Pajjiż: Irlanda
Lingwa: Ingliż
Sors: HPRA (Health Products Regulatory Authority)
MONTELUKAST SODIUM
Merck Sharp and Dohme Limited
5 Milligram
Tablets Chewable
1998-02-20
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Singulair Paediatric 5 mg chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains montelukast sodium, which is equivalent to 5 mg montelukast. Excipient: Aspartame (E 951) 1.5 mg per tablet. _For a full list of excipients, see section 6.1._ 3 PHARMACEUTICAL FORM Chewable tablet Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on one side, MSD 275 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SINGULAIR is indicated in the treatment of asthma as add-on therapy in those patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as -needed” short acting - agonists provide inadequate clinical control of asthma. SINGULAIR may also be an alternative treatment option to low-dose inhaled corticosteroids for patients with mild persistent asthma who do not have a recent history of serious asthma attacks that required oral corticosteroid use, and who have demonstrated that they are not capable of using inhaled corticosteroids _(see section 4.2)._ SINGULAIR is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION The dosage for pediatric patients 6-14 years of age is one 5-mg chewable tablet daily to be taken in the evening. If taken in connection with food, SINGULAIR should be taken 1 hour before or two hours after food. No dosage adjustment within this age group is necessary. _General recommendations. _The therapeutic effect of SINGULAIR on parameters of asthma control occurs within one day. Patients should be advised to continue taking SINGULAIR even if their asthma is under contr Aqra d-dokument sħiħ