Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
Ethinyloestradiol; Levonorgestrel
Bayer Australia Ltd
Medicine Registered
MICROGYNON ® 20 ED CMI 1 MICROGYNON ® 20 ED (MY CROW GUY NON 20 EE DEE) Contraceptive tablets for women. _ethinyloestradiol and levonorgestrel_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Microgynon 20 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 Microgynon 20 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 MICROGYNON 20 ED IS USED FOR Microgynon 20 ED is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. Microgynon 20 ED is used to prevent pregnancy. When taken correctly, it prevents you from becoming pregnant in several 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 changing the lining of the uterus, making it less suitable for implantation. 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 life the pill is around 92% effective. This is because pills might be missed, or taken with medicines that may interfere with their effectiveness. Like all oral contraceptives, Microgynon 20 ED is intended to prevent pregnancy. It does not protect against HIV infection (AIDS) and other sexually transmitted diseases. Read the complete document
1105 Microgynon 20 ED PI 1 PRODUCT INFORMATION MICROGYNON 20 ED NAME OF THE MEDICINE Microgynon 20 ED is a combined oral contraceptive (COC) containing the synthetic progestogen, levonorgestrel and the synthetic oestrogen ethinyloestradiol. The chemical name for ethinyloestradiol is 19-nor-17 α-pregna-1,3,5(10)-trien-20-yne-3, 17β- 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 Melting Point: 181-185°C CAS No: 57-63-6 The chemical name for levonorgestrel is 13 β-ethyl-17β-hydroxy-18, 19-dinor-17α-pregn-4- en-20-yn-3-one and has the following structural formula: H OH C CH O H H H Chemical Formula: C 21 H 28 O 2 Molecular Weight: 312.45 Melting Point: 232-239°C CAS No: 797-63-7 DESCRIPTION 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. _ _ Levonorgestrel is a white or almost white, odourless or almost odourless, crystalline powder. Practically insoluble in water; slightly soluble in alcohol, acetone and ether; soluble in chloroform; sparingly soluble in methylene chloride. 1105 Microgynon 20 ED PI 2 Each pink active tablet contains levonorgestrel 100 µg and ethinyloestradiol 20 µg and the excipients: lactose, maize starch, purified talc, magnesium stearate, povidone, pregelatinised starch, sucrose, macrogol 6000, calcium carbonate, glycerol, titanium dioxide, iron oxide red, iron oxide yellow, glycol montanate. Each white placebo tablet contains lactose, maize starch, purified talc, magnesium stearate, povidone, sucrose, macrogol 6000, calcium carbonate, glycol montanate. PHARMACOLOGY The hormonal compone Read the complete document