Land: Ástralía
Tungumál: enska
Heimild: Department of Health (Therapeutic Goods Administration)
ethinylestradiol, Quantity: 20 microgram; levonorgestrel, Quantity: 100 microgram
Pfizer Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; macrogol 1500; magnesium stearate; microcrystalline cellulose; glycol montanate; polacrilin potassium; titanium dioxide; hypromellose; hyprolose; macrogol 400
Oral
4 x 21 active & 7 placebo, 3 x 21 active & 7 placebo, 1 x 21 active & 7 placebo, 2 x 21 active & 7 placebo
(S4) Prescription Only Medicine
1. The prevention of pregnancy. 2. The treatment of moderate acne vulgaris not controlled with topical preparations in post-menarchal, pre-menopausal women who accept contraception.
Visual Identification: White film-coated round tablet with convex faces; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Registered
2018-01-23
LOETTE ® _Levonorgestrel and Ethinylestradiol Tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Loette. 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 Loette against the benefits this medicine is expected to have for you. IF YOU HAVE ANY QUESTIONS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT LOETTE IS USED FOR Loette is an oral contraceptive, commonly known as a "birth control pill" or "the Pill". Loette tablets contain two hormones (levonorgestrel and ethinylestradiol), which prevent you from becoming pregnant if taken correctly. They are similar to the hormones that your body normally produces. Loette prevents pregnancy in several ways: • It inhibits the egg release by stopping it maturing • It changes the cervical mucus consistency making it difficult for the sperm to reach the egg • It changes the lining of the uterus making it less suitable for implantation. Loette is also used to treat moderate acne in women when this has not improved with acne treatments applied to the skin and who are also willing to be on a contraceptive. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY LOETTE HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Loette for another reason. This medicine is available only with a doctor's prescription. Loette is not habit-forming. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE LOETTE _WHEN YOU MUST NOT TAKE_ _LOETTE_ DO NOT TAKE LOETTE IF YOU HAVE AN ALLERGY TO: • Any medicine containing ethinylestradiol or levonorgestrel • Any of the ingredients listed at the end of this leaflet • Any other similar medicines (such as other oral contraceptives). Some of the symptoms of an allergic reaction may include: • Lestu allt skjalið
Version: pfploent10320 Supersedes: pfploent11018 Page 1 of 29 AUSTRALIAN PRODUCT INFORMATION - LOETTE (LEVONORGESTREL AND ETHINYLESTRADIOL) TABLETS 1. NAME OF THE MEDICINE Levonorgestrel and Ethinylestradiol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each pink tablet contains levonorgestrel 100 g and ethinylestradiol 20 g. Each white tablet contains no active ingredients. EXCIPIENTS WITH KNOWN EFFECT • Lactose monohydrate For the full list of excipients, see Section 6.1 - List of Excipients. 3. PHARMACEUTICAL FORM Tablet. Each blister contains 21 pink active tablets and 7 white inactive tablets. Pink tablet: Round, pink, biconvex, film coated tablets with "W" debossed on one side and "912" debossed on the other side. White tablets: White film-coated round tablet with convex faces. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS LOETTE is indicated for: The prevention of pregnancy. The treatment of moderate acne vulgaris not controlled with topical preparations in post-menarchal, pre-menopausal women who accept contraception. 4.2 DOSE AND METHOD OF ADMINISTRATION How to Take LOETTE Version: pfploent10320 Supersedes: pfploent11018 Page 2 of 29 Each package of LOETTE contains 21 active pink tablets and 7 white inactive tablets. To achieve maximum contraceptive effectiveness, LOETTE must be administered as directed and at the same time every day, at intervals not exceeding 24 hours. The recommended dose for the prevention of pregnancy and the treatment of acne is the same. Where poor compliance is a concern, an oral contraceptive with higher levels of estrogens and progestogens should be considered (see Section 5.1 - Pharmacodynamic Properties, Clinical Trials). How to Start LOETTE _NO PRECEDING HORMONAL CONTRACEPTIVE USE (IN THE PAST MONTH) _ On the first day of the menstrual cycle, i.e. the first day of bleeding, the woman is instructed to take a pink active tablet corresponding to that day of the week from the pink shaded section of the LOETTE pack. Thereafter, one pink active tablet is taken da Lestu allt skjalið