cannot terminate pregnancy, so Levonorgestrel One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Levonorgestrel One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Levonorgestrel One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel One

Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Levonorgestrel One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Levonorgestrel One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Levonorgestrel One Step from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonorgestrel One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Levonorgestrel One Step” for further advice).

Levonorgestrel One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Levonorgestrel One Step You should only use Levonorgestrel One Step in emergencies and not as a regular method of contraception.

If Levonorgestrel One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Levonorgestrel One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Levonorgestrel One Step will harm a baby that develops in your uterus/womb if you use Levonorgestrel One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Levonorgestrel One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Patient Information Leaflet (continued)

Fertility

Levonorgestrel One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

Driving and using machines

Your Levonorgestrel One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Levonorgestrel One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonorgestrel One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

3 How to take Levonorgestrel One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex. Levonorgestrel One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Levonorgestrel One Step from working properly (see section above "Other medicines and Levonorgestrel One Step”) or if you have used one of these medicines in the past 4 weeks, Levonorgestrel One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Levonorgestrel One Step

After you have taken Levonorgestrel One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Levonorgestrel One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Levonorgestrel One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonorgestrel One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Levonorgestrel One Step

After the use of Levonorgestrel One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Levonorgestrel One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

^ How to store Levonorgestrel One Step

Keep out of the sight and reach of children.

Do not use Levonorgestrel One Step after the expiry date which is stated on the

package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

Q Contents of the pack and other information

What Levonorgestrel One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Levonorgestrel One Step looks like and contents of the pack

Each pack of Levonorgestrel One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Gedeon Richter Plc, Gyomroi ut 19-21, H-1103, Budapest, Hungary and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Revision date: 14/11/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

(levonorgestrel)

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Levonelle One Step 1500 microgram Tablet but will be called Levonelle One Step throughout this leaflet.

What is in this leaflet

^ What Levonelle One Step is and what it is used for

What you need to know before you take Levonelle One Step ^ How to take Levonelle One Step Possible side effects & How to store Levonelle One Step ^ Contents of the pack and other information

^ What Levonelle One Step is and what is it used for

Levonelle One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Levonelle One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Levonelle One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Levonelle One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonelle One Step, it will not stop you from becoming pregnant.

^ What you need to know before you take Levonelle One Step

Do not use Levonelle One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Levonelle One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Levonelle One Step cannot terminate pregnancy, so Levonelle One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Levonelle One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Levonelle One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

Your doctor may decide that Levonelle One Step is not suitable for you, or that another type of emergency contraception would be better for you.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonelle One Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Levonelle One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Levonelle One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Levonelle One Step from working effectively. If you have used any of the medicines below during the last 4 weeks,

Levonelle One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonelle One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Levonelle One Step” for further advice).

Levonelle One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Levonelle One Step You should only use Levonelle One Step in emergencies and not as a regular method of contraception.

If Levonelle One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Levonelle One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Levonelle One Step will harm a baby that develops in your uterus/womb if you use Levonelle One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Levonelle One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Patient Information Leaflet (continued)

Fertility

Levonelle One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

Driving and using machines

Your Levonelle One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Levonelle One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonelle One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

^ How to take Levonelle One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.

Levonelle One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Levonelle One Step from working properly (see section above "Other medicines and Levonelle One Step”) or if you have used one of these medicines in the past 4 weeks, Levonelle One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonelle One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Levonelle One Step

After you have taken Levonelle One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Levonelle One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Levonelle One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonelle One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Levonelle One Step

After the use of Levonelle One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Levonelle One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

[4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

^ How to store Levonelle One Step

Keep out of the sight and reach of children.

Do not use Levonelle One Step after the expiry date which is stated on the package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

[6    Contents of the pack and other information

What Levonelle One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Levonelle One Step looks like and contents of the pack

Each pack of Levonelle One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Bayer Schering Pharma AG, Mullerstrasse 170-178, D-13353, Berlin, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Levonelle is a registered trademark of Bayer Schering Pharma Aktiengesellschaft.

