Package leaflet: Information for the user

Levonelle 1500microgram 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.

-    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 or pharmacist. This includes any possible side effects not listed in this leaflet.

The name of your medicine is Levonelle 1500microgram tablet, but will be referred to as Levonelle 1500 throughout this leaflet.

What is in this leaflet:

1.    What Levonelle 1500 is and what it is used for

2.    What you need to know before you take Levonelle 1500

3.    How to take Levonelle 1500

4.    Possible side effects

5.    How to store Levonelle 1500

6.    Contents of the pack and other information

1.    What Levonelle 1500 is and what it is used for

Levonelle 1500 is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or if your usual contraceptive method has failed.

It is about the following cases:

-    No contraception was used during the sexual intercourse.

-    The contraception measure was used incorrectly, for example as if a condom was penetrated, slipped away or used in a wrong way, if vaginal pessary or diaphragm changed position, burst, was broken or taken out ahead of time, in the case of a failed interruption during coitus interruptus (e.g. sperm ejaculated in vagina or on external genitalia).

Levonelle 1500 contains a synthetic hormone like active 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 1500 is thought to work by:

-    stopping your ovaries from releasing an egg.

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

Levonelle 1500 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 another unprotected intercourse takes place after the use of Levonelle 1500 (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.

2.    What you need to know before you take Levonelle 1500 Do not use Levonelle 1500

-    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 1500 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 1500 cannot terminate pregnancy, so Levonelle 1500 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.

The use of Levonelle 1500 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 a history salpingitis (inflammation of the Fallopian tubes).

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

Children and adolescents

This medicine is not recommended for use in children. Very limited data are available in women under 16 years of age.

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 1500

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Some medicines may prevent Levonelle 1500 from working properly, these include:

-    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)

-    a medicine used to treat fungal infections (griseofulvin)

-    herbal remedies containing St John’s Wort (Hypericum perforatum)

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

Consult a doctor or pharmacist before using Levonelle 1500 if you use any of the above mentioned medicines.

How often can you use Levonelle 1500

You should only use Levonelle 1500 in emergencies and not as a regular method of contraception. If Levonelle 1500 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 1500 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 and 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 any medicine.

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 1500 will harm a baby that develops in your uterus/womb if you use Levonelle 1500 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 1500 or if you have previously had an ectopic pregnancy, Fallopian tube surgery or pelvic inflammatory disease.

The active ingredient of this medicine is excreted into your breast milk. Therefore, it is suggested that you take your tablet immediately after a breast-feeding and avoid nursing at least 8 hours following levonorgestrel administration then drain your milk with a breast pump for 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.

Levonelle 1500 increases the possibility of menstruation disturbances which can sometimes lead to earlier or later ovulation date resulting in modified fertility date. Although there are no fertility data in the long term, after treatment with Levonelle 1500 a rapid return to fertility is expected and therefore, regular contraception should be continued or initiated as soon as possible after Levonelle 1500 use.

Driving and using machines

Your Levonelle 1500 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 1500 contains lactose

In case of milk sugar (lactose) intolerance it should be considered that each Levonelle 1500 tablet also contains 142.5mg 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.

3.    How to take Levonelle 1500

Always use this medicine exactly as described in the leaflet or as your pharmacist or doctor 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 1500 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 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 Levonelle 1500 (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.

In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is some evidence that Levonelle 1500 may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Levonelle 1500 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.

Use in children and adolescents

This medicine is not recommended for use in children. Very limited data are available in women under 16 years of age.

What to do if you are sick (vomit)

If you are sick (vomit) within three hours of taking the tablet, you should immediately take another tablet.

After you have taken Levonelle 1500

After you have taken Levonelle 1500, 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 1500 will not work if you have unprotected sex again, before your next period is due.

After you have taken Levonelle 1500, you are advised to make an appointment to see your doctor about three weeks later, to make sure that Levonelle 1500 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 1500

After the use of Levonelle 1500, 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 1500 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)

•    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 10,000 people):

•    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, 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 Levonelle 1500

Keep out of the sight and reach of children.

Do not use Levonelle 1500 after the expiry date which is stated on the package after ‘Exp'. The expiry date refers to the last day of that 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 become discoloured or show any signs of deterioration, seek the advice of your pharmacist.

6.    Contents of the pack and other information What Levonelle 1500 contains

The active substance is levonorgestrel. Each tablet contains 1500micrograms of levonorgestrel.

The other ingredients are potato starch, maize starch, colloidal silica anhydrous, magnesium stearate, talc, lactose monohydrate

What Levonelle 1500 looks like and contents of the pack

Each pack of Levonelle 1500 contains a complete treatment which is one round, white tablet with an impressed mark of ‘G00' on one side.

Manufactured by: Bayer Schering Pharma AG, Mullerstrasse 170-178, D-13353 Berlin, Germany or Schering GmbH and CO Produktions KG, Dobereinerstrasse 20, D-99427 Welmar, Germany or Gedeon Richter Plc. Gyomroi ut 19-21, H-1103 Budapest, Hungary.

Procured from within the EU and repackaged by Product Licence holder: B&S Healthcare, Unit 4, Bradfield Road, Ruislip, Middlesex, hA4 0NU, UK.

Levonelle® 1500microgram tablet

PL No: 18799/2107    ^POM

Leaflet date: 20.02.2015

Levonelle is a registered trademark of Bayer Schering Pharma AG.