Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Nomegestrol acetate, estradiol
Theramex Ireland Limited
G03AA14
nomegestrol, estradiol
Sex hormones and modulators of the genital system,
Contraception
Oral contraception,
Revision: 23
Authorised
2011-07-26
29 B. PACKAGE LEAFLET 30 PACKAGE LEAFLET: INFORMATION FOR THE USER ZOELY 2.5 MG/1.5 MG FILM-COATED TABLETS nomegestrol acetate/estradiol 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 USING 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, pharmacist or nurse. - 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Zoely is and what it is used for 2. What you need to know before you use Zoely 3. How to use Zoely 4. Possible side effects 5. How to store Zoely 6. Contents of the pack and other information 1. WHAT ZOELY IS AND WHAT IT IS USED FOR Zoely is a contraceptive pill that is used to prevent pregnancy. • All 24 white film-coated tablets are active tablets that contain a small amount of two different female hormones. These are nomegestrol acetate (a progestogen) and estradiol (an oestrogen). • The 4 yellow film-coated tablets are inactive tablets that do not contain hormones and are called placebo tablets. • Contraceptive pills that contain two different hormones, like Zoely, are called ‘combined pills’. • • Nomegestrol acetate (the progestogen in Zoely) and estradiol (the oestrogen in Zoely) work together to prevent ovulation (release of an egg from the ovary) Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Zoely 2.5 mg/1.5 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each white active tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate). Each yellow placebo tablet does not contain active substances. Excipients with known effect Each white active tablet contains 57.7 mg of lactose monohydrate. Each yellow placebo tablet contains 61.8 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablet (tablet). The active tablet is white, round and coded ‘ne’ on both sides. The placebo tablet is yellow, round and coded ‘p’ on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. The decision to prescribe Zoely should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with Zoely compares with other combined hormonal contraceptives (CHCs) (see sections 4.3 and 4.4). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology One tablet is to be taken daily for 28 consecutive days. Each pack starts with 24 white active tablets, followed by 4 yellow placebo tablets. A subsequent pack is started immediately after finishing the previous pack, without a break in daily tablet intake and irrespective of presence or absence of withdrawal bleeding. Withdrawal bleeding usually starts on day 2-3 after intake of the last white tablet and may not have finished before the next pack is started. See ‘Cycle control’ in section 4.4. _Special populations _ _Renal impairment_ Although data in renal impaired patients are not available, renal impairment is unlikely to affect the elimination of nomegestrol acetate and estradiol. _Hepatic impairment_ No clinical studies have been performed in patients with hepatic insufficiency. Since the metabolism of steroid hormones might be impaired in patients with severe hepatic disease, the use of Aqra d-dokument sħiħ