Krajina: Austrália
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
ethinylestradiol, Quantity: 30 microgram; drospirenone, Quantity: 3 mg
Lupin Australia Pty Limited
Drospirenone,ethinylestradiol
Tablet
Excipient Ingredients: maize starch; magnesium stearate; pregelatinised maize starch; lactose monohydrate; titanium dioxide; hypromellose; macrogol 400
Oral
4 x 28 Tablets (21 active and 7 placebo), 3 x 28 Tablets (21 active and 7 placebo), 1 x 28 Tablets (21 active and 7 placebo), 2 x 28 Tablets (21 active and 7 placebo)
(S4) Prescription Only Medicine
For use as an oral contraceptive
Visual Identification: White to off-white coloured, round, biconvex, film coated tablets, plain on both sides.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-01-20
CONSUMER MEDICINE INFORMATION ISABELLE (DROSPIRENONE AND ETHINYLESTRADIOL) FILM COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Isabelle. 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 Isabelle 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 ISABELLE IS USED FOR Isabelle is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. Isabelle is used to prevent pregnancy. You may also experience the following benefits: • improvement in symptoms like bloating, swelling or weight gain related to fluid retention; • 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 and cancer of the uterus (womb) and ovaries may be less common in women taking oral contraceptives. When taken correctly, it prevents you from becoming pregnant in several ways including: • inhibiting the egg release by stopping it maturing; • changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg. When oral contraceptives are taken by women under close observation in clinical trials, it is more than 99% effective in preventing pregnancy. However, in real life the oral contraceptives are around 92% effective. This is because pills might be missed, or taken with medicines that may interfere with their effectiveness, or may not be absorbed due to vomiting and diarrhoea. Like all oral contraceptives, Isabelle is intended to prevent pregnancy. It does not protec Prečítajte si celý dokument
AUSTRALIAN PRODUCT INFORMATION – ISABELLE (DROSPIRENONE AND ETHINYLESTRADIOL) FILM COATED TABLET 1 NAME OF THE MEDICINE Drospirenone and Ethinylestradiol. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Isabelle is a combined oral contraceptive tablet containing the synthetic progestogen, drospirenone and the synthetic estrogen, ethinylestradiol. Each yellow active tablet contains drospirenone 3 mg and ethinylestradiol 30 µg. List of excipients with known effects: Lactose monohydrate. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM ACTIVE TABLETS: Yellow coloured, round, biconvex, film coated tablets, debossed with 'DR2' on one side and plain on the other side. PLACEBO TABLETS: White to off-white coloured, round, biconvex, film coated tablets, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Isabelle is indicated for use as an oral contraceptive. 4.2 DOSE AND METHOD OF ADMINISTRATION 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 pack. Withdrawal bleeding usually starts on Day 2 to 3 after starting the white placebo tablets and may not have finished before the next pack is started. HOW TO START ISABELLE No preceding hormonal contraceptive use (in the past month) Tablet-taking has to start on Day 1 of the woman's natural cycle (ie. the first day of her menstrual bleeding). The women should be instructed to take a yellow active tablet from the pink section of the Isabelle v3.0 Page 2 of 22 (drospirenone and ethinylestradiol) film coated tablet pack, corresponding to that day of the week. If started on Day 1 in this way, protection against pregnancy is i Prečítajte si celý dokument