PACKAGE LEAFLET: INFORMATION FOR THE USER

UPOSTELLE®

1500 microgram 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. See section 4.

What is in this leaflet:

1.    What Upostelle 1500 microgram tablet (hereinafter Upostelle) is and what it is used for

2.    What you need to know before you take Upostelle

3.    How to take Upostelle

4.    Possible side effects

5.    How to store Upostelle

6.    Contents of the pack and other information

1.    WHAT UPOSTELLE IS AND WHAT IT IS USED FOR

Upostelle is an emergency contraceptive that can be used within 72 hours of unprotected sex or if your usual contraceptive method has failed.

Upostelle 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.

Upostelle is thought to work by:

•    stopping your ovaries from releasing an egg;

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

Upostelle 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 Upostelle, it will not stop you from becoming pregnant.

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

2.    WHAT YOU NEED TO KNOW BEFORE YOU TAKE UPOSTELLE

Do not use Upostelle

•    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 Upostelle 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, Upostelle cannot terminate pregnancy, so Upostelle 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 Upostelle 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 previous infection of the fallopian tubes increases 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 Upostelle may be less effective with increasing body weight or body mass index (BMI), but these data were limited and inconclusive. Therefore, Upostelle 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 Upostelle

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

•    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 (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 (also see section 3 “How to take Upostelle” for further advice).

Upostelle may also affect how well other medicines work:

•    a medicine used to suppress the immune system (cyclosporine).

How often can you use Upostelle

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

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

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

Fertility

Upostelle increases the possibility of menstruation disturbances which can some-times 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

No studies on the effects on the ability to drive and use machines have been performed.

Upostelle contains lactose

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

Always use 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.

•    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. Upostelle 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 Upostelle from working properly (see section above “Other medicines and Upostelle”) or if you have used one of these medicines in the past 4 weeks, Upostelle may work less effectively for you. Your doctor may prescri be 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 Upostelle (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 Upostelle (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. 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 take another tablet.

After you have taken Upostelle

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

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

After the use of Upostelle, 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 Upostelle 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 10000 people):

•    Rash, urticaria, pruritus, swelling of the face, pelvic pain, painful period, abdominal pain.

Reporting on 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 UPOSTELLE

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. The expiry date refers to the last day of that month.

Store in the original package in order to protect from light.

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 Upostelle contains

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

The other ingredients are:

Potato starch,

Maize starch,

Silica, colloidal anhydrous,

Magnesium stearate,

Talc,

Lactose monohydrate.

What Upostelle looks like and contents of the pack

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.

Marketing Authorisation Holder and Manufacturer

Gedeon Richter Plc.

Gyomroi ut 19-21,

H-1103 Budapest Hungary

Distributor:

Consilient Health (UK) Ltd.,

No.1 Church Road, Richmond upon Thames, Surrey. TW9 2QE.

This leaflet was last revised in October 2016

© GEDEON RICHTER