Land: Neuseeland
Sprache: Englisch
Quelle: Medsafe (Medicines Safety Authority)
Cyproterone acetate 2mg; ; Ethinylestradiol 0.035mg;
Douglas Pharmaceuticals Limited
Cyproterone acetate 2 mg
Film coated tablet
Active: Cyproterone acetate 2mg Ethinylestradiol 0.035mg Excipient: Croscarmellose sodium Lactose monohydrate Magnesium stearate Microcrystalline cellulose Opadry buff OY-3690 Opadry white Y-1R-7000B Opaglos white 6000 Povidone Purified water Quinoline yellow Sucrose Lactose monohydrate Magnesium stearate Microcrystalline cellulose
Blister pack, PVC/PVDC/Al pack, 28 tabs, 28 tablets
Prescription
Prescription
Sicor de Mexico SA de CV
ESTELLE-35 and ESTELLE-35 ED are indicated for the treatment of androgen dependent diseases in women, such as acne (where oral antibiotics or local treatment alone has not been successful), especially pronounced forms and those which are accompanied by seborrhoea or by inflammation or formation of nodes (acne papulopustulosa, acne nodulocystica), androgenic alopecia, mild forms of hirsutism. ESTELLE-35 and ESTELLE-35 ED are also indicated for oral contraception in women requiring treatment for these androgen-dependent diseases; it is not recommended in women solely for contraception. ESTELLE-35 and ESTELLE-35 ED are also indicated for treating the symptoms of polycystic ovary syndrome.
Package - Contents - Shelf Life: Blister pack, PVC/PVDC/Al pack - 28 tablets - 36 months from date of manufacture stored at or below 30°C - Blister pack, PVC/PVDC/Al pack,3x28 tabs - 84 tablets - 36 months from date of manufacture stored at or below 30°C
2000-11-23
CONSUMER MEDICINE INFORMATION ESTELLE-35® ED _cyproterone acetate and ethinylestradiol _ 2 mg/0.035 mg WHAT IS IN THIS LEAFLET PLEASE READ THIS LEAFLET CAREFULLY BEFORE YOU START USING ESTELLE-35 ED. This leaflet answers some common questions about Estelle-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 Estelle-35 ED against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. YOU MAY NEED TO READ IT AGAIN. WHAT ESTELLE-35 ED IS USED FOR Estelle-35 ED 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, hair loss (alopecia) or moderately increased growth of facial and body hair (hirsutism). Estelle-35 ED may also be used to treat the symptoms of polycystic ovary syndrome. Estelle 35-ED should be withdrawn 3 to 4 cycles after the treated condition has been completely resolved. Estelle-35 ED provides effective oral contraception in women being treated for androgen-dependent diseases. It is not intended to be used solely for contraceptive purposes. Your doctor may have prescribed Estelle-35 ED for another reason. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ESTELLE-35 ED HAS BEEN PRESCRIBED FOR YOU. This medicine is available only with a doctor's prescription. BEFORE YOU TAKE ESTELLE-35 ED _WHEN YOU MUST NOT TAKE IT _ DO NOT TAKE ESTELLE-35 ED IF YOU HAVE AN ALLERGY TO: • any medicine containing cyproterone acetate and/or ethinylestradiol (the active ingredients in Estelle-35 ED). • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include: • difficulty in breathing or wheezing. • shortness of breath. • swelling of the face, tongue, lips, or other parts of Lesen Sie das vollständige Dokument
1 | P a g e NEW ZEALAND DATA SHEET 1. PRODUCT NAME Estelle-35® 2 mg/35 microgram film coated tablet Estelle-35® ED 2 mg/35 microgram film coated tablet 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each active tablet of Estelle-35 and Estelle-35 ED contains: Cyproterone acetate 2 mg Ethinylestradiol 35 micrograms EXCIPIENTS WITH KNOWN EFFECT Lactose monohydrate Sucrose For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM ESTELLE-35 Film coated, yellowish buff, round, biconvex, active tablets that are plain on both sides, with a diameter of 5 mm. ESTELLE-35 ED Active tablets are film coated, yellowish buff, round, biconvex tablets that are plain on both sides, with a diameter of 5 mm. Placebo tablets are white, round, biconvex tablets that are plain on both sides, with a diameter of 7.1 mm. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS ESTELLE-35/ESTELLE-35 ED IS NOT RECOMMENDED IN WOMEN SOLELY FOR CONTRACEPTION. Estelle-35/Estelle-35 ED is indicated for the treatment of androgen-dependent diseases in women, such as acne (where oral antibiotics or local treatment alone has not been successful), especially pronounced forms and those which are accompanied by seborrhoea or by inflammation or 2 | P a g e formation of nodes (acne papulopustulosa, acne nodulocystica), androgenic alopecia, mild forms of hirsutism. Estelle-35/Estelle-35 ED is also indicated for oral contraception in women requiring treatment for these androgen-dependent diseases; it is not recommended in women solely for contraception. It should not be used in combination with other hormonal contraceptives. Estelle-35/Estelle-35 ED is also indicated for treating the symptoms of polycystic ovary syndrome. 4.2. DOSE AND METHOD OF ADMINISTRATION Estelle-35/Estelle-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 Estelle-35/Estelle-35 ED is similar to the usual regimen of most combi Lesen Sie das vollständige Dokument