Quốc gia: Úc
Ngôn ngữ: Tiếng Anh
Nguồn: Department of Health (Therapeutic Goods Administration)
montelukast sodium, Quantity: 5.2 mg
Accord Healthcare Pty Ltd
montelukast sodium
Tablet, chewable
Excipient Ingredients: aspartame; croscarmellose sodium; magnesium stearate; microcrystalline cellulose; mannitol; iron oxide red; Flavour
Oral
28 Tablets in blister pack
(S4) Prescription Only Medicine
-Prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. ,-Symptomatic treatment of seasonal allergic rhinitis.
Visual Identification: Pink colored mottled round biconvex uncoated tablet debossed M5 on one side and plain on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 36 Months; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-05-17
MONTELUKAST-APOTEX 1 MONTELUKAST APOTEX _Montelukast sodium _ CONSUMER MEDICINE INFORMATION FOR A COPY OF A LARGE PRINT LEAFLET, PH: 1800 195 055 WHAT IS IN THIS LEAFLET This leaflet answers some common questions about this medicine. 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 this medicine 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 THIS MEDICINE IS USED FOR Montelukast is used to prevent asthma symptoms, including those that occur during the day and at night-time. It also prevents the narrowing of airways triggered by exercise. If you have seasonal allergic rhinitis (hay fever), montelukast also treats your allergic rhinitis symptoms. Montelukast is not used to treat an acute attack of asthma. If an acute attack occurs, follow your doctor's instructions for your reliever medicine, and keep taking your montelukast each night or as prescribed. As a preventive medicine for asthma, montelukast can be used alone or in combination with other preventive medicines, such as inhaled corticosteroids. Asthma is a lung disease and has the following characteristics: • narrowed airways causing breathing to become difficult • inflamed airways, which means the lining of airways become swollen • sensitive airways that react to many things, such as cigarette smoke, pollen, or cold air Symptoms of asthma include coughing, wheezing and chest tightness. Not all people with asthma wheeze. For some, coughing may be the only symptom of asthma. Symptoms often occur during the night or after exercise. Seasonal allergic rhinitis (also known as hay fever) is an allergic response often caused by airborne pollens from trees, grasses, and weeds. The daytime and night-time symptoms of seasonal allergic rhinitis ty Đọc toàn bộ tài liệu
1 Montelukast Apotex v2 11.21 AUSTRALIAN PRODUCT INFORMATION – MONTELUKAST APOTEX (MONTELUKAST SODIUM) 1 NAME OF THE MEDICINE Montelukast sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 4 mg chewable tablet contains 4.16 mg montelukast sodium, which is equivalent to 4.0 mg of montelukast. Each 5 mg chewable tablet contains 5.2 mg montelukast sodium, which is equivalent to 5.0 mg of montelukast Each 10 mg film-coated tablet contains 10.4 mg montelukast sodium, which is equivalent to 10.0 mg of montelukast. Excipients with known effects: • Aspartame (4 mg and 5 mg chewable tablets only). • Lactose monohydrate (10 mg film-coated tablets only). For the full list of excipients, see Section 6.1 List of Excipients. 3 PHARMACEUTICAL FORM 4 mg chewable tablets: Pink coloured, mottled, oval, biconvex, uncoated tablet, debossed “M4” on one side and plain on other side. 5 mg chewable tablets: Pink coloured, mottled, round, biconvex, uncoated tablet, debossed “M5” on one side and plain on other side. 10 mg film-coated tablets: Beige coloured, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. Symptomatic treatment of seasonal allergic rhinitis. 4.2 DOSE AND METHOD OF ADMINISTRATION ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS Montelukast Tablets should be taken once daily. For asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualised to suit patient needs. Patients with both asthma and seasonal allergic rhinitis should take only one tablet daily in the evening. 2 Montelukast Apotex v2 11.21 Adults 15 Years of Age and Older The dosage for adults 15 years of age and older is one 10 mg tablet daily. Paediatric Patients 6 to 14 Years of Age The dosage for paediatric patients 6 to 14 years of age is one 5 mg chewable tablet daily. Paediatric Patients 2 Đọc toàn bộ tài liệu