Escapelle Tablet 1.5mg

Country: Malaysia

Bahasa: Inggeris

Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Bahan aktif:

LEVONORGESTREL

Boleh didapati daripada:

PAHANG PHARMACY SDN. BHD.

INN (Nama Antarabangsa):

LEVONORGESTREL

Unit dalam pakej:

1Tablet Tablets

Dikeluarkan oleh:

Gedeon Richter Plc.

Risalah maklumat

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _
ESCAPELLE
® TABLET
Levonorgestrel (1.5 mg)
1
WHAT IS IN THIS LEAFLET
1.
What _Escapelle_ is used for
2.
How _Escapelle_ works
3.
Before you use _Escapelle_
4.
How to use _Escapelle_
5.
While you are using it
6.
Side effects
7.
Storage and Disposal of _Escapelle_
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10. Date of revision
WHAT _ESCAPELLE_ IS USED FOR
_Escapelle_ is an emergency contraceptive
that can be used within 72 hours
(3 days) of unprotected sex or if your
usual contraceptive method has failed.
HOW _ESCAPELLE_ WORKS
_Escapelle_ contains a synthetic hormone
called levonorgestrel. _Escapelle_
prevents about 84% of expected
pregnancies when you take it within
72 hours of having unprotected sex. It
will not prevent a pregnancy every time.
If another unprotected sex takes place
after the use of _Escapelle _(also if this is
during the same menstrual cycle), the
tablet will not exert its contraceptive
effect and there is again the risk of
pregnancy.
_Escapelle_ is thought to work by:
•
stopping your ovaries from releasing
an egg;
•
preventing sperm from fertilising
any egg you may have already
released.
BEFORE YOU USE _ESCAPELLE_
-
_When you must not use it _
If you are hypersensitive to
levonorgestrel or any of the ingredients
of this medicine.
_Escapelle_ is not indicated for use before
the first menstrual bleeding (menarche).
Pregnancy and lactation
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
any medicine.
_Pregnancy _
You should not take this medicine if you
are already pregnant. If you do become
pregnant even after taking this
medicine, it is important that you see
your doctor. There is no evidence that
_Escapelle_ will harm a baby that
develops in your uterus/womb if you
use _Escapelle_ as described.
Nevertheless, your doctor may want to
check that the pregnancy is not ectopic
(where the baby develops somewhere
outsi

Ciri produk

7
Package Insert
BRAND OR PRODUCT NAME
ESCAPELLE
®
1.5 MG TABLET
NAME AND STRENGTH OF ACTIVE SUBSTANCE(S)
Each tablet contains 1.5 mg of levonorgestrel.
Excipient with known effect: each tablet contains 142.5 mg of lactose
monohydrate.
PRODUCT DESCRIPTION
Tablet.
Almost white, flat,rimmed tablets of about 8 mm diameter, with an
impressed mark of ‘GOO’ on one side.
Detailed composition:
Potato starch,
Corn starch,
Colloidal silica anhydrous,
Magnesium stearate,
Talc,
Lactose monohydrate.
PHARMACODYNAMICS/ PHARMACOKINETICS
_Pharmacodynamic properties _
Pharmacotherapeutic group:_ _Sex hormones and modulators of the
genital system, Emergency contraceptives, ATC code: G03AD01
The precise mode of action of levonorgestrel is not known.
At the recommended regimen, levonorgestrel is thought to work mainly
by preventing ovulation and fertilisation if intercourse has taken
place in the preovulatory phase, when the likelihood of fertilisation
is the highest. Levonorgestrel is not effective once the process of
implantation has begun.
_ _
_Efficacy_
It was estimated from the results of an earlier clinical study, that
750 micrograms of levonorgestrel (taken as two 750 microgram doses
with a 12 hour interval) prevents 85% of expected pregnancies.
Efficacy appears to decline with time of start of treatment after
intercourse (95% within 24 hours, 85% 24-48 hours, 58% if started
between 48 and 72 hours)
Results from a recent clinical study showed that two 750 microgram
tablets of levonorgestrel taken at the same time (and within 72
hours of unprotected sex) prevented 84% of expected pregnancies. There
was no difference between pregnancy rates in case of women
who were treated on the third or the fourth day after the unprotected
act of intercourse (p>0.2).
There is limited and inconclusive data on the effect of high body
weight/high BMI on the contraceptive efficacy. In three WHO studies
no trend for a reduced efficacy with increasing body weight/BMI was
observed (Table 1), whereas in the two other studies (Creinin et
al., 200