Document: leaflet MAH GENERIC_PL 32821-0053 change

• leaflet MAH GENERIC_PL 32821-0053
• leaflet MAH GENERIC_PL 35507-0126

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PACKAGE LEAFLET

Package leaflet: Information for the user Levonorgestrel 1.5 mg tablet Levonorgestrel

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

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

-    If you have any further questions, ask your doctor, pharmacist or nurse.

-    This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-    If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1.    What Levonorgestrel 1.5 mg Tablet is and what it is used for

2.    What you need to know before you use Levonorgestrel 1.5 mg Tablet

3.    How to use Levonorgestrel 1.5 mg Tablet

4.    Possible side effects

5.    How to store Levonorgestrel 1.5 mg Tablet

6.    Contents of the pack and other information

1. What Levonorgestrel 1.5 mg Tablet is and what it is used for

Levonorgestrel 1.5 mg Tablet is an oral emergency contraceptive.

What is emergency contraception?

Emergency contraception is a rescue method intended to prevent pregnancy after unprotected intercourse or failure of contraception.

When should emergency contraception be used?

You should take Levonorgestrel 1.5 mg Tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected intercourse or after failure of a contraceptive method. Levonorgestrel 1.5 mg Tablet is most effective if you take it as soon as possible after unprotected intercourse. Levonorgestrel 1.5 mg Tablet can only prevent you from becoming pregnant if you take it within 72 hours after unprotected intercourse. It will not work if you are already pregnant. If you have had unprotected sex after you have taken Levonorgestrel 1.5 mg tablet, it will not stop you from becoming pregnant.

If you suspect that you are pregnant because of:

•    If you have had sex without contraception;

•    If you forget to take your pill on time;

•    If your partner’s condom has broken, slipped or traveled by;

•    If you think your IUD (intrauterine contraceptive) has been expelled;

•    If your diaphragm has come out of alignment or if you have taken out too early;

•    If you are afraid of interrupted intercourse or calendar method has not worked;

•    In the case of rape.

The precise mode of action of Levonorgestrel 1.5 mg Tablet is not known. Most likely it stops your ovaries from the release of an egg. Perhaps there are other processes involved, including the prevention of implantation of a fertilized ovum into the uterus. It is not effective once the process of nidation has begun.

This tablet is intended only as emergency contraception, not as a regular contraceptive method because these are less effective than the 'normal' birth control pill ("the pill").

2. What you need to know before you use Levonorgestrel 1.5 mg Tablet Do not use Levonorgestrel 1.5 mg Tablet

-    If you are allergic (hypersensitive) to levonorgestrel or any of the other ingredients of Levonorgestrel 1.5 mg Tablet (see section 6).

Warnings and precautions

The use of Levonorgestrel 1.5 mg Tablet is not recommended in the following cases:

-    If you have had a pregnancy outside the uterus (ectopic pregnancy)

-    If you have had a pelvic inflammatory disease (salpingitis)

-    If you or someone in your family has a known risk factor for thrombosis (blood clotting)

-    If you have a serious digestive disorder that impairs the absorption of food and drugs

-    If you have severe liver disease or any serious illness in the small intestine, such as Crohn’s disease.

A history of tubal (ectopic) pregnancy and a previous infection of the fallopian tubes increase the risk of a (new) ectopic pregnancy. Therefore if you previously had a tubal (ectopic) pregnancy or an infection of the fallopian tubes you should contact your doctor before taking Levonorgestrel 1.5 mg Tablet

If you have had another unprotected intercourse for more than 72 hours ago, conception may have occurred. Treatment with Levonorgestrel 1.5 mg Tablet after the second act of intercourse may therefore be ineffective in preventing

pregnancy.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonorgestrel 1.5 mg Tablet may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonorgestrel 1.5 mg Tablet 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.

Repeated administration of Levonorgestrel 1.5 mg Tablet within a menstrual cycle is not advisable because it can disrupt your cycle.

Levonorgestrel 1.5 mg Tablet does not work as well as regular methods of contraception (the pill, condoms). Your doctor can talk about long-term methods of contraception which are more effective in preventing from getting pregnant.

After using this medicine: It is mandatory to exclude pregnancy by performing a pregnancy test:

•    when your next menstrual period is delayed more than five days;

•    in case of abnormal bleeding, including the expected period date.

