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, tablet
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.
• This medicine has been prescribed strictly for a specific individual. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If you experience any adverse effects, including any not listed in this leaflet, inform your doctor or pharmacist. 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 case 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or contraceptive ring changed position, ruptured, was damaged or removed at the wrong time, or if the penis was not withdrawn from the vagina at the appropriate moment during withdrawal method (e.g. ejaculation occurred inside the vagina or on external genital organs).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, this medicine prevents pregnancy in 84% of cases.
It does 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 waiting until the third day after unprotected intercourse.
Escapelle 1500 is believed to work by:

• inhibiting the release of an egg from the ovary
• 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 patient is already pregnant.
If unprotected sexual intercourse occurred after taking Escapelle 1500 (including within the same menstrual cycle), the tablet may not provide contraceptive protection, and there may again be a risk of pregnancy.
Escapelle 1500 is not indicated for use before the onset of the first menstrual bleeding (menarche).

2. Important information before taking Escapelle 1500

When not to use Escapelle 1500

• if the patient is 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 the patient, inform the doctor before taking Escapelle 1500, as emergency contraception may not be suitable. The doctor may prescribe another type of emergency contraception.

• If the patient is pregnant or suspects she may be pregnant. This medicine is not effective if the patient is already pregnant. If the patient is already pregnant, Escapelle 1500 cannot terminate the pregnancy, as Escapelle 1500 is not an abortion pill.

The patient may already be pregnant if:

• menstrual bleeding is delayed by more than 5 days or irregular bleeding occurs on the expected day of menstruation,
• more than 72 hours have passed since unprotected intercourse in the same menstrual cycle.

Use of Escapelle 1500 is not recommended if:

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

A previous 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 regarding 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 onset of the first menstrual bleeding (menarche).
If the patient is concerned about sexually transmitted infections
If a condom was not used during intercourse (or was torn or slipped), it is possible that the patient may have contracted a sexually transmitted infection or HIV.
This medicine does not protect against sexually transmitted infections. Only the use of condoms can prevent infection. If in doubt, consult a 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 the patient has taken any of the following medicines within the last 4 weeks, Escapelle 1500 may not be suitable.
The 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 the patient or the patient cannot see a doctor immediately, a double dose of Escapelle 1500 may be taken:

• 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 the correct dosage, contact your doctor or pharmacist.
After taking the tablet, the patient should contact a 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 be used only in emergency situations, 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 cycle disturbances (periods) increases.
Escapelle 1500 is not as effective as regular contraceptive methods. For information on long-term contraceptive methods that are more effective in preventing pregnancy, consult your doctor, nurse, or family planning specialist.
Pregnancy, breastfeeding, and effect on fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult a doctor or pharmacist before using this medicine.
Pregnancy
Pregnant women should not use this medicine. If the patient becomes pregnant despite using the medicine, it is important to consult a doctor. There is no evidence that Escapelle 1500 has harmful effects on the developing fetus if used according to instructions. However, the doctor will want to check whether it is not an ectopic pregnancy (when the fetus develops outside the uterus). This is particularly important if severe abdominal pain occurs after taking Escapelle 1500 or if the patient has previously had an ectopic pregnancy, undergone fallopian tube surgery, or had pelvic inflammatory disease.
Breastfeeding
The active substance of this medicine passes into breast milk. It is recommended that the patient take the tablet immediately after breastfeeding and then avoid breastfeeding for at least 8 hours after taking levonorgestrel, and express milk from the breasts using a breast pump for 8 hours after taking the tablet. By taking the tablet well before the next feeding, the amount of active substance that could pass into the infant's body through breast milk can be reduced.
Fertility
Taking Escapelle 1500 may increase the likelihood of menstrual disturbances, which may sometimes delay or accelerate ovulation, thereby affecting the fertile period. As there are no data on long-term effects on fertility, rapid return of fertility should be expected after taking Escapelle 1500. Therefore, after taking Escapelle 1500, regular contraception should be continued or started 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 the patient experiences fatigue or dizziness, she should not drive or operate machinery.
Escapelle 1500 contains monohydrate lactose
In cases of lactose (milk sugar) intolerance, note that one tablet of Escapelle 1500 contains 142.5 mg of monohydrate lactose.
If the patient has previously been diagnosed with intolerance to certain sugars, the patient should consult a doctor before taking the medicine.

3. How to use Escapelle 1500 tablets

This medicine should always be taken in accordance with your doctor's instructions. If in doubt, consult your 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 sooner the tablet is taken after unprotected sex, the more effective it will be. The tablet can prevent pregnancy only if taken within 72 hours after unprotected sexual intercourse.

• Escapelle 1500 tablets may be taken 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 within the last 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 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 (i.e. 2 tablets taken together) may be taken.
• If the woman is using regular contraception, such as oral contraceptive pills, she may continue taking them as directed.

If another 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.
If in any doubt about 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 taking Escapelle 1500
If the woman is not using oral contraceptives and plans to have sexual intercourse after taking Escapelle 1500, she should use condoms or a diaphragm together with spermicidal agents until her next menstrual period. This is necessary because Escapelle 1500 is not effective in preventing pregnancy from further unprotected sexual intercourse before the next expected menstrual bleeding.
Approximately three weeks after taking Escapelle 1500, it is recommended that the woman visits a doctor to confirm that the treatment was effective. If menstrual bleeding is delayed by more than 5 days or if bleeding is unusually light or heavy, the woman should contact her 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 contraceptive pills, and does not experience menstrual bleeding during the tablet-free interval, she should consult a doctor to rule out pregnancy.
Next menstrual bleeding after taking Escapelle 1500
After taking Escapelle 1500, menstrual bleeding usually occurs normally and at the expected time, although it may sometimes occur a few 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 occurs, 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 reactions

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

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

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

Common (may occur in no more than 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 differ from 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 no more than 1 in 10,000 women):

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

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor or pharmacist. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the 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 reactions helps to provide more information on the safety of this medicine.

5. How to store Escapelle 1500 tablets

Keep this 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 stated month.
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. 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, 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, approximately 8 mm in diameter, with the imprint "G00" on one side.
Pack: one tablet in a PVC/Aluminum blister pack contained in a cardboard box.
For more detailed information, please contact the responsible party or the parallel importer.
Marketing Authorisation Holder in Belgium, 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:
InPharm Sp. z o.o., Strumykowa 28/11, 03-138 Warsaw, Poland
Repackaged in:
InPharm Sp. z o.o. Services sp. k., Chełmżyńska 249, 04-458 Warsaw, Poland
Marketing Authorisation Number in Belgium, country of export: BE285196
Parallel Import Authorisation Number: 367/22
This medicinal product is authorised for sale in the European Economic Area countries 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