Package leaflet: Information for the user

LEVONELLE-2 750 micrograms tablets

Levonorgestrel

Read all of this leaflet carefully before you start taking this medicine you.

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

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

-    This medicine has been prescribed for you only. Do not pass it on to

-    If you get any side effects, talk to your doctor or pharmacist or nurse. in this leaflet. See section 4.

What is in this leaflet:

1.    What Levonelle-2 is and what it is used for

2.    What you need to know before you take Levonelle-2

3.    How to take Levonelle-2

4.    Possible side effects

5.    How to store Levonelle-2

6.    Contents of the pack and other information

1.    What Levonelle-2 is and what it is used for

Levonelle-2 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-2 contains a synthetic hormone like active substance called levonorgestrel. It prevents about 84% of expected pregnancies when you take it within 72hrs 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 12hrs rather than delay until the third day.

Levonelle-2 is thought to work by:

-    stopping your ovaries from releasing an egg;

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

Levonelle-2 can only prevent you becoming pregnant if you take it within 72hrs of unprotected sex. It does not work if you are already pregnant. If you have unprotected sex after taking Levonelle-2, it will not stop you from becoming pregnant.

2.    What you need to know before you take Levonelle-2 Do not use Levonelle-2

-    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 points apply to you, tell your doctor before you take Levonelle-2 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. If you are already pregnant, Levonelle-2 cannot terminate pregnancy, so Levonelle-2 is not an "abortion pill".

You may already be pregnant if:

-    your period is more than 5 days late, or you have sufferered 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 a history of ectopic pregnancy (where the baby develops somewhere outside the womb)

-    you have a history of inflamed fallopian tubes (salpingitis).

Your doctor may decide that Levonelle-2 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-2 may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonelle-2 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 Levonelle-2

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 Levonelle-2 from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonelle-2 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-2:

-    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-2" for further advice).

Levonelle-2 may also affect how well other medicines work

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

If you are worried about sexually transmitted diseases

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.

How often can you use Levonelle-2

You should only use Levonelle-2 in emergencies and not as a regular method of contraception. If Levonelle-2 is used more than once in a menstrual cycle, it is less reliable and it is more likely to upset your menstrual cycle (period).

Levonelle-2 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 Pregnancy

You should not take this medicine if you are already pregnant. If you have had unprotected sex which was more than 72 hours ago, and since your last period, you may already be pregnant and the treatment won't work. If your last period was more than 5 days late or was unusually light or unusually heavy, you should check with your doctor that you are not already pregnant.

If you are already pregnant, Levonelle-2 can not break down the pregnancy, Levonelle-2 is thus not an "abortion pill".

If you do become pregnant even after taking this medicine, it is important that you see your doctor. There is no evidence that Levonelle-2 will harm a baby that develops in your uterus/womb if you use Levonelle-2 as described, but there are no clinical data that if you have taken more than two tablets of Levonelle-2 it might harm your baby. 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-2 or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

Breast-feeding

Women who breast-feed can use Levonelle-2 but should take the following measures.

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

Levonelle-2 can alter your menstruational cycle (period) 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-2 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-2 contains lactose

Each Levonelle-2 tablets contains 71.25 mg 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 Levonelle-2

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

•    Take the two tablets at the same time as soon as possible, preferably within 1 2 hours, and no later than 72 hours (3 days) after you have had unprotected sex. Levonelle-2 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 Levonelle-2 from working properly (see section above "Other medicines and Levonelle-2") or if you have used one of these medicines in the past 4 weeks, Levonelle-2 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-2 (i.e. 4 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 Levonelle-2 (also if this is during the same menstrual cycle), the tablets will not exert its contraceptive effect and there is again the risk of pregnancy.

Use in children and adolescents

There is no relevant use of Levonelle-2 in children below the age at which menstruation begins.

What to do if you are sick (vomit)

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

After you have taken Levonelle-2

After you have taken Levonelle-2, if you want to have sex, and are not using the contraceptive pill, you should use condoms or a cap plus spermicide. This is because Levonelle-2 will not work if you have unprotected sex again, before your next period is due.

After you have taken Levonelle-2, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonelle-2 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.

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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-2

After the use of Levonelle-2, 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, '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-2 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 tablets may not have worked properly.

If you have any further questions on the use of this product, 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)

-    You might have some irregular bleeding until your next period.

-    You might have lower abdominal (tummy) pain.

-    Tiredness (fatigue)

-    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 10,000 people):

rash, urticaria, pruritus, face edema, 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.

5. How to store Levonelle-2

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

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

Do not store above 25°C.

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 Levonelle-2 contains

The active substance is levonorgestrel. Each tablet contains 750 micrograms of levonorgestrel.

The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate (E572), talc (E533b) and lactose monohydrate.

What Levonelle-2 looks like and contents of the pack

Each pack contains two round and white tablets with an imprinted mark of "INOR" on one side.

Marketing Authorisation Holder and Manufacturer

The Marketing Authorisation Holder is:

Medimpex UK Limited 127 Shirland Road London W9 2EP United Kingdom

Manufacturer

Gedeon Richter Plc.

Gyomroi ut 19-21.

H-1103 Budapest Hungary

Levonelle-2 is distributed in the UK by:

For more information, you can also contact the company who distribute Levonelle-2 in the UK.

The E-mail address is:

This leaflet was last revised in: Aug 2016

© GEDEON RICHTER

product name	labelling number	country code design code plant code	“ “ ®
colour	printing technology	font (size (leading]):	Studio
			date
			made by
packaging material size UTAS 213 x 660 (±0,5)/27 x 66 (±1) mm	technical drawing PIL_RTU_66x27_213x660 /Page02	supervised technical drawing by/date	approved technical drawing by/date