国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
levonorgestrel, Quantity: 150 microgram; ethinylestradiol, Quantity: 30 microgram
Lupin Australia Pty Limited
ethinylestradiol,Levonorgestrel
Tablet, film coated
Excipient Ingredients: magnesium stearate; maize starch; lactose monohydrate; pregelatinised maize starch; titanium dioxide; hypromellose; macrogol 400
Oral
4 blisters x 28 tablets (21 active and 7 placebo in each blister), 2 blisters x 28 tablets (21 active and 7 placebo in each blister), 3 blisters x 28 tablets (21 active and 7 placebo in each blister), 1 blister x 28 tablets (21 active and 7 placebo in each blister)
(S4) Prescription Only Medicine
ORAL CONTRACEPTION
Visual Identification: White to Off-white, round shaped, biconvex film coated tablets, plain on both side.; Container Type: Blister Pack; Container Material: PVC/PCTFE (Aclar)/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2014-02-03
CONSUMER MEDICINE INFORMATION EVELYN 150/30 ED (LEVONORGESTREL AND ETHINYLESTRADIOL) FILM-COATED TABLET WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Evelyn 150/30 ED. 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 Evelyn 150/30 ED 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 EVELYN 150/30 ED IS USED FOR Evelyn 150/30 ED is a combined oral contraceptive, commonly known as a ‘birth control pill’ or ‘the Pill’. Evelyn 150/30 ED is used to prevent pregnancy. You may also experience the following benefits: • 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, acne and cancer of the uterus (womb) and ovaries may be less common in women taking the Pill. When taken correctly, Evelyn 150/30 ED prevents you from becoming pregnant in several ways, including: • inhibiting ovulation (egg release); • changing the cervical mucus consistency, making it more difficult for the sperm to reach the egg; • changing the lining of the uterus, making it less suitable for implantation. When the Pill is taken by women under close observation in clinical trials, it is more than 99% effective in preventing pregnancy. However, in real life the Pill is around 92% effective. This is because pills might have been missed, may have been taken with medicines that interfere with their effectiveness, or may not be absorbed due to vomiting or diarrhoea. Like all oral contraceptives, Evelyn 150/30 ED is intended to prevent pregna 阅读完整的文件
AUSTRALIAN PRODUCT INFORMATION – EVELYN 150/30 ED (LEVONORGESTREL AND ETHINYLESTRADIOL) FILM-COATED TABLET 1 NAME OF THE MEDICINE Levonorgestrel and ethinylestradiol. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Evelyn 150/30 ED is a combined oral contraceptive (COC) tablet containing the synthetic progestogen levonorgestrel and the synthetic estrogen ethinylestradiol. Each yellow film-coated active tablet contains 30 micrograms ethinylestradiol and 150 micrograms levonorgestrel. 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 TABLET: Yellow, round biconvex film-coated tablets debossed with LE4 on one side and plain on other side. PLACEBO TABLET: White to off-white, round shaped, biconvex film-coated tablets, plain on both sides. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Oral contraception. 4.2 DOSE AND METHOD OF ADMINISTRATION HOW TO TAKE EVELYN 150/30 ED Combined oral contraceptives (COCs), when taken correctly, have a failure rate of approximately 1% per year. The failure rate may increase when pills are missed or taken incorrectly. One tablet is to be taken daily. The tablets must be taken in the order directed on the package at about the same time every day, 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 coloured section of the Evelyn 150/30 ED pack. If a woman starts on a Monday, Tuesday, Wednesday, Thursday or Friday, her first tablet is a white placebo one, while if she starts on a Saturday or Sunday her first tablet will be a yellow active one. Evelyn 150/30 ED v4 Page 2 of 20 (levonorgestrel and ethinylestradiol) film-coated tablet 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 starts on day 2 t 阅读完整的文件