Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
Ethinyloestradiol; Levonorgestrel
Pfizer Australia Pty Ltd
Medicine Registered
LOETTE ® _Levonorgestrel and Ethinyloestradiol 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 ethinyloestradiol), 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 ethinyloestradiol 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 reactio Baca dokumen lengkap
Version: pfploett10611 Supersedes: wyploett10211 Commercial/Non-Commercial Page 1 of 22 PRODUCT INFORMATION LOETTE TABLETS NAME OF THE MEDICINE Levonorgestrel and Ethinyloestradiol Chemically, levonorgestrel is 13 -ethyl-17-hydroxy-18, 19-dinor-17-pregn-4-en-20-yn-3- one and has the following chemical structure: Chemical Formula: C 21 H 28 0 2 Molecular Weight: 312.45 Melting Point: 232-239 C CAS No: 797-63-7 Chemically, ethinyloestradiol is 19-nor-17 -pregna-1,3,5 (10)-trien-20-yne-3,17-diol and has the following chemical structure: Chemical Formula: C 20 H 24 0 2 Molecular Weight: 296.41 Melting Point: 181-185 C CAS No: 57-63-6 Version: pfploett10611 Supersedes: wyploett10211 Commercial/Non-Commercial Page 2 of 22 DESCRIPTION LOETTE is a combined oral contraceptive tablet containing the synthetic progestogen, levonorgestrel, and the synthetic oestrogen, ethinyloestradiol. Levonorgestrel is a progestogen. Levonorgestrel is a white, odourless crystalline powder. It is practically insoluble in water, slightly soluble in alcohol, acetone, ether, and soluble in chloroform. Ethinyloestradiol is an oestrogen. Ethinyloestradiol is a white to creamy white, odourless, crystalline powder. It is insoluble in water and soluble in alcohol, chloroform, ether, vegetable oils, and aqueous solutions of alkali hydroxides. Each pink active tablet contains 100 g levonorgestrel and 20g ethinyloestradiol and the excipients: cellulose-microcrystalline, lactose, polacrilin potassium, magnesium stearate, macrogol 1450, glycol montanate, hypromellose, titanium dioxide and the colourant, Iron Oxide Red CI 77491. Each white inactive tablet contains cellulose-microcrystalline, lactose, polacrilin potassium, magnesium stearate, macrogol 1500, glycol montanate, hypromellose and titani Baca dokumen lengkap