Země: Malta
Jazyk: angličtina
Zdroj: 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
Authorised
2008-09-22
Page 1 of 21 BP23002_REC20788+REC30040 PACKAGE LEAFLET: INFORMATION FOR THE USER Yaz 0.02 mg/3 mg film-coated tablets ethinylestradiol/drospirenone READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. - 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 only. Do not pass it on to others. It may harm them. - If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. IMPORTANT THINGS TO KNOW ABOUT COMBINED HORMONAL CONTRACEPTIVES (CHCS): - They are one of the most reliable reversible methods of contraception if used correctly - They slightly increase the risk of having a blood clot in the veins and arteries, especially in the first year or when restarting a combined hormonal contraceptive following a break of 4 or more weeks - Please be alert and see your doctor if you think you may have symptoms of a blood clot (see section 2 “Blood clots”). WHAT IS IN THIS LEAFLET 1. What Yaz is and what it is used for .............................................................................. 2 2. What you need to know before you take Yaz .............................................................. 3 When you should not use Yaz ....................................................................................... 3 Warnings and precautions ............................................................................................. 4 Blood clots .................................................................................................................... 5 Yaz and cancer ............................................................................................................ 10 Psychiatric disorders ................................................................................................... 11 Bleeding between periods .................... Přečtěte si celý dokument
Page 1 of 19 BP23002_REC20788+REC30040 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT YAZ 0.02 mg/3 mg film coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 24 light pink film-coated tablets: Each film-coated tablet contains 0.020 mg ethinylestradiol (as betadex clathrate) and 3 mg drospirenone. Excipient with known effect: lactose 46 mg (as lactose monohydrate 48.18 mg) 4 white placebo (inactive) film-coated tablets: The tablet does not contain active substances. Excipient with known effect: lactose 22 mg (as lactose monohydrate 23.21 mg) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet The active tablets are light pink, round with convex faces, one side marked with the letters "DS" in a regular hexagon. The placebo tablets are white, round with convex faces, one side marked with the letters "DP" in a regular hexagon. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe YAZ should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with YAZ compares with other Combined Hormonal Contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _METHOD OF ADMINISTRATION: _oral use _POSOLOGY _ HOW TO TAKE YAZ 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. Tablet taking is continuous. One tablet is to be taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually starts on day 2-3 after starting the placebo tablets (last row) and may not have finished before the next pack is started. HOW TO START YAZ • No preceding hormonal contraceptive use (in the past month) Page 2 of 19 BP23002_REC20788+REC30040 Tablet-taking has to start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual bl Přečtěte si celý dokument