Escapelle tablet 1500 micrograms

Package leaflet: Information for the patient

Warning! Keep this leaflet. Information on the immediate packaging in a foreign language.
Escapelle 1500 microgram tablet (Postinor)
1500 micrograms, tablets
Levonorgestrelum
Escapelle 1500 microgram tablet and Postinor are different trade names for the same medicine.
Please read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet so that you can read it again if necessary.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for a specific individual. Do not pass it on to others. The medicine may harm someone else, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of the leaflet

1. What Escapelle 1500 microgram tablet (hereinafter referred to as Escapelle 1500) is and what it is used for
2. Important information before taking Escapelle 1500
3. How to take Escapelle 1500
4. Possible side effects
5. How to store Escapelle 1500
6. Contents of the pack and other information

1. What Escapelle 1500 is and what it is used for
Escapelle 1500 is an emergency contraceptive method that may be used within 72 hours (3 days) after unprotected sexual intercourse or in the event of failure of a contraceptive method used.
This applies to the following situations:

• If no contraception was used during sexual intercourse.
• If the contraceptive method was used incorrectly, for example, if a condom slipped or was used improperly, if a diaphragm or contraceptive ring changed position, ruptured, was damaged or removed at the wrong time, or if the penis was not withdrawn from the vagina at the appropriate moment during withdrawal (e.g. ejaculation occurred inside the vagina or on external genital organs).

Escapelle 1500 contains as its active substance a synthetic hormone called levonorgestrel.
When taken within 72 hours after unprotected sexual intercourse, Escapelle 1500 prevents pregnancy in 84% of cases. It will not prevent pregnancy in every case, and its effectiveness is greater if taken as soon as possible after unprotected intercourse. It is best to take the medicine within the first 12 hours rather than wait until the third day after unprotected intercourse.
Escapelle 1500 is believed to work by:

• inhibiting the release of an egg from the ovaries
• preventing fertilization of an already released egg.

Escapelle 1500 prevents pregnancy only if used within 72 hours after unprotected sexual intercourse. This medicine is not effective if the woman is already pregnant.
If unprotected sexual intercourse occurred after taking Escapelle 1500 (including within the same menstrual cycle), the tablet may not act as a contraceptive, and there may again be a risk of pregnancy.
Escapelle 1500 is not indicated for use before the first menstrual bleeding (menarche).

2. Important information before taking Escapelle 1500

When not to use Escapelle 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 apply to you, inform your doctor before taking Escapelle 1500, as emergency contraception may not be suitable for you. Your doctor may prescribe you another type of emergency contraception.

• If you are pregnant or suspect you may be pregnant. This medicine is not effective if you are already pregnant. If you are already pregnant, Escapelle 1500 cannot terminate the pregnancy, as Escapelle 1500 is not an abortion pill. You may already be pregnant if:
• your menstrual bleeding is delayed by more than 5 days or you experience unusual bleeding on the day your period was expected,
• more than 72 hours have passed since unprotected sexual intercourse in the same menstrual cycle.

The use of Escapelle 1500 is not recommended if:

• you have a small intestine disorder (e.g. Crohn's disease) that impairs absorption of the medicine,
• you have severe liver function disorders,
• you have ever had an ectopic pregnancy (pregnancy developing outside the uterus),
• you have had salpingitis (inflammation of the fallopian tubes).

A history of ectopic pregnancy or tubal infection increases the risk of another ectopic pregnancy.
For all women, emergency contraception should be used as soon as possible after unprotected intercourse. There is evidence that Escapelle 1500 may be less effective with increasing body weight or body mass index (BMI), but these data are limited and inconclusive. Therefore, Escapelle 1500 is still recommended for all women, regardless of body weight or BMI.
If you have any doubts about the use of emergency contraception, consult your doctor, pharmacist or nurse.
Use in children and adolescents
Escapelle 1500 is not indicated for use before the first menstrual bleeding (menarche).
If you are concerned about sexually transmitted infections
If a condom was not used during intercourse (or it was torn or slipped off), you may have been exposed to a sexually transmitted infection or HIV.
This medicine does not protect against sexually transmitted infections. Only the use of condoms can protect against infection. If in doubt, consult your doctor, nurse, family planning specialist or pharmacist.
Escapelle 1500 and other medicines
Tell your doctor or pharmacist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take.
Some medicines may reduce the effectiveness of Escapelle 1500. If you have taken any of the following medicines within the last 4 weeks, Escapelle 1500 may not be suitable for you. Your doctor may prescribe another type (non-hormonal) of emergency contraception (after unprotected intercourse), such as a copper intrauterine device (Cu-IUD). If this does not apply to you or you cannot see a doctor immediately, you may take a double dose of Escapelle 1500:

• barbiturates and other medicines used to treat epilepsy (e.g. primidone, phenytoin and carbamazepine);
• medicines used to treat tuberculosis (e.g. rifampicin, rifabutin);
• medicines used to treat HIV infection (ritonavir, efavirenz);
• medicines used to treat fungal infections (griseofulvin);
• herbal medicines containing St John's wort (Hypericum perforatum).

