País: Irlanda
Idioma: anglès
Font: HPRA (Health Products Regulatory Authority)
DROSPIRENONE ; ETHINYL ESTRADIOL
Teva Pharma B.V.
G03AA12
DROSPIRENONE ; ETHINYL ESTRADIOL
0.02/3.0 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
drospirenone and ethinylestradiol
Not Marketed
2012-11-16
1 PACKAGE LEAFLET: INFORMATION FOR THE USER VEYANN 0.02 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 Veyann is and what it is used for 2. What you need to know before you take Veyann 3. How to take Veyann 4. Possible side effects 5. How to store Veyann 6. Contents of the pack and other information 1. WHAT VEYANN IS AND WHAT IT IS USED FOR Veyann is a contraceptive pill and is used to prevent pregnancy. Each of the 24 pink tablets contains a small amount of two different female hormones, namely drospirenone and ethinylestradiol. The 4 white tablets contain no active substances and are also called placebo tablets. Contraceptive pills that contain two hormones are called “combination” pills. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE VEYANN GENERAL NOTES Before you start using Veyann 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 Llegiu el document complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Veyann 0.02 mg/3 mg Film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION 24 pink film-coated tablets (active tablets): Each film-coated tablet contains 0.02 mg ethinylestradiol and 3 mg drospirenone. Excipient with known effect: Lactose monohydrate 44 mg 4 white placebo (inactive) film-coated tablets: The tablet does not contain active substances Excipient with known effect: Lactose anhydrous 89.5 mg For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. The active tablet is pink, round film-coated tablet of 5.7 mm diameter. The placebo tablet is white, round film-coated tablet of 5.7 mm diameter. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Veyann should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Veyann compares with other CHCs (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology _How to take Veyann_ The tablets must be taken every day at about the same time, if necessary with a little liquid, in the order shown on blister. Tablet taking is continuous. One tablet is to be taken daily for 28 consecutive days. Each subsequent blister is started the day after the last tablet of the previous blister. Withdrawal bleeding usually starts on day 2-3 after starting the placebo tablets (last row) and may not have finished before the next blister is started. _How to start Veyann_ 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). H E A L T H P R O D U C T S R E G U L A T O R Y A U T H O R I T Y ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ ___ __ Llegiu el document complet