Pays: Malte
Langue: anglais
Source: Malta Medicines Authority
MONTELUKAST
FAIR-MED HEALTHCARE GmbH Planckstr. 13, 22765 Hamburg, Germany
R03DC03
MONTELUKAST 4 mg
CHEWABLE TABLET
MONTELUKAST 4 mg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2012-08-24
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE USER MONTELUKAST FAIR-MED 4 MG CHEWABLE TABLETS FOR CHILDREN FROM 2 TO 5 YEARS Montelukast READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOUR CHILD STARTS TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR 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 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 child’s. - If your child gets 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 Montelukast Fair-Med is and what it is used for 2. What you need to know before your child takes Montelukast Fair-Med 3. How to give Montelukast Fair-Med to your child 4. Possible side effects 5. How to store Montelukast Fair-Med 6. Contents of the pack and other information 1. WHAT MONTELUKAST FAIR-MED IS AND WHAT IT IS USED FOR Montelukast Fair-Med is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast Fair-Med improves asthma symptoms and helps control asthma. Your doctor has prescribed Montelukast Fair-Med to treat your child’s asthma, preventing asthma symptoms during the day and night. • Montelukast Fair-Med is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy. • Montelukast Fair-Med may also be used as an alternative treatment to inhaled corticosteroi Lire le document complet
Page 1 of 12 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Montelukast Fair-Med 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 (E 951) 0.6 mg per tablet. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable tablet. Pink, flat, round chewable tablets with beveled edges, marked with ‘4’ on one side and plain on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Montelukast Fair-Med 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. Montelukast Fair-Med 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). Montelukast Fair-Med 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. 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, Montelukast Fair-Med should be taken 1 hour before or 2 hour Lire le document complet