If you are not using a condom during intercourse (or if it is torn or slipped) it is possible that you have contracted a STD (sexually transmitted disease, STD) or the HIV virus. The use of emergency contraceptive pills does not protect against sexually transmitted diseases or from infection with the HIV virus and cannot replace the necessary precautions and measures to be taken in case of risk of transmission (see "Additional Information" below this leaflet).

Children and adolescents

Paediatric population :

Levonorgestrel 1.5 mg Tablet is not recommended in children.

Very limited data are available in women under 16 years of age.

Other medicines and Levonorgestrel 1.5 mg Tablet

The medicines listed below, including non-prescription drugs, can reduce or inhibit the effect or inhibit the effect of Levonorgestrel 1.5 mg Tablet:

-    Some drugs used to treat epilepsy (phenobarbitol, phenytoin, primidone, carbamazepine);

-    Some drugs to treat HIV infection (ritonavir);

-    Some drugs used to treat infections (rifabutin, rifampicin, griseofulvin)

-    Herbal products containing St. John's Wort (Hypericum perforatum).

-    A medicine called cyclosporin (suppresses the immune system)

Levonorgestrel 1.5 mg Tablet should not be used together with emergency contraceptives containing ulipristal acetate.

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

Pregnancy, breast-feeding and fertility

If you are pregnant:

If you are pregnant, this drug cannot abort an ongoing pregnancy.

If you are taking this medicine and get pregnant, studies have so far shown no risk of malformation of the fetus. However you should not take this medication if you are pregnant.

If you become pregnant after taking Levonorgestrel 1.5 mg Tablet you should contact your doctor. Your doctor will perhaps check if you have no ectopic pregnancy (the fetus develops somewhere outside of your uterus). This is especially important if you have severe pain in your stomach gets after Levonorgestrel 1.5 mg Tablet intake or if you have previously ectopic (ectopic) pregnancy or surgery on your fallopian tubes or have had pelvic inflammatory disease.

If you are breastfeeding:

Breast-feeding is possible but because levonorgestrel is excreted in human milk. You should breastfeed immediately before taking Levonorgestrel 1.5 mg Tablet and refrain from nursing for at least 8 hours following Levonorgestrel 1.5 mg Tablet administration.

Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

After taking Levonorgestrel 1.5 mg Tablet, some women experience fatigue and dizziness (see section 4 "Possible side effects'): do not drive or use machinery if you suffer from these symptoms.

No studies on the effects of Levonorgestrel 1.5 mg Tablet on driving and ability to operate machinery.

Levonorgestrel 1.5 mg Tablet contains Lactose

Levonorgestrel 1.5 mg Tablet contains lactose monohydrate. If your doctor has told you that you have intolerance to sugars, contact with him / her before you take this medicine to use.

3. How to use Levonorgestrel 1.5 mg Tablet

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

Levonorgestrel 1.5 mg Tablet is intended for oral use. The tablet should be swallowed with a glass of water and should not be chewed.

If you vomit within three hours after taking tablet, you should take another tablet. Contact your doctor if there are more than 72 hours have elapsed since unprotected intercourse.

After using Levonorgestrel 1.5 mg Tablet use a contraceptive (condom, spermicide, and diaphragm) until the next menstrual period begins. If you have further unprotected intercourse after you have taken Levonorgestrel 1.5 mg Tablet (even during the same menstrual cycle), the tablets are not to have contraception and the risk is that you become pregnant. If you use a regular method of contraception and such as oral contraceptives, you should continue to use this as normal.

If you use oral contraceptives ("the pill"), after taking Levonorgestrel 1.5 mg Tablet you just continue with the pill. If you have no menstrual bleeding during your next tablet-free interval, you should take a pregnancy test to exclude pregnancy. Your doctor can advise you about birth control methods for the longer term that is effective to prevent you from becoming pregnant.

If you continue to use regular hormonal contraception like birth control pills and you have not had any bleeding during your tablet-free interval, contact your doctor to check that you are not pregnant.

Your next period after you have taken Levonorgestrel 1.5 mg Tablet

After using Levonorgestrel 1.5 mg Tablet your period is usually normal and will on the expected day, but sometimes it can be a few days late or early. If your period is more than 5 days late or is unusually light or extensive, or if you think you may be pregnant for some other reason, check if you are pregnant with a pregnancy test. If you become pregnant even after you have taken this drug, it is important that you contact your doctor.

