ESCAPELLE 1500 MCG Tabletka powlekana

Treść ulotki

1. Escapelle 1500 micrograms tablets
   1. What is Escapelle and what is it used for
   2. What you need to know before taking ESCAPELLE
   3. How to take Escapelle
   4. Possible side effects
   5. How to store Escapelle
   6. Contents of the pack and other information

Escapelle 1500 micrograms tablets

levonorgestrel

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Take this medicine exactly as described in this leaflet or as your pharmacist has told you.
• Keep this leaflet. You may need to read it again.
• If you want more information or advice, ask your pharmacist.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of 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 is Escapelle and what is it used for

Escapelle is an emergency contraceptive that can be used within 72 hours (3 days) after unprotected sexual intercourse, or in case of failure of your usual contraceptive method.
It concerns the following cases:

• No form of contraception was used during sexual intercourse.
• The contraceptive measure was not used correctly, for example in case of penetration, slippage or incorrect use of the condom; if the vaginal pessary or diaphragm has shifted, burst, broken or was removed prematurely; in case of failure to withdraw during interrupted intercourse (e.g. with ejaculation of sperm inside the vagina or on the external genitalia).

Escapelle contains a synthetic active ingredient similar to a hormone, called levonorgestrel. It prevents
about 84% of expected pregnancies if taken within 72 hours after unprotected sexual intercourse.
It may not always be able to prevent a pregnancy and is more effective if taken as soon as possible
after unprotected intercourse. It is advisable to take it within 12 hours, rather than delaying its
administration until the third day.
Escapelle is believed to work by:

• preventing the ovaries from releasing an egg
• preventing sperm from fertilizing an egg already released from the ovaries

Escapelle can only prevent a pregnancy if taken within 72 hours after unprotected sexual
intercourse. It will have no effect if the pregnancy is already established. If another unprotected sexual
intercourse occurs after using Escapelle (even if this happens during the same menstrual cycle), the
tablet will not exert its contraceptive effect and there is again a risk of pregnancy.
The use of Escapelle is not indicated before the first menstrual period (menarche).

2. What you need to know before taking ESCAPELLE

Do not take Escapelle:

• if you are allergic to the active substance or to any of the other ingredients of this medicine listed in section 6.

Warnings and precautions
If you suffer from any of the following conditions, tell your doctor before taking Escapelle, as
emergency contraception may not be suitable for you. Your doctor may prescribe you a
different type of emergency contraception.

• If you are pregnant or think you may already be pregnant, as this medicine will have no effect if the pregnancy is already in progress. If you are already pregnant, Escapelle is not able to terminate the pregnancy, therefore Escapelle is not an “abortion pill”.

You may already be pregnant if:

• your menstrual period is already more than 5 days late, or if you have had unusual bleeding between your periods
• you have had unprotected sexual intercourse more than 72 hours ago, and after your last menstrual period.

The use of Escapelle is not recommended if:

• you suffer from a disease of the small intestine (such as Crohn's disease) that inhibits the absorption of the medicine
• you suffer from severe liver problems
• you have had ectopic pregnancies in the past (where the baby develops outside the uterus)
• you have suffered from salpingitis in the past (inflammation of the fallopian tubes).

In the case of a previous ectopic pregnancy or previous infection of the fallopian tubes, the risk
of a new ectopic pregnancy increases.
In all women, emergency contraception should be taken as soon as possible after unprotected intercourse.
There is evidence that Escapelle may be less effective with increasing body weight
or body mass index (BMI), but this data has been limited and inconclusive.
Therefore, Escapelle is still recommended for all women regardless of their weight or
body mass index (BMI).
If you are concerned about any problem related to taking emergency contraception, it is
recommended to talk to a healthcare professional.

Children and adolescents
The use of Escapelle is not indicated before the first menstrual period (menarche).

If you are concerned about the risk of sexually transmitted diseases
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If you have not used a condom (or if it has broken or slipped) during sexual intercourse
you may have contracted a sexually transmitted disease or the HIV virus.
This medicine will not protect you from sexually transmitted diseases: only condoms can
offer such protection. If this concerns you, contact your doctor, nurse, family planning
clinic or pharmacist for advice.

