Jeanine 0.03mg+2mg tablets coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

ethinylestradiol, dienogest

Available from:

Bayer Weimar GmbH & Co. KG

ATC code:

G03AA16

INN (International Name):

ethinylestradiol, dienogest

Dosage:

0.03mg+2mg

Pharmaceutical form:

tablets coated

Units in package:

(21/1x21/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2018-10-16

Summary of Product characteristics

1
RESTRICTED
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Jeanine
®
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each coated tablet contains 0.030 mg ethinylestradiol and 2 mg
dienogest
Excipient with known effect: lactose 27 mg
glucose 1.65 mg
sucrose 23.69 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Coated tablet, white
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Jeanine should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with
Jeanine compares with other combined hormonal contraceptives (CHCs)
(see sections 4.3 and 4.4).
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Oral use
Posology
2
RESTRICTED
HOW TO TAKE JEANINE
The tablets must be taken every day at about the same time, if
necessary with a little liquid, in the
order shown on the blister pack. One tablet is to be taken daily for
21 consecutive days. Each
subsequent pack is started after a 7-day tablet-free interval, during
which time a withdrawal bleed
usually occurs. This usually starts on day 2-3 after the last tablet
and may not have finished before
the next pack is started.
HOW TO START JEANINE
No preceding hormonal contraceptive use (in the past month)
Tablet-taking has to start on day 1 of the woman’s natural cycle
(i.e. the first day of her menstrual
bleeding).

Changing from another combined oral contraceptive (COC)
The woman should start with Jeanine preferably on the day after the
last hormone-containing tablet
of her previous COC, but at the latest on the day following the usual
tablet-free or hormone-free
tablet interval of her previous COC.

Changing from a vaginal ring or transdermal patch
The woman should start using Jeanine preferably on the day of removal
of the last ring or patch of a
cycle pack, but at the latest when the next application would have
been due.

Changing from a progestogen-only-method (progestogen-only pill,