Revision date: 14/11/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Postinor One Step 1500 microgram Tablet but will be called Postinor One Step throughout this leaflet.

what is in this leaflet

^ What Postinor One Step is and what it is used for

rp What you need to know before you take Postinor One Step

3 How to take Postinor One Step

[4 Possible side effects

[4 How to store Postinor One Step

^ Contents of the pack and other information

^ What Postinor One Step is and what is it used for

Postinor One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Postinor One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Postinor One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Postinor One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Postinor One Step, it will not stop you from becoming pregnant.

What you need to know before you take Postinor One Step

Do not use Postinor One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Postinor One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Postinor One Step cannot terminate pregnancy, so Postinor One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Postinor One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Postinor One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Postinor One Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Postinor One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Postinor One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Postinor One Step from working effectively. If you have used any of the medicines below during the last 4 weeks, Postinor One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Postinor One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Postinor One Step” for further advice).

Postinor One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Postinor One Step You should only use Postinor One Step in emergencies and not as a regular method of contraception.

If Postinor One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Postinor One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Postinor One Step will harm a baby that develops in your uterus/womb if you use Postinor One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Postinor One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Fertility

Postinor One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

(levonorestrel)

Patient Information Leaflet (continued)

Driving and using machines

Your Postinor One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Postinor One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Postinor One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Postinor One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.

Postinor One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Postinor One Step from working properly (see section above "Other medicines and Postinor One Step”) or if you have used one of these medicines in the past 4 weeks, Postinor One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Postinor One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Postinor One Step

After you have taken Postinor One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Postinor One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Postinor One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Postinor One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Postinor One Step

After the use of Postinor One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Postinor One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Postinor One Step

Keep out of the sight and reach of children.

Do not use Postinor One Step after the expiry date which is stated on the package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

Contents of the pack and other information

What Postinor One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Postinor One Step looks like and contents of the pack

Each pack of Postinor One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Bayer Schering Pharma AG, Mullerstrasse 170-178, D-13353, Berlin, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Postinor is a registered trademark of Bayer Schering Pharma Aktiengesellschaft.

Revision date: 14/11/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Levonorgestrel One Step 1500 microgram Tablet but will be called Levonorgestrel One Step throughout this leaflet.

What is in this leaflet

^ What Levonorgestrel One Step is and what it is used for ^ What you need to know before you take Levonorgestrel One Step How to take Levonorgestrel One Step ^ Possible side effects ,5 How to store Levonorgestrel One Step

Contents of the pack and other information

^ What Levonorgestrel One Step is and what is it used for

Levonorgestrel One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Levonorgestrel One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Levonorgestrel One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Levonorgestrel One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonorgestrel One Step, it will not stop you from becoming pregnant.

What you need to know before you take Levonorgestrel One Step

Do not use Levonorgestrel One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Levonorgestrel One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Levonorgestrel One Step cannot terminate pregnancy, so Levonorgestrel One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Levonorgestrel One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Levonorgestrel One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel One

Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Levonorgestrel One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Levonorgestrel One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Levonorgestrel One Step from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonorgestrel One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Levonorgestrel One Step” for further advice).

Levonorgestrel One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Levonorgestrel One Step You should only use Levonorgestrel One Step in emergencies and not as a regular method of contraception.

If Levonorgestrel One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Levonorgestrel One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Levonorgestrel One Step will harm a baby that develops in your uterus/womb if you use Levonorgestrel One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Levonorgestrel One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Patient Information Leaflet (continued)

Fertility

Levonorgestrel One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

Driving and using machines

Your Levonorgestrel One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Levonorgestrel One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonorgestrel One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

3 How to take Levonorgestrel One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex. Levonorgestrel One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Levonorgestrel One Step from working properly (see section above "Other medicines and Levonorgestrel One Step”) or if you have used one of these medicines in the past 4 weeks, Levonorgestrel One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Levonorgestrel One Step

After you have taken Levonorgestrel One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Levonorgestrel One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Levonorgestrel One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonorgestrel One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Levonorgestrel One Step

After the use of Levonorgestrel One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Levonorgestrel One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

^ How to store Levonorgestrel One Step

Keep out of the sight and reach of children.

