Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
CYPROTERONE ACETATE
BAYER ISRAEL LTD
G03HA01
TABLETS
CYPROTERONE ACETATE 10 MG
PER OS
Required
BAYER WEIMAR GMBH UND CO.KG, GERMANY
CYPROTERONE
CYPROTERONE
Treatment of pronounced signs of virilisation in women, which make hormone therapy necessary:• severe forms of acne, when it is accompanied by inflammation and the formation of nodes (Acne papulopustulosa, Acne nodulocystica) or if there is a risk of scarring,• moderate to severe forms of hirsutism,• moderate to severe forms of androgenic alopecia.Cyproterone acetate 10 mg is indicated for pronounced signes of virilisation in women, which make hormone therapy necessary if satisfactory results could not be obtained with medicinal products containing low-dose cyproterone or with other treatment options. When treating acne, hormone treatment should be weighed against systemic antibiotic treatment
2020-09-30
PACKAGING TECHNOLOGY BERLIN SHNEB page 3 Bayer AG client: JS86 material-no.: 87994953 PZ: 2589W-3B code-no.: name: LF-INS-ANDROCUR 10MG TAB IL country: IL/-/BPH colors: BLACK version: 17.06.2021/02 Restricted Document dimension: 297 X 594 MM 87994953 87994953 ANDROCUR ® 10 EACH TABLET CONTAINS: Cyproterone acetate 10 mg Inactive ingredients and allergens: see section 6 “Further Information”. READ THE LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them even if it seems to you that their condition is similar. The medicine is not intended for children and adolescents before completion of puberty. ESSENTIAL INFORMATION ABOUT ANDROCUR 10: This section mentions the most essential information about treatment with Androcur 10, summarized from the leaflet. Even if you do not carefully read the entire leaflet, be sure to carefully read this short section: • Use Androcur 10 in combination with a medicine that contains estrogen or an estrogen-progesterone combination. • A treatment cycle is 21 days long. On the first day, start treatment with Androcur 10 together with a medicine that contains estrogen or an estrogen-progesterone combination for 15 days. After 15 days, Androcur 10 treatment will end and you will have to continue treatment with a medicine that contains estrogen or an estrogen- progesterone combination for 6 additional days. After completion of the treatment cycle, you will have to stop treatment for 7 days, during which bleeding is expected to occur. Begin the next treatment cycle after the 7-day break, irrespective of bleeding (see section 3 “How should you use the medicine?”). • Do not use Androcur 10 as an exclusive contraceptive (see “Special warnings regarding use of the medicine” in section 2). 1) WHAT IS THE MEDICINE INTENDED FOR? Androcur 10 is intended for anti Olvassa el a teljes dokumentumot
1. NAME OF THE MEDICINAL PRODUCT Androcur 10 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Cyproterone acetate One tablet contains 10 mg cyproterone acetate (CPA). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Tablet White to pale yellow tablets with a breaking score line on one side and embossed with ‘BW’ in a regular hexagon on the other. The score line is to break the tablet for ease of swallowing; not to divide the tablet into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of pronounced signs of virilisation in women, which make hormone therapy necessary: • severe forms of acne, when it is accompanied by inflammation and the formation of nodes (Acne papulopustulosa, Acne nodulocystica) or if there is a risk of scarring, • moderate to severe forms of hirsutism, • moderate to severe forms of androgenic alopecia. Cyproterone acetate 10 mg is indicated for pronounced signs of virilisation in women, which make hormone therapy necessary if satisfactory results could not be obtained with medicinal products containing low-dose cyproterone or with other treatment options. When treating acne, hormone treatment should be weighed against systemic antibiotic treatment 4.2 POSOLOGY AND METHOD oF ADMINISTRATION _Method of administration _ Oral administration _Dosage _ Pregnant women may not take Androcur. Consequently, pregnancy has to be excluded prior to the start of therapy (see section 4.4). Androcur 10 mg has to be used in combination with a suitable oestrogen or a suitable progestogen-oestrogen combination (combined oral contraceptive ‘pill’), in order to ensure necessary contraceptive protection and to avoid irregular bleeding. This combination therapy shall be carried out as follows: Both products have to be started on day 1 of the cycle (day 1 of menstruation). One Androcur 10 mg tablet has to be taken daily from day 1 to day 15 of the combination therapy. Additionally, from day 1 to day 21, a suitable oestrogen or a suitable progest Olvassa el a teljes dokumentumot