Država: Malta
Jezik: engleski
Izvor: Medicines Authority
DROSPIRENONE, ETHINYLESTRADIOL
Bayer Limited 1st Floor The Grange Offices The Grange Brewery Road Stillorgan Co. Dublin, A94 H2K7 , Ireland
G03AA12
DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.02 mg
FILM-COATED TABLET
DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.02 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Withdrawn
2006-08-04
Page 1 of 13 PACKAGE LEAFLET: INFORMATION FOR THE USER Aliane 0.02 mg / 3 mg film-coated tablets Ethinylestradiol / Drospirenone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. _ _ _Keep this leaflet, you may need to read it again. _ _ _ _If you have any further questions, ask your doctor or pharmacist. _ _ _ _This medicine has been prescribed for you, do not pass it on to others. It may harm them. _ _ _ _If any of the side effects gets serious, or if you notice any side effects not listed in this _ _leaflet, please tell your doctor or pharmacist_. _ _ IN THIS LEAFLET 1. [/PIL_MA639_00201.html#2] WHAT ALIANE IS AND WHAT IT IS USED FOR ..................................................... 2 [/PIL_MA639_00201.html#2] 2. [/PIL_MA639_00201.html#2] BEFORE YOU TAKE ALIANE ..................................................................................... 2 [/PIL_MA639_00201.html#2] When you should not use Aliane ............................................................................................... 2 [/PIL_MA639_00201.html#2] When to take special care with Aliane ..................................................................................... 3 [/PIL_MA639_00201.html#3] Aliane and venous and arterial blood clots ................................................................................ 3 [/PIL_MA639_00201.html#3] Aliane and cancer ...................................................................................................................... 5 [/PIL_MA639_00201.html#5] Bleeding between periods .......................................................................................................... 5 [/PIL_MA639_00201.html#5] What to do if no bleeding occurs during the gap week ............................................................. 5 [/PIL_MA639_00201.html#5] Aliane and using other medicines ..................... Pročitajte cijeli dokument
Page 1 of 16 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Aliane 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 ALIANE 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 ALIANE 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). Page 2 of 16 Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch The woman should start with Aliane 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 Aliane preferably on the day of removal, but at the latest when the next applica Pročitajte cijeli dokument