Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
DROSPIRENONE ETHINYLESTRADIOL
Rowex Ltd
0.03 / 3 Milligram
Film Coated Tablet
2012-03-16
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ethinylestradiol / Drospirenone Leon Farma 0.03 mg/3 mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.03 mg of ethinylestradiol and 3 mg of drospirenone Excipient: Lactose monohydrate 62 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. Yellow, round film-coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Route of administration: oral use. HOW TO TAKE ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA 0.03MG/3MG FILM-COATED TABLETS The tablets must be taken every day at about the same time, if necessary with a little liquid in the order shown on blister pack. One tablet is to be taken daily for 21 consecutive days. Each subsequent pack is started after 7-day tablet-free interval, during which time withdrawal bleed 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 TAKE ETHINYLESTRADIOL / DROSPIRENONE LEON FARMA 0.03MG/3MG FILM-COATED TABLETS · 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 another combined oral contraceptive (COC) The woman should start Ethinylestradiol / Drospirenone Leon Farma 0.03mg/3mg Film-coated Tablets on the day following the usual hormone free interval (tablet-free or placebo tablet interval) of herprevious combined oral contraceptive method. In case a vaginal ring or transdermal patch has been used the woman should start using Ethinylestradiol / Drospirenone Leon Farma 0.03mg/3mg Film-coated tablets preferably Read the complete document