Pays: Australie
Langue: anglais
Source: 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: Gelatin; hypromellose; iron oxide yellow; titanium dioxide; magnesium stearate; lactose monohydrate; maize starch; macrogol 4000
Oral
3 x 21 Tablets, 1 x 21 Tablets sample pack
(S4) Prescription Only Medicine
ORAL CONTRACEPTION
Visual Identification: brownish 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 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 30/150. It will advise you about how to take Femme-Tab 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 30/150 USED FOR AND HOW DOES IT WORK Femme-Tab 30/150 is a combined oral contraceptive (often called "the Pill") consisting of 21 active tablets. Each 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 30/150 is considered to be a low-dose combined oral contraceptive preparation. _HOW DOES FEMME-TAB 30/150 WORK?_ _ _ Combined oral contraceptive Pills, such as Femme-Tab 30/150, provide one of the most e/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 30/150 USED FOR?_ _ _ Femme-Tab 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-Tab 30/150 may also have non- contraceptive health benefits. • Your period may be lighter and shorter. As a result, the risk of anemia may be lower. Your period pains may become less severe or may completely disappear. • Some serious disorders hav Lire le document complet
1 AUSTRALIAN PRODUCT INFORMATION FEMME-TAB 30/150 (LEVONORGESTREL/ETHINYLESTRADIOL) FILM-COATED TABLET 1 NAME OF THE MEDICINE Levonorgestrel and Ethinylestradiol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Femme-Tab 30/150 is a combined oral contraceptive (COC) tablet containing the synthetic progestogen levonorgestrel and the synthetic estrogen, ethinylestradiol. Each 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 30/150 tablets are available in blister packs. Each blister contains 21 brownish round convex tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Femme-Tab 30/150 is used for oral contraception. 4.2 DOSE AND METHOD OF ADMINISTRATION Combined oral contraceptives, such as Femme-Tab 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 30/150 One tablet is to be taken daily. Tablets must be taken in the order directed on the package every day at about the same time with some liquid as needed. Tablet-taking is continuous for 21 consecutive days. Start with a tablet marked with the corresponding day of the week. Thereafter, one tablet is taken daily, following the arrows marked on the pack, until all tablets are taken. The woman should be instructed to have a tablet free break of one week. Each subsequent pack is to be started immediately following the 7-day break. During the tablet free period a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last tablet and may not have finished before the next pack is started. 2 HOW TO START FEMME-TAB 30/150 _No preceding hormonal contraceptive use (in the past month) _ Tablet taking has to start on day 1 of the woman's natural cycle (i.e. the first day of her menstrual bleeding). Femme-Tab 30/150 is effective from the first day of therapy if Lire le document complet