Ország: Málta
Nyelv: angol
Forrás: 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 0.03 mg
FILM-COATED TABLET
DROSPIRENONE 3 mg ETHINYLESTRADIOL 0.03 mg
POM
SEX HORMONES AND MODULATORS OF THE GENITAL SYSTEM
Authorised
2007-07-25
Page 1 of 18 BP22056_REC30965 PACKAGE LEAFLET: INFORMATION FOR THE USER YASMIN 0.03 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 Yasmin is and what it is used for................................................. 2 2. What you need to know before you take Yasmin ................................. 2 When you should not use Yasmin ......................................................... 3 Warnings and precautions ..................................................................... 4 BLOOD CLOTS ................................................................................... 5 Yasmin and cancer .............................................................................. 10 Psychiatric disorders ........................................................................... 10 Bleeding between periods ................................................................... 10 What to do if no bleeding occurs during the gap week ....................... 10 Other medicines and Yasmin .......................... Olvassa el a teljes dokumentumot
Page 1 of 18 BP22056_REC30965 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Yasmin 0.03 mg / 3 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 0.030 mg ethinylestradiol and 3 mg drospirenone Excipient with known effect: lactose 46 mg (as lactose monohydrate 48.17 mg) For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets Light yellow, round tablets with convex faces, one side marked with the letters "DO" in a regular hexagon 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception The decision to prescribe Yasmin should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Yasmin 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 YASMIN 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 YASMIN • 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 18 BP22056_REC30965 • Changing from a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start with Yasmin 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 C Olvassa el a teljes dokumentumot