País: Irlanda
Língua: inglês
Origem: HPRA (Health Products Regulatory Authority)
Montelukast sodium
Imbat Limited
R03DC; R03DC03
Montelukast sodium
5 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 5MG CHEWABLE TABLETS (montelukast) Your medicine is available using the name SINGULAIR Paediatric 5mg chewable tablets but will be referred to as SINGULAIR Paediatric throughout this leaflet. READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START 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 you or your child. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours or 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 you take SINGULAIR Paediatric 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 asthma, preventing your asthma symptoms during the day and night. SINGULAIR Paediatric is used for the treatment of 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 6 to 14 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. Your doctor will determine how SINGULAIR Paediatric should be Leia o documento completo
Health Products Regulatory Authority 11 November 2019 CRN009FZ0 Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Singulair Paediatric 5 mg chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains montelukast sodium equivalent to 5mg montelukast. Also contains aspartame (E951). For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet _Product sourced from Poland:_ Pink, round, biconvex tablets marked with ‘SINGULAIR’ on one side and ‘MSD 275’ 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 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 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 control, as well as during periods of worsening asthma. No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic imp Leia o documento completo