Krajina: Spojené kráľovstvo
Jazyk: angličtina
Zdroj: MHRA (Medicines & Healthcare Products Regulatory Agency)
Nomegestrol acetate; Estradiol hemihydrate
Merck Sharp & Dohme Ltd
Nomegestrol acetate; Estradiol hemihydrate
2.5mg ; 1.5mg
Tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 07030100; GTIN: 5013945300154
PACKAGE LEAFLET: INFORMATION FOR THE USER ZOELY® 2.5 MG/1.5 MG FILM-COATED TABLETS Nomegestrol acetate/estradiol This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects. 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 tablets are inactive tablets that do not contain hormones and are called placebo tablets. Contraceptive pills that contain two different hormones, like Zoely, are Prečítajte si celý dokument
OBJECT 1 ZOELY 2.5 MG/1.5 MG FILM-COATED TABLETS Summary of Product Characteristics Updated 28-Mar-2017 | Merck Sharp & Dohme Limited This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. 1. Name of the medicinal product Zoely ® 2.5 mg/1.5 mg film-coated tablets 2. Qualitative and quantitative composition White active film-coated tablets: Each film-coated tablet contains 2.5 mg nomegestrol acetate and 1.5 mg estradiol (as hemihydrate). Yellow placebo film-coated tablets: The tablet does not contain active substances. Excipients with known effect Each white active film-coated tablet contains 57.71 mg of lactose monohydrate. Each yellow placebo film-coated tablet contains 61.76 mg of lactose monohydrate. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Film-coated tablet (tablet). Active film-coated tablets: white, round and coded 'ne' on both sides. Placebo film-coated tablets: 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 Prečítajte si celý dokument