Страна: Ирландия
Език: английски
Източник: HPRA (Health Products Regulatory Authority)
MONTELUKAST SODIUM, MONTELUKAST
Cipla (EU) Limited
R03DC03
MONTELUKAST SODIUM, MONTELUKAST
5 Milligram
Tablets Chewable
Product subject to prescription which may be renewed (B)
Leukotriene receptor antagonists
Authorised
2014-10-17
PACKAGE LEAFLET: INFORMATION FOR THE USER MONTELUKAST PAEDIATRIC 5 MG CHEWABLE TABLETS montelukast READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD STARTS TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. Keep this leaflet. You may need to read it again. If you have any further questions, please ask your or your child’s 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 signs of illness are the same as yours or your child’s. If you or your child gets any side effects, talk to your or your child’s 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 Paediatric is and what it is used for 2. What you need to know before you or your child takes Montelukast Paediatric 3. How to take Montelukast Paediatric 4. Possible side effects 5. How to store Montelukast Paediatric 6. Contents of the pack and other information 1. WHAT MONTELUKAST PAEDIATRIC IS AND WHAT IT IS USED FOR Montelukast Paediatric contains the active substance montelukast. Montelukast Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast Paediatric improves asthma symptoms and helps control asthma. Your or your child’s doctor has prescribed Montelukast Paediatric to treat asthma, preventing your or your child’s asthma symptoms during the day and night. Montelukast Paediatric is used for the treatment of patients who are not adequately controlled on their medication a Прочетете целия документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT M ontelukast Paediatric 5 mg chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each chewable tablet contains montelukast sodium, which is equivalent to 5 mg montelukast. Excipient with known effect: Each chewable tablet contains 1.5 mg of aspartame (E 951). For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Pink coloured, circular, biconvex, uncoated chewable tablet debossed with '5' on one side and plain on other side. Diameter: 9.5 mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Montelukast 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 -agonists provide inadequate clinical control of asthma. Montelukast 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). Montelukast is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Paediatric population: The dosage for paediatric patients 6-14 years of age is one 5 mg chewable tablet daily to be taken in the evening. The tablets are to be chewed before swallowing. If taken in connection with food, montelukast 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 montelukast Прочетете целия документ