Država: Novi Zeland
Jezik: engleski
Izvor: Medsafe (Medicines Safety Authority)
Cyproterone acetate 2mg; Ethinylestradiol 0.035mg
Bayer New Zealand Limited
Cyproterone acetate 2 mg
Film coated tablet
Active: Cyproterone acetate 2mg Ethinylestradiol 0.035mg Excipient: Calcium carbonate Glycerol Glycol montanate Iron oxide yellow Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Purified talc Sucrose Titanium dioxide Calcium carbonate Glycol montanate Lactose monohydrate Macrogol 6000 Magnesium stearate Maize starch Povidone Purified talc Sucrose
Blister pack, 1 x(21+7) sample pack, 28 tablets
Prescription
Prescription
Bayer AG
· 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.
Package - Contents - Shelf Life: Blister pack, 3 x (21+7) pack - 84 tablets - 60 months from date of manufacture stored at or below 25°C
1992-03-31
2103 DIANE-35 ® ED CMI 1 DIANE ® -35 ED (DI·ANNE EE·DEE) _cyproterone acetate and ethinyloestradiol _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Diane-35 ED. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Diane-35 ED against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS, OR ARE UNSURE ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST FOR MORE ADVICE. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT DIANE-35 ED IS USED FOR Diane-35 ED is used for the treatment of signs of physical male characteristics caused by the male sex hormone, androgen, produced by in women in small amounts (androgenisation), such as: • severe acne where 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. Diane-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. Diane-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 Diane-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 Diane-35 ED. ASK YOUR DOCTOR I Pročitajte cijeli dokument
210308 Diane-35 ED DS 1 RESTRICTED NEW ZEALAND DATA SHEET 1. PRODUCT NAME DIANE ® 35 ED cyproterone acetate 2 mg, ethinylestradiol 35 micrograms, film coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each active beige tablet contains: Cyproterone acetate 2 mg Ethinylestradiol 35 micrograms For full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM 21 beige, round active tablets. 7 white, round placebo tablets. All tablets have a lustrous sugar coating. Tablets cannot be halved. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 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. DIANE-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 (androgen-producing tumour or an adrenal-enzyme defect) must be clarified by differential diagnosis. 210308 Diane-35 ED DS 2 RESTRICTED 4.2 DOSE AND METHOD OF ADMINISTRATION DIANE-35 ED 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 DIANE-35 ED is similar to the usual regimen of most 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 DIANE-35 ED can lead to intermenstrual bleeding and could deteriorate the therapeutic and contraceptive reliability. LENGTH OF USE Treatment will probably need to be continued for about 6 months and probably much longer to gain an acceptable therapeutic effect, especially if Diane-35 ED is being Pročitajte cijeli dokument