Country: Malaysia
Language: English
Source: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
THE ZYFAS MEDICAL CO.,
MONTELUKAST SODIUM
28tablet Tablets; 30tablet Tablets
DR. REDDY`S LABORATORIES LTD
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ LUKAKLINE TABLETS 10MG MONTELUKAST SODIUM (10 MG) 1 WHAT IS IN THIS LEAFLET 1. What Lukakline is used for 2. How Lukakline works 3. Before you use Lukakline 4. How to take Lukakline 5. While you are using Lukakline 6. Side effects 7. Storage and Disposal of Lukakline 8.Product description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT LUKAKLINE IS USED FOR Lukakline used ● For the prophylaxis and chronic treatment of asthma in adults and patients 15 years of age and older. ● For the relief of daytime and night time symptoms of seasonal allergic rhinitis in adults and patients 15 years of age and older HOW LUKAKLINE WORKS This medicine is a leukotriene receptor antagonist. It blocks substances in your lungs that narrows and swells your airways. The substance is called leukotriene. By blocking leukotrienes, your asthma symptoms will improve and this helps prevents asthma attacks. Lukakline also improves hay fever symptoms. BEFORE YOU USE LUKAKLINE _When you must not take it _ Do not take this medicine if: ● you are allergic to montelukast or any of the excipients ● you are already taking any medicine containing montelukast ● you are galactose intolerance, have Lapp lactase deficiency or glucose-galactose malabsorption _Before you start to take it _ Tell your doctor if: ● you are pregnant, plan to get pregnant ● you are breastfeeding or plan to breastfeed. PREGNANCY & NURSING MOTHERS Lukakline may be used during pregnancy only if it is considered to be clearly essential. _Taking other medicines _ Talk to your doctor or pharmacist if you are taking any other medicines in any form including any that you buy or obtained without a prescription. Some medicines interfere with the active ingredients in Lukakline. They include: - ● Other medicines containing montelukast ● Phenobarbital ● Phenytoin ● Rifampicin Other interactions not stated may occur. Talk to your doctor or pharmacist if you have any other concerns. HOW TO TAK Read the complete document
QUALITATIVE AND QUANTITATIVE COMPOSITION LUKAKLINE CHEWABLE TABLET 4 MG Each uncoated tablet contains Montelukast sodium equivalent to Montelukast 4mg. LUKAKLINE CHEWABLE TABLET 5 MG Each uncoated tablet contains Montelukast sodium equivalent to Montelukast 5mg. LUKAKLINE TABLET 10 MG Each film-coated tablet contains Montelukast sodium equivalent to Montelukast 10mg. EXCIPIENTS LUKAKLINE CHEWABLE TABLET 4 MG AND 5 MG Mannitol, Hydroxypropyl cellulose (Klucel EXF), Croscarmellose sodium, Ferric oxide (Iron Oxide red), Isopropyl alcohol, Cherry flavour ART#594, Modified food starch, Aspartame, Cellulose microcrystalline (Avicel PH112), Magnesium stearate. LUKAKLINE TABLET 10 MG Lactose monohydrate, Cellulose microcrystalline (Avicel PH 101), Croscarmellose sodium, Hydroxypropyl cellulose (Klucel LF), Cellulose microcrystalline (Avicel PH 112), Magnesium stearate, HPMC 2910/Hypromellose 3cps, Titanium dioxide, Macrogol 400, Iron oxide yellow, Iron oxide red, Iron oxide black. PHARMACEUTICAL FORM LUKAKLINE CHEWABLE TABLET 4 MG Light pink to pink coloured, speckled oval shaped, biconvex tablets debossed with "MTS" on one side and "4" on the other side. LUKAKLINE CHEWABLE TABLET 5 MG Light pink to pink coloured, speckled round shaped, biconvex tablets debossed with "MTS" on one side and "5" on the other side. LUKAKLINE TABLET 10 MG Brown coloured rounded square shaped, film-coated tablets debossed with “MTS” on one side and “10” on the other side. CLINICAL INFORMATION INDICATIONS Lukakline is indicated in adults and pediatric patients 2 years of age and older for the: v prophylaxis and chronic treatment of asthma, including the prevention of day- and night- time symptoms, the treatment of aspirin-sensitive asthmatic patients, and the prevention of exercise-induced bronchoconstriction. v relief of day-time and n me symptoms of allergic rhinitis (seasonal and perennial ight-ti allergic rhinitis). DOSAGE AND ADMINISTRATION The therapeutic effect of montelukast on parameters of asthma control occurs within one Read the complete document