Other medicines and Escapelle
Tell your doctor or pharmacist if you are taking, have recently taken or might take
any other medicines.
Some medicines can prevent Escapelle from working effectively. If you have used any
of the medicines listed below during the last 4 weeks, Escapelle may be less suitable
for you. Your doctor may prescribe you another type (non-hormonal) of emergency contraception, namely a
copper intrauterine device (Cu-IUD). If this is not an acceptable option for you
or if you cannot promptly see a doctor, take a double dose of Escapelle:

• barbiturates and other medicines used for the treatment of epilepsy (e.g. primidone, phenytoin and carbamazepine)
• medicines used in the treatment of tuberculosis (e.g. rifampicin, rifabutin)
• a treatment for HIV (ritonavir, efavirenz)
• a medicine used to treat fungal infections (griseofulvin)
• herbal preparations containing St John's Wort (Hypericum perforatum).

Ask your doctor or pharmacist if you need further advice on the correct dose of medicine
for you.
After taking the tablets, see your doctor as soon as possible for further advice on how to use regular
and reliable contraception and to rule out a
pregnancy (See also section 3 “How to take Escapelle” for more information).
Escapelle may also have effects on the way other medicines work:

• a medicine called cyclosporine (suppresses the immune system).

How often can you use Escapelle
Escapelle must only be used in emergency situations, not as a regular method of contraception.
If Escapelle is used more than once in the same menstrual cycle, it is less reliable and will more
likely have effects on your cycle (menstruation).
Escapelle is not as effective as regular methods of contraception. Your doctor, nurse
or family planning clinic can inform you about long-term methods of contraception that
are more effective in preventing pregnancy.

Pregnancy, breastfeeding and fertility
If you are pregnant, if you suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before taking any medicine.

Pregnancy
Do not take this medicine if you are already pregnant. If you become pregnant despite taking
this medicine, it is important that you see your doctor. It has not been shown that Escapelle is
harmful to the fetus while growing in your uterus if taken as directed. However, the
doctor may want to check that you are not having an ectopic pregnancy (where the fetus grows
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outside the uterus). This is particularly important if you suffer from severe abdominal pain
after taking Escapelle, or if you have had an ectopic pregnancy, surgery on your fallopian tubes or a pelvic inflammatory disease in the past.

Breastfeeding
The active substance of this medicine is excreted in breast milk. Therefore, it is recommended
to take the tablet immediately after breastfeeding and to avoid breastfeeding for at least 8
hours after taking levonorgestrel and then collect the milk with a pump 8 hours after
taking the tablet. This way you will take the tablet a long time before the next feeding
and reduce the amount of active substance that your baby could take with breast milk.

Fertility
Escapelle increases the possibility of menstrual disorders that can sometimes lead to
early or delayed ovulation causing changes in the period of fertility. Although there is no data
on long-term fertility, a rapid return to
normal fertility is expected after treatment with Escapelle and therefore regular contraception should be continued or
started as soon as possible after use of Escapelle.

Driving and using machines
It is unlikely that Escapelle will affect your ability to drive or operate machinery.
However, do not drive or operate machinery if you feel tired or dizzy.

Escapelle contains lactose
If you have intolerance to sugar from milk (lactose), note that each Escapelle tablet
also contains 142.5 mg of lactose monohydrate.
If your doctor has diagnosed you with intolerance to certain sugars, contact him before taking
this medicine.

3. How to take Escapelle

Take this medicine following exactly the instructions of your doctor or pharmacist. If you
have any doubts, ask your doctor or pharmacist.
Take the tablet as soon as possible, preferably within 12 hours and no later than 72 hours (3 days)
after you have had unprotected sex. Do not delay taking the tablet.
The effectiveness of the tablet is greater the sooner it is taken after unprotected sex. It can
prevent pregnancy only if it is taken within 72 hours of unprotected sex.

• Escapelle can be taken at any time during your menstrual cycle, provided that you are not already pregnant or think you might be. Do not chew and swallow the tablet whole with water.
• If you are using any of the medicines that may prevent Escapelle from working properly (see the paragraph above “Other medicines and Escapelle”) or if you have used any of these medicines in the last 4 weeks, Escapelle may be less effective for you. Your doctor may prescribe you another type of emergency contraception (non-hormonal), i.e. a copper intrauterine device (Cu-IUD). If this is not an acceptable option for you or if you cannot promptly see a doctor, take a double dose of Escapelle (i.e. 2 tablets taken together at the same time).

