Country: Malaysia
Bahasa: Inggeris
Sumber: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
PAHANG PHARMACY SDN. BHD.
MONTELUKAST SODIUM
28Tablet Tablets
KRKA, d.d., Novo mesto
1.3.1 Montelukast sodium SPC, Labeling and Package Leaflet MY SmPCPIL136738_4 31.07.2019 – Updated: 22.04.2021 Page 1 of 6 NAME OF THE MEDICINAL PRODUCT Monkasta chewable tablets 4 mg Monkasta chewable tablets 5 mg QUALITY AND QUANTITATIVE COMPOSITION Each chewable tablet contains 5 mg montelukast (equivalent to 5.20 mg montelukast sodium). Each chewable tablet contains 4 mg montelukast (equivalent to 4.16 mg montelukast sodium). Excipient: 4 mg tablets 5 mg tablets aspartame 1.2 mg 1.5 mg PHARMACEUTICAL FORM Chewable tablet. Monkasta chewable tablets 4 mg are presented as pink, marbled, round, slightly biconvex tablets with bevelled edges and inscription 4 on one side. Monkasta chewable tablets 5 mg are presented as pink, marbled, round, slightly biconvex tablets with bevelled edges and inscription 5 on one side. CLINICAL PARTICULARS THERAPEUTIC INDICATIONS For the prophylaxis and chronic treatment of asthma in adults and paediatric patients 2 years of age and older. Monkasta is indicated if adults 15 years of age and older for the relief of daytime and night-time symptoms of seasonal allergic rhinitis. POSOLOGY AND METHOD OF ADMINISTRATION Monkasta should be taken once daily. For the treatment of asthma, the dose should be taken in the evening. For seasonal allergic rhinitis, the time of administration may be individualised to suit patient needs. Patients with asthma and seasonal allergic rhinitis should take only one tablet daily, in the evening. _Pediatric Patients 6 to 14 Years of Age with Asthma _ The dosage for children 6 to 14 years of age is one 5 mg chewable tablet daily. _Pediatric Patients 2 to 5 Years of Age with Asthma _ The dosage for children 2 to 5 years of age is one 4 mg chewable tablet daily . _General recommendations_ The therapeutic effect of Monkasta on parameters of asthma control occurs within one day. Patients should be advised to continue taking Monkasta even if their asthma is under control, as well as during periods of worsening asthma. 1.3.1 Montelukast sodium SPC, Labeling and Pac Baca dokumen lengkap