Do not use Levonorgestrel One Step after the expiry date which is stated on the

package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

Q Contents of the pack and other information

What Levonorgestrel One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Levonorgestrel One Step looks like and contents of the pack

Each pack of Levonorgestrel One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Bayer Schering Pharma AG, Mullerstrasse 170-178, D-13353, Berlin, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Revision date: 14/11/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

(levonorgestrel)

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Levonelle One Step 1500 microgram Tablet but will be called Levonelle One Step throughout this leaflet.

What is in this leaflet

^ What Levonelle One Step is and what it is used for

What you need to know before you take Levonelle One Step 3 How to take Levonelle One Step ft Possible side effects 3 How to store Levonelle One Step

Contents of the pack and other information

^ What Levonelle One Step is and what is it used for

Levonelle One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Levonelle One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Levonelle One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Levonelle One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonelle One Step, it will not stop you from becoming pregnant.

^ What you need to know before you take Levonelle One Step

Do not use Levonelle One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Levonelle One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Levonelle One Step cannot terminate pregnancy, so Levonelle One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Levonelle One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Levonelle One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

Your doctor may decide that Levonelle One Step is not suitable for you, or that another type of emergency contraception would be better for you.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonelle One Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Levonelle One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Levonelle One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Levonelle One Step from working effectively. If you have used any of the medicines below during the last 4 weeks,

Levonelle One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonelle One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Levonelle One Step” for further advice).

Levonelle One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Levonelle One Step You should only use Levonelle One Step in emergencies and not as a regular method of contraception.

If Levonelle One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Levonelle One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Levonelle One Step will harm a baby that develops in your uterus/womb if you use Levonelle One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Levonelle One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Patient Information Leaflet (continued)

Fertility

Levonelle One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

Driving and using machines

Your Levonelle One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Levonelle One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonelle One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

^ How to take Levonelle One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.

Levonelle One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Levonelle One Step from working properly (see section above "Other medicines and Levonelle One Step”) or if you have used one of these medicines in the past 4 weeks, Levonelle One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonelle One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Levonelle One Step

After you have taken Levonelle One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Levonelle One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Levonelle One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonelle One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Levonelle One Step

After the use of Levonelle One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Levonelle One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

[4 Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

^ How to store Levonelle One Step

Keep out of the sight and reach of children.

Do not use Levonelle One Step after the expiry date which is stated on the package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

[6    Contents of the pack and other information

What Levonelle One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Levonelle One Step looks like and contents of the pack

Each pack of Levonelle One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Schering GmbH & Co Produktions KG, Dobereinerstrasse 20, D-99427 Weimar, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Levonelle is a registered trademark of Bayer Schering Pharma Aktiengesellschaft.

Revision date: 14/11/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Postinor One Step 1500 microgram Tablet but will be called Postinor One Step throughout this leaflet.

what is in this leaflet

^ What Postinor One Step is and what it is used for

rp What you need to know before you take Postinor One Step

3 How to take Postinor One Step

[4 Possible side effects

[4 How to store Postinor One Step

^ Contents of the pack and other information

^ What Postinor One Step is and what is it used for

Postinor One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Postinor One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Postinor One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Postinor One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Postinor One Step, it will not stop you from becoming pregnant.

What you need to know before you take Postinor One Step

Do not use Postinor One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Postinor One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Postinor One Step cannot terminate pregnancy, so Postinor One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Postinor One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Postinor One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Postinor One Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Postinor One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Postinor One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Postinor One Step from working effectively. If you have used any of the medicines below during the last 4 weeks, Postinor One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Postinor One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Postinor One Step” for further advice).

