Country: Singapura
Bahasa: Inggeris
Sumber: HSA (Health Sciences Authority)
CYPROTERONE ACETATE; ETHINYLOESTRADIOL
APEX PHARMA MARKETING PTE. LTD.
G03HB01
2 mg
TABLET, FILM COATED
CYPROTERONE ACETATE 2 mg; ETHINYLOESTRADIOL 0.035 mg
ORAL
Prescription Only
DOUGLAS PHARMACEUTICALS LTD
ACTIVE
2002-06-04
ESTELLE TM -35ED Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Estelle-35ED tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 hormone-containing small, yellow coated tablets: Each coated tablet contains 0.035 mg ethinylestradiol, 2.0 mg cyproterone acetate. 7 large non-active white coated tablets: Each coated non-active tablet contains lactose, microcrystalline cellulose, magnesium stearate. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL PARTICULARS 4.1 Indications For the treatment of androgen-dependent diseases in women, such as moderate to severe acne, and mild forms of hirsutism. When used for the treatment of acne, Estelle-35ED should only be used after topical therapy or systemic antibiotic treatments have failed. If the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis. Estelle-35ED should not be prescribed for the purpose of contraception alone. 4.2 Dosage and Method of Administration _Method of Administration_ Oral use. _Dosage Regimen_ _How to take Estelle-35ED_ Estelle-35ED is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be discontinued. The dose regimen of Estelle-35ED is similar to the usual regimen of most of the combined oral contraceptives. Thus, the same administration rules must be considered. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The irregular intake of Estelle-35ED Baca dokumen lengkap
ESTELLE TM -35ED Summary of Product Characteristics 1. NAME OF THE MEDICINAL PRODUCT Estelle-35ED tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 21 hormone-containing small, yellow coated tablets: Each coated tablet contains 0.035 mg ethinylestradiol, 2.0 mg cyproterone acetate. 7 large non-active white coated tablets: Each coated non-active tablet contains lactose, microcrystalline cellulose, magnesium stearate. 3. PHARMACEUTICAL FORM Coated tablet. 4. CLINICAL PARTICULARS 4.1 Indications For the treatment of androgen-dependent diseases in women, such as moderate to severe acne, and mild forms of hirsutism. When used for the treatment of acne, Estelle-35ED should only be used after topical therapy or systemic antibiotic treatments have failed. If the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis. Estelle-35ED should not be prescribed for the purpose of contraception alone. 4.2 Dosage and Method of Administration _Method of Administration_ Oral use. _Dosage Regimen_ _How to take Estelle-35ED_ Estelle-35ED is to be taken regularly in order to achieve the therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be discontinued. The dose regimen of Estelle-35ED is similar to the usual regimen of most of the combined oral contraceptives. Thus, the same administration rules must be considered. Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The irregular intake of Estelle-35ED can lead to intermenstrual bleedings and could deteriorate the therapeutic and contraceptive reliability. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. One yellow tablet is to be taken daily for 21 consecutive days, followed by one white tablet for 7 days during which time a withdrawal bleed usually occurs. This u Baca dokumen lengkap