Escapelle

Package Leaflet: Information for the User

Escapelle 1500 micrograms tablets

levonorgestrel
Please read all of this leaflet carefully before 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 instructed you to do.
• Keep this leaflet. You may need to read it again.
• If you need more advice or information, contact your pharmacist.
• If you experience any side effects, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet

1. What Escapelle is and what it is used for
2. What you need to know before taking Escapelle
3. How to take Escapelle
4. Possible side effects
5. How to store Escapelle
6. Contents of the pack and other information

1. What Escapelle is and what it is used for

Escapelle is an emergency contraceptive that can be used within 72 hours (3 days) after unprotected sexual intercourse, or in case of failure of your usual contraceptive method.
This includes the following situations:

• No contraceptive method was used during sexual intercourse.
• The contraceptive method was not used correctly, for example in case of penetration, slippage or incorrect use of a condom; if a vaginal ring or diaphragm has moved, burst, broken, or been removed too early; in case of failure to withdraw in time during withdrawal method (e.g. with ejaculation of sperm inside the vagina or onto the external genitals).

Escapelle contains a synthetic active substance similar to a hormone called levonorgestrel. It prevents approximately 84% of expected pregnancies if taken within 72 hours after unprotected sexual intercourse.
It may not always be able to prevent pregnancy and is more effective when taken as soon as possible after unprotected intercourse. It is advisable to take it within 12 hours, rather than delaying intake until the third day.
Escapelle is believed to work by:

• preventing the ovaries from releasing an egg
• preventing sperm from fertilizing an egg already released by the ovaries

Escapelle can prevent pregnancy only if taken within 72 hours after unprotected sexual intercourse. It will have no effect if pregnancy is already established. If another unprotected intercourse occurs after taking Escapelle (even if this occurs during the same menstrual cycle), the tablet will not provide contraceptive protection and there is again a risk of pregnancy.
The use of Escapelle is not indicated before the first menstrual period (menarche).
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2. What you need to know before taking ESCAPELLE

Do not take Escapelle:

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

Warnings and precautions
If you suffer from any of the following conditions, inform your doctor before taking Escapelle, as emergency contraception may not be suitable for you. Your doctor may prescribe you another type of emergency contraception.

• If you are pregnant or think you may already be pregnant, because this medicine will have no effect if pregnancy has already occurred. If you are already pregnant, Escapelle cannot terminate the pregnancy; therefore, Escapelle is not an “abortion pill”.

You may already be pregnant if:

• your menstrual period is already more than 5 days late, or if you have had unusual vaginal bleeding around the time of your expected period
• you had unprotected sexual intercourse more than 72 hours ago, and after your last menstrual period.

The use of Escapelle is not recommended if:

• you suffer from a disease of the small intestine (such as Crohn’s disease) that interferes with the absorption of the medicine
• you suffer from severe liver problems
• you have had an ectopic pregnancy in the past (a pregnancy where the embryo develops outside the uterus)
• you have previously suffered from salpingitis (inflammation of the Fallopian tubes).

If you have had a previous ectopic pregnancy or a previous infection of the Fallopian tubes, your risk of another ectopic pregnancy increases.
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse. There is evidence that Escapelle may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive.
Therefore, Escapelle is still recommended for all women regardless of their weight or body mass index (BMI).
If you have concerns about any issues related to taking emergency contraception, it is advisable to speak with a healthcare provider.

Children and adolescents
The use of Escapelle is not indicated before the first menstrual period (menarche).

If you are concerned about the risk of sexually transmitted infections
If you did not use a condom (or if it broke or slipped off) during sexual intercourse, you may have contracted a sexually transmitted infection or HIV.
This medicine will not protect you from sexually transmitted infections: only condoms can provide such protection. If you are concerned about this, consult your doctor, nurse, family planning clinic, or pharmacist for advice.

Other medicines and Escapelle
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
Some medicines may prevent Escapelle from working effectively. If you have taken any of the medicines listed below within the past 4 weeks, Escapelle may be less suitable for you. Your doctor may prescribe you another type (non-hormonal) of emergency contraceptive, namely a copper intrauterine device (Cu-IUD). If this is not an acceptable option for you or if you cannot see a doctor promptly, take a double dose of Escapelle:

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

Consult your doctor or pharmacist if you need further advice on the correct dosage for you.
After taking the tablets, consult your doctor as soon as possible for further advice on how to use regular and reliable contraception and to rule out pregnancy (See also section 3 “How to take Escapelle” for further information).
Escapelle may also affect how other medicines work:

• a medicine called cyclosporine (which suppresses the immune system).

How often can you use Escapelle
Escapelle should only be used in emergency situations, not as a regular method of contraception.
If Escapelle is used more than once in the same menstrual cycle, it is less reliable and more likely to affect your menstrual cycle (periods).
Escapelle is not as effective as regular contraceptive methods. Your doctor, nurse, or family planning clinic can advise you on long-term contraceptive methods that are more effective in preventing pregnancy.

Pregnancy, breastfeeding and fertility

If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor before taking any medicine.

Pregnancy
Do not take this medicine if you are already pregnant. If you become pregnant despite taking this medicine, it is important that you see your doctor. There is no evidence that Escapelle is harmful to the fetus when taken as directed during early pregnancy. However, your doctor may wish to rule out an ectopic pregnancy (a pregnancy where the embryo develops outside the uterus). This is particularly important if you experience severe abdominal pain after taking Escapelle, or if you have previously had an ectopic pregnancy, surgery on the Fallopian tubes, or pelvic inflammatory disease.

Breastfeeding
The active ingredient of this medicine is excreted in breast milk. Therefore, it is recommended that you take the tablet immediately after breastfeeding and avoid breastfeeding for at least 8 hours after taking levonorgestrel. Then, express and discard your milk with a pump 8 hours after taking the tablet. This way, you will take the tablet well before the next breastfeeding session, thereby reducing the amount of active ingredient that your baby may receive through breast milk.

