Страна: Австралия
Език: английски
Източник: Department of Health (Therapeutic Goods Administration)
ethinylestradiol, Quantity: 0.02 mg; levonorgestrel, Quantity: 0.1 mg
Alphapharm Pty Ltd
ethinylestradiol,Levonorgestrel
Tablet
Excipient Ingredients: povidone; croscarmellose sodium; iron oxide yellow; magnesium stearate; brilliant blue FCF aluminium lake; microcrystalline cellulose; lactose monohydrate
Oral
4 x 28 (21 active and 7 placebo), 2 x 28 (21 active and 7 placebo), 3 x 28 (21 active and 7 placebo), 1 x 28 (21 active and 7 placebo)
(S4) Prescription Only Medicine
Lenest 20 ED is indicated for the prevention of pregnancy.
Visual Identification: Round, green, uncoated flat tablets debossed 471 on one side and other side plain.; Container Type: Blister Pack; Container Material: PVC/PVDC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius; Container Closure: Neither child resistant closure nor restricted flow insert
Licence status A
2014-11-21
LENEST 20 ED _contains the active ingredients levonorgestrel and ethinylestradiol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about LENEST 20 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 benefits and risks. Your doctor has weighed the risks of you taking LENEST 20 ED against the benefits expected 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 YOUR MEDICINE. You may need to read it again. WHAT LENEST 20 ED IS USED FOR LENEST 20 ED is a combined oral contraceptive, commonly known as 'birth control pill' or 'the Pill'. LENEST 20 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, LENEST 20 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, LENEST 20 ED is intended to prevent pregnancy. It does not protect against HIV infection Прочетете целия документ
AUSTRALIAN PRODUCT INFORMATION LENEST 20 ED _Levonorgestrel/ethinylestradiol tablets _ 1 NAME OF THE MEDICINE Levonorgestrel/ethinylestradiol 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pink active tablet contains levonorgestrel 100 μg and ethinylestradiol 20 μg as the active ingredients. Excipients of known effect: lactose monohydrate (present in both pink active tablet and green placebo tablet). For the full list of excipients see section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM LENEST 20 ED is a combined oral contraceptive (COC) tablet containing the synthetic progestogen levonorgestrel and the synthetic estrogen ethinylestradiol. The pink active tablets are round, pink, uncoated flat tablets debossed ‘405’ on one side and the other side is plain. The green placebo tablets are round, green, uncoated flat tablets debossed ‘471’ on one side and the other side is plain. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LENEST 20 ED is indicated for the prevention of pregnancy. 4.2 DOSE AND METHOD OF ADMINISTRATION HOW TO TAKE LENEST 20 ED Combined oral contraceptives (COC), 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 each day, with some liquid as needed. Daily tablet taking should be continuous for 28 consecutive days, starting with a pink active tablet marked with the corresponding day of the week from the green area of the LENEST 20 ED pack. Each subsequent pack is to be started the day after the last tablet of the previous pack. A withdrawal bleed usually starts on day 2 to 3 after starting the green placebo tablets (last row) and may not have finished before the next pack is started. HOW TO START LENEST 20 ED No Preceding Hormonal Contraceptive Use (in the past month) Tablet-taking must start on day 1 of the woman’s natural cycle (i.e. the first day of her menstrual blee Прочетете целия документ