ESCAPELLE TBL 1.5MG

ATC code: G03AC03 

Active substances: Levonorgestrelum

Vendor, principal: Gedeon Richter. 
No prescription needed/Patient care products, dressings, gloves, medical devices,...

ESCAPELLE 1.5MG

Package leaflet: Information for the user

Escapelle, 1.5 mg tablet

Levonorgestrel

Read all of this leaflet carefully before you start taking this medicine because it contains important information for you.

-   Always use this medication exactly in the way that is described in this leaflet or was explained to you by your doctor or pharmacist.
-   Keep this leaflet. You may need to read it again.
-   If you have any further questions, ask your doctor or pharmacist.
-   If any side effects occur, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1.   What Escapelle is and what it is used for
2.   What you need to know before you take Escapelle
3.   How to take Escapelle
4.   Possible side effects
5.   How to store Escapelle
6.   Contents of the pack and other information

1.   What Escapelle is and what it is used for

Escapelle contains levonorgestrel (gestagen) as the active substance. The effect of the medicine lies in avoiding ovulation and conception if the intercourse has occurred in the preovulatory phase, when the probability of conception is the highest.
Escapelle is not effective once the process of implantation of a fertilised egg has begun.

Indication

Emergency contraception within 72 hours after unprotected sexual intercourse or in case of failure of a contraceptive method.
Escapelle is not intended for use before the first menstrual cycle.

2.   What you need to know before you take Escapelle Do not take Escapelle

- if you are allergic to levonorgestrel or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions

Talk to your doctor or pharmacist before using Escapelle._
Emergency contraception is an occasional method and it should in no instance replace a regular contraceptive method.
Emergency contraception does not prevent a pregnancy in every instance. If there is uncertainty about the timing of the unprotected intercourse or if the woman has had unprotected intercourse more than 72 hours earlier during the same menstrual cycle, conception may have occurred. Treatment with Escapelle following the second sexual intercourse may therefore be ineffective in preventing pregnancy.
If, after taking Escapelle, the menstrual period is delayed by more than 5 days or abnormal bleeding occurs at the expected date of menstrual period or pregnancy is suspected because of any other reason, your doctor must perform an examination to exclude pregnancy.
If pregnancy occurs after treatment with Escapelle, the attending doctor should consider the possibility of an ectopic pregnancy. The absolute risk of ectopic pregnancy is likely to be low, as levonorgestrel prevents ovulation and conception. Ectopic pregnancy may continue despite the occurrence of uterine bleeding.
Therefore, levonorgestrel is not recommended for patients who are at risk of ectopic pregnancy (a history of salpingitis or ectopic pregnancy).
Gastrointestinal diseases impairing your digestion (e.g. in case of Crohn’s disease) may reduce the efficacy of Escapelle.
After Escapelle intake, menstrual bleeding is usually normal and occurs at the expected date.
This can sometimes occur a few days earlier or later than expected. In this case, the doctor should recommend that you come to an appointment to initiate a method of regular contraception.
If no menstrual period occurs after the tablet-free period of regular hormonal contraceptive method, your doctor must perform an examination to exclude pregnancy.
Due to the risk of disturbances of the menstrual cycle, the repeated administration of Escapelle during one menstrual cycle is not recommended.
Escapelle is not as effective as traditional regular contraception methods and is suitable for use only as an emergency method. Women who use emergency contraception repeatedly should be recommended by the attending doctor to consider the use of long-term methods of contraception.
The use of emergency contraception does not replace the required precautions against sexually transmitted diseases.
Please tell your doctor if any of the above applies to you, even in the past.
All women must take the emergency contraceptive as soon as possible after the unprotected intercourse. There is some evidence that Escapelle may be less effective with increased body weight and body mass index, but these data were limited and inconclusive. Therefore, Escapelle is still recommended for all women, regardless of their body weight or body mass index.
If you have questions regarding the emergency contraceptives, you are recommended to talk to your healthcare specialist.

Children and adolescents

Escapelle is not intended for use before the first menstrual cycle.

Other medicines and Escapelle

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought without prescription or herbal products.
Some medicines might decrease the efficacy of Escapelle. If you have used any of the following medicines during the last 4 weeks, Escapelle might not be suitable for you. Your doctor might prescribe some other (non-hormonal) emergency contraception method, e.g. a copper intrauterine device. If this does not suit you or you are not able to visit your doctor, you may administer a double dose of Escapelle:
-   barbiturates and other anti-epileptic medicines (e.g. primidone, phenytoin, and carbamazepine),
-   tuberculosis medicines (e.g. rifampicine, rifabutin),
-   antiretroviral treatment (ritonavir, efavirens),
-   antifungal medicines (griseofulvin),
-   herbal medicines containing St. John’s wort (Hypericum perforatum).
Consult your pharmacist or doctor if you need advice on suitable dosage.
Consult your doctor as soon as possible after taking the pills in order to find a suitable long-term contraceptive method for you, and to exclude pregnancy (for additional information, see section 3 ‘How to take Escapelle’).
Escapelle might affect the effect of other medicines. Therefore, co-administration of the following medicine with Escapelle is not recommended:
- immunosuppressive drug (cyclosporine).