Postinor One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Postinor One Step You should only use Postinor One Step in emergencies and not as a regular method of contraception.

If Postinor One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Postinor One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Postinor One Step will harm a baby that develops in your uterus/womb if you use Postinor One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Postinor One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Fertility

Postinor One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

(levonorestrel)

Patient Information Leaflet (continued)

Driving and using machines

Your Postinor One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Postinor One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Postinor One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

How to take Postinor One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.

Postinor One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Postinor One Step from working properly (see section above "Other medicines and Postinor One Step”) or if you have used one of these medicines in the past 4 weeks, Postinor One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Postinor One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Postinor One Step

After you have taken Postinor One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Postinor One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Postinor One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Postinor One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Postinor One Step

After the use of Postinor One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Postinor One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

How to store Postinor One Step

Keep out of the sight and reach of children.

Do not use Postinor One Step after the expiry date which is stated on the package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

Contents of the pack and other information

What Postinor One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Postinor One Step looks like and contents of the pack

Each pack of Postinor One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Schering GmbH & Co Produktions KG, Dobereinerstrasse 20, D-99427 Weimar, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Postinor is a registered trademark of Bayer Schering Pharma Aktiengesellschaft.

Revision date: 14/11/16

Blind or partially sighted?

Is this leaflet hard to see or read?

Phone Lexon (UK) Limited, Tel: 01527 505414 for help.

Patient Information Leaflet

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

*    Always take this medicine exactly as described in this leaflet or as your pharmacist has told you.

*    Keep this leaflet. You may need to read it again.

*    Ask your pharmacist if you need more information or advice. If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Your medicine is called Levonorgestrel One Step 1500 microgram Tablet but will be called Levonorgestrel One Step throughout this leaflet.

What is in this leaflet

^ What Levonorgestrel One Step is and what it is used for ^ What you need to know before you take Levonorgestrel One Step How to take Levonorgestrel One Step >4 Possible side effects ,5 How to store Levonorgestrel One Step [4 Contents of the pack and other information

^ What Levonorgestrel One Step is and what is it used for

Levonorgestrel One Step is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

Levonorgestrel One Step contains a synthetic hormone like substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72 hours of having unprotected sex. It will not prevent a pregnancy every time and is more effective if you take it as soon as possible after unprotected sex. It is better to take it within 12 hours rather than delay until the third day.

Levonorgestrel One Step is thought to work by:

*    stopping your ovaries from releasing an egg;

*    preventing sperm from fertilising any egg you may have already released;

*    stopping a fertilised egg from attaching itself to your womb lining.

Levonorgestrel One Step can only prevent you becoming pregnant if you take it within 72 hours of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonorgestrel One Step, it will not stop you from becoming pregnant.

What you need to know before you take Levonorgestrel One Step

Do not use Levonorgestrel One Step if:

*    you are allergic to levonorgestrel or any of the other ingredients of this medicine listed in section 6.

Warnings and precautions

If any of the following applies to you, talk to your doctor before taking Levonorgestrel One Step as emergency contraception may not be suitable for you. Your doctor may prescribe another type of emergency contraception for you.

*    If you are pregnant or think that you may already be pregnant. This medicine will not work if you are already pregnant. If you are already pregnant, Levonorgestrel One Step cannot terminate pregnancy, so Levonorgestrel One Step is not an "abortion pill”.

You may already be pregnant if:

*    your period is more than 5 days late, or you have experienced unusual bleeding when your next period is due

*    you have had unprotected sex more than 72 hours ago, and since your last period.

Children and adolescents

Levonorgestrel One Step is not recommended for young women under 16 years of age without medical supervision.

The use of Levonorgestrel One Step is not advised if:

*    you have a disease of your small bowel (such as Crohn's disease) that inhibits the absorption of the drug

*    you have severe liver problems

*    you have a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

*    you have ever had a disease called salpingitis (inflammation of the Fallopian tubes).

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel One

Step may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive.

