POSTINOR-2 TABLET 0.75MG

国家: 马来西亚

语言: 英文

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

有效成分:

LEVONORGESTREL

可用日期:

PAHANG PHARMACY SDN. BHD.

INN（国际名称）:

LEVONORGESTREL

每包单位数:

10Tablet Tablets; 2Tablet Tablets

厂商:

Gedeon Richter Plc.

资料单张

_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_
POSTINOR-2
® TABLETS
Levonorgestrel (0.75 mg)
1
WHAT IS IN THIS LEAFLET
1.
What _Postinor-2_ is used for
2.
How _Postinor-2_ works
_3._
_ _
Before you use _Postinor-2 _
4.
How to use _Postinor-2_
5.
While you are using it
6.
Side effects
_7._
_ _
Storage and Disposal of _Postinor-2 _
8.
Product Description
9.
Manufacturer and Product
Registration Holder
10.
Date of revision
WHAT _POSTINOR-2_ IS USED FOR
_Postinor-2_ tablet is an emergency
contraceptive preparation that can be used
within 72 hours (3 days) of unprotected
sex or if your usual contraceptive method
has failed.
HOW _POSTINOR-2_ WORKS
_Postinor-2_ tablet contains a synthetic
hormone-like active substance called
levonorgestrel.
It prevents about 84% of expected
pregnancies when you take it within 72
hours (3 days) of having unprotected sex.
It will not prevent a pregnancy in every
time
_Postinor-2_ tablet is thought to work by:
•
stopping your ovaries from releasing
an egg;
•
preventing sperm from fertilising any
egg you may have already released.
_Postinor-2_ can only prevent you
becoming pregnant if you take it within
72 hours of unprotected sex. It does not
work if you are already pregnant.
BEFORE YOU USE _POSTINOR-2 _
_- When you must not use it _
- If you are allergic to levonorgestrel or
any of the other ingredients of this
medicine (listed in section Product
Description).
- A previous ectopic pregnancy or
previous infection of the Fallopian tubes
(the tubes that connect the ovaries (where
the eggs are produced) with the womb)
increases the risk of a new ectopic
pregnancy.
If any of these apply to you, _Postinor-2_
tablet may not be suitable for you, or
other types of emergency contraception
may be better for you.
There is some evidence that _Postinor-2_
may be less effective with increasing
body weight or body mass index (BMI),
but these data were limited and
inconclusive. Therefore, _Postinor-2_ is still
recommended for all women regardless of
their weight or BMI.
_Children and adolescents _

产品特点

ACTIVE SUBSTANCE
0.75 mg levonorgestrel in each tablet.
Other ingredients:
silica colloidal anhydrous, magnesium stearate, potato starch, talc,
maize starch, lactose monohydrate.
PRODUCT DESCRIPTION
Tablet.
Almost white, round, rimmed, flat tablets with an impressed mark of
“INOR”on one side.
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., 2006 and Glasier et al., 2010) a reduced contraceptive
efficacy was observed with increasing body weight or BMI
(Table 2). Both meta‑analyses excluded intake later than 72 hours
after unprotected intercourse