If you take more Levonorgestrel 1.5 mg Tablet than you should

There are no reports of acute poisoning or severe adverse effects after taking

Levonorgestrel 1.5 mg Tablet too much doses at once. You can, however nausea, vomiting or vaginal bleeding. You should contact your doctor or pharmacist for advice.

4. Possible side effects

Like all medicines, Levonorgestrel 1.5 mg Tablet cause side effects, although not everybody gets them.

The occurrence of possible side effects listed below are defined as follows:

Very common (affects more than 1 in 10 users)

Common (affects 1 to 10 of 100)

Very rare (affects less than 1 in 10,000 users)

Not known (frequency cannot be estimated from the available data).

The following adverse reactions have been observed:

Very common side effects:

-    Dizziness, headache

-    Nausea, abdominal pain

-    Breast tenderness, delayed period, heavy periods, bleeding

-    Tiredness

Common side effects:

-    Diarrhea,

-    vomiting

Not known:

-    Post-marketing cases of thromboembolic events (blood clots) have been reported.

-    Hypersensitivity to the skin may occur after taking this medicine.

If any of the side effects or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse. 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.

5. How to store Levonorgestrel 1.5 mg Tablet

Keep this medicine out of the sight and reach of children.

This medicinal product does not require any special storage conditions.

Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.

Do not use this medicine if you notice visible signs of deterioration, the product should then be returned to your pharmacist.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help to protect the environment.

6. Contents of the pack and other information

What Levonorgestrel 1.5 mg Tablet contains

The active substance is levonorgestrel.

- The other ingredients are Lactose monohydrate, Povidone (E1201), Maize starch, Silica colloidal anhydrous (E551) and Magnesium stearate (E572).

Levonorgestrel belongs to a group of medicines called as emergency contraception.

What Levonorgestrel 1.5 mg Tablet looks like and contents of the pack

Levonorgestrel 1.5 mg Tablet is a round, white to off-white, uncoated flat tablet debossed 145 on one side and other side plain.

Each pack contains one tablet Levonorgestrel 1.5 mg Tablet of levonorgestrel. Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Famy Care Europe Ltd.

One Wood Street,

London, EC2V 7WS United Kingdom

Manufacturer

Accord Healthcare Limited Sage House,

319 Pinner Road,

North Harrow,

Middlesex- HA1 4HF United Kingdom

This leaflet was last revised in 10/2014.

a)    Some information about the menstrual cycle and contraception The menstrual cycle

The menstrual cycle is the time between two menstrual periods. Usually, the life cycle 28 days, but the duration may vary from woman to woman. Menstrual periods occur when a woman is not pregnant.

Fertilization

In the middle of each cycle, an egg (ovum) into one of the two ovaries (currently is called "ovulation"). Typically, ovulation mid-cycle position, but this may at any other time during the Performance cycle.

After intercourse, male sperm (sperm cells) near the exposed egg, and fertilize the egg (i.e., a fusion of a sperm with the egg which an embryo is formed). After a few days the fertilized egg implants in the uterus and pregnancy begins.

Contraceptives (birth control)

Contraceptive methods are aimed to prevent:

-    Ovulation: using the contraceptive pill

-    Fertilization (fusion of a sperm with the egg): using a condom

-    Implantation of a fertilized ovum into the uterus: use of the IUD.

Emergency contraception

Emergency contraception acts by blocking ovulation or preventing implantation following sexual intercourse. It is not effective if implantation has already started. When a woman has intercourse without using a contraceptive method the chance of pregnancy can not be excluded. If this medicine, but not normal contraceptive method used, strongly advised to seek medical or visit the Public Health Service. You will receive advice on the contraceptive method that suits you best.

b)    Advise on risk of transmission of a sexually transmitted disease

If you have unprotected sexual intercourse you may be at risk of contracting a sexually transmitted disease, particularly if you are unaware of your partner’s sexual history or have multiple partners. For questions, please contact your doctor, pharmacist or family planning clinic.

GLOSSARY

•    Ectopic (ectopic) pregnancy: a pregnancy that develops outside the uterus, usually in the fallopian tubes. Symptoms include persistent abdominal pain, missed menstrual periods, vaginal bleeding, signs of pregnancy (nausea, sensitivity breasts). If you have these symptoms, you should immediately consult your doctor.

•    Salpingitis: infection of the fallopian tubes. Symptoms include abdominal

pain, fever and severe vaginal discharge.