Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
Cyproterone acetate; Ethinylestradiol ph.eur.
Bayer Limited
G03HB; G03HB01
Cyproterone acetate; Ethinylestradiol ph.eur.
2/35 milligram(s)
Coated tablet
Product subject to prescription which may be renewed (B)
Antiandrogens and estrogens; cyproterone and estrogen
Marketed
1988-11-18
BP22046_REC30885 1 INTERNAL PACKAGE LEAFLET: INFORMATION FOR THE USER DIANETTE ® 2MG/35 MICROGRAM COATED TABLETS cyproterone acetate/ethinylestradiol 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 Dianette is and what it is used for 2. What you need to know before you take Dianette Do not take Dianette Warnings and precautions Blood clots (thrombosis) Dianette and cancer Meningioma Psychiatric disorders Bleeding between periods What to do if no bleeding occurs during the gap week Other medicines and Dianette Dianette with food and drink Laboratory tests Pregnancy and breast-feeding Driving and using machines Dianette contains lactose and sucrose 3. How to take Dianette When can you start with the first strip? If you take more Dianette than you should If you forget to take Dianette What to do in the case of vomiting or severe diarrhoea If you stop taking Dianette 4. Possible side effects 5. How to store Dianette 6. Contents of the pack and other information BP22046_REC30885 2 INTERNAL 1. WHAT DIANETTE IS AND WHAT IT IS USED FOR • Dianette contains ethinylestradiol, an estrogen, and cyproterone acetate, an anti- androgen. • Dianette is used to treat skin conditions such as acne, very oily skin and excessive hair growth in women of reproductive age. Due to its contraceptive properties it should only be prescribed for you if your doctor considers that treatment with a hormonal contraceptive is appropriate. • You should only take Dianette if your skin condition has not improved Đọc toàn bộ tài liệu
Health Products Regulatory Authority 21 November 2022 CRN00D75R Page 1 of 14 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dianette 2mg/35 microgram coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 2.0 mg cyproterone acetate and 0.035 mg ethinylestradiol. Excipients with known effect Each tablet contains 31 mg lactose monohydrate and 19 mg sucrose. Please see section 4.4 for further information. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Coated tablet (tablet). Beige, sugar-coated, biconvex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of moderate to severe acne related to androgen-sensitivity (with or without seborrhoea) and/or hirsutism, in women of reproductive age. For the treatment of acne, Dianette should only be used after topical therapy or systemic antibiotic treatments have failed. Since Dianette is also a hormonal contraceptive, it should not be used in combination with other hormonal contraceptives (see section 4.3). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology HOW TO TAKE DIANETTE Dianette is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. Combined oral contraceptives when taken correctly have a failure rate of approximately 1 % per year. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. 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 DIANETTE _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). Starting on days 2 - 5 is allowed, but during the first cycle a barrier method is recommende Đọc toàn bộ tài liệu