Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
ethinylestradiol, Quantity: 20 microgram; drospirenone, Quantity: 3 mg
Arrotex Pharmaceuticals Pty Ltd
Drospirenone,ethinylestradiol
Tablet, film coated
Excipient Ingredients: lactose; magnesium stearate; povidone; titanium dioxide; purified talc; polyvinyl alcohol; macrogol 3350
Oral
6 x 28s (24 Active Tablets + 4 Placebo Tablets), 1 x 28s (24 Active Tablets + 4 Placebo Tablets), 3 x 28s (24 Active Tablets + 4 Placebo Tablets)
(S4) Prescription Only Medicine
This medicine is indicated for use as: ? an oral contraceptive. ? treatment of moderate acne vulgaris in women who seek oral contraception. ? treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of drospirenone 3 mg /ethinylestradiol 20 ?g for PMDD was not assessed beyond 3 cycles. Drospirenone 3 mg /ethinylestradiol 20 ?g has not been evaluated for treatment of PMS (premenstrual syndrome), see section 5.1 Pharmacodynamic Properties - Clinical trials.
Visual Identification: Plain, round, white, film coated tablets; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 21 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2013-07-15
YANA ® 1 YANA ® _Contains the active ingredients drospirenone and ethinylestradiol _ CONSUMER MEDICINE INFORMATION _FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 _ WHAT IS IN THIS LEAFLET READ THIS LEAFLET CAREFULLY BEFORE TAKING YOUR MEDICINE. This leaflet answers some common questions about drospirenone and ethinylestradiol. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the last page. More recent information on this medicine may be available. ASK YOUR DOCTOR OR PHARMACIST: • if there is anything you do not understand in this leaflet, • if you are worried about taking your medicine, or • to obtain the most up-to-date information. You can also download the most up to date leaflet from www.apotex.com.au. All medicines have risks and benefits. Your doctor has weighed the risks of you using this medicine against the benefits they expect it will have for you. Pharmaceutical companies cannot give you medical advice or an individual diagnosis. Keep this leaflet with your medicine. You may want to read it again. WHAT THIS MEDICINE IS USED FOR The name of your medicine is YANA ® . It contains the active ingredients drospirenone and ethinylestradiol. This medicine is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. It is used as: • an oral contraceptive • treatment of moderate acne vulgaris in women who seek oral contraception • treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. You may also experience the following benefits: • improvement in symptoms like bloating, swelling or weight gain related to fluid retention • more regular and shorter, lighter periods • a decrease in anaemia (iron deficiency) • a decrease in period pain. Some medical conditions such as pelvic inflammatory disease, ovarian cysts, ectopic pre Pročitajte cijeli dokument
1 AUSTRALIAN PRODUCT INFORMATION YANA ® (DROSPIRENONE, ETHINYLESTRADIOL) FILM COATED TABLETS 1 NAME OF THE MEDICINE Drospirenone, Ethinylestradiol (EE) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION YANA ® is a combined oral contraceptive (COC) tablet containing the synthetic progestogen, drospirenone and the synthetic estrogen, ethinylestradiol. Each pink active tablet contains drospirenone 3 mg and ethinylestradiol 20 μg. EXCIPIENTS WITH KNOWN EFFECT Active tablet: Lactose monohydrate Placebo tablet: Lactose For the full list of excipients see section 6.1 LIST OF EXCIPIENTS 3 PHARMACEUTICAL FORM YANA ® Active tablet: Plain, round, pink, film coated tablet. Placebo tablet: Plain, round, white, film coated tablets. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS This medicine is indicated for use as: • an oral contraceptive. • treatment of moderate acne vulgaris in women who seek oral contraception. • treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who have chosen oral contraceptives as their method of birth control. The efficacy of drospirenone 3 mg /ethinylestradiol 20 µg for PMDD was not assessed beyond 3 cycles. Drospirenone 3 mg /ethinylestradiol 20 µg has not been evaluated for treatment of PMS (premenstrual syndrome), see section 5.1 PHARMACODYNAMIC PROPERTIES - CLINICAL TRIALS. 4.2 DOSE AND METHOD OF ADMINISTRATION YANA ® is intended for oral administration. DOSAGE Combined oral contraceptives, when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. 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. One tablet is taken daily for 28 consecutive days. Each subsequent pack is started the day after the last tablet of the previous 2 pack. A withdrawal bleed usually starts on day 2 - 3 after starting the white placebo tablets (last row) and may not have finished before the next pack is star Pročitajte cijeli dokument