Pajjiż: Awstralja
Lingwa: Ingliż
Sors: Department of Health (Therapeutic Goods Administration)
montelukast sodium, Quantity: 10.4 mg
Arrotex Pharmaceuticals Pty Ltd
montelukast sodium
Tablet, film coated
Excipient Ingredients: hyprolose; croscarmellose sodium; iron oxide red; magnesium stearate; hypromellose; iron oxide yellow; macrogol 6000; titanium dioxide; lactose monohydrate; microcrystalline cellulose
Oral
14 Tablets in blister pack, 4 Tablets in blister pack, 28 Tablets in blister pack
Medicine Registered
(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: Beige coloured rounded square biconvex film coated tablet debossed M10 on one side and plain on other side; Container Type: Blister Pack; Container Material: Al/Al; Container Life Time: 48 Months; Container Temperature: Store below 25 degrees Celsius
Registered
2012-05-17
_Montelukast AN tablets – Consumer Medicine Information _ _ _ _Doc ID: 78.116.AN.M.1.0 _ _ _ _ _ _Page 1 _ MONTELUKAST AN TABLETS _montelukast sodium _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Montelukast AN. 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 Montelukast AN 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 MONTELUKAST AN IS USED FOR Montelukast AN 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 AN also treats your allergic rhinitis symptoms. It can be used in children 2 years of age and older, teenagers and adults. Montelukast AN are 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 AN each night or as prescribed. As a preventive medicine for asthma, Montelukast AN can be used alone or in combination with other preventive medicines, such as inhaled corticosteroids. Your doctor may reduce your dose of inhaled corticosteroid while you are taking Montelukast AN. 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 Aqra d-dokument sħiħ
1 AUSTRALIAN PRODUCT INFORMATION – MONTELAIR 4, 5 & 10 (MONTELUKAST SODIUM) TABLETS 1 NAME OF THE MEDICINE Montelukast (as sodium) 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each MONTELAIR 10 film-coated tablet contains 10.4 mg montelukast sodium, which is equivalent to 10.0 mg of montelukast. Each MONTELAIR 5 chewable tablet contains 5.2 mg montelukast sodium, which is equivalent to 5.0 mg of montelukast. Each MONTELAIR 4 chewable tablet contains 4.16 mg montelukast sodium, which is equivalent to 4.0 mg of montelukast. Excipients with known effect: Aspartame and mannitol in the 4 mg and 5 mg tablets only. Lactose monohydrate in the 10 mg tablets only. For the full list of excipients, see Section 6.1 List of excipients. 3 PHARMACEUTICAL FORM MONTELAIR 4 tablets - Pink coloured, mottled, oval, biconvex, uncoated tablet, debossed “M4” on one side and plain on other side. MONTELAIR 5 tablets - Pink coloured, mottled, round, biconvex, uncoated tablet, debossed “M5” on one side and plain on other side. MONTELAIR 10 tablets - Beige coloured, rounded square, biconvex, film coated tablet debossed “M10” on one side and plain on other side. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Prophylaxis and treatment of chronic asthma in adults and children 2 years of age and older. Symptomatic treatment of seasonal allergic rhinitis. 2 4.2 D OSE AND METHOD OF ADMINISTRATION ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS MONTELAIR 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. 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 TO 5 YEARS OF AGE The dosage for paediatr Aqra d-dokument sħiħ