Country: মাল্যাশিয়া
ভাষা: ইংরেজি
সূত্র: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CYPROTERONE ACETATE
BAYER CO. (MALAYSIA) SDN. BHD.
CYPROTERONE ACETATE
50Tablet Tablets
Bayer Weimar GmbH und Co. KG
Androcur ® 50mg Tablets 1. NAME OF THE MEDICINAL PRODUCT Androcur 50 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 50 mg cyproterone acetate. For full list of excipients, see section ‘List of excipients’. 3. PHARMACEUTICAL FORM Tablet. White to faintly yellowish tablets, scored on one side, with an embossed "BV" in a regular hexagon on the other side. The tablet can be divided into equal halves. 4. CLINICAL PARTICULARS 4.1 Indication(s) ► Indications in the woman Severe signs of androgenization, e.g. very severe hirsutism, severe androgenetic alopecia, often attended by severe forms of acne and/or seborrhoea. ► Indications in the man Reduction of drive in sexual deviations in men. Antiandrogen treatment in inoperable carcinoma of the prostate. 4.2 Dosage and method of administration Method of administration Oral use Dosage regimen The tablets are to be taken with some liquid after meals. The maximum daily dose is 300 mg. ► Dosage in the women Pregnant women must not take Androcur 50. Therefore, pregnancy must be excluded before the start of therapy. In women of childbearing age, the treatment is commenced on the 1st day of the cycle (= 1st day of bleeding). Two Androcur 50 tablets are to be taken daily from the 1st to the 10th day of the cycle. In addition, these women receive a progestogen-estrogen-containing preparation, e.g. from the 1st to the 21st day of the cycle 1 tablet Diane-35 daily, to provide the necessary contraceptive protection and to stabilize the cycle. Women receiving the cyclical combined therapy should keep to a particular time of the day for tablet-taking. A 7-day tablet-free interval is observed after 21 days, during which time a withdrawal bleeding occurs. Exactly 4 weeks after the first course of treatment was started, i. e. on the same day of the week, the next cyclical course of combined treatment is started, regardless of whether bleeding has stopped or not. Reference : Androcur 50 / 50 mg Tablets (for use in men) / CCDS / Version 13 / 13 Jun 2017 সম্পূর্ণ নথি পড়ুন