Therefore, Levonorgestrel One Step is still recommended for all women regardless of their weight or BMI.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

If you are worried about sexually transmitted diseases

If you did not use a condom (or if it has been torn or slid down) during the intercourse, it might be possible that you have caught a sexually transmitted disease or the HIV virus.

This medicine will not protect you against sexually transmitted diseases, only condoms can do this. Ask your doctor, nurse, family planning clinic or pharmacist for advice if you are worried about this.

Other medicines and Levonorgestrel One Step

Tell your pharmacist or doctor if you are taking or have recently taken or might take any other medicines, including medicines obtained without a prescription or herbal medicines.

Some medicines may prevent Levonorgestrel One Step from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonorgestrel One Step may be less suitable for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel One Step:

*    barbiturates and other medicines (used to treat epilepsy (for example, primidone, phenytoin, and carbamazepine)

*    medicines used to treat tuberculosis (for example, rifampicin, rifabutin)

*    a treatment for HIV infection (ritonavir, efavirenz)

*    a medicine used to treat fungal infections (griseofulvin)

*    herbal remedies containing St John's wort (Hypericum perforatum)

Speak to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult your doctor as soon as possible after taking the tablets for further advice on a reliable form of regular contraception and to exclude a pregnancy. (See section also 3 "How to take Levonorgestrel One Step” for further advice).

Levonorgestrel One Step may also affect how well other medicines work

*    a medicine called cyclosporin (suppresses the immune system).

How often can you use Levonorgestrel One Step You should only use Levonorgestrel One Step in emergencies and not as a regular method of contraception.

If Levonorgestrel One Step is used more than once in a menstrual cycle it is more likely to upset your menstrual cycle (period).

Levonorgestrel One Step does not work as well as regular methods of contraception. Your doctor, practice nurse or family planning clinic can tell you about long-term methods of contraception which are more effective in preventing you from getting pregnant.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Pregnancy

You should not take this medicine if you are already pregnant. If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Levonorgestrel One Step will harm a baby that develops in your uterus/womb if you use Levonorgestrel One Step as described. Nevertheless, your doctor may want to check that the pregnancy is not ectopic (where the baby develops somewhere outside the womb). This is especially important if you develop severe abdominal pain after taking Levonorgestrel One Step or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Very small amounts of the active ingredient of this medicine may appear in your breast milk. This is not thought to be harmful to the baby, but if you are worried you can take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following tablet taking. In this way you are taking your tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

Patient Information Leaflet (continued)

Fertility

Levonorgestrel One Step increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date. These changes can result in modified fertility date, however there are no fertility data in the long term.

Driving and using machines

Your Levonorgestrel One Step tablet is unlikely to affect your ability to drive a car or use machines. However, if you feel tired or dizzy do not drive or operate machinery.

Levonorgestrel One Step tablet contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonorgestrel One Step tablet also contains 142.5 mg lactose monohydrate.

If you have been told by your doctor that you have an intolerance to some sugars, contact your doctor before taking this medicinal product.

family planning clinic for advice, especially if you have been sick, as the tablet may not have worked properly.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

3 How to take Levonorgestrel One Step

Always use this medicine exactly as described in the leaflet or as your pharmacist has told you. Check with your doctor or pharmacist if you are not sure.

*    Take the tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex. Levonorgestrel One Step can be taken at any time in your menstrual cycle assuming you are not already pregnant or think you may be pregnant. Do not chew but swallow the tablet whole with water. Do not delay taking the tablet. The tablet works best better the sooner you take it after having unprotected sex.

*    If you are using one of the medicines that may prevent Levonorgestrel One Step from working properly (see section above "Other medicines and Levonorgestrel One Step”) or if you have used one of these medicines in the past 4 weeks, Levonorgestrel One Step may work less effectively for you. Your doctor may prescribe another type of (non-hormonal) emergency contraceptive, i.e. a copper intrauterine device (Cu-IUD). If this is not an option for you or if you are unable to see your doctor promptly, you can take a double dose of Levonorgestrel One Step (i.e. 2 tablets taken together at the same time).

