Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
drospirenone,ethinylestradiol
Bayer Australia Ltd
Drospirenone,ethinylestradiol
Registered
180925 PETIBELLE PI AUST R 178481 Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION PETIBELLE ® (DROSPIRENONE & ETHINYLESTRADIOL) TABLET 1 NAME OF THE MEDICINE PETIBELLE (drospirenone and ethinylestradiol) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each light yellow active tablet contains ethinylestradiol 30 µg and drospirenone 3 mg. Excipients with known effect: Each light yellow active tablet contains 48.17 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 PETIBELLE active tablet is light yellow, round and marked on one side with the letters "DO" in a regular hexagon. Each PETIBELLE placebo tablet is white, round and marked on one side with the letters “DP” in a regular hexagon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PETIBELLE is indicated for use as an oral contraceptive. 4.2 DOSE AND METHOD OF ADMNISTRATION 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. 180925 PETIBELLE PI AUST R 178481 Page 2 of 27 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. Withdrawal bleeding 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 PETIBELLE _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). The women should be instructed to take a light yellow active tablet from the green section of the pack, corresponding to that day of the week. If started on Day 1 in this way, protection against pregnancy is immediate Leggi il documento completo