Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Cyproterone acetate; Ethinylestradiol
Lexon (UK) Ltd
G03HB01
Cyproterone acetate; Ethinylestradiol
2mg ; 35microgram
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 13060200
Your medicine is called Dianette Tablets, and will be referred to as Dianette throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. • Keep this leaflet. You may need to read it again. • If you have any questions or need more advice, ask your doctor or pharmacist. • This medicine has been prescribed for you. Do not pass it on to others. It may harm them. • IF ANY OF THE SIDE EFFECTS GETS SEVERE, or if you notice any not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: WHAT DIANETTE IS AND WHAT IT IS USED FOR WHAT YOU NEED TO KNOW BEFORE YOU TAKE DIANETTE 2.1 BEFORE YOU TAKE DIANETTE When should you contact your doctor Dianette and cancer 2.2 MAKE SURE DIANETTE IS OK FOR YOU Dianette should not be taken by some women Dianette can make some illnesses worse Taking other medicines Taking Dianette with food and drink Pregnancy and breast-feeding Driving and using machines Dianette contains lactose Dianette and sun-beds or sun-lamps TAKING DIANETTE Duration of use How to take it Starting Dianette A missed pill A lost pill If you are sick or have diarrhoea Missed a period – could you be pregnant? Taking more than one pill should not cause harm When you want to get pregnant POSSIBLE SIDE EFFECTS 4.1 Serious side effects – see a doctor straight away 4.2 Less serious side effects 4.3 Bleeding between periods should not last long HOW TO STORE DIANETTE WHAT IS IN DIANETTE AND WHO MAKES IT WHAT DIANETTE IS AND WHAT IT IS USED FOR Dianette contains an oestrogen and 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 after use of other anti-acne treatments, including topical treatments and antibiotics. If you are taking Dianet Read the complete document
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Dianette ® 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains: Actives: Cyproterone acetate 2.00 mg Ethinylestradiol 35 micrograms Excipients: Lactose monohydrate 30.965 mg Sucrose 19.371 mg For full list of excipients, see section 6.1 3 PHARMACEUTICAL FORM Sugar-coated tablets. Beige, round tablet, with convex faces. 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 _METHOD OF ADMINISTRATION _ Oral use _DOSAGE REGIMEN _ _ _ Dianette inhibits ovulation and thereby prevents conception. Patients who are using Dianette should not therefore use an additional hormonal contraceptive, as this will expose the patient to an excessive dose of hormones and is not necessary for effective contraception. _First treatment course:_ One tablet daily for 21 days, starting on the first day of the menstrual cycle (the first day of menstruation counting as Day 1). _Subsequent courses:_ Each subsequent course is started after 7 tablet-free days have followed the preceding course. When the contraceptive action of Dianette is also to be employed, it is essential that the above instructions be rigidly adhered to. Should bleeding fail to occur during the tablet-free interval, the possibility of pregnancy must be excluded before the next pack is started. When changing from an oral contraceptive and relying on the contraceptive action of Dianette, follow the instructions given below: _Changing from 21-day combined oral contraceptives: _The first tablet of Dianette should be taken on the first day immediately after t Read the complete document