Land: Australien
Sprache: Englisch
Quelle: Department of Health (Therapeutic Goods Administration)
Oestradiol hemihydrate; Nomegestrol acetate
Merck Sharp & Dohme Australia Pty Ltd
Medicine Registered
ZOELY ® 1 ZOELY ® _Nomegestrol Acetate and Oestradiol _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about ZOELY. 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 ZOELY against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS INFORMATION CAREFULLY BEFORE YOU START TAKING ZOELY TABLETS. KEEP THIS LEAFLET. You may need to read it again. WHAT ZOELY IS USED FOR ZOELY is an oral contraceptive, commonly known as a "Birth Control Pill" or "The Pill" that has been prescribed to prevent you from getting pregnant. ZOELY prevents pregnancy in several ways: · It inhibits the egg release by stopping it maturing. · Changing the cervical mucus consistency making it difficult for the sperm to reach the egg. · Changing the lining of the uterus making it less suitable for implantation. ZOELY consists of 24 white tablets, each containing 2 active ingredients: 2.5 milligrams of nomegestrol acetate (a progestogen) and 1.5 milligrams of oestradiol (the natural oestrogen) and 4 yellow inactive tablets. ZOELY contains oestradiol, the natural oestrogen, compared with most Pills which contain the synthetic oestrogen ethinyloestradiol. Oral contraceptives are an effective method of birth control. When taken correctly (without missing tablets) the chance of becoming pregnant is very low. The following non-contraceptive health benefits have been associated with the combined Pill: · Your periods may be lighter and shorter. As a result, Lesen Sie das vollständige Dokument
1 PRODUCT INFORMATION ZOELY ® NAME OF THE MEDICINE ZOELY Each blister strip consists of 24 white active tablets each containing 2.5mg nomegestrol acetate and 1.5 mg oestradiol (as hemihydrate) and 4 yellow placebo tablets that do not contain active substances. NOMEGESTROL ACETATE O CH 3 CH 3 O H C CH 3 O C H 3 O H H H Chemical name: 17 -acetoxy-6-methyl-19-norpregna-4,6-dien-3,20-dione Molecular formula: C 23 H 30 O 4 Molecular mass: 370.48 CAS No.: 58652-20-3 OESTRADIOL Chemical name: estra-1,3,5(10)-triene-3,17 -diol Molecular formula: C 18 H 24 O 2 Molecular mass: 281.4 CAS No.: 50-28-2 DESCRIPTION ZOELY is a combined oral contraceptive (COC) preparation containing the progestogen nomegestrol acetate and the natural oestrogen 17 -oestradiol as the active substances. H CH 3 OH O H H H H 1/2 H 2 O 2 Nomegestrol acetate: a white to off white crystalline powder that is freely soluble in methylene chloride, acetone and ethyl acetate, soluble in dioxane and acetonitrile and sparing soluble in methanol and ethanol. Melting range is between 177 and 180 o C. Oestradiol: a white to almost white, crystalline powder and is practically insoluble in water. Melting range is between 173 and 179 o C. PHARMACOLOGY Nomegestrol acetate is a highly selective progestogen derived from, and structurally similar to, the naturally occurring steroid hormone, progesterone. Nomegestrol acetate has a strong affinity for the human progesterone receptor and has strong anti- gonadotropic activity, moderate anti-androgenic activity, and is devoid of any oestrogenic, androgenic, glucocorticoid or mineralocorticoid activit Lesen Sie das vollständige Dokument