País: Australia
Idioma: inglés
Fuente: Department of Health (Therapeutic Goods Administration)
levonorgestrel, Quantity: 150 microgram; ethinylestradiol, Quantity: 30 microgram
AFT Pharmaceuticals Pty Ltd
ethinylestradiol,Levonorgestrel
Tablet, film coated
Excipient Ingredients: titanium dioxide; iron oxide red; Gelatin; maize starch; macrogol 4000; magnesium stearate; hypromellose; lactose monohydrate
Oral
4x28 tablets (112 tablets), 3 x 28 Tablets, 1 x 28 Tablets sample pack
(S4) Prescription Only Medicine
ORAL CONTRACEPTION
Visual Identification: red-brown round convex film-coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2012-01-10
FEMME-TAB ED 30/150 LEVONORGESTREL 150 ΜG AND ETHINYLOESTRADIOL 30 ΜG TABLETS WHAT IS IN THIS LEAFLET Please read this leaflet carefully before you start using Femme-Tab ED 30/150. It will advise you about how to take Femme-Tab ED 30/150 properly and when to tell your doctor about health-related conditions. If you have any questions or need more advice, ask your doctor, professional health care provider or pharmacist. WHAT IS FEMME-TAB ED 30/150 USED FOR AND HOW DOES IT WORK Femme-Tab ED 30/150 is a combined oral contraceptive (often called "the Pill") consisting of 21 yellow to brownish active tablets and 7 red-brown inactive (placebo) tablets. Each round yellow to brownish film-coated tablet contains a small amount of two different female hormones. These are levonorgestrel (a progestogen) and ethinyloestradiol (an oestrogen). Because of the small amount of hormones, Femme- Tab ED 30/150 is considered to be a low-dose combined oral contraceptive preparation. The red-brown inactive tablets do not contain any active ingredients. _HOW DOES FEMME-TAB ED 30/150 WORK?_ _ _ Combined oral contraceptive Pills, such as Femme-Tab ED 30/150, provide one of the most effective reversible methods of contraception known. Usually, when Femme-Tab ED 30/150 is taken according to the instructions, the egg cells (normally released by the ovary each month) are prevented from maturing to the point where they can be fertilised. In addition, the cervical mucus remains thick, so it is more difficult for a man's sperm to enter the womb. Also, the lining of the womb is not prepared sufficiently for a fertilised egg to grow in. _WHAT IS FEMME-TAB ED 30/150 USED FOR?_ _ _ Femme-Tab ED 30/150 is used to prevent pregnancy. Combined oral contraceptives are a very effective method of birth control. When taken correctly (without missing tablets) the chance of becoming pregnant is very low (approximately 1% per year). The failure rate may increase when tablets are missed or taken incorrectly. Like other combined oral contraceptive pills, Femme-T Leer el documento completo
1 AUSTRALIAN PRODUCT INFORMATION FEMME-TAB ED 30/150 (LEVONORGESTREL/ETHINYLESTRADIOL) FILM-COATED TABLET 1 NAME OF THE MEDICINE Levonorgestrel and Ethinylestradiol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Femme-Tab ED 30/150 is a combined oral contraceptive (COC) tablet containing the synthetic progestogen levonorgestrel and the synthetic estrogen, ethinylestradiol. Each round brownish active tablet contains ethinylestradiol 30 µg and levonorgestrel 150 µg. Excipients with known effect: lactose For the full list of excipients, see Section 6.1 List of excipients 3 PHARMACEUTICAL FORM Film-coated tablet Femme-Tab ED 30/150 tablets are available in blister packs. Each blister contains 28 tablets consisting of 21 brownish round convex active tablets, followed by 7 red-brown round convex placebo tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Femme-Tab ED 30/150 is used for oral contraception. 4.2 DOSE AND METHOD OF ADMINISTRATION Combined oral contraceptives, such as Femme-Tab ED 30/150, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. HOW TO TAKE FEMME-TAB ED 30/150 One tablet is to be taken daily. The tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Daily tablet taking should be continuous for 28 consecutive days, starting with a tablet corresponding to that day of the week from the red section of the Femme-Tab ED 30/150 pack. If a woman starts on a Monday, Tuesday, Wednesday, Thursday or Friday, her first tablet is a red-brown placebo one, while if she starts on a Saturday or Sunday her first tablet will be a yellow to brownish active one. Thereafter, one tablet is taken daily, following the arrows marked on the pack, until all tablets have been taken. Each subsequent pack is started the day after the last tablet of the previous pack. Withdrawal bleeding usually 2 starts on days 2 to 3 after starting the red-brown placebo tablets an Leer el documento completo