Country: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
DROSPIRENONE ; ETHINYLESTRADIOL
Teva Pharma B.V.
G03AA12
DROSPIRENONE ; ETHINYLESTRADIOL
0.03 / 3 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
drospirenone and ethinylestradiol
Not Marketed
2009-10-09
1 PACKAGE LEAFLET: INFORMATION FOR THE USER _DRETINE 0.03 MG/3 MG FILM-COATED TABLETS _ _ _ ETHINYLESTRADIOL/DROSPIRENONE 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”). 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, even if their signs of illness are the same as yours. 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. WHAT IS IN THIS LEAFLET 1. What Dretine is and what it is used for 2. What you need to know before you take Dretine 3. How to take Dretine 4. Possible side effects 5. How to store Dretine 6. Contents of the pack and other information 1. WHAT DRETINE IS AND WHAT IT IS USED FOR Dretine is a contraceptive pill and is used to prevent pregnancy. Each tablet contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol. Contraceptive pills that contain two hormones are called “combination” pills. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE DRETINE GENERAL NOTES Before you start using Dretine you should read the information on blood clots in section 2. It is particularly important to read the symptoms of a blood clot – see section 2 “Blood clots”. 2 Before you can begin taking Dretine, your doctor will ask you some questions about Aqra d-dokument sħiħ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dretine 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(s) with known effect: Lactose monohydrate 62 mg For the 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 The decision to prescribe Dretine should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Dretine compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HOW TO TAKE DRETINELLE 0.02 MG/3 MG 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 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 DRETINELLE 0.02 MG/3 MG 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 a combined hormonal contraceptive (combined oral contraceptive (COC), vaginal ring, or transdermal patch) The woman should start with Dretinelle 0.02 mg/3 mg Film-coated Tablets 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 Dretinelle 0.02 mg/ Aqra d-dokument sħiħ