Land: Irland
Sprog: engelsk
Kilde: HPRA (Health Products Regulatory Authority)
DROSPIRENONE ETHINYLESTRADIOL
Bayer Limited
3.0/0.020 Milligram
Tablets
2007-11-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Liofora 0.02 mg/3 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.020 mg ethinylestradiol (as betadex clathrate) and 3 mg drospirenone. Excipient: lactose 46 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Light pink, round tablet with convex faces, one side embossed with the letters "DS" in a regular hexagon. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral use HOW TO TAKE LIOFORA 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 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 LIOFORA • 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 Liofora 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 previous COC. In case a vaginal ring or transdermal patch has been used, the woman should start using Liofora preferably on the day of removal, but at the Læs hele dokumentet