Χώρα: Ιρλανδία
Γλώσσα: Αγγλικά
Πηγή: HPRA (Health Products Regulatory Authority)
MONTELUKAST SODIUM
Primecrown 2010 Ltd
R03DC03
MONTELUKAST SODIUM
4 Milligram
Tablets Chewable
Product subject to prescription which may be renewed (B)
Leukotriene receptor antagonists
Authorised
2012-08-31
PACKAGE LEAFLET: INFORMATION FOR THE USER SINGULAIR® PAEDIATRIC 4 MG CHEWABLE TABLETS montelukast 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 docto Διαβάστε το πλήρες έγγραφο
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SINGULAIR Paediatric 4 mg Chewable Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains montelukast sodium, which is equivalent to 4 mg montelukast. _Excipient with known effect: _Aspartame (E951) 1.2 mg per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable Tablet. _Product imported from Lithuania and Poland:_ Pink, oval, bi-convex-shaped, SINGULAIR engraved on one side, MSD 711 on the other. 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 -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 shou Διαβάστε το πλήρες έγγραφο