ESCAPELLE TABLET

Land: Sør-Afrika

Språk: engelsk

Kilde: South African Health Products Regulatory Authority (SAHPRA)

Tilgjengelig fra:

LITHA PHARMA (PTY) LTD

Dosering :

See ingredients

Legemiddelform:

TABLET

Sammensetning:

EACH TABLET CONTAINS LEVONORGESTREL 1,5 mg

Autorisasjon status:

Registered

Autorisasjon dato:

2008-08-02

Informasjon til brukeren

_________________________________________________________________________________________
Applicant: Litha Pharma (Pty) Ltd
Proprietary name: Escapelle tablet
Dosage form and strength: Each tablet contains 1,50 mg of
levonorgestrel
March 2021
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1
of
6
PROPOSED CLEAN PATIENT INFORMATION LEAFLET
SCHEDULING STATUS:
ESCAPELLE
Levonorgestrel
Tablet
Contains sugar
PLEASE READ THIS LEAFLET CAREFULLY BEFORE TAKING ESCAPELLE TABLETS.

Keep this leaflet. You may need to read it again.

If you have any further questions, please ask your doctor, pharmacist,
nurse or other healthcare
provider.

ESCAPELLE has been prescribed for you personally and you should not
share your medicine with
other people. It may harm them, even if their symptoms are the same as
yours.
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 tablet contains a synthetic luteal hormone-like active
substance, levonorgestrel.
ESCAPELLE is an oral emergency contraceptive. It may help to prevent a
pregnancy if taken within
72 hours of unprotected sexual intercourse or failure of a
contraceptive method or the used method of
contraception was not considered as safe.
S2
_________________________________________________________________________________________
Applicant: Litha Pharma (Pty) Ltd
Proprietary name: Escapelle tablet
Dosage form and strength: Each tablet contains 1,50 mg of
levonorgestrel
March 2021
Page
2
of
6
It has been estimated that ESCAPELLE prevents 84 % of expected
pregnancies when administered
within 72 hours after unprotected intercourse. If you are uncertain
about the timing of unprotected
intercourse or if you have had unprotected sex more than 72 hours
earlier in the same menstrual
cycle, conception may have occurred. Treatment with ESCAPELLE
following the second act of
intercourse may the

Preparatomtale

_____________________________________________________________________________________________
Applicant: Litha Pharma (Pty) Ltd
Proprietary name: Escapelle tablet
Dosage form and strength: Each tablet contains 1,50 mg of
levonorgestrel
March 2021
Page
1
of
9
PROFESSIONAL INFORMATION
SCHEDULING STATUS:
1.
NAME OF MEDICINE
ESCAPELLE tablet
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION:
Each tablet contains 1,50 mg of levonorgestrel.
Contains sugar. Each tablet contains 142.5 mg lactose monohydrate.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Almost white, flat, rimmed tablet of about 8 mm diameter, with an
impression mark of “G00” on one
side.
4.
CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS:
Emergency contraception within 72 hours of unprotected sexual
intercourse or failure of a contraceptive
method.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Posology
The tablet should be taken, no later than 72 hours after unprotected
intercourse.
S2
_____________________________________________________________________________________________
Applicant: Litha Pharma (Pty) Ltd
Proprietary name: Escapelle tablet
Dosage form and strength: Each tablet contains 1,50 mg of
levonorgestrel
March 2021
Page
2
of
9
If the patient vomits within three to four hours of taking the tablet,
another tablet should be taken
immediately.
ESCAPELLE can be used at any time during the menstrual cycle unless
menstrual bleeding is overdue.
After using emergency contraception it is recommended to use a local
barrier method (e.g. condom) until
the next menstrual period starts. The use of ESCAPELLE does not
contraindicate the continuation of
regular hormonal contraception.
Children: ESCAPELLE is not recommended in children.
Very limited data are available in women under 16 years of age.
METHOD OF ADMINISTRATION
For oral administration.
4.3 CONTRAINDICATIONS:

Hypersensitivity to the active substance levonorgestrel or to any of
the excipients.

Severe hepatic insufficiency.

Pregnancy or suspected pregnancy (see sect