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnant women should not take Escapelle. Escapelle will not interrupt an ongoing pregnancy.
Limited epidemiological data indicate that in case of inefficiency of Escapelle and ongoing pregnancy, no adverse effects on the foetus are expected. There are no clinical data about possible effects on the foetus if levonorgestrel is taken in higher doses than 1.5 mg.
If you become pregnant after taking Escapelle, contact your doctor immediately.
Levonorgestrel is excreted into breast milk (0.1% of the administered dose). Infant’s exposure to levonorgestrel can be reduced if the breast-feeding woman takes the tablet immediately after nursing and avoids breast-feeding for at least 8 hours after the administration of the tablet.
Escapelle increases the risk of menstrual disorders that may sometimes lead to an earlier or later occurrence of ovulation. The result of these changes may be the change of fertile dates; nonetheless, there are no long-term data about fertility.

Patients with hepatic impairment

Escapelle is not recommended in patients with severe hepatic dysfunction.

Driving and using machines

No studies on the effects on the ability to drive and use machines have been reported.

Escapelle contains lactose monohydrate

If you have been told by your doctor that you have intolerance to some sugars, talk to your doctor before taking this medicine.

3. How to take Escapelle

Always take this medicine exactly as explained in this information leaflet or by your pharmacist. Check with your doctor or pharmacist if you are not sure.
Take the Escapelle tablet as soon as possible, preferably in 12 hours, but not later than 72 hours (3 days) after unprotected sexual intercourse. Escapelle may be used at any time during the menstrual cycle, except when you are already pregnant or think you may be pregnant. Do not chew the tablet; swallow it whole with water. Do not postpone taking the tablet. The sooner you take the tablet after the unprotected sexual intercourse, the more effective the tablet is.
If you are using some medicine which may decrease the effectiveness of Escapelle (see section ‘Other medicines and Escapelle’) or you have used any of these medicines during the last 4 weeks, Escapelle might not be effective for you. Your doctor might prescribe some other (non-hormonal) emergency contraception method, e.g. copper intrauterine device. If this does not suit you or you are not able to visit your doctor, you may administer a double dose of Escapelle (e.g. administering two tablets at once).
If you are already using regular contraception (e.g. contraceptive pills), you may continue its regular use.
If you vomit within three hours of taking Escapelle tablet, you should take another tablet immediately. After using emergency contraception, it is recommended to use a barrier method (e.g. condom, pessary, spermicide, cervical cap) until your next menstrual period.

If you take more Escapelle than you should

If you take a bigger dose than you should, talk to your doctor or pharmacist immediately.

If you forget to take Escapelle

Escapelle is not effective if taken more than 72 hours after unprotected intercourse, as pregnancy may occur during the same menstrual cycle.
If you have any further questions on the use of this medicine, ask your 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 people in 10): nausea, non-menstrual bleeding, headaches, lower abdominal pain, fatigue
Common (may affect up to 1 people in 10): delay of menstruation by more than 7 days, irregular bleeding and spotting, breast tenderness, dizziness, diarrhoea, vomiting
Very rare (may affect up to 1 people in 10,000): pelvic pain, painful menstruation, abdominal pain, facial swelling, rash, urticaria, pruritus
The character of the bleeding may be temporarily impaired, but in most women, the menstrual cycle starts when expected.
If the following menstrual cycle is delayed by more than 5 days, contact your doctor immediately to exclude pregnancy.
If you need more detailed information about the side effects mentioned above, talk to your doctor or pharmacist.

Reporting of side effects

If any side effects occur, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via www.ravimiamet.ee. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Escapelle

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton. The expiry date refers to the last day of that month.
Store in the original package, protected from light.
Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information What Escapelle contains

-   The active substance is levonorgestrel (synthetic luteal hormone-like substance).
-   The other ingredients are potato starch, corn starch, anhydrous colloidal silica, magnesium stearate, talcum, lactose monohydrate.

What Escapelle looks like and contents of the pack

Almost white flat-edged tablet with a diameter of about 8 mm, with the marking “G00” on one side. Escapelle is packed in aluminium/PVC blister (1 tablet), which is packed in a carton.

Marketing Authorisation Holder and Manufacturer

Gedeon Richter Plc.
Gyömröi ut 19-21.
H-1103 Budapest Hungary
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Richter Gedeon Estonian branch Adamsoni 2 Tallinn 10137 Phone 608 5301

This leaflet was last revised in January 2018