Država: Avstralija
Jezik: angleščina
Source: Department of Health (Therapeutic Goods Administration)
drospirenone,ethinylestradiol
Bayer Australia Ltd
Drospirenone,ethinylestradiol
Registered
180925 YAZ Pl 133649 Page 1 of 31 AUSTRALIAN PRODUCT INFORMATION YAZ ® (DROSPIRENONE & ETHINYLESTRADIOL) TABLET 1 NAME OF THE MEDICINE YAZ (drospirenone and ethinylestradiol) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each light pink active tablet contains drospirenone 3 mg and ethinylestradiol (as betadex clathrate) 20 g. Excipients with known effect: Each light pink active tablet contains 48.18 mg of lactose monohydrate. Each white placebo tablet contains 52.14 mg of lactose monohydrate. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM Each YAZ active tablet is light pink in colour, marked on one side with the letters "DS" in a regular hexagon. Each YAZ placebo tablet is white in colour, marked on one side with the letters "DP" in a regular hexagon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS YAZ is indicated for use as: an oral contraceptive. treatment of moderate acne vulgaris in women who seek oral contraception. 180925 YAZ Pl 133649 Page 2 of 31 treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of YAZ for PMDD was not assessed beyond 3 cycles. YAZ has not been evaluated for treatment of PMS (premenstrual syndrome). See Section 5.1 PHARMACODYNAMIC PROPERTIES – Clinical trials. 4.2 DOSE AND METHOD OF ADMINISTRATION Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet taking is continuous. One tablet is taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. A withdrawal bleed usually starts on Day 2-3 after starting the white placebo tablets and may not have finished before the next pack is started. HOW TO START YAZ _No preceding Preberite celoten dokument