Страна: Австралія
мова: англійська
Джерело: Department of Health (Therapeutic Goods Administration)
cyproterone acetate,ethinylestradiol
Aspen Pharma Pty Ltd
cyproterone acetate,ethinylestradiol
Registered
CHELSEA-35 ED 1 CHELSEA ® -35 ED _Contraceptive tablets for women _ _Contains: _ _21 yellow tablets, each containing the active ingredients cyproterone acetate and ethinyloestradiol (2 _ _mg/35 microgram (µg)) _ _7 white placebo tablets _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CHELSEA ® -35 ED. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have benefits and risks. Your doctor has weighed the risks of you taking CHELSEA ® -35 ED against the benefits they expect it will have 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 THIS MEDICINE IS USED FOR CHELSEA ® -35 ED is a hormonal preparation used to treat the following androgen-dependent conditions in women: • severe acne when other treatments have failed • mild to moderate increased growth of facial or body hair (hirsutism). Androgens are male sex hormones, produced by women in small amounts. If a woman's body produces too much of these hormones or is overly sensitive, then androgen-dependent conditions occur. CHELSEA ® -35 ED works by blocking the action of these hormones. CHELSEA ® -35 ED is also an effective oral contraceptive, commonly known as the "Pill" or "birth control pill". As a contraceptive, CHELSEA ® -35 ED prevents pregnancy by: • preventing ovulation • thickening the cervical mucus to act as a barrier to sperm • making the lining of the uterus less suitable for implantation of the fertilised egg. Oral contraceptives such as CHELSEA ® -35 ED may have the following theoretical benefits: • a decrease in the amount of blood you lose each cycle during your period • a decrease in anaemia • a decrease in period pain • a reduced risk of pelvic inflammatory disease • a reduced risk of developing ovarian cysts • an improvement in acne • a reduced risk of tu Прочитайте повний документ
CHELSEA-35 ED – Product Information Page 1 of 15 Chelsea-35 ED PRODUCT INFORMATION NAME OF THE MEDICINE Cyproterone acetate and ethinylestradiol CYPROTERONE ACETATE The chemical name for cyproterone acetate is 6-chloro-17 α -hydroxy-1 α ,2 α - methylene-pregna-4,6- diene- 3,20-dione acetate. Its structural formula is: C 24 H 29 ClO 4 Molecular weight: 416.96 CAS No.: 427-51-0 ETHINYLESTRADIOL The chemical name for ethinyloestradiol is 19-nor-17 α -pregna-1,3,5,(10)-triene-20-yne-3,17 β -diol. Its structural formula is: C 20 H 24 O 2 Molecular weight: 296.41 CAS No.: 57-63-6 DESCRIPTION Cyproterone acetate: - white to pale yellow crystalline powder, which is very soluble in chloroform and dioxane, freely soluble in acetone and benzene, soluble in ethanol, methanol and ethyl acetate, sparingly soluble in solvent hexane and almost insoluble in water. The melting point is 206 – 213 O C. Ethinyloestradiol: - white to slightly yellowish white crystalline powder, which is practically insoluble in water, freely soluble in ethanol (96%) and ether, sparingly soluble in chloroform. It dissolves in dilute alkaline solutions. The melting point is 181 – 185 O C. CHELSEA-35 ED – Product Information Page 2 of 15 Chelsea-35 ED is a memo-pack containing 21 yellow active tablets, containing 2 mg of cyproterone acetate and 35 microgram (µg) ethinylestradiol. The pack also contains 7 white inactive (placebo) tablets. The tablets also contain the following excipients: lactose, povidone, purified talc, magnesium stearate, sucrose, calcium carbonate, titanium dioxide, macrogol 6000, glycerol, glycol montanate. maize starch (active tablets only) and iron oxide yellow (active tablets only). The tablets are gluten free. PHARMACOLOGY Chelsea-35 ED is a progestogen/oestrogen combination for the treatment of signs of androgenisation in women. At the same time, it is a reliable contraceptive for women who suffer primarily from these signs, or in whom acne and similar conditions occur or deteriorate under the use of other ovulatio Прочитайте повний документ