Levonelle 1500 microgram tablet

• 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. See section 4.

1. What Levonelle 1500 microgram tablet (hereinafter 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

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

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 of 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.

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.

Levonelle 1500 is not indicated for use before the first menstrual bleeding (menarche).

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.

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

Some medicines may prevent Levonelle 1500 from working effectively. If you have used any of the medicines below during the last 4 weeks, Levonelle 1500 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 1500:

• barbiturates and other medicines used to treat epilepsy (for example primidone, phenytoin, and carbamazepine)
• medicines used to treat tuberculosis (for example, rifampicin, rifabutin)
• treatment for HIV (ritonavir, efavirenz)
• a medicine used to treat fungal infections (griseofulvin)
• herbal remedies containing St John’s wort (Hypericum perforatum).

Talk to your pharmacist or doctor if you need further advice on the correct dose for you.

Consult a 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 also section 3 “How to take Levonelle 1500” for further advice).

Levonelle 1500 may also affect how well other medicines work

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

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.

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.

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 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.

Breast-feeding

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.

Fertility

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.

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. Do not delay taking the tablet. The tablet works best the sooner you take it after having unprotected sex. It can only prevent you becoming pregnant, if you take it within 72 hours of 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.
• If you are using one of the medicines that may prevent Levonelle 1500 from working properly (see section above ”Other medicines and Levonelle 1500”) or if you have used one of these medicines in the past 4 weeks, Levonelle 1500 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 1500 (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 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.

You are advised to speak to a healthcare professional if you are concerned about any problems related to taking emergency contraception.

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

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.

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.

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 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 or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

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

The other ingredients are:

Potato starch,

Maize starch,

Colloidal silica anhydrous,

Magnesium stearate,

Talc,

Lactose monohydrate.

Tablet: almost white, flat, rimmed tablet of about 8 mm diameter with an impressed mark of “G00” on one side.

Packaging: one tablet in PVC//aluminium blister and cardboard cartons.

Levonelle 1500 is distributed in the UK by