Escapelle tabletka 1500 mikrogramuv

Leaflet attached to the packaging: patient information

Warning! The leaflet should be kept. Information on the immediate packaging in a foreign language.

Escapelle 1500 microgram tablet (Postinor)

1500 micrograms, tablets

Levonorgestrel
Escapelle 1500 microgram tablet and Postinor are different trade names for the same medicine.

You should read the leaflet before taking the medicine, as it contains

important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• If you have any doubts, you should consult a doctor or pharmacist.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet

• 1. What Escapelle 1500 microgram tablet 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 packaging and other information

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

Escapelle 1500 is an emergency contraceptive that can be used within 72 hours (3 days) of unprotected sex or when a contraceptive method has failed.
This includes the following situations:

• If no contraception was used during sex.
• If the contraceptive method was not used correctly, for example, if the condom slipped or was not used correctly, if the diaphragm or contraceptive cap was displaced, torn, damaged, or removed at the wrong time, or if the penis was not withdrawn from the vagina at the right time during interrupted sex (e.g., ejaculation occurred in the vagina or on the external genitalia).

Escapelle 1500 contains a synthetic hormone called levonorgestrel as the active substance.
Taken within 72 hours of unprotected sex, it prevents pregnancy in 84%. It will not prevent pregnancy in every case, and its effectiveness is greater if taken as soon as possible after unprotected sex. It is best to take the medicine within the first 12 hours, rather than waiting until the third day after unprotected sex.
It is thought that Escapelle 1500 works by:

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

Escapelle 1500 will only prevent pregnancy if taken within 72 hours of unprotected sex. The medicine is not effective if the patient is already pregnant.
If unprotected sex occurs after taking Escapelle 1500 (also during the same menstrual cycle), the tablet may not work as a contraceptive, and there may again be a risk of pregnancy.
Escapelle 1500 is not indicated for use before the first menstrual period (menarche).

2. Important information before taking Escapelle 1500

When not to take Escapelle 1500

Warnings and precautions

If any of the following apply to the patient, they should inform their doctor before taking Escapelle 1500, as emergency contraception may not be suitable for them. The doctor may prescribe a different type of emergency contraception.

• If the patient is pregnant or thinks they may be pregnant. This medicine is not effective if the patient is already pregnant. If the patient is already pregnant, Escapelle 1500 will not terminate the pregnancy, as it is not an abortion pill. The patient may already be pregnant if:
• their menstrual period is delayed by more than 5 days or they experience unusual bleeding at the time of their expected period,
• more than 72 hours have passed since unprotected sex in the same menstrual cycle.

It is not recommended to take Escapelle 1500 if:

• the patient has a disease of the small intestine (e.g., Crohn's disease) that impairs the absorption of the medicine,
• the patient has severe liver function disorders,
• the patient has had an ectopic pregnancy (development of the embryo outside the uterus) in the past,
• the patient has had salpingitis (inflammation of the fallopian tubes).

A history of ectopic pregnancy or salpingitis increases the risk of another ectopic pregnancy.
All women should use emergency contraception as soon as possible after unprotected sex. There is evidence that Escapelle 1500 may be less effective with increasing body weight or body mass index (BMI), but the data are limited and inconclusive. Therefore, Escapelle 1500 is still recommended for all women, regardless of their weight or BMI.
If the patient has any doubts about emergency contraception, they should consult a doctor, pharmacist, or nurse.

Use in children and adolescents

Escapelle 1500 is not indicated for use before the first menstrual period (menarche).

If the patient is concerned about sexually transmitted diseases

If a condom was not used during sex (or it was damaged or slipped), the patient may have been exposed to a sexually transmitted disease or HIV.
This medicine does not protect against sexually transmitted diseases. Only the use of condoms can protect against infection. If in doubt, the patient should consult a doctor, nurse, family planning specialist, or pharmacist.

Escapelle 1500 and other medicines

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.
Some medicines may reduce the effectiveness of Escapelle 1500. If the patient has taken any of the following medicines in the last 4 weeks, Escapelle 1500 may not be suitable for them. The doctor may prescribe a different type of emergency contraception (non-hormonal), such as a copper intrauterine device (Cu-IUD). If this is not the case or the patient cannot see a doctor immediately, they can 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 further information on the correct dose, the patient should consult their doctor or pharmacist.
After taking the tablets for further advice on regular contraception and to rule out pregnancy, the patient should consult their doctor or pharmacist as soon as possible (see also section 3 "How to take Escapelle 1500").
Escapelle 1500 may also affect the action of other medicines:

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

How often can Escapelle 1500 be taken

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 reduced, and the risk of menstrual disturbances (menstruation) is increased.
Escapelle 1500 is not as effective as regular contraceptive methods. For information on long-term contraceptive methods that are more effective in preventing pregnancy, the patient should consult a doctor, nurse, or family planning specialist.

Pregnancy, breastfeeding, and fertility

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, they should consult their doctor or pharmacist before taking this medicine.
Pregnancy
Pregnant women should not take this medicine. If the patient becomes pregnant despite taking the medicine, it is essential that they consult their doctor. There is no evidence that Escapelle 1500 has a harmful effect on the developing fetus if the patient takes it according to the instructions. However, the doctor will want to check that it is not an ectopic pregnancy (when the embryo develops outside the uterus). This is particularly important if the patient experiences severe abdominal pain after taking Escapelle 1500 or if they have had an ectopic pregnancy, undergone tubal surgery, or had pelvic inflammatory disease in the past.
Breastfeeding
The active substance of this medicine passes into breast milk. It is recommended that the patient takes the tablet immediately after breastfeeding and then avoids breastfeeding for at least 8 hours after taking levonorgestrel and expresses milk from the breast during this time using a breast pump. By taking the tablet much earlier before the next breastfeeding, the amount of active substance that may pass into the baby's body through breast milk can be reduced.
Fertility
Taking Escapelle 1500 can increase the likelihood of menstrual disturbances, which can sometimes lead to delayed or accelerated ovulation, affecting the fertility period. Since there is a lack of data on the long-term effect on fertility, after taking Escapelle 1500, the patient should expect a rapid return to fertility.
Therefore, after taking Escapelle 1500, the patient should continue to use regular contraception or start using it as soon as possible.

