Ezinelle 1.5 mg Tablet

(levonorgestrel)

Package leaflet: Information for the user

Ezinelle 1.5 mg Tablet

(levonorgestrel)

Read all of this leaflet carefully before you start taking 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.

What is in this leaflet

1.    What Ezinelle is and what it is used for

2.    What you need to know before you take Ezinelle

3.    How to take Ezinelle

4.    Possible side effects

5.    How to store Ezinelle

6.    Contents of the pack and other information

1.    What Ezinelle is and what it is used for

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

Ezinelle 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.

Ezinelle is thought to work by:

•    stopping your ovaries from releasing an egg;

•    preventing sperm from fertilising any egg you may have already released.

Ezinelle 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 this medicine, it will not stop you from becoming pregnant.

Ezinelle is not indicated for use before the first menstrual bleeding (menarche).

2.    What you need to know before you take Ezinelle Do not take Ezinelle:

•    if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before taking Ezinelle.

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

emergency contraception for you.

•    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, Ezinelle cannot terminate pregnancy, so Ezinelle 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

Ezinelle is not recommended for young women under 16 years of age without medical supervision.

The use of Ezinelle 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)

A previous ectopic pregnancy or a previous infection of the fallopian tubes increases the risk of a new ectopic pregnancy.

Your doctor may decide that Ezinelle 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.

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 Ezinelle

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

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

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

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

•    medicines used to treat HIV (for example, 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 3 "How to take Ezinelle for further advice).

Ezinelle may also affect how well other medicines work

•    a medicine called ciclosporin (suppresses the immune system).

How often can you use Ezinelle

You should only use Ezinelle in emergencies and not as a regular method of contraception.

If Ezinelle is used more than once in a menstrual cycle, it is more likely to upset your menstrual cycle (period).

Ezinelle 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 Ezinelle will harm a baby that develops in your uterus/womb if you use Ezinelle 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 Ezinelle 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 the tablet well before the next feed and reducing the amount of active ingredient your baby may take in with the breast milk.

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Fertility

Ezinelle 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 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

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

3. How to take Ezinelle

Always take 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.

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.

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.

•    Ezinelle 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 the sooner you take it after having unprotected sex.

•    If you are using one of the medicines that may prevent Ezinelle from working properly (see section above "Other medicines and Ezinelle) or if you have used one of these medicines in the past 4 weeks, Ezinelle 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 Ezinelle (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.

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.

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

After you have taken Ezinelle, 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 think that you 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 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.

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)

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

•    Abdominal pain

•    Rash

•    Hives (urticaria)

•    Itching (pruritus)

•    Swelling of the face (facial oedema)

•    Pain in the hips (pelvic pain)

•    Painful periods

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.

5.    How to store Ezinelle

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

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

This medicinal product does not require any special storage conditions.

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 protect the environment.

6.    Contents of the pack and other information What Ezinelle contains

•    The active substance is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.

•    The other ingredients are povidone K-25, lactose monohydrate (see section 2, "Ezinelle contains lactose"), maize starch, colloidal anhydrous silica and magnesium stearate.

What Ezinelle looks like and contents of the pack

Your medicine comes as a round, white to off-white, uncoated flat tablet marked '145' on one side and plain on the other side.

Ezinelle is available in a blister pack containing 1 tablet.

Marketing Authorisation Holder

Mylan, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom.

Manufacturers

Accord Healthcare Limited, 319 Pinner Road, North Harrow, HA1 4HF, Middlesex, United Kingdom.

Gerard Laboratories, 35/36 Baldoyle Industrial Estate,

Grange Road, Dublin 13, Ireland.

Mylan Hungary Kft., Mylan Utca 1., Komarom 2900, Hungary.

This leaflet was last revised in 10/2016    980204

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Date: 11 OCT 2016

Time: 15:35

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Min Text Size used

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