Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Nomegestrol acetate, estradiol
N.V. Organon
G03AA14
nomegestrol acetate, estradiol
Sex hormones and modulators of the genital system,
Contraception
Oral contraception.
Revision: 4
Withdrawn
2011-11-16
B. PACKAGE LEAFLET 27 Medicinal product no longer authorised PACKAGE LEAFLET: INFORMATION FOR THE USER IOA 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 IOA is and what it is used for 2. What you need to know before you use IOA When you should not use IOA When to take special care with IOA When should you contact your doctor Blood clots Cancer Laboratory tests Children and adolescents Other medicines and IOA Pregnancy and breast-feeding Driving and using machines IOA contains lactose 3. How to use IOA When and how to take the tablets Starting your first pack of IOA If you take more IOA than you should (overdose) If you forget to take IOA If you vomit or have severe diarrhoea If you want to delay your period If you want to change the starting day of your period Læs hele dokumentet
ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 1 Medicinal product no longer authorised 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 IOA 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 IOA should take into consideration the individual woman’s current risk factors, particularly those for venous thromboembolism (VTE), and how the risk of VTE with IOA compares with other 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 rena Læs hele dokumentet