Country: Malaysia
Language: English
Source: 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 WHAT IS IN THIS LEAFLET 1. What M-KAST is used for 2. How M-KAST works 3. Before you use M-KAST 4. How to use M-KAST 5. While you are using it 6. Side effects 7. Storage and Disposal of M- KAST 8. Product Description 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. M-KAST contains an ingredient called aspartame. Do not use this product if you suffer from a condition called phenylketonuria. Please get your doctor or pharmacist’s advice if you are unsure. Effects on ability to drive and use machines: montelukast has no or negligible influence on the ability to drive and use machines. However, drowsiness or dizziness may occur. -Taking other medications Please seek your doctor or pharmacist’s advice if you are on these current medications as they have a potential to interact with M- KAST. • Medicines used in treatment of epilepsy such as phenytoin and phenobarbital • Antibiotics such as rifampicin HOW TO USE M-KAST Read the complete document
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 Read the complete document