Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
ETHINYLESTRADIOL DROSPIRENONE
Bayer Limited
0.03/3 Milligram
Film Coated Tablet
2010-10-29
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Palandra 0.03 mg / 3 mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 0.030 mg ethinylestradiol 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 yellow, round tablet with convex faces, one side embossed with the letters "DO" 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 PALANDRA 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 PALANDRA • 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 Palandra 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 Palandra preferably on the day of removal, but at the latest when the Read the complete document