Yarina 3mg+30mcg tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

drospirenone, ethinylestradiol

Available from:

Bayer Pharma AG

ATC code:

G03AA12

INN (International Name):

drospirenone, ethinylestradiol

Dosage:

3mg+30mcg

Pharmaceutical form:

tablets film-coated

Units in package:

(21/1x21/) blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-10-11

Summary of Product characteristics

YARINA SmPC
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SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Yarina 0.03 mg / 3 mg film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each tablet contains 0.030 mg ethinylestradiol and 3 mg drospirenone
Excipient with known effect: lactose 46 mg
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablets
Light yellow, round tablets with convex faces, one side embossed with
the letters "DO" in a
regular hexagon
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception
The decision to prescribe Yarina should take into consideration the
individual woman’s
current risk factors, particularly those for venous thromboembolism
(VTE), and how the risk
of VTE with Yarina compares with other combined hormonal
contraceptives (CHCs), see
sections 4.3 and 4.4.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
_METHOD OF ADMINISTRATION _
Oral use
_POSOLOGY _
HOW TO TAKE YARINA
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
YARINA SmPC
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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 YARINA

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 a combined hormonal contraceptive (combined oral
contraceptive
(COC), vaginal ring, or transdermal patch)
The woman should start with Yarina preferably on the day after the
last active tablet (the last
tablet containing the active substances) of her previous COC, but at
the latest on the day
following the usual tablet-free or placebo tablet interval of her