Země: Irsko
Jazyk: angličtina
Zdroj: HPRA (Health Products Regulatory Authority)
Montelukast
Clonmel Healthcare Ltd
R03DC; R03DC03
Montelukast
5 milligram(s)
Chewable tablet
Product subject to prescription which may be renewed (B)
Leukotriene receptor antagonists; montelukast
Marketed
2010-10-29
Page 1 of 6 PACKAGE LEAFLET: INFORMATION FOR THE USER MONTELAIR 5 MG CHEWABLE TABLETS FOR CHILDREN FROM 6 TO 14 YEARS Montelukast READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. - Keep this leaflet. You may need to read it again. - If you have any further questions, ask your doctor or pharmacist. - This medicine has been prescribed for you or your child only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as your or your child’s. - If you or your child get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET 1. What Montelair 5 mg is and what it is used for 2. What you need to know before you take Montelair 5 mg 3. How to take Montelair 5 mg 4. Possible side effects 5. How to store Montelair 5 mg 6. Contents of the pack and other information 1. WHAT MONTELAIR 5 MG IS AND WHAT IT IS USED FOR WHAT MONTELAIR IS Montelair is a leukotriene receptor antagonist that blocks substances called leukotrienes. HOW MONTELAIR WORKS Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelair improves asthma symptoms and helps control asthma. WHEN MONTELAIR SHOULD BE USED Your doctor has prescribed Montelair to treat asthma, preventing your asthma symptoms during the day and night. • Montelair is used for the treatment of paediatric patients 6 to 14 years of age who are not adequately controlled on their medication and need additional therapy. • Montelair 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. • Montelair also helps prevent the narrowing of airways triggered by exercise. Your doctor will determine how Montelair should be used depending Přečtěte si celý dokument
Health Products Regulatory Authority 21 March 2024 CRN00F29D Page 1 of 9 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Montelair 5 mg Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains montelukast sodium, which is equivalent to 5 mg montelukast. Excipient(s) with known effect: Each chewable tablet contains 6 mg of aspartame (E951) and 0.56 mg sodium. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM _Chewable tablet. _Pink, round, biconvex-shaped tablets with 'M5' engraved on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Montelairis indicated in the treatment of asthma as add-on therapy in those 6 to 14 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. Montelair may also be an alternative treatment option to low-dose inhaled corticosteroids for 6 to 14 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). Montelair is also indicated in the prophylaxis of asthma for 6 to 14 year old patients in which the predominant component is exercise-induced bronchoconstriction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose for paediatric 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, Montelair should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary. General recommendations: The therapeutic effect of Montelair on parameters of asthma control occurs within one day. Patients should be advised to continue taking Montelair even if their asthma is under control, as well as during periods of worsening asthma. No dosage adjustment is nec Přečtěte si celý dokument