*    If you are already using a regular method of contraception such as the contraceptive pill, you can continue to take this at your regular times.

Use in children and adolescents

This medicine is not recommended for use in children. If you are under 16, you must visit your doctor or family planning clinic to get emergency contraception.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should take another tablet. You will need to contact your pharmacist, doctor, practice nurse or family planning clinic immediately for one more tablet.

After you have taken Levonorgestrel One Step

After you have taken Levonorgestrel One Step, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide until your next menstrual period. This is because Levonorgestrel One Step won't work if you have unprotected sex again, before your next period is due.

After you have taken Levonorgestrel One Step, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonorgestrel One Step has worked. If your period is more than 5 days late or is unusually light or unusually heavy, you should contact your doctor as soon as possible. If you do become pregnant even after taking this medicine, it is important that you see your doctor.

Your doctor can also tell you about longer-term methods of contraception which are more effective in preventing you from getting pregnant.

If you continue to use regular hormonal contraception such as the contraceptive pill and you do not have a bleed in your pill-free period, see your doctor to make sure you are not pregnant.

Your next period after you took Levonorgestrel One Step

After the use of Levonorgestrel One Step, your period is usually normal and will start at the usual day; however sometimes, this will be a few days later or earlier. If your period starts more than 5 days later than expected, an ‘abnormal' bleeding occurs at that time or if you think that you might be pregnant, you should check whether you are pregnant by a pregnancy test.

If you take more Levonorgestrel One Step than you should

Although there have been no reports of serious harmful effects from taking too many tablets at once, you may feel sick, actually be sick (vomit), or have vaginal bleeding. You should ask your pharmacist, doctor, practice nurse or

Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 people):

*    Feeling sick (nausea)

*    You might have some irregular bleeding until your next period

*    You might have lower abdominal pain

*    Tiredness

*    Headache.

Common (may affect up to 1 in 10 people):

*    Being sick (vomiting). If you are sick, read the section ‘What to do if you are sick (vomit) '.

*    Your period might be different. Most women will have a normal period at the expected time, but some may have their period later or earlier than normal. You might also have some irregular bleeding or spotting until your next period. If your period is more than 5 days late or is unusually light

or unusually heavy, you should contact your doctor as soon as possible.

*    You might have tender breasts, diarrhoea, feel dizzy after taking this medicine.

Very rare effects (may affect up to 1 in 10000 people):

*    Abdominal pain, rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at:

www.mhra.gov.uk/yellowcard. By reporting side effects you can help provide more information on the safety of this medicine.

^ How to store Levonorgestrel One Step

Keep out of the sight and reach of children.

Do not use Levonorgestrel One Step after the expiry date which is stated on the

package "after EXP”. The expiry date refers to the last day of the month. Store in the original packaging in order to protect from light.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

If your tablets show any sign of deterioration or discoloration consult your pharmacist for advise.

Q Contents of the pack and other information

What Levonorgestrel One Step contains

The active substance is levonorgestrel. One tablet contains 1.5 mg of levonorgestrel. The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Levonorgestrel One Step looks like and contents of the pack

Each pack of Levonorgestrel One Step contains a complete treatment which is one white round tablet marked with G00 on one side and plain on the other side.

Manufacturer and Licence Holder

This medicine is manufactured by Schering GmbH & Co Produktions KG, Dobereinerstrasse 20, D-99427 Weimar, Germany and is procured from within the EU and repackaged by the Product Licence Holder: Lexon (UK) Limited, Unit 18, Oxleasow Road, East Moons Moat, Redditch, Worcestershire, B98 0RE.

If you have any questions or are not sure about anything, ask your doctor or pharmacist. They will have additional information about this medicine and will be able to advise you.

|~P|    PL 15184/1280

Revision date: 14/11/16

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