Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
Drospirenone; Ethinyloestradiol
Bayer Australia Ltd
Medicine Registered
YAZ ® Flex _ethinyloestradiol (as betadex clathrate) and drospirenone _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about YAZ Flex. 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 YAZ Flex 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 YAZ FLEX IS USED FOR YAZ Flex is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. YAZ Flex is used to prevent pregnancy. It is also used to treat moderate acne in women seeking oral contraception. You may also experience the following benefits: improvement in symptoms like bloating, swelling or weight gain related to fluid retention fewer bleeding/spotting days a decrease in anaemia (iron deficiency) a decrease in period pain. Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy, fibrocystic breast changes and cancer of the uterus (womb), ovaries may be less common in women taking the Pill. When taken correctly, it prevents you from becoming pregnant in various ways, including: inhibiting the egg release by stopping it maturing changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg When the pill is taken by women under close observation in clinical trials, it is more than 99% effective in preventing pregnancy. However, in real Прочетете целия документ
1301 YAZ FLEX Pl 1 PRODUCT INFORMATION YAZ ® FLEX NAME OF THE MEDICINE YAZ Flex is a combined oral contraceptive (COC) tablet containing the synthetic progestogen, drospirenone and the synthetic oestrogen, ethinyloestradiol (as betadex clathrate). Ethinyloestradiol betadex-clathrate is an inclusion complex of the compendially described substances ethinyloestradiol and betadex and when dissolved in water it dissociates into the active moiety ethinyloestradiol and the ligand betadex. The chemical name for ethinyloestradiol is 19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3, 17 –diol and has the following structural formula: C H 3 OH C CH O H H H H Chemical Formula: C 20 H 24 O 2 Molecular Weight: 296.41 CAS No: 57-63-6 The chemical name for drospirenone is 6 , 7 ,15 , 16 -Dimethylene-3-oxo-17 -pregn-4- ene-21, 17-carbolactone and has the following structural formula: O O CH 3 H 3 C O H H H _ _ Chemical formula: C 24 H 30 O 3 Molecular weight: 366.50 CAS No: 67392-87-4 DESCRIPTION 1301 YAZ FLEX Pl 2 Ethinyloestradiol is a white to creamy white, odourless, crystalline powder. It is insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils, and aqueous solutions of alkali hydroxides. Drospirenone is a white to off-white crystalline powder. It is freely soluble in methylene chloride, soluble in acetone, methanol, sparingly soluble in ethylacetate and ethanol 96% (v/v) and practically insoluble in hexane and water. Each YAZ Flex tablet contains drospirenone 3 mg and ethinyloestradiol (as betadex clathrate) 20 g and the excipients: lactose, maize starch, magnesium stearate, hypromellose, purified talc, titanium dioxide and iron oxide red. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES The contr Прочетете целия документ