Pays: Irlande
Langue: anglais
Source: HPRA (Health Products Regulatory Authority)
Montelukast sodium
Imbat Limited
R03DC; R03DC03
Montelukast sodium
4 milligram(s)
Chewable tablet
Product subject to prescription which may be renewed (B)
Leukotriene receptor antagonists; montelukast
Authorised
2013-07-26
Page 1 of 2 PACKAGE LEAFLET: INFORMATION FOR THE USER SINGULAIR ® PAEDIATRIC 4MG CHEWABLE TABLETS (montelukast) Your medicine is available using the name SINGULAIR Paediatric 4mg chewable tablets but will be referred to as Singulair Paediatric throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING THIS MEDICINE. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your doctor or pharmacist. This medicine has been prescribed for your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as your child’s. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. IN THIS LEAFLET: 1. What SINGULAIR Paediatric is and what it is used for 2. Before SINGULAIR Paediatric is taken 3. How to take SINGULAIR Paediatric 4. Possible side effects 5. How to store SINGULAIR Paediatric 6. Further information 1. WHAT SINGULAIR PAEDIATRIC IS AND WHAT IT IS USED FOR SINGULAIR Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, SINGULAIR Paediatric improves asthma symptoms and helps control asthma. Your doctor has prescribed SINGULAIR Paediatric to treat your child’s asthma, preventing asthma symptoms during the day and night. SINGULAIR Paediatric is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy. SINGULAIR Paediatric may also be used as an alternative treatment to inhaled corticosteroids for 2 to 5 year old patients who have not recently taken oral corticosteroids for their asthma and have shown that they are unable to use inhaled corticosteroids. SINGULAIR Paediatric also helps prevent the narrowing of airways triggered by exercise for patients 2 years of age and older. Your doctor will dete Lire le document complet
Health Products Regulatory Authority 11 November 2019 CRN009FZ0 Page 1 of 10 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Singulair Paediatric 4mg chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains montelukast sodium equivalent to 4mg montelukast. Also containsaspartame (E951). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet _Product sourced from Poland:_ Pink, oval, bi-convex-shaped tablets marked with ‘SINGULAIR’ on one side and ‘MSD 711’ on the other side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS SINGULAIR is indicated in the treatment of asthma as add-on therapy in those 2 to 5 year old patients with mild to moderate persistent asthma who are inadequately controlled on inhaled corticosteroids and in whom “as-needed” short acting β‑agonists provide inadequate clinical control of asthma. SINGULAIR may also be an alternative treatment option to low-dose inhaled corticosteroids for 2 to 5 year old 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 from 2 years of age and older in which the predominant component is exercise-induced bronchoconstriction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION This medicinal product is to be given to a child under adult supervision. For children who have problems consuming a chewable tablet, a granule formulation is available (see SINGULAIR 4 mg granule SPC). The dosage for paediatric patients 2-5 years of age is one 4-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. The SINGULAIR 4mg chewable tablet is not recommended below 2 years of age. _General recommenda Lire le document complet