Страна: Австралия
Язык: английский
Источник: Department of Health (Therapeutic Goods Administration)
cyproterone acetate, Quantity: 2 mg; ethinylestradiol, Quantity: 35 microgram
Alphapharm Pty Ltd
Tablet, sugar coated
Excipient Ingredients: maize starch; calcium carbonate; purified talc; sucrose; glycol montanate; macrogol 6000; povidone; lactose monohydrate; magnesium stearate; glyceryl montanate
Oral
1 x 28 tablets (1 x 21 beige, 1 x 7 white), 3 x 28 tablets (3 x 21 beige, 3 x 7 white)
(S4) Prescription Only Medicine
Brenda-35 ED is indicated for the treatment of signs of androgenisation in women such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree.,Brenda-35 ED will also provide effective oral contraception in this patient group. It should not be used in combination with other hormonal contraceptives (see CONTRAINDICATIONS).,If the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (i.e. androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis.
Visual Identification: White, round tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius; Container Closure: Child resistant closure
Registered
1996-05-09
BRENDA-35 ED _cyproterone acetate and ethinylestradiol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Brenda-35 ED. It does not contain all the available information. It does not take the place of talking to your doctor, pharmacist or health clinic. All medicines have benefits and risks. Your doctor has weighed the risks of you taking Brenda-35 ED against the benefits expected for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, TALK TO YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT BRENDA-35 ED IS USED FOR Brenda-35 ED is used for the treatment of signs of physical male characteristics caused by the male sex hormone, androgen, produced by the male sex hormone, androgen, produced in women in small amounts (androgenisation), such as: • severe acne when other treatments have not been successful • for excessive growth of facial or body hair (known as hirsutism) of a mild to moderate degree, where no underlying cause has been found. Brenda-35 ED can also be used as a contraceptive to prevent pregnancy in women who are taking it for the treatment of signs of physical male characteristics as described above. Brenda-35 ED contains a progestogen and an oestrogen hormone, and therefore works similarly to the combined oral contraceptive birth control pill, also known as 'the Pill'. It should not be used in combination with another hormonal contraceptive. While taking Brenda-35 ED you may also experience the following benefits: • more regular and lighter periods - potentially resulting in a decreased risk in anaemia (iron deficiency) • a decrease in period pain • reduction of greasiness in skin and hair. Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy (where the foetus is carried outside of your womb), lumpy breasts and cancer of the uterus (womb) and ovaries may be less common in women taking Brenda-35 ED. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY Прочитать полный документ
AUSTRALIAN PRODUCT INFORMATION _ _ _ _ BRENDA-35 ED _Cyproterone acetate/ethinylestradiol _ 1 NAME OF THE MEDICINE Cyproterone acetate and Ethinylestradiol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Brenda-35 ED contains the synthetic progestogen, cyproterone acetate and the synthetic estrogen, ethinylestradiol. Each beige active tablet, contains ethinylestradiol 35 µg and cyproterone acetate 2 mg. Excipients with known effect: Lactose monohydrate. For the full list of excipients, see Section 6.1 LIST OF EXCIPIENTS . 3 PHARMACEUTICAL FORM Tablet, sugar coated Brenda-35 ED tablets are available in blister packs of 28 tablets. Each blister contains 21 beige round active tablets followed by 7 white round placebo tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Brenda-35 ED is indicated for: • The treatment of signs of androgenisation in women such as severe acne (involving inflammation or nodularity or risk of scarring) where prolonged oral antibiotics or local treatment alone has not been successful, or idiopathic hirsutism of mild to moderate degree. • Brenda-35 ED will also provide effective oral contraception in this patient group. It should not be used in combination with other hormonal contraceptives (see section 4.3 CONTRAINDICATIONS ). If the hirsutism has only recently appeared or has lately intensified to a considerable extent, the cause (i.e. androgen-producing tumour or an adrenal enzyme defect) must be clarified by differential diagnosis. 4.2 DOSE AND METHOD OF ADMINISTRATION Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. Brenda-35 ED is to be taken regularly in order to achieve therapeutic efficacy and the required contraceptive protection. Previously used hormonal contraception should be discontinued. The dose regimen of Brenda-35 ED is similar to the usual regimen of most of the COCs. Thus, the same administration rules must be considered. The irregular intake of Brenda-35 ED can lead to intermenstrual bleeding and could deteriora Прочитать полный документ