Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
CYPROTERONE ACETATE; ETHINYLESTRADIOL
SCHMIDT BIOMEDTECH SDN BHD
CYPROTERONE ACETATE; ETHINYLESTRADIOL
21Pill Pills; 63Pill Pills
DOUGLAS MANUFACTURING LTD
ESTELLE-35 TABLET (Cyproterone acetate 2mg and ethinyloestradiol 0.035mg) 1 Consumer Medication Information Leaflet (RiMUP) What is in this leaflet 1. What ESTELLE tablet is used for 2. How ESTELLE tablet works 3. Before you use ESTELLE tablet 4. How to take ESTELLE tablet 5. While you are using ESTELLE tablet 6. Side effects 7. Storage and Disposal of ESTELLE tablet 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision What ESTELLE tablet is used for ESTELLE tablet is used to treat women who suffer from conditions arising from increased secretion of or increased response to androgen (male) hormones. Such conditions include acne, or moderately increased growth of facial and body hair (hirsutism). ESTELLE tablet should be withdrawn 3 to 4 cycles after the treated condition has been completely resolved. ESTELLE tablet provides effective oral contraception in women being treated for androgen-dependent diseases. How ESTELLE tablet works ESTELLE tablet contains two ingredients, ethinylestradiol and cyproterone. Ethinylestradiol is an oestrogen, which is a female sex hormone. Cyproterone is an anti- androgen. Androgens are responsible for stimulating the glands on your skin which produce sebum (grease) and they also encourage hair growth. Too much androgen can cause the glands in your skin to become blocked and inflamed, causing acne spots to develop ESTELLE tablet works by reducing the amount of androgen you produce, which helps to clear acne and reduces excess hair growth. Before you use ESTELLE tablet - When you must not use it Do not take ESTELLE tablet if: You are pregnant or breast-feeding. You have had severe disturbances of liver function, jaundice (yellowing of the skin) or other problems associated with the liver. You have or have had blood clots in your legs. You have or have had any pro- coagulant disorder such as Protein C deficiency, Protein S deficiency, Leiden Factor V mutation, Antithrombin III deficiency or other familial disorders. You have or Leggi il documento completo
ESTELLE TM -35 AND ESTELLE TM -35 ED Cyproterone Acetate / Ethinylestradiol Tablets PRESENTATION ESTELLE™-35: 21 active tablets that are described as yellow buff, round biconvex coated plain tablets, plain on both faces. Tablet diameter is approximately 5.6 mm. ESTELLE™-35 ED: 21 active tablets that are described as yellow buff, round biconvex coated plain tablets, plain on both faces. Tablet diameter is approximately 5.6 mm. 7 placebo tablets that are described as white, round, biconvex tablets, plain on both sides with a diameter of approximately 7.1 mm. USES _ACTIONS_ The substance cyproterone acetate contained in ESTELLE™-35 and ESTELLE™-35 ED inhibits the influence of the androgens, which are also produced by the female system. It is thus possible to treat diseases caused by either an increased production of androgens or a particular sensitivity to these hormones. While ESTELLE™-35 and ESTELLE™-35 ED is being taken, the increased sebaceous gland function, which plays an important role in the development of acne and seborrhoea, is reduced. This leads - usually after 3 to 4 months of therapy - to the healing of existing acne efflorescence. The excessive greasiness of the hair and skin generally disappears earlier. The loss of hair, which frequently accompanies seborrhoea likewise diminishes. Treatment with ESTELLE™-35 and ESTELLE™-35 ED is indicated in women of child-bearing age who exhibit mild forms of hirsutism, and in particular in slightly increased facial hair; results do not, however, become apparent until after several months of use. Apart from the described antiandrogen effect, cyproterone acetate also has a pronounced progestational action. The sole administration of cyproterone acetate would thus lead to cycle disturbances, which are avoided by its combination with ethinylestradiol in ESTELLE™-35 and ESTELLE™-35 ED. This holds true as long as the preparation is taken cyclically according to the instructions. The contraceptive effect of ESTELLE™-35 and ESTELLE™-35 ED is based Leggi il documento completo