For additional information on correct dosing, contact your doctor or pharmacist.
After taking the tablets, you should contact your doctor or pharmacist as soon as possible for further advice on regular contraception and to rule out pregnancy (see also section 3 "How to take Escapelle 1500").
Escapelle 1500 may also affect the action of other medicines:

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

How often can Escapelle 1500 be used
Escapelle 1500 should only be used in emergency situations and not as a regular contraceptive method. If Escapelle 1500 is used more than once in the same menstrual cycle, its contraceptive effect is weaker, and there is a greater risk of menstrual cycle disturbances.
Escapelle 1500 is not as effective as regular contraceptive methods. To obtain information on long-term contraceptive methods that are more effective in preventing pregnancy, consult your doctor, nurse or family planning specialist.
Pregnancy, breastfeeding and effects on fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a child, consult your doctor or pharmacist before using this medicine.
Pregnancy
Pregnant women should not use this medicine. If you become pregnant despite using this medicine, it is important to consult your doctor. There is no evidence that Escapelle 1500 has harmful effects on the developing fetus if used according to instructions. However, your doctor will want to check that it is not an ectopic pregnancy (when the embryo develops outside the uterus). This is particularly important if you experience severe abdominal pain after taking Escapelle 1500 or if you have previously had an ectopic pregnancy, undergone surgery on the fallopian tubes, or had pelvic inflammatory disease.
Breastfeeding
The active ingredient of this medicine passes into breast milk. It is recommended that you take the tablet immediately after breastfeeding and then avoid breastfeeding for at least 8 hours after taking levonorgestrel, and during these 8 hours after taking the tablet, express milk from the breast using a breast pump. By taking the tablet well before the next feeding, you can reduce the amount of active substance that could pass into the infant's body through breast milk.
Fertility
Taking Escapelle 1500 may increase the likelihood of menstrual disturbances, which may sometimes lead to delayed or accelerated ovulation, thereby affecting the fertile period. As there are no data on long-term effects on fertility, a rapid return to fertility should be expected after using Escapelle 1500. Therefore, after taking Escapelle 1500, you should continue using regular contraception or start using it as soon as possible.
Driving and operating machinery
It is unlikely that Escapelle 1500 will affect the ability to drive or operate machinery. However, if you experience fatigue or dizziness, you should not drive or operate machinery.
Escapelle 1500 contains monohydrate lactose
In cases of lactose intolerance, please note that one tablet of Escapelle 1500 contains 142.5 mg of monohydrate lactose.
If you have previously been diagnosed with intolerance to certain sugars, you should contact your doctor before taking this medicine.

3. How to use Escapelle 1500

This medicine should always be used as directed by a doctor. If in doubt, consult a doctor or pharmacist.

The tablet should be taken as soon as possible, preferably within 12 hours and no later than 72 hours (3 days) after unprotected sexual intercourse. Do not delay taking the tablet. The earlier the tablet is taken after unprotected sexual intercourse, the more effective it will be. The tablet can prevent pregnancy only if taken within 72 hours after unprotected sexual intercourse.

• Escapelle 1500 may be used on any day of the menstrual cycle, provided the woman is not pregnant and does not suspect she might be pregnant. The tablet must not be chewed; it should be swallowed whole with water.
  • If the woman is taking any medicines that may reduce the effectiveness of Escapelle 1500 (see section above “Escapelle 1500 and other medicines”) or if she has taken any of these medicines in the past 4 weeks, Escapelle 1500 may not be suitable. The doctor may prescribe another type of (non-hormonal) emergency contraception (after unprotected sexual intercourse), such as a copper-containing intrauterine device (Cu-IUD). If this does not apply to the woman or if she cannot see a doctor immediately, a double dose of Escapelle 1500 may be taken (i.e. 2 tablets taken at the same time).
• If the woman is using a regular method of contraception, such as oral contraceptives, she may continue taking them as directed.

If another episode of unprotected sexual intercourse occurs after taking Escapelle 1500 (including within the same menstrual cycle), the tablet will not provide contraceptive protection, and there is again a risk of pregnancy.

In case of any doubts regarding emergency contraception, consult a doctor, pharmacist, or nurse.

