Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
ethinylestradiol, Quantity: 0.03 mg; levonorgestrel, Quantity: 0.125 mg
Pfizer Australia Pty Ltd
Tablet, film coated
Excipient Ingredients: lactose monohydrate; magnesium stearate; maize starch; glycol montanate; sucrose; povidone; titanium dioxide; iron oxide yellow; calcium carbonate; glycerol; purified talc; macrogol 6000
Oral
4 x 28 tablets
(S4) Prescription Only Medicine
Indicated for the prevention of pregnancy.
Visual Identification: 10 yellow round biconvex 6mm diameter tablets.; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 3 Years; Container Temperature: Store below 25 degrees Celsius
Registered
1992-06-05
TRIFEME ® _Levonorgestrel and Ethinylestradiol 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 ethinylestradiol), 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 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: • shortness of breath • wheezing or difficulty breathing • swelling of the face, lips, tongue or other parts of the body • rash, itching or hives on th Přečtěte si celý dokument
Version: pfptrift11219 Supersedes: pfptrift11118 Page 1 of 27 AUSTRALIAN PRODUCT INFORMATION - TRIFEME (LEVONORGESTREL AND ETHINYLESTRADIOL) TABLETS 1. NAME OF THE MEDICINE Levonorgestrel and Ethinylestradiol 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each brown tablet contains 30 microgram of ethinylestradiol and 50 microgram of levonorgestrel. Each white tablet contains 40 microgram of ethinylestradiol and 75 microgram of levonorgestrel. Each yellow tablet contains 30 microgram of ethinylestradiol and 125 microgram of levonorgestrel Each red tablet contains no active ingredients. EXCIPIENTS WITH KNOWN EFFECT Sucrose Lactose monohydrate For the full list of excipients, see Section 6.1 - List of Excipients. 3. PHARMACEUTICAL FORM Tablet, sugar coated. Each blister contains 6 brown tablets, followed by 5 white tablets, followed by 10 yellow tablets and followed by 7 red inert tablets. Brown tablets: Round, biconvex, sugar coated brown tablets with diameter of approximately 6 mm. White tablets: Round, biconvex, sugar coated white tablets with diameter of approximately 6 mm. Yellow tablets: Round, biconvex, sugar coated yellow tablets with diameter of approximately 6 mm. Red tablets: Round, biconvex, sugar coated red inert tablets. Version: pfptrift11219 Supersedes: pfptrift11118 Page 2 of 27 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TRIFEME is indicated for the prevention of pregnancy. 4.2 DOSE AND METHOD OF ADMINISTRATION _HOW TO TAKE TRIFEME _ Each package of TRIFEME contains 6 brown active tablets, 5 white active tablets, 10 yellow active tablets and 7 red inactive tablets. To achieve maximum contraceptive effectiveness, TRIFEME must be taken as directed and at intervals not exceeding 24 hours. Women should be instructed to take the tablets at the same time every day, preferably after the evening meal or at bedtime. _HOW TO START TRIFEME _ 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 will take Přečtěte si celý dokument