Fertility
Escapelle may increase the likelihood of menstrual disturbances, which can sometimes lead to earlier or delayed ovulation, thereby altering your fertile period. Although there are no data on long-term fertility, normal fertility is expected to return rapidly after treatment with Escapelle. Therefore, regular contraception should be continued or started as soon as possible after using Escapelle.

Driving and using machines
It is unlikely that Escapelle will affect your ability to drive or operate machinery.
However, do not drive or operate machinery if you feel tired or dizzy.

Escapelle contains lactose
If you have an intolerance to milk sugar (lactose), please note that each Escapelle tablet also contains 142.5 mg of monohydrated lactose.
If your doctor has diagnosed you with an intolerance to certain sugars, contact them before taking this medicine.

3. How to take Escapelle

Take this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor or pharmacist.
Take the tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after having unprotected sex. Do not delay taking the tablet.
The tablet is more effective the sooner it is taken after unprotected intercourse. It can prevent pregnancy only if taken within 72 hours of unprotected sex.

• Escapelle can be taken at any time during the menstrual cycle, provided you are not already pregnant or suspect you may be pregnant. Do not chew; swallow the tablet whole with water.
• If you are taking any medicines that may reduce the effectiveness of Escapelle (see section above “Other medicines and Escapelle”) or if you have taken any of these medicines in the past 4 weeks, Escapelle may be less effective for you. Your doctor may prescribe you another type of emergency contraceptive (non-hormonal), namely a copper intrauterine device (Cu-IUD). If this is not an acceptable option for you or if you cannot see a doctor promptly, take a double dose of Escapelle (i.e. 2 tablets taken together at the same time).

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• If you are already using a regular contraceptive method, such as the pill, you may continue taking it at your usual times.

If you have another unprotected sexual intercourse after taking Escapelle (even if this occurs in the same menstrual cycle), the tablet will not provide any contraceptive protection and there will again be a risk of pregnancy.
If you have any concerns about emergency contraception, it is recommended that you speak with a healthcare provider.
What to do in case of vomiting
If you vomit within three hours of taking the tablet, take another tablet immediately.
After taking Escapelle
After taking Escapelle, if you wish to have sex and are not using oral contraceptives, use condoms or a diaphragm with spermicide until your next menstrual period. Escapelle will not protect you if you have another unprotected sexual intercourse before your next period.
After taking Escapelle, it is advisable to schedule an appointment with your doctor about three weeks later to confirm that Escapelle has been effective. If your period is more than 5 days late, or is unusually light or heavy, contact your doctor as soon as possible. If you become pregnant despite taking this medicine, it is important to see your doctor.
Your doctor can also advise you on longer-term contraceptive methods that are more effective in preventing pregnancy.
If you continue using your regular hormonal contraception, such as the pill, and do not have withdrawal bleeding during the break period, consult your doctor to rule out pregnancy.
Your next menstrual period after taking Escapelle
After using Escapelle, your menstrual bleeding usually returns normally and starts on the expected day, although sometimes it may be a few days earlier or later. If your period is more than 5 days late, if you notice 'abnormal' vaginal bleeding around this time, or if you think you might be pregnant, perform a pregnancy test to check whether you are pregnant.
If you take more Escapelle than you should
Although no serious harmful effects have been reported from taking too many tablets at once, you may feel unwell, nauseous (vomit), or experience vaginal bleeding. Contact your pharmacist, doctor, nurse, or family planning clinic for advice, especially if you have vomited, as the tablet may not have worked properly in this case.
If you have any doubts about how to use Escapelle, consult your doctor or pharmacist.

4. Possible side effects

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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 unwell (nausea)
• Possible irregular bleeding until the next menstrual period
• Possible lower abdominal pain
• Tiredness
• Headache.

Common (may affect up to 1 in 10 people):

• Vomiting. If you vomit, read the section 'What to do in case of vomiting'.
• Your menstrual period may be different from usual. Most women will have normal bleeding at the expected time, but in some cases the period may be delayed or occur earlier. Irregular bleeding or spotting may also occur until the next menstrual period. If your period is delayed by more than 5 days, or is unusually light or heavy, contact your doctor as soon as possible.
• You may experience breast tenderness, diarrhoea, dizziness after taking this medicine.

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

• Skin rash, urticaria, itching, facial swelling, pelvic pain, painful menstruation.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escapelle

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the pack after "Exp." The expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Escapelle contains
The active substance is levonorgestrel. Each tablet contains 1500 micrograms of levonorgestrel.
The other components are:
Potato starch,
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Maize starch,
Anhydrous colloidal silica,
Magnesium stearate,
Talc,
Lactose monohydrate.

Description of the appearance of Escapelle and contents of the pack
Tablet: white, flat, bevelled-edged tablet with a diameter of approximately 8 mm, marked with the code "G00" imprinted on one side.
Pack: One tablet in a PVC/aluminum blister pack, with a cardboard carton.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21
H-1103 Budapest, Hungary

Manufacturer responsible for batch release
Gedeon Richter Plc.
Gyömrői út 19-21
H-1103 Budapest, Hungary

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria: Postinor
Belgium: Postinor 1500
Czech Republic: Escapelle
France: Levonorgestrel Biogaran
Germany: Postinor
Greece: Postinor 1500
Iceland: Postinor
Ireland: Ramonna
Italy: Escapelle
Lithuania: Escapelle
Luxembourg: Postinor
Netherlands: Postinor
Norway: Postinor
Poland: Escapelle
Portugal: Postinor
Spain: Postinor
Sweden: Postinor
United Kingdom: Levonelle 1500
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