Country: Australia
Bahasa: Inggeris
Sumber: Department of Health (Therapeutic Goods Administration)
Ethinyloestradiol; Levonorgestrel
Pfizer Australia Pty Ltd
Medicine Registered
TRIFEME ® _Levonorgestrel and Ethinyloestradiol Tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Trifeme. It does not contain all of 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 Trifeme 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 TRIFEME IS USED FOR Trifeme is an oral contraceptive, commonly known as a "birth control pill" or "the Pill". Trifeme 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. Trifeme 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. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY TRIFEME HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Trifeme for another reason. This medicine is only available with a doctor's prescription. Trifeme is not habit-forming. This medicine is not expected to affect your ability to drive a car or operate machinery. BEFORE YOU TAKE TRIFEME _WHEN YOU MUST NOT TAKE_ _TRIFEME_ DO NOT TAKE TRIFEME 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 reaction may include: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itc Baca dokumen lengkap
Version: pfptrift10611 Supersedes: wyptrife11109 Page 1 of 18 PRODUCT INFORMATION TRIFEME TABLETS NAME OF THE MEDICINE Levonorgestrel and Ethinyloestradiol Chemically, ethinyloestradiol is 19-nor-17 -pregna-1,3,5(10)-trien-20-yne-3,17-diol and has the following structure: - Chemical Formula: C 20 H 24 0 2 Molecular Weight: 296.41 Melting Point: 181-185 C CAS No: [57-63-6] Chemically, levonorgestrel is (-)-13 -Ethyl-17-hydroxy-18,19-dinor-17-pregn-4-en-20- yn-3-one and has the following structure: - Chemical Formula: C 21 H 28 0 2 Molecular Weight: 312.45 Melting Point: 232-239 C CAS No: [797-63-7] DESCRIPTION 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. Levonorgestrel is a white crystalline powder that is very slightly soluble in water, slightly soluble in alcohol and acetone, and soluble in chloroform. Each TRIFEME package contains 28 tablets; 6 brown tablets each containing 30 microgram ethinyloestradiol and 50 microgram levonorgestrel, followed by 5 white tablets each containing 40 microgram of ethinyloestradiol and 75 microgram levonorgestrel, followed by 10 yellow tablets, each containing 30 microgram ethinyloestradiol and 125 microgram levonorgestrel, followed by 7 red inert tablets. Each tablet contains the following excipients; calcium carbonate, glycol montanate, macrogol 6000, magnesium stearate, sucrose, maize starch, povidone, glycerol, purified talc and Version: pfptrift10611 Supersedes: wyptrife11109 Page 2 of 18 lactose. The brown tablets contain the colourants iron oxide yellow CI 77492, iron oxide red CI 77491 and titanium dioxide. The yellow tablets contain the colourants iron oxide red CI 77491 and titanium dioxide. The red inactive tablets Baca dokumen lengkap