What to do if vomiting occurs

If vomiting occurs within three hours of taking the tablet, another tablet should be taken immediately.

After using Escapelle 1500

If the woman is not using oral contraceptives and intends to have sexual intercourse after taking Escapelle 1500, she should use condoms or a diaphragm together with spermicidal agents until the next menstrual bleeding occurs. This is necessary because Escapelle 1500 is not effective in preventing pregnancy from further episodes of unprotected sexual intercourse before the next expected menstrual period.

Approximately three weeks after taking Escapelle 1500, it is recommended that the woman visits a doctor to confirm that the treatment has been effective. If menstrual bleeding is delayed by more than 5 days or is unusually light or heavy, the woman should contact a doctor as soon as possible. If pregnancy occurs despite taking the medicine, it is important to consult a doctor.

The doctor may also provide information about long-term contraceptive methods that offer more effective protection against pregnancy.

If the woman continues using regular hormonal contraception, such as oral contraceptives, and does not experience menstrual bleeding during the tablet-free interval, she should consult a doctor to rule out pregnancy.

Next menstrual bleeding after using Escapelle 1500

After using Escapelle 1500, menstrual bleeding is usually normal and occurs around the expected time, although it may sometimes occur several days earlier or later. If menstrual bleeding starts more than 5 days later than expected, if bleeding is unusual, or if the woman suspects she might be pregnant, she should confirm whether she is pregnant using a pregnancy test.

Taking more than the recommended dose of Escapelle 1500

Although severe adverse effects have not been reported after taking a large number of tablets at once, nausea, vomiting, and vaginal bleeding may occur. Consult a pharmacist, doctor, nurse, or family planning specialist, especially if vomiting has occurred, as the tablet may not have been effective in such a case.

If there are any further doubts about using this medicine, consult a doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Very common (may occur in more than 1 in 10 women):

• Nausea;
• Irregular intermenstrual bleeding may occur until the next menstrual bleeding;
• Abdominal pain may occur;
• Feeling of fatigue;
• Headache.

Common (may occur in up to 1 in 10 women):

• Vomiting. If vomiting occurs, refer to the information provided in the section "What to do if vomiting occurs".
• Menstrual bleeding may be different than usual. Most women will have normal menstrual bleeding at the expected time, but in some women it may occur earlier or later than usual. Irregular bleeding or intermenstrual spotting may also occur. If menstrual bleeding is delayed by more than 5 days, or is unusually light or heavy, the woman should contact her doctor as soon as possible.
• Breast tenderness, diarrhoea, dizziness, which may occur after taking the medicine.

Very rare (may occur in up to 1 in 10,000 women):

• Rash, urticaria, itching, facial swelling, pelvic pain, painful menstruation.

Reporting of adverse effects
If any adverse effects occur, including any not listed in this leaflet, inform your doctor, pharmacist or nurse. Adverse effects can also be reported directly to the Department of Monitoring Adverse Drug Reactions, Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Reporting adverse effects helps to provide more information on the safety of this medicine.

5. How to store Escapelle 1500 tablets

Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.
Store in the original packaging to protect from light.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. Such practices will help protect the environment.

6. Contents of the package and other information

What Escapelle 1500 contains

• The active substance is levonorgestrel. Each tablet contains 1500 micrograms of levonorgestrel.
• The other ingredients are: potato starch, corn starch, colloidal anhydrous silica, magnesium stearate, talc, lactose monohydrate.

What Escapelle 1500 looks like and contents of the pack
The tablet is almost white, flat, with a diameter of approximately 8 mm, imprinted with the code "G00" on one side.
Packaging: one tablet in a blister pack made of PVC/Aluminium foil, contained in a cardboard box.
For further information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Greece, country of export:
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Manufacturer:
Gedeon Richter Plc., Gyömrői út 19-21., 1103 Budapest, Hungary
Parallel Importer:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Repackaged by:
Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź, Poland
Marketing Authorisation number in Greece, country of export: 39664/9-6-2015
Parallel Import Licence number: 117/23
This medicinal product is authorised for sale in the European Economic Area under the following names:
Austria: Postinor
Belgium: Postinor
France: Levonorgestrel Biogaran
Greece: Postinor
Spain: Postinor
Netherlands: Postinor
Ireland: Ramonna
Iceland: Postinor
Lithuania: Escapelle
Luxembourg: Postinor
Germany: Postinor
Norway: Postinor
Poland: Escapelle tabletka 1500 mikrogramów
Czech Republic: Escapelle
Sweden: Postinor
United Kingdom: Levonelle
Italy: Escapelle