Country: Аустралија
Језик: Енглески
Извор: Department of Health (Therapeutic Goods Administration)
desogestrel, Quantity: 150 microgram; ethinylestradiol, Quantity: 30 microgram
Arrotex Pharmaceuticals Pty Ltd
Desogestrel,ethinylestradiol
Tablet
Excipient Ingredients: povidone; titanium dioxide; magnesium stearate; maize starch; hypromellose; polysorbate 80; triacetin; indigo carmine aluminium lake; colloidal anhydrous silica; iron oxide yellow; lactose monohydrate
Oral
21 active tablets + 7 placebo tablets
(S4) Prescription Only Medicine
ORAL CONTRACEPTION
Visual Identification: Round, biconvex, plain, green, film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-09-23
MADELINE ® 1 MADELINE ® _Ethinylestradiol and Desogestrel _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. READ THIS INFORMATION CAREFULLY BEFORE YOU START TAKING MADELINE TABLETS. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is Madeline. It contains the active ingredients desogestrel and ethinylestradiol. It is a combined oral contraceptive, commonly known as a "birth control pill" or "the Pill". It is used to prevent pregnancy. You may also experience the following benefits: • more regular periods, lighter bleeding • a decrease in the occurrence of anaemia (iron deficiency) • a decrease in period pain. There is also evidence that some medical conditions such as benign breast disease, ovarian cysts, pelvic inflammatory disease (pelvic infections), ectopic pregnancy (pregnancy in which the embryo implants outside of the womb) and cancer of the endometrium (lining of the womb) and ovaries may be less common in women using combined oral contraceptives containing 50 micrograms of ethinylestradiol (high- dose Pills). This may also be the case for low-dose Pills but so far this has only been confirmed for endometrial and ovarian cancer. Ask your doctor if you have any questions about why this medicine has been prescribed for you. Your doctor may have prescribed this medicine for another reason. This medicine is available only with a doctor's prescription. _HOW IT WORKS _ When taken correctly, this medicine prevents pregnancy in two ways: • it inhibits the Прочитајте комплетан документ
1 AUSTRALIAN PRODUCT INFORMATION MADELINE ® (DESOGESTREL AND ETHINYLESTRADIOL) FILM-COATED TABLETS 1 NAME OF THE MEDICINE Desogestrel and Ethinylestradiol. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION MADELINE is a combined oral contraceptive (COC) tablet containing the synthetic progestogen, desogestrel and the synthetic estrogen, ethinylestradiol. Each white active tablet contains 150 µg desogestrel and 30 µg ethinylestradiol. EXCIPIENTS WITH KNOWN EFFECT Active tablets Lactose monohydrate, d-alpha-tocopherol. Placebo tablets Lactose monohydrate. For the full list of excipients see section 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM MADELINE is available in blister packs. Each blister contains 28 tablets consisting of 21 active tablets and 7 placebo tablets. Active tablet: Round, biconvex, white, film-coated tablets with “MI” debossed on one side, and “7” debossed on the other. Placebo tablet: Round, biconvex, plain, green, film coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 DOSE AND METHOD OF ADMINISTRATION MADELINE is intended for oral administration. DOSAGE HOW TO TAKE THIS MEDICINE One tablet is to be taken daily. The tablets must be taken in the order directed on the package at about the same time each day, with some liquid as needed. Daily tablet taking should be continuous, starting with the tablet marked with the corresponding day from the blue zone. Each subsequent pack is to be started immediately following the last placebo (green) tablet. 2 During the placebo days a withdrawal bleed usually occurs. This usually starts on day 2-3 after the last active (white) tablet and may not have finished before the next pack is started. HOW TO START THIS MEDICINE The tablets are taken starting with the tablet marked with the corresponding day from the blue zone of the pack. This way, the woman will virtually always have a menstruation-free weekend. _• _ _No preceding hormonal contraceptive use (in the past month) _ Tablet-taking has to start on day 1 of the Прочитајте комплетан документ