Escapelle

Leaflet accompanying the packaging: information for the user

ESCAPELLE, 1.5 mg, orally disintegrating tablet

(Levonorgestrel)

You should carefully read the contents of 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.
• 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 as yours.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor or pharmacist. See section 4.

Table of contents of the leaflet

• 1. What is ESCAPELLE and what is it used for
• 2. Important information before taking ESCAPELLE
• 3. How to take ESCAPELLE
• 4. Possible side effects
• 5. How to store ESCAPELLE
• 6. Contents of the packaging and other information

1. What is ESCAPELLE and what is it used for

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

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the diaphragm or contraceptive ring was displaced, torn, damaged, or removed at the wrong time, or if the penis was not withdrawn from the vagina at the right time during interrupted intercourse (e.g., ejaculation occurred in the vagina or on the external genitalia).

ESCAPELLE contains a synthetic hormone called levonorgestrel as an active substance. If taken within 72 hours after 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 works by:

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

ESCAPELLE prevents pregnancy only if taken within 72 hours after unprotected sex. This medicine is not effective if the patient is already pregnant.
If unprotected sex occurs after taking ESCAPELLE (also during the same menstrual cycle), the tablet may not have a contraceptive effect, and there is again a risk of pregnancy.
ESCAPELLE is not indicated for use before the first menstrual bleeding (menarche).
ESCAPELLE is available in the form of an orally disintegrating tablet that dissolves in the mouth.

2. Important information before taking ESCAPELLE

When not to take ESCAPELLE:

• 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 points apply to the patient, they should inform their doctor before taking ESCAPELLE, as emergency contraception may not be suitable for the patient. The doctor may prescribe another type of emergency contraception (after unprotected sex), such as a copper intrauterine device (Cu-IUD).

• 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 will not terminate the pregnancy, as ESCAPELLE is not an abortion pill. The patient may be pregnant if:
• menstrual bleeding is delayed by more than 5 days or unusual bleeding occurs on the expected day of menstruation,
• more than 72 hours have passed since unprotected sex in the same menstrual cycle.

Using ESCAPELLE is not recommended 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 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 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 body weight or BMI.
In case of any doubts about emergency contraception, the patient should consult a doctor or pharmacist.

Use in children and adolescents

ESCAPELLE is not indicated for use before the first menstrual bleeding (menarche).

If the patient is concerned about sexually transmitted diseases

If a condom was not used during sex (or 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. In case of doubts, the patient should consult a doctor, nurse, family planning specialist, or pharmacist.

ESCAPELLE and other medicines

The patient should tell their pharmacist or doctor 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. If the patient has taken any of the following medicines in the last 4 weeks, ESCAPELLE may not be suitable for them. The doctor may prescribe another type of emergency contraception (after unprotected sex), such as a copper intrauterine device (Cu-IUD). If this is not the case for the patient or the patient cannot immediately consult a doctor, they can take a double dose of ESCAPELLE (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, the patient should consult their pharmacist or doctor.
After taking the tablets for further advice on regular contraception and to rule out pregnancy, the patient should consult their doctor as soon as possible (see also section 3 "How to take ESCAPELLE").
ESCAPELLE may also affect the action of other medicines:

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

The patient should consult their doctor before taking ESCAPELLE if they are taking any of the above medicines.

How often can ESCAPELLE be used

ESCAPELLE should only be used in emergency situations and not as a regular contraceptive method. If ESCAPELLE is used more than once in the same menstrual cycle, its contraceptive effect is weaker, and the risk of menstrual cycle disorders (menstruation) is higher.
ESCAPELLE 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 their doctor, nurse, or family planning specialist.

ESCAPELLE with food and drink

ESCAPELLE can be taken at any time, regardless of meals.
The orally disintegrating tablet can be used without the need to drink a liquid.

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 ESCAPELLE, it is essential that they consult their doctor. There is no evidence that ESCAPELLE has a harmful effect on the developing fetus if the patient takes ESCAPELLE 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 especially important if the patient experiences severe abdominal pain after taking ESCAPELLE or if they have had an ectopic pregnancy, undergone fallopian tube 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 using a breast pump for 8 hours after taking the tablet. By taking the tablet much earlier before the next breastfeeding, the amount of active substance that could pass into the baby's body through breast milk can be reduced.
Fertility
ESCAPELLE increases the likelihood of menstrual disorders, 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, the patient should expect a rapid return to fertility. Therefore, after taking ESCAPELLE, 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 will affect the ability to drive and use machines. However, if the patient feels tired or dizzy, they should not drive or operate machinery.

ESCAPELLE contains orange yellow S (E110), aspartame (E951), and sodium

The medicine contains orange yellow S (E110), which may cause allergic reactions.
The medicine contains 0.80 mg of aspartame (E951) in each orally disintegrating tablet. Aspartame is a source of phenylalanine. It may be harmful to patients with phenylketonuria. This is a rare genetic disorder in which phenylalanine accumulates in the body due to its impaired excretion.
The medicine contains less than 1 mmol (23 mg) of sodium per orally disintegrating tablet, which means the medicine is considered "sodium-free".

3. How to take ESCAPELLE

This medicine should always be taken according to the doctor's instructions. In case of doubts, the patient should consult their doctor.
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 is. The tablet can only prevent pregnancy if taken within 72 hours after unprotected sex.

