Escapelle tabletka 1500 mikrogramuv

Package Leaflet: Information for the Patient

Escapelle 1500 microgram tablet

1500 micrograms, tablet

(Levonorgestrel)

Read the leaflet carefully before taking the medicine, as it contains important information for you.

Important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor.
• This medicine has been prescribed specifically for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. See section 4.

Table of Contents of the Leaflet

• 1. What is Escapelle 1500 microgram tablet (hereafter referred to as Escapelle 1500) and what is it 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 is Escapelle 1500 and what is it 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 contraceptive method was used during sexual intercourse.
• If the contraceptive method was not used correctly, for example, if the condom slipped or was not used correctly, if the diaphragm or contraceptive ring changed position, broke, was damaged, or was removed at the wrong time, or if the penis was not withdrawn from the vagina at the right time during interrupted sex (e.g., ejaculation occurred in the vagina or on the external genitalia).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.
Taking this medicine within 72 hours of unprotected sex 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 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. This medicine is not effective if you are already pregnant.
If you have unprotected sex after taking Escapelle 1500 (also during the same menstrual cycle), the tablet may not work as a contraceptive, and you may be at risk of becoming pregnant again.
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 you, you should tell your doctor before taking Escapelle 1500, as emergency contraception may not be suitable for you. Your doctor may prescribe a different type of emergency contraception for you.

• If you are pregnant or think you might be pregnant. This medicine is not effective if you are already pregnant. If you are pregnant, Escapelle 1500 will not terminate the pregnancy, as it is not an abortion pill. You may already be pregnant if:
• your menstrual period is more than 5 days late or you experience unusual bleeding at the time of your 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:

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

A history of ectopic pregnancy or fallopian tube inflammation 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 you have any doubts about emergency contraception, you 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 you are concerned about sexually transmitted diseases

If you did not use a condom (or it was damaged or slipped) during sex, you may be at risk of contracting 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 you have any doubts, you should consult a doctor, nurse, family planning specialist, or pharmacist.

Escapelle 1500 and other medicines

You should tell your doctor or pharmacist about all medicines you are 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 in the last 4 weeks, Escapelle 1500 may not be suitable for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal) after unprotected sex, such as a copper intrauterine device (Cu-IUD). If this does not apply to you or you cannot see a doctor immediately, you can take a double dose of Escapelle 1500 (i.e., 2 tablets at the same time):

• 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, you should consult a doctor or pharmacist.
After taking the tablets for further advice on regular contraception and to rule out pregnancy, you should see a 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 ciclosporin (which suppresses the immune system).

How often can Escapelle 1500 be taken

Escapelle 1500 should only be taken in emergency situations and not as a regular contraceptive method. If Escapelle 1500 is taken 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, you should consult a doctor, nurse, or family planning specialist.

Pregnancy, breastfeeding, and fertility

If you are pregnant, breastfeeding, think you may be pregnant, or plan to have a baby, you should consult a doctor or pharmacist before taking this medicine.
Pregnancy
Pregnant women should not take this medicine. If you become pregnant despite taking Escapelle 1500, it is essential to consult a doctor. There is no evidence that Escapelle 1500 has a harmful effect on the developing baby if taken according to the instructions. However, your doctor will want to check that it is not an ectopic pregnancy (when the embryo develops outside the uterus). This is especially important if you experience severe abdominal pain after taking Escapelle 1500 or if you have had an ectopic pregnancy, had fallopian tube surgery, or had pelvic inflammatory disease.
Breastfeeding
The active substance 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 express milk from the breast during this time using a breast pump. By taking the tablet much earlier before the next breastfeeding, you can reduce the amount of active substance that may pass into your baby's body through breast milk.
Fertility
Taking Escapelle 1500 can increase the likelihood of menstrual disturbances, which can sometimes lead to delayed or accelerated ovulation, affecting fertility. Since there is a lack of data on the long-term effect on fertility, after taking Escapelle 1500, you should expect a rapid return to fertility.
Therefore, after taking Escapelle 1500, you should continue or start using regular contraception as soon as possible.

Driving and using machines

It is unlikely that Escapelle 1500 will affect your ability to drive or use machines. However, if you feel tired or dizzy, you should not drive or operate machinery.

Escapelle 1500 contains lactose

In cases of lactose intolerance, note that one Escapelle 1500 tablet contains 142.5 mg of lactose monohydrate.
If you have been diagnosed with an intolerance to some sugars, you should consult a doctor before taking this medicine.

3. How to take Escapelle 1500

This medicine should always be taken according to the doctor's instructions. If you have any doubts, you should 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 sex. Do 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 you are not pregnant or do not think you might be pregnant. The tablet should not be chewed, swallow the tablet whole with water.
• If you are taking any medicines that may reduce the effectiveness of Escapelle 1500 (see "Escapelle 1500 and other medicines" above) or if you have taken any of these medicines in the last 4 weeks, Escapelle 1500 may not be suitable for you. Your doctor may prescribe a different type of emergency contraception (non-hormonal) after unprotected sex, such as a copper intrauterine device (Cu-IUD). If this does not apply to you or you cannot see a doctor immediately, you can take a double dose of Escapelle 1500 (i.e., 2 tablets at the same time).
• If you are using a regular contraceptive method, such as birth control pills, you can continue to take them as instructed.

If you have unprotected sex again (also during the same menstrual cycle) after taking Escapelle 1500, the tablet will not have a contraceptive effect, and you may be at risk of becoming pregnant again.
If you have any doubts about emergency contraception, you should consult a doctor, pharmacist, or nurse.

What to do if you vomit

If you vomit within 3 hours of taking the tablet, you should take another tablet immediately.

After taking Escapelle 1500

If you are not taking birth control pills and plan to have sex after taking Escapelle 1500, you should use condoms or a diaphragm with spermicides until your next menstrual period. This is necessary because Escapelle 1500 is not effective in the event of another unprotected sexual encounter before your next menstrual period.
About 3 weeks after taking Escapelle 1500, you should see a doctor to ensure that the medicine has worked. If your menstrual period is more than 5 days late or you experience unusual bleeding, you should see a doctor as soon as possible. If you become pregnant despite taking Escapelle 1500, it is essential to consult a doctor.
Your doctor may also provide information on long-term contraceptive methods that are more effective in preventing pregnancy.
If you continue to take regular hormonal contraception, such as birth control pills, and do not experience menstrual bleeding during the pill-free period, you should see a doctor to rule out pregnancy.

Next menstrual period after taking Escapelle 1500

After taking Escapelle 1500, your menstrual period is usually normal and starts on the expected date, but it may start a few days later or earlier than usual. You may also experience irregular bleeding or spotting. If your menstrual period is more than 5 days late or you experience unusual bleeding, you should see a 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, you may experience nausea, vomiting, and bleeding from the genital tract. You should consult a pharmacist, doctor, nurse, or family planning specialist, especially if you have vomited, as the tablet may not work.
If you have any further doubts about taking this medicine, you should consult a 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 women):

• Nausea;
• Until the next menstrual period, you may experience irregular bleeding or spotting;
• You may experience lower abdominal pain;
• You may feel tired;
• You may experience headache.

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

• Vomiting. If you vomit, you should read the information in the section "What to do if you vomit".
• Your menstrual period may be different than usual. Most women experience a normal menstrual period at the expected time, but some women may experience it later or earlier than usual. You may also experience irregular bleeding or spotting. If your menstrual period is more than 5 days late or you experience unusual bleeding, you should see a 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 women):

• Rash, urticaria, itching, swelling of the face, pelvic pain, painful menstruation.

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, you should tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, you can help provide more information on the safety of this medicine.

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 after EXP.
The expiry date refers to the last day of the month stated.
Store in the original packaging to protect from light.
Medicines should not be disposed of via wastewater or household waste. You should ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Escapelle 1500 contains

• The active substance of the medicine 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 about 8 mm in diameter, with the inscription "G00" on one side.
Packaging: one tablet in a PVC/Aluminum blister pack and a cardboard box.

Marketing authorization holder and manufacturer:

Gedeon Richter Plc.
1103 Budapest
Gyömrői út 19-21
Hungary
To obtain more detailed information about the medicine and its names in other European Economic Area member states, you should contact:
GEDEON RICHTER POLSKA Sp. z o.o.
Medical Department
ul. Ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki
Phone: +48 (22)755 96 48
lekalert@grodzisk.rgnet.org

This medicinal product is authorized in the European Economic Area member states 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
Portugal: Postinor
Czech Republic: Escapelle
Sweden: Postinor
United Kingdom: Levonelle
Italy: Escapelle

Date of last revision of the leaflet: July 2021