Država: Južnoafriška republika
Jezik: angleščina
Source: South African Health Products Regulatory Authority (SAHPRA)
Bayer (Pty) Ltd û Isando
See ingredients
TABLET
EACH TABLET CONTAINS CYPROTERONE ACETATE 10 mg
Registered
1990-07-04
APPLICANT: BAYER (PTY) LTD PRODUCT NAME: Androcur 10 mg DOSAGE FORM: Tablet STRENGTHS: 10, 0 mg CCPI 10 /14.02.12/SA 2/12.2021 Page 1 of 8 variation 3082; 4801 PATIENT INFORMATION LEAFLET SCHEDULING STATUS: S4 ANDROCUR 10 MG TABLETS cyproterone acetate Contains sugar – 59,9 mg lactose per tablet READ THIS LEAFLET CAREFULLY BEFORE YOU START TAKING ANDROCUR 10 MG. • Keep this leaflet. You may need to read it again. • If you have further questions, please ask your doctor or your pharmacist. • ANDROCUR 10 mg has been prescribed for you personally and you should not share your medicine with other people. It may harm them, even if their symptoms are the same as yours. WHAT IS IN THIS LEAFLET 1. What ANDROCUR 10 mg is and what it is used for 2. What you need to know before you take Androcur 10mg 3. How to take ANDROCUR 10 mg 4. Possible side effects 5. Contents of the pack and other information 1. WHAT ANDROCUR 10 MG IS AND WHAT IT IS USED FOR: ANDROCUR 10 mg is a hormone preparation that blocks the effect of androgens, which are sex hormones produced mainly in males but also – to a lesser extent – in females. The active substance is cyproterone acetate. In addition to ANDROCUR 10 mg, your doctor will prescribe a progestogen-oestrogen contraceptive to provide contraceptive protection and cycle stabilisation. For the duration of ANDROCUR therapy women of child-bearing age must also receive a combination oral contraceptive. During combined treatment ovarian function is blocked. These changes are reversible after stopping treatment. ANDROCUR 10 mg tablets are used for moderately severe signs of androgenisation, such as: • moderately severe hirsutism (increased facial and body hair) • moderately severe androgen-dependent loss of scalp hair (moderately severe androgenetic alopecia), • severe and moderately severe forms of acne and/or seborrhoea. APPLICANT: BAYER (PTY) LTD PRODUCT NAME: Androcur 10 mg DOSAGE FORM: Tablet STRENGTHS: 10, 0 mg CCPI 10 /14.02.12/SA 2/12.2021 Page 2 of 8 variation 3082; 4801 2. W Preberite celoten dokument
APPLICANT: BAYER (PTY) LTD PRODUCT NAME: ANDROCUR 10 mg DOSAGE FORM: Tablet STRENGTHS: 10,0 mg CCDS10 /14.02.12/SA3 /12.2021 Page 1 of 9 variation 3082/4801 PROFESSIONAL INFORMATION SCHEDULING STATUS S4 1 NAME OF MEDICINE ANDROCUR 10 mg Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Tablets Each ANDROCUR 10 mg tablet contains cyproterone acetate 10 mg. Contains 59,9 mg lactose per tablet (see section 4.4). For full list of excipients see “section 6.1” 3 PHARMACEUTICAL FORM White to faintly yellowish tablets, scored on one side, with an embossed "BW" in a regular hexagon on the other side. The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Moderately severe signs of androgenisation in women of child-bearing age, e.g.: • moderately severe forms of hirsutism. • moderately severe androgen-dependent loss of scalp hair (moderately severe androgenetic alopecia). • severe and moderately severe forms of acne and seborrhoea. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION POSOLOGY Pregnant women must not take ANDROCUR, pregnancy must be excluded. For the duration of ANDROCUR therapy women of child-bearing age must also receive a combination oral contraceptive. This will provide the necessary contraceptive protection and will stabilise the menstrual cycle. Dosage and directions for use as per the package insert of that product should be strictly adhered to. APPLICANT: BAYER (PTY) LTD PRODUCT NAME: ANDROCUR 10 mg DOSAGE FORM: Tablet STRENGTHS: 10,0 mg CCDS10 /14.02.12/SA3 /12.2021 Page 2 of 9 variation 3082/4801 Prior to commencing ANDROCUR treatment it is always necessary for the patient to receive one complete cycle of a combination oral contraceptive. Extra non-hormonal methods (with the exception of the rhythm and temperature methods) should be employed during the first 3 weeks of the first cycle, which may be shorter than 4 weeks. Subsequent cycles should then be regular. In the subsequent cycle of the combin Preberite celoten dokument