Country: Malaysia
Bahasa: Inggeris
Sumber: 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 4 (MONTELUKAST CHEWABLE TABLETS 4MG) M-KAST 5 (MONTELUKAST CHEWABLE TABLETS 5MG) Montelukast sodium as Montelukast 4mg, Montelukast sodium as Montelukast 5mg 1 1. What M-KAST is used for product if you suffer from a allergic rhinitis: The dosage for 2. How M-KAST works condition called phenylketonuria. paediatric patients 6 to 14 years of 3. Before you use M-KAST Please get your doctor or age is one 5mg chewable tablet daily. 4. How to use M-KAST pharmacist’s advice if you are 5. While you are using it unsure. You may take M-KAST with or 6. Side effects without food. 7. Storage and Disposal of M- Effects on ability to drive and use KAST machines: montelukast has no or -When to use it 8. Product Description negligible influence on the ability to Use M-KAST exactly as your doctor WHAT IS IN THIS LEAFLET M-KAST contains an ingredient called aspartame. Do not use this For paediatric patients 6 to 14 years of age with asthma and/or seasonal 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT IS PRODUCT M-KAST FOR M-KAST is used to prevent and treat chronic asthma in adults and in children from 12 months of age and older. It is also indicated in adults and children from 2 years of age onwards in the relief of daytime and night- time symptoms of seasonal allergic rhinitis. HOW M-KAST WORKS Montelukast is the active ingredient in M-KAST. It binds to special receptors found in your airways, preventing the symptoms of asthma and seasonal allergic rhinitis. BEFORE YOU USE M-KAST -When you must not use it Do not use M-KAST if you are allergic to its active ingredient or any of the inactive ingredients listed. -Before you start to use it Do not use M-KAST to treat an acute asthmatic attack. Please use an appropriate medication as recommended by your doctor or pharmacist (usually an inhaler type medicine) to treat your asthmatic attack. drive and use machines. However, drowsiness or dizziness may occur. -Taking other medications Baca dokumen lengkap
Black A/s: 165 x 240 mm NAME OF DRUG PRODUCT: Montelukast Chewable Tablets 4 mg Montelukast Chewable Tablets 5 mg (TRADE) NAME OF PRODUCT: M-KAST 4 M-KAST 5 STRENGTHS: 4 mg & 5 mg PHARMACEUTICAL DOSAGE FORM: Chewable Tablet QUALITATIVE AND QUANTITATIVE COMPOSITION: M-KAST 4: Each chewable tablet contains Montelukast Sodium Ph.Eur. equivalent to Montelukast 4 mg. M-KAST 5: Each chewable tablet contains Montelukast Sodium Ph.Eur. equivalent to Montelukast 5 mg. PHARMACEUTICAL FORM: M-KAST 4: Pink coloured, mottled, oval, biconvex, uncoated tablets, debossed with ‘X’ on one side and ‘52’ on the other side. M-KAST 5: Pink coloured, mottled, round, biconvex, uncoated tablets, debossed with ‘X’ on one side and ‘53’ on other side. CLINICAL PARTICULARS: THERAPEUTIC INDICATIONS: Montelukast is indicated 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. 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. _Pediatric Patients 2 to 5 Years of Age with Asthma and/or Seasonal Allergic _ _Rhinitis_ The dosage for pediatric patients 2 to 5 years of age is one 4mg chewable tablet daily. _Pediatric Patients 6 to 14 years of Age with Asthma and/or Seasonal Allergic _ _Rhinitis_ The dosage for pediatric patients 6 to 14 years of age is one 5mg chewable tablet daily. _General Recommendations_ The therapeutic effect of Montelukast on parameters of asthma control occurs within one day. Montelukast chewable tablets can be taken with or without food. Patients should be advised to continue taking Montelukast while their asthma is cont Baca dokumen lengkap