Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
SANDOZ PRODUCTS MALAYSIA SDN. BHD.
MONTELUKAST SODIUM
30 Tablets; 100 Tablets; 28 Tablets; 28 Tablets
LEK S.A.
MONTELUKAST SANDOZ Montelukast Sodium (4mg Chewable Tablets, 5mg Chewable Tablets, 10mg Film-Coated Tablets) 1 _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ WHAT IS IN THIS LEAFLET: 1. What is Montelukast Sandoz used for 2. How Montelukast Sandoz works 3. Before you use Montelukast Sandoz 4. How to use Montelukast Sandoz 5. While you are using it 6. Side effects 7. Storage and disposal of Montelukast Sandoz 8. Product description 9. Manufacturer & Product Registration Holder 10. Date of revision WHAT IS MONTELUKAST SANDOZ USED FOR You have been prescribed Montelukast Sandoz for: • Asthma, including preventing your asthma symptoms during the day and night. • Allergic rhinitis, including daytime and nighttime symptoms: nasal congestion, runny nose, nasal itching, and sneezing; tearing, itchy, red, and puffy eyes. HOW MONTELUKAST SANDOZ WORKS Montelukast Sandoz is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. Blocking leukotrienes improves asthma symptoms and helps prevent asthma attacks. Leukotrienes also cause allergy symptoms. Blocking leukotrienes improves allergic rhinitis (seasonal and perennial, also known as outdoor and indoor nasal allergies). BEFORE YOU USE MONTELUKAST SANDOZ - _When you must not use it _ • If you are allergic (hypersensitive) to montelukast, or to any of the ingredients. - _Before you start use it _ • Tell your doctor (or health care provider) about any medical problems or allergies you had. • The chewable tablets contain Aspartame, hence is unsuitable for patients with phenylketonuria. _USE IN CHILDREN _ For children 6 to 14 years old, Montelukast Sandoz 5 mg chewable tablets are available. For children 2 to 5 years old, Montelukast Sandoz 4 mg chewable tablets and montelukast 4 mg oral granules are available. For children 12 months to 2 years old with asthma, montelukast 4 mg oral granules are available. Safety and effectiveness of Montelukast Sandoz in children less th Baca dokumen lengkap
1. NAME OF THE MEDICINAL PRODUCT Montelukast Sandoz 4 mg Chewable Tablet. Montelukast Sandoz 5 mg Chewable Tablet. Montelukast Sandoz 10 mg Film-coated Tablet. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Montelukast Sandoz 4 mg Chewable Tablet Each chewable tablet contains montelukast sodium equivalent to 4 mg of montelukast. Excipient: Aspartame 0.96 mg per tablet. Montelukast Sandoz 5 mg Chewable Tablet Each chewable tablet contains montelukast sodium equivalent to 5 mg of montelukast. Excipient: Aspartame 1.20 mg per tablet. Montelukast Sandoz 10 mg film-coated tablet One film-coated tablet contains montelukast sodium equivalent to 10 mg montelukast. Excipient: Lactose 89.10 mg per tablet. For a full list of excipients, see 6.1. 3. PHARMACEUTICAL FORM Montelukast Sandoz 4 mg Chewable Tablet Chewable tablet. Oval pink tablet to slightly speckled pink tablet with odour of cherry, encoded 4 on one side. Mo ntelukast Sandoz 5 mg Chewable Tablet Chewable tablet. Round pink tablet to slightly speckled pink tablet with odour of cherry, encoded 5 on one side. M ontelukast Sandoz 10 mg film-coated tablet Film-coated tablet. A beige, round, biconvex, coated tablet (plain on both sides). 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS For the prophylaxis and chronic treatment of asthma in adults and pediatric patients 12 months of age and older. Montelukast is indicated in adults and pediatric patients 2 years of age and older for the relief of daytime and nighttime symptoms of seasonal allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _RECOMMENDED DOSAGE _ Montelukast should be taken once daily. For asthma, the dose should be taken in the evening. For allergic rhinitis, the time of administration may be individualized to suit patient needs. Patients with both asthma and allergic rhinitis should take only one dose daily in the evening. _Adults 15 Years of Age and Older with Asthma and/or Seasonal Allergic Rhinitis _ The dosage for adults 15 years of age and older is one 10 mg tablet daily. _Pediatric Patie Baca dokumen lengkap