国家: 澳大利亚
语言: 英文
来源: Department of Health (Therapeutic Goods Administration)
theophylline, Quantity: 200 mg
iNova Pharmaceuticals (Australia) Pty Ltd
Tablet, modified release
Excipient Ingredients: Guar Gum; magnesium stearate; purified water
Oral
100, 60, 500, 1000 tablets
(S4) Prescription Only Medicine
For the relief and prophylaxis of reversible bronchospasm associated with bronchial asthma, bronchitis, emphysema and related conditions.
Visual Identification: White round biconvex tablet N/L on one side and 200 on the other.; Container Type: Bottle; Container Material: HDPE; Container Life Time: 3 Years; Container Temperature: Store below 30 degrees Celsius; Container Closure: Child resistant closure
Registered
1997-05-16
NUELIN-SR™ TABLETS _(NEW-LIN)_ _Theophylline (thee-off-o-lin) Tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Nuelin-SR tablets. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. IF YOU NEED ANY MORE INFORMATION ABOUT NUELIN-SR TABLETS, PLEASE ASK YOUR DOCTOR OR PHARMACIST. All medicines have risks and benefits. Your doctor has weighed the risks of you taking Nuelin-SR tablets against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT TAKING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT NUELIN-SR TABLETS ARE USED FOR Nuelin-SR tablets are used to treat asthma and other conditions where breathing is difficult. It also helps to prevent asthma attacks. The active ingredient in Nuelin-SR tablets is theophylline, which causes the muscle lining of the airways to relax. Nuelin-SR tablets are a slow release medicine which means each tablet works for about 12 hours. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY THIS MEDICINE HAS BEEN PRESCRIBED FOR YOU. Your doctor may prescribe Nuelin- SR tablets for another purpose. Nuelin-SR tablets are available only with a doctor's prescription. IF YOU ARE NOT SURE WHY YOU ARE TAKING THIS MEDICINE, ASK YOUR DOCTOR. BEFORE YOU TAKE NUELIN-SR TABLETS _WHEN YOU MUST NOT TAKE IT_ DO NOT TAKE NUELIN-SR TABLETS IF YOU HAVE AN ALLERGY TO: • Any medicine containing theophylline, aminophylline or caffeine • Any of the ingredients listed at the end of this leaflet • Any other similar medicines used to treat asthma and other conditions where breathing is difficult 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 the skin DO NOT TAKE THIS MEDICINE AFTER THE EXPIRY DATE PRINTED ON THE PACK 阅读完整的文件
1 AUSTRALIAN PRODUCT INFORMATION – NUELIN ® -SR (THEOPHYLLINE) TABLETS AND NUELIN ® (THEOPHYLLINE) SYRUP 1 NAME OF THE MEDICINE Theophylline. 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Nuelin-SR Tablets contain 200 mg, 250 mg or 300 mg anhydrous theophylline in the form of sustained release tablets. Nuelin-SR Tablets also contain guar gum, magnesium stearate and purified water. Nuelin Syrup contains 133.3 mg anhydrous theophylline per 25 mL in immediate release form. Nuelin Syrup also contains methyl hydroxybenzoate, propyl hydroxybenzoate, sorbitol, berry citrus flavouring, sucrose and purified water. 3 PHARMACEUTICAL FORM NUELIN SR 200 theophylline 200mg tablet bottle – white round biconvex tablet N/L on one side and 200 on the other. NUELIN SR 250 theophylline 250mg tablet bottle – white, round biconvex tablets marked N/L 250. NUELIN SR 300 theophylline 300mg tablet bottle – white round biconvex tablet N/L on one side and 300 on the other. NUELIN Syrup theophylline 26.67mg/5mL bottle – clear liquid, berry flavour. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS For the relief and prophylaxis of reversible bronchospasm associated with bronchial asthma, bronchitis, emphysema and related conditions. 4.2 D OSE AND METHOD OF ADMINISTRATION Desirable therapeutic levels are considered to be between 10-20 µg/mL (55-110 µmol/L). Higher levels may produce toxic effects. Toxic effects may also occur at therapeutic levels. When maximum response is required, dose levels should be individually titrated. Serum theophylline may be monitored to confirm that levels are within the therapeutic range. Monitoring is particularly recommended when dose levels exceed 1 g daily in adults or 24 mg/kg daily in children. Appropriate dosage adjustments should be made for smoking, heart failure, acute pulmonary oedema, chronic alcohol ingestion, established hepatic cirrhosis, severe airways obstruction, severe pneumonia, severe hypoxia, thyroid function, adolescence (12-18 years), children (8-12 years) and concomitant use 阅读完整的文件