POSTINOR-2

Страна: Индонезия

Език: индонезийски

Източник: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Активна съставка:

LEVONORGESTREL

Предлага се от:

TUNGGAL IDAMAN ABDI - Indonesia

INN (Международно Name):

LEVONORGESTREL

дозиране:

0.75 MG

Лекарствена форма:

TABLET

Броя в опаковка:

DUS, 1 BLISTER @ 2 TABLET

Произведено от:

GEDEON RICHTER PLC. - Hungary

Дата Оторизация:

2020-05-24

Данни за продукта

SUMMARY OF PRODUCT
CHARACTERISTICS
POSTINOR-2 TABLETS
DISETUJUI OLEH BPOM: 06/10/2021
ID REG: EREG10015512000004; EREG10015512000066
1.
NAME OF THE MEDICINAL PRODUCT
Postinor - 2 tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Levonorgestrel 0.75 mg per each tablet
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Tablets
4.
CLINICAL
PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Postinor-2 is an emergency contraceptive which can be used to prevent
pregnancy if taken within 72
hours (three days) following unprotected intercourse or a
contraceptive accident.
As an emergency contraceptive, Postinor-2 is indicated following any
unprotected act of sexual
intercourse, including:
• when no contraceptive has been used
• when a contraceptive method may have failed, including
– condom rupture, slippage or misuse
– diaphragm or cap dislodgement, breakage or early removal
– failed coitus interruptus
– miscalculation of periodic abstinence method
– IUD expulsion
– missed regular oral contraceptive pills for three or more days in
a cycle
• in cases of sexual assault
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
For oral administration:
Two tablets should be taken together, as soon as possible, preferably
within 12 hours, and no later than
72 hours after unprotected intercourse (see section 5.1).
Postinor-2 can be used at any time during the menstrual cycle unless
menstrual bleeding is overdue.
If vomiting occurs within three hours of taking the tablets, another
two tablets should be taken
immediately.
Women
who
have
used enzyme-inducing drugs
during
the last
4
weeks
and
need emergency
contraception are recommended to use a non-hormonal EC, i.e. Cu-IUD or
take a double dose of
levonorgestrel (i.e. 4 tablets together at the same time) for those
women unable or unwilling to use Cu-
IUD (see section 4.5).
After a single act of unprotected intercourse, the treatment fails in
about 1-2% of women who use it
within 72 hours (3 days) after unprotected intercourse
4.3
CONTRAINDICATIONS
Hypersensitivity