Nazione: Australia
Lingua: inglese
Fonte: Department of Health (Therapeutic Goods Administration)
ethinylestradiol, Quantity: 20 microgram; levonorgestrel, Quantity: 100 microgram
Bayer Australia Ltd
Tablet, sugar coated
Excipient Ingredients: calcium carbonate; maize starch; povidone; glycol montanate; lactose monohydrate; macrogol 6000; magnesium stearate; sucrose; purified talc
Oral
4 x 28 tablets, 3 x 28 tablets, 1 x 28 tablets, 2 x 28 tablets
(S4) Prescription Only Medicine
Microlevlen ED is indicated for the prevention of pregnancy.
Visual Identification: White, lustrous, coated biconvex tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
1998-11-17
1802 MICROLEVLEN ED CMI 1 MICROLEVLEN ® ED (MY ⋅ CROW ⋅ LEV ⋅ LEN EE ⋅ DEE) Contraceptive tablets for women _ethinyloestradiol and levonorgestrel_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Microlevlen 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 Microlevlen 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 MICROLEVLEN ED IS USED FOR Microlevlen ED is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. Microlevlen ED is used to prevent pregnancy. You may also experience the following benefits: • more regular and lighter periods – potentially resulting in a decrease in anaemia (iron deficiency) • a decrease in period pain. Some conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pregnancy (where the foetus is carried outside of your womb), lumpy breasts, acne and cancer of the uterus (womb) and ovaries may be less common in women taking the Pill. When taken correctly, Microlevlen ED prevents you from becoming pregnant in several ways, including: • inhibiting ovulation (egg release) • 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 have been missed, may have been taken with medicines that interfere with their effectiveness, or may not be absorbed due to vomiting or diarrhoea. Like all Leggi il documento completo
1801 Microlevlen ED PI 1 PRODUCT INFORMATION MICROLEVLEN ED NAME OF THE MEDICINE MICROLEVLEN ED is a combined oral contraceptive (COC) tablet containing the synthetic oestrogen, ethinyloestradiol and the synthetic progestogen, levonorgestrel. The chemical name for ethinyloestradiol is 19-nor-17 α -pregna-1,3,5(10)-trien-20-yne-3, 17 β -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-17 β -hydroxy-18, 19-dinor-17 α -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 practically insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils and aqueous solutions of alkali hydroxides. 1801 Microlevlen ED PI 2 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. Each pink active tablet contains ethinyloestradiol 20 µ g and levonorgestrel 100 µ g and the excipients: calcium carbonate, glycerol, glycol montanate, iron oxide red, iron oxide yellow, lactose, macrogol 6000, magnesium stearate, maize starch, povidone, pregelatinised starch, purified talc, sucrose and titanium dioxide. Each white placebo tablet contains calcium carbonate, glycol montanate, lactose, macrogol 6000, magnesium stearate, maize starch, povidone, purified talc and sucrose. PHARMACOLOGY The hormonal components of MICROLEVLEN ED inhibit ovulation by suppressing gonadotrophin release. Secondary mechanisms which may contribute to the effectiveness of MICROLEVLEN ED as a contraceptive include changes in the cervical mucus (which increase the di Leggi il documento completo