Driving and using machines

It is unlikely that Escapelle 1500 will affect the ability to drive or use machines. However, if the patient feels tired or dizzy, they should not drive or operate machinery.

Escapelle 1500 contains lactose monohydrate

In cases of lactose intolerance, note that one Escapelle 1500 tablet contains 142.5 mg of lactose monohydrate.
If the patient has been diagnosed with an intolerance to some sugars, they should consult their doctor before taking the medicine.

3. How to take Escapelle 1500

This medicine should always be taken according to the doctor's instructions. If in doubt, the patient should consult their 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 sex. The patient should not delay taking the tablet. The sooner the tablet is taken after unprotected sex, the more effective it will be. The tablet will only prevent pregnancy if taken within 72 hours of unprotected sex.

• Escapelle 1500 can be taken at any time during the menstrual cycle, provided the patient is not pregnant or does not think they may be pregnant. The tablet should not be chewed and should be swallowed whole with water.
• If the patient is taking any medicines that may reduce the effectiveness of Escapelle 1500 (see "Escapelle 1500 and other medicines" above) or if they have taken any of these medicines in the last 4 weeks, Escapelle 1500 may not be suitable for them. The doctor may prescribe a different type of emergency contraception (non-hormonal) after unprotected sex, such as a copper intrauterine device (Cu-IUD). If this is not the case or the patient cannot see a doctor immediately, they can take a double dose of Escapelle 1500 (i.e., 2 tablets taken at the same time).
• If the patient is using a regular contraceptive method, such as the contraceptive pill, they can continue to take it as instructed.

If the patient has unprotected sex again (also during the same menstrual cycle) after taking Escapelle 1500, the tablet will not have a contraceptive effect, and there is again a risk of pregnancy.
If in doubt about emergency contraception, the patient should consult a doctor, pharmacist, or nurse.

What to do if the patient vomits

If the patient vomits within 3 hours of taking the tablet, they should take another tablet immediately.

After taking Escapelle 1500

If the patient is not taking the contraceptive pill and intends to have sex after taking Escapelle 1500, they should use condoms or a diaphragm with spermicides until their next menstrual period. This is necessary because Escapelle 1500 is not effective in the event of another unprotected sexual encounter before the next scheduled menstrual period.
About 3 weeks after taking Escapelle 1500, the patient should have a medical check-up to ensure that the medicine has been effective. If their menstrual period is delayed by more than 5 days or they experience unusual bleeding, the patient should consult their doctor as soon as possible. If the patient becomes pregnant despite taking the medicine, it is essential that they consult their doctor.
The doctor may also provide information on long-term contraceptive methods that are more effective in preventing pregnancy.
If the patient continues to use regular hormonal contraception, such as the contraceptive pill, and does not experience menstrual bleeding during the pill-free period, they should consult their doctor to rule out pregnancy.

Next menstrual period after taking Escapelle 1500

After taking Escapelle 1500, menstrual bleeding is usually normal and starts on the expected date, but it may occur a few days later or earlier. If the menstrual period is delayed by more than 5 days, or if there is unusual bleeding, the patient should consult their doctor as soon as possible.

Overdose of Escapelle 1500

Although no serious side effects have been reported when taking a large number of tablets at the same time, nausea, vomiting, and bleeding from the genital tract may occur. The patient should consult their pharmacist, doctor, nurse, or family planning specialist, especially if they have vomited, as the tablet may not work.
If the patient has any further doubts about taking this medicine, they should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, Escapelle 1500 can cause side effects, although not everybody gets them.

Very common (may affect more than 1 in 10 patients):

• Nausea;
• Until the next menstrual period, irregular bleeding or spotting may occur;
• Lower abdominal pain may occur;
• Feeling tired;
• Headache.

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

• Vomiting. If vomiting occurs, the patient should read the information in the section "What to do if the patient vomits".
• Menstrual bleeding may be different from usual. Most women experience normal menstrual bleeding at the expected time, but some may experience it later or earlier than usual. Irregular bleeding or spotting may also occur. If the menstrual period is delayed by more than 5 days or is unusually light or heavy, the patient should consult their doctor as soon as possible.
• Breast tenderness, diarrhea, dizziness, which may occur after taking the medicine.

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

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

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety, Ministry of Health, or via the website.

5. How to store Escapelle 1500

The medicine should be stored out of 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.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. The patient should ask their pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the packaging 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, maize 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, and approximately 8 mm in diameter, with the inscription "G00" on one side.
Packaging: one tablet in a PVC/Aluminum blister pack and a cardboard box.
For more detailed information, the patient should consult the marketing authorization holder or parallel importer.

Marketing authorization holder in Belgium, the 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

Repackaged by:

Delfarma Sp. z o.o., ul. Św. Teresy od Dzieciątka Jezus 111, 91-222 Łódź
Belgian marketing authorization number: BE285196

Parallel import authorization number: 275/23

This medicinal product is authorized in the Member States of 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 1500 microgram tablet
Portugal: Postinor
Czech Republic: Escapelle
Sweden: Postinor
Italy: Escapelle

Date of leaflet approval: 27.11.2023

[Information about the trademark]