Land: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
HEALOL PHARMACEUTICALS SDN. BHD.
MONTELUKAST SODIUM
30tablet Tablets
Aurobindo Pharma Limited, Unit-VII (SEZ)
_Consumer Medication Information Leaflet (RiMUP) _ M-KAST 10 (MONTELUKAST TABLETS 10MG) Montelukast Sodium Tablets (10mg) 1 WHAT IS IN THIS LEAFLET 1. What M-KAST 10 is used for 2. How M-KAST 10 works 3. Before you use M-KAST 10 4. How to use M-KAST 10 5. While you are using it 6. Side effects 7. Storage and Disposal of M- KAST 10 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS M-KAST 10 USED FOR Montelukast sodium is the active ingredient in M-KAST 10. It is used as a prevention and also as a treatment for chronic asthma in adults and adolescents from 15 years old onwards. It is also used for the relief of daytime and night-time symptoms of seasonal allergic rhinitis in adults and adolescents from 15 years old onwards. HOW M-KAST 10 WORKS Montelukast 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 M-KAST 10 -When you must not use it You must not use this product if you are hypersensitive to active ingredient or excipients of this product. -Before you start to use it Tell your doctor about any medical problems or allergies you have now or have had. If your asthma or breathing gets worse, tell your doctor immediately. This product is not meant to treat acute asthma attacks. Please follow doctor’s instructions in case you have an acute asthma attack. Do not take this medication if your doctor has not prescribed it to you. This medication is not meant to substitute current medications that your doctor has prescribed to you. Please consult your doctor if you experience symptoms such as a flu- like illness, numbness of arms or legs, worsening of your asthma condition or a rash while on this Lestu allt skjalið
NAME OF DRUG PRODUCT : Montelukast Tablets 10 mg. (TRADE) NAME OF PRODUCT: M - KAST 10 STRENGTH: 10 mg. PHARMACEUTICAL DOSAGE FORM: Film coated Tablet. QUALITATIVE AND QUANTITATIVE COMPOSITIONS: _Montelukast Tablets 10 mg:_ Each film coated tablet contains Montelukast Sodium Ph.Eur. equivalent to Montelukast 10 mg. PHARMACEUTICAL FORM: _Montelukast Tablets 10 mg: _ Beige, rounded square shaped, film coated tablets debossed with 'X' on one side and '54' on other side. CLINICAL PARTICULARS: THERAPEUTIC INDICATIONS For the prophylaxis and chronic treatment of asthma in adults and patients 15 years of age and older. For the relief of daytime and nighttime symptoms of seasonal allergic rhinitis in adults and patients 15 years of age and older. POSOLOGY AND METHOD OF ADMINISTRATION 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 tablet 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. _General recommendations_ The therapeutic effect of montelukast on parameters of asthma control occurs within one day. Montelukast tablets and chewable tablets can be taken with or without food. Patients should be advised to continue taking Montelukast while their asthma is controlled, as well as during periods of worsening asthma. No dosage adjustment is necessary for pediatric patients, for the elderly, for patients with renal insufficiency, or mild-to-moderate hepatic impairment, or for patients of either gender. Montelukast is a long term-controller medication which should not be substituted for short acting beta-agonists. It is effective alone or in combination with other prophylactic agent. Montelukast is a preventive agent, which should be used in addition to other drugs for the management of asth Lestu allt skjalið