Country: Australia
Language: English
Source: Department of Health (Therapeutic Goods Administration)
montelukast sodium, Quantity: 4.16 mg (Equivalent: montelukast, Qty 4 mg)
ORGANON PHARMA PTY LTD
Tablet, chewable
Excipient Ingredients: aspartame; mannitol; iron oxide red; hyprolose; croscarmellose sodium; microcrystalline cellulose; magnesium stearate; Flavour
Oral
4 tablets - sample pack, 28 tablets
(S4) Prescription Only Medicine
Prophylaxis and treatment of chronic asthma in adults and children two years of age and over. Symptomatic treatment of seasonal allergic rhinitis
Visual Identification: Pink, oval, biconvex tablet with 'SINGULAIR' debossed on one side and 'MSD 711' on other; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 30 degrees Celsius
Registered
2001-05-23
SINGULAIR ® _Montelukast sodium_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about SINGULAIR. 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 SINGULAIR 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 SINGULAIR IS USED FOR SINGULAIR 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), SINGULAIR also treats your allergic rhinitis symptoms. It can be used in children 2 years of age and older, teenagers and adults. SINGULAIR tablets 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 SINGULAIR each night or as prescribed. As a preventive medicine for asthma, SINGULAIR 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 SINGULAIR. 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. For further information about asthma, contact the Asthma Foundation in your state on 1800 645 130, or www.asthmaaustralia.org.au Seasonal Read the complete document
S-WPC-MK0476-MF-112018 Page 1 of 18 AUSTRALIAN PRODUCT INFORMATION SINGULAIR ® (MONTELUKAST SODIUM) TABLETS AND GRANULES 1 NAME OF THE MEDICINE Montelukast sodium 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each 10 mg film-coated tablet contains 10.4 mg montelukast sodium, which is equivalent to 10.0 mg of montelukast, the free acid. Excipients with known effects: - lactose monohydrate Each 5 mg chewable tablet contains 5.2 mg montelukast sodium, which is equivalent to 5.0 mg of montelukast, the free acid. Each 4 mg chewable tablet contains 4.16 mg of montelukast sodium, which is equivalent to 4.0 mg of montelukast, the free acid. Excipients with known effects: - aspartame Each packet of 4 mg oral granules contains 4.16 mg of montelukast sodium, which is equivalent to 4.0 mg of montelukast, the free acid. For the full list of excipients, see SECTION 6.1 LIST OF EXCIPIENTS. 3 PHARMACEUTICAL FORM 10 mg film-coated tablet - A beige biconvex rounded square film-coated tablet engraved with SINGULAIR on one side and MSD 117 on the other. 5 mg chewable tablet - A pink biconvex round chewable tablet engraved with SINGULAIR on one side and MSD 275 on the other. 4 mg chewable tablet - A pink, oval, biconvex chewable tablet with SINGULAIR debossed on one side and MSD 711 on the other. 4 mg oral granules - Coarse, white free-flowing granules sealed in a foil packet. 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. S-WPC-MK0476-MF-112018 Page 2 of 18 4.2 DOSE AND METHOD OF ADMINISTRATION ASTHMA AND/OR SEASONAL ALLERGIC RHINITIS SINGULAIR 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 Read the complete document