Country: Israel
Language: English
Source: Ministry of Health
DIENOGEST; DIENOGEST; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE
BAYER ISRAEL LTD
G03CA03
FILM COATED TABLETS
ESTRADIOL VALERATE 1 MG; ESTRADIOL VALERATE 3 MG; DIENOGEST 2 MG; DIENOGEST 3 MG; ESTRADIOL VALERATE 2 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
ESTRADIOL
ESTRADIOL
Oral contraception.Treatment of heavy menstrual bleeding in women without organic pathology who desire oral contraception.
2016-04-30
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT QLAIR 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 monohydrate 48.36, 47.36, 46.36, 50.36, 52.1455 mg, respectively. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets 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. The decision to prescribe Qlair should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Qlair 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 QLAIR Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet tak Read the complete document