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• If you are already using a regular method of contraception, such as the pill, you can continue taking it at your usual times.

If you have had another unprotected sexual intercourse after using Escapelle (even if this occurs in the
same menstrual cycle), the tablet will have no contraceptive effect and there will be a risk of pregnancy again.
If you are concerned about any problem related to taking emergency contraception, it is
recommended to talk to a healthcare professional.

What to do in case of vomiting
If you vomit within three hours of taking the tablet, immediately take another
tablet.

After taking Escapelle
After taking Escapelle, if you want to have intercourse and are not using the contraceptive pill,
use condoms or a diaphragm plus a spermicide until your next menstrual period. In fact,
Escapelle will have no effect if you have another unprotected sexual intercourse before your next
menstruation.
After taking Escapelle, it is advisable to make an appointment with your doctor about three weeks
later, to check that Escapelle has been successful. If your menstruation is delayed by more than 5
days, or is unusually light or heavy, contact your doctor as soon as possible. If you become
pregnant despite taking this medicine, it is important that you see your doctor.
Your doctor can also inform you about long-term contraceptive methods that are more
effective in preventing pregnancies.
If you continue to use your regular hormonal contraception, such as the pill, and do not have bleeding
during the period when you stop taking it, see your doctor to rule out pregnancy.

Your next menstrual period after taking Escapelle
After using Escapelle, your menstrual flow is normally normal and starts on the usual day,
although sometimes there will be a few days delay or advance. If your menstruation is delayed by more than 5
days compared to your expectations, if you notice ‘abnormal’ bleeding around that date, or if you think you
are pregnant, check if you are pregnant by taking a pregnancy test.

If you take more Escapelle than you should
Although no serious adverse effects have been reported due to taking an
excessive number of tablets simultaneously, you may feel unwell, feel sick (vomit) or
have vaginal bleeding. Contact your pharmacist, doctor, nurse or family planning
clinic for advice, especially if you have vomited, as in this case the tablet may not
have worked correctly.
If you have any doubts about using Escapelle, contact your doctor or pharmacist.

4. Possible side effects

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Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

• Feeling unwell (nausea)
• Possible irregular bleeding until the next menstrual period
• Possible lower abdominal pain
• Fatigue
• Headache.

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

• Vomiting. If you vomit, read the paragraph ‘What to do if you vomit’.
• Your menstrual period may be different from usual. Most women will have a normal flow on the expected date, but in some cases the period may be delayed or early. Irregular bleeding or the appearance of slight spotting is also possible, until the next menstrual period. If your period is delayed by more than 5 days, or is unusually light or heavy, contact your doctor as soon as possible.
• You may experience breast tenderness, diarrhoea, dizziness after taking this medicine.

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

• Skin rash, urticaria, itching, facial swelling, pelvic pain, painful menstruation.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor, pharmacist or nurse. You can also report side effects directly through the national reporting system at
www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
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 packaging after “Exp.” The
expiry date refers to the last day of that month.
Store in the original packaging to protect the medicine from light.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Escapelle contains
The active ingredient is levonorgestrel. Each tablet contains 1500 micrograms of levonorgestrel.
The other ingredients are:
Potato starch,
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Corn starch,
Anhydrous colloidal silica,
Magnesium stearate,
Talc,
Lactose monohydrate.

Description of the appearance of Escapelle and contents of the pack
Tablet: whitish, flat, edged tablet with a diameter of approximately 8 mm, bearing the inscription
“G00” imprinted on one side.
Pack: One tablet in a PVC/aluminium blister and a cardboard box.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder
Gedeon Richter Plc.
Gyömrői út 19-21
H-1103 Budapest, Hungary

Manufacturer responsible for batch release
Gedeon Richter Plc.
Gyömrői út 19-21.
H-1103 Budapest, Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the
following denominations:
Austria: Postinor
Belgium: Postinor 1500
Czech Republic: Escapelle
France: Levonorgestrel Biogaran
Germany: Postinor
Greece: Postinor 1500
Iceland: Postinor
Ireland: Ramonna
Italy: Escapelle
Lithuania: Escapelle
Luxembourg: Postinor
Netherlands: Postinor
Norway: Postinor
Poland: Escapelle
Portugal: Postinor
Spain: Postinor
Sweden: Postinor
United Kingdom: Levonelle 1500
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