• ESCAPELLE can be taken on any day of the menstrual cycle, provided the patient is not pregnant or does not think they may be pregnant. The tablet should be removed from the blister pack with dry hands, placed on the tongue, where it will dissolve, and then swallowed. The tablets should not be chewed.
• If the patient is taking any medicines that may reduce the effectiveness of ESCAPELLE (see "ESCAPELLE and other medicines" above) or if the patient has taken any of these medicines in the last 4 weeks, ESCAPELLE may not be suitable for them. The doctor may prescribe another type of emergency contraception (after unprotected sex), such as a copper intrauterine device (Cu-IUD). If this is not the case for the patient or the patient cannot immediately consult a doctor, they can take a double dose of ESCAPELLE (i.e., 2 tablets at the same time).

If the patient is using a regular contraceptive method, such as birth control pills, they can continue to take them as instructed.

If the patient has unprotected sex again (also during the same menstrual cycle) after taking ESCAPELLE, the tablet will not have a contraceptive effect, and there is again a risk of pregnancy.
In case of any problems related to emergency contraception, the patient should consult a medical professional.

What to do if vomiting occurs

If vomiting occurs within 3 hours of taking the tablet, the patient should take another tablet immediately.

After taking ESCAPELLE

If the patient is not taking birth control pills and plans to have sex after taking ESCAPELLE, they should use condoms or a diaphragm with spermicides until the next menstrual period. This is necessary because ESCAPELLE is not effective in the event of another unprotected sex before the next scheduled menstrual period.
About 3 weeks after taking ESCAPELLE, the patient is advised to have a medical check-up to ensure that the medicine was effective. If menstrual bleeding is delayed by more than 5 days or is unusually light or heavy, the patient should consult their doctor as soon as possible. If the patient becomes pregnant despite taking ESCAPELLE, 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 birth control pills, 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

After taking ESCAPELLE, menstrual bleeding is usually normal and starts on the same day as usual, but it may sometimes occur a few days later or earlier. If menstrual bleeding is delayed by more than 5 days, or if it is unusually light or heavy, the patient should consult their doctor as soon as possible.

Overdose of ESCAPELLE

Although no serious side effects have been reported in case of overdose, nausea, vomiting, and bleeding from the genital tract may occur. The patient should consult their pharmacist, doctor, nurse, or family planning specialist, especially if vomiting has occurred, as the tablet may not work.
In case of any further doubts about the use of this medicine, the patient should consult their 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 people):

• Nausea.
• Irrregular bleeding may occur until the next menstrual period.
• Lower abdominal pain may occur.
• Feeling tired.
• Headache.

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

• Vomiting. If vomiting occurs, the patient should read the information in the section "What to do if vomiting occurs".
• Menstrual bleeding may be different than usual. In most women, menstrual bleeding is normal and occurs at the expected time, but in some women, it may occur later or earlier than usual. Irregular bleeding or spotting may also occur. If menstrual bleeding 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 people):

• Rash, hives, itching, facial swelling, pelvic pain, painful menstruation, abdominal pain.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in the leaflet, they should tell their 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 02-222 Warsaw Tel.: +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, more information can be collected on the safety of the medicine.

5. How to store ESCAPELLE

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.
There are no special precautions for storage temperature.
Store in the original packaging to protect from moisture.
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 contains

The active substance of the medicine is levonorgestrel. Each tablet contains 1.5 mg of levonorgestrel.
The other ingredients are: mannitol, maize starch, hydroxypropylcellulose, low-substituted crospovidone type B, sodium stearyl fumarate, anhydrous colloidal silica, aspartame (E951), orange flavor [maize maltodextrin, flavoring substances, alpha-tocopherol], Opadry orange 03A230010: hypromellose 2910, titanium dioxide (E171), orange yellow S (E110), iron oxide yellow (E172), indigo carmine (E132),

What ESCAPELLE looks like and what the packaging contains

A round tablet with a diameter of 6 mm, convex on both sides, pale orange with darker spots.

With an embossed inscription on one side of the tablet, the other side of the tablet is not embossed. The tablet has a light orange odor.
ESCAPELLE orally disintegrating tablet is packaged in a blister pack of PVC/Aluminum foil. The blister pack is placed in a laminated sachet of PET/Aluminum/PE foil and packed in a cardboard box with a patient leaflet attached.
Pack size:
ESCAPELLE is available in packaging containing 1 orally disintegrating tablet.

Marketing authorization holder and manufacturer:

Gedeon Richter Polska Sp. z o.o.
ul. ks. J. Poniatowskiego 5
05-825 Grodzisk Mazowiecki

Manufacturer:

Gedeon Richter Plc.
Gyömrői út 19-21
1103 Budapest
Hungary

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Poland
ESCAPELLE
Czech Republic
ESCAPELLE
Lithuania
ESCAPELLE 1,5 mg burnoji tirpstanti tabletė
France
LEVONORGESTREL BIOGARAN 1.5 mg, comprimé orodispersible
Portugal
POSTINOR ODIS
Spain
POSTINOR 1,5 mg comprimido bucodispersable

Date of last revision of the leaflet: