Warnings and precautions

Falk to your doctor or pharmacist before taking Ezinelle.

If any of the following points apply to you, tell your doctor before you take Ezinelle as emergency contraception may not be suitable for you.

•    you are pregnant or think that you may already be pregnant; as this medicine will not work if you are already pregnant.

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

You should also tell your doctor if:

•    you have a disease of your small bowel (such as Crohn's disease) that interferes with the way you digest your food

•    you have severe liver problems

•    you have ever had an ectopic pregnancy (where the baby develops somewhere outside the womb)

•    you have ever had inflamed fallopian tubes (salpingitis)

A previous ectopic pregnancy and a previous infection of the fallopian tubes increase the risk of a new ectopic pregnancy.

Your doctor may decide that this medicine 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 Ezinelle may be less effective with increasing body weight or body mass index (BMI), but this data was limited and inconclusive. Therefore, Ezinelle 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.

Other medicines and Ezinelle

fell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

fell your doctor if you are taking any of the medicines listed below, as these medicines may prevent Ezinelle from working properly:

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

•    rifampicin or rifabutin, medicines used to treat tuberculosis

•    ritonavir, a treatment for HIV infection

•    griseofulvin, a medicine used to treat fungal infections

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

•    a medicine called ciclosporin (used to suppress the immune system)

f you are worried about sexually transmitted diseases

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

How often can you use Ezinelle

You should only use Ezinelle in emergencies and not as a regular method of contraception. If this medicine is used more than once in a menstrual cycle (period), it is less reliable and it is more likely to upset your menstrual cycle.

Ezinelle does not work as well as regular methods of contraception. Your doctor, practice nurse or family alanning clinic can tell you about long-term methods of contraception which are more effective in preventing you ^:rom getting pregnant.

³regnancy and breast-feeding

Askyour doctor or pharmacist for advice before taking any medicine.

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

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Women who breast-feed can use Ezinelle but should take the following measures.

Yery 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. However if you are worried you can take your tablet immediately after a areast-feed and then drain your milk with a breast pump br 6 hours after taking Ezinelle and throw away the milk, n this way you can reduce the amount of active ingredient your baby may take in with the breast milk.

Driving and using machines

Your Ezinelle 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.

Ezinelle contains lactose

f you have been told by your doctor that you have an ntolerance to some sugars, contact your doctor before taking this medicine.

3. Howto take Ezinelle

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

The recommended dose is one tablet as soon as possible, preferably within 12 hours, and no later than 72 hours (3 days) after you have had unprotected sex.

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

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.

If another unprotected intercourse takes place after the use of Ezinelle (also if this is during the same menstrual cycle), the tablet will not exert its contraceptive effect and there is again the risk of pregnancy.

Use in children and adolescents

This medicine is not recommended for use in children 12 years of age and under.

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 Ezinelle

After you have taken Ezinelle, 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 this medicine won't work if you have unprotected sex again, before your next period is due.

After you have taken this medicine, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Ezinelle 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 Ezinelle

After the use of Ezinelle, 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 thinkthatyou might be pregnant,you should check whether you are pregnant by a pregnancy test.

If you take more Ezinelle 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 askyour 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, askyour doctor or pharmacist.

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)

•    Lower abdominal pain

•    Tiredness (fatigue)

•    Headache

•    Irregular bleeding until your next period

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)'(see section 3)

•    Diarrhoea

•    Dizziness

•    Tender breasts

•    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. 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

Very rare (may affect up to 1 in 10,000 people):

•    Rash

•    Hives (urticaria)

•    Itching (pruritus)

•    Swelling of the face (facial oedema)

•    Pain in the hips (pelvis)

•    Painful periods