Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
LEVONORGESTREL ETHINYLESTRADIOL
Pfizer Healthcare Ireland
100, 20 Microgram
Film Coated Tablet
2010-09-24
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Alesse film coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 100 microgram levonorgestrel and 20 microgram ethinylestradiol. For excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film coated tablets. Round pink biconvex film coated tablets with “W” embossed on one side and “912” embossed on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION HOW TO TAKE ALESSE Regular daily intake of tablets for 21 consecutive days is important for the preservation of contraceptive efficacy. Tablets must be taken in the order directed on the package, every day, at about the same time, with some liquid as needed. 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 occurs. This usually starts on days 2-3 after the last tablet and may not have finished before the next pack is started. HOW TO START ALESSE _No preceding hormonal contraceptive use [in the past month]_ Tablet-taking should start on day 1 of the woman’s natural cycle (i.e., the first day of her menstrual bleeding). Starting on days 2-7 is allowed, but during the first cycle a back-up method of birth control [such as condoms and spermicide] is recommended in addition for the first 7 days of tablet-taking. _Changing from another combined oral contraceptive (COC)_ The woman should start ALESSE preferably on the day after the last active tablet of her previous COC, but at the latest on the day following the usual tablet-free or inactive tablet interval of her previous COC. _Changing from a progestin-only method (progestin-only pill, injectio Read the complete document