Qlaira tablets film-coated

Country: Armenia

Language: English

Source: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում

Active ingredient:

I tablet-dark yellow- estradiol (estradiol valerate), II tablet-pink- estradiol (estradiol valerate), dienogest, III tablet- light yellow- estradiol (estradiol valerate), dienogest, IV tablet-red-estradiol (estradiol valerate), V tablet-white-inactive

Available from:

Bayer Weimar GmbH & Co. KG

ATC code:

G03AB08

INN (International Name):

I tablet-dark yellow- estradiol (estradiol valerate), II tablet-pink- estradiol (estradiol valerate), dienogest, III tablet- light yellow- estradiol (estradiol valerate), dienogest, IV tablet-red-estradiol (estradiol valerate), V tablet-white-inactive

Dosage:

3mg+ (2mg+ 2mg)+ (2mg+ 3mg)+ 1mg

Pharmaceutical form:

tablets film-coated

Units in package:

(28/1x28/(2-I tablet)(5-II tablet)/(17-III tablet)(2-IV tablet)(2-V tablet)/), in blister

Prescription type:

Prescription

Authorization status:

Registered

Authorization date:

2019-12-11

Summary of Product characteristics

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Qlaira SmPC, clean version – Dec 2018 – EPITT ref.no. 19144
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Qlaira, film-coated tablets
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each wallet (28 film-coated tablets) contains in the following order:
2 dark yellow tablets each containing 3 mg estradiol valerate
5 medium red tablets each containing 2 mg estradiol valerate and 2 mg
dienogest
17 light yellow tablets each containing 2 mg estradiol valerate and 3
mg dienogest
2 dark red tablets each containing 1 mg estradiol valerate
2 white tablets do not contain active substances
Excipient with known effect: lactose (not more than 50 mg per tablet)
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Film-coated tablet (tablet).
Dark yellow film-coated tablet, round with biconvex faces, one side is
marked with the letters “DD” in a
regular hexagon
Medium red film-coated tablet, round with biconvex faces, one side is
marked with the letters “DJ” in a
regular hexagon
Light yellow film-coated tablet, round with biconvex faces, one side
is marked with the letters “DH” in a
regular hexagon
Dark red film-coated tablet, round with biconvex faces, one side is
marked with the letters “DN” in a
regular hexagon
White film-coated tablet, round with biconvex faces, one side is
marked with the letters “DT” in a regular
hexagon
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Oral contraception.
Treatment of heavy menstrual bleeding in women without organic
pathology who desire oral
contraception.
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Qlaira SmPC, clean version – Dec 2018 – EPITT ref.no. 19144
The decision to prescribe Qlaira should take into consideration the
individual woman’s current risk
factors, particularly those for venous thromboembolism (VTE), and how
the risk of VTE with Qlaira
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