Land: Malta
Taal: Engels
Bron: Medicines Authority
MONTELUKAST
Generics UK Limited
R03DC03
MONTELUKAST
CHEWABLE TABLET
MONTELUKAST 4 mg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Authorised
2012-02-01
PAGE 1 OF 6 PACKAGE LEAFLET: INFORMATION FOR THE USER PAGE 2 OF 6 MONTELUKAST MYLAN 4MG montelukast READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU 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 Montelukast Mylan 4mg is and what it is used for 2. Before you take Montelukast Mylan 4mg 3. How to take Montelukast Mylan 4mg 4. Possible side effects 5. How to store Montelukast Mylan 4mg 6. Further information 1. WHAT MONTELUKAST MYLAN 4MG IS AND WHAT IT IS USED FOR Montelukast Mylan 4mg is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. By blocking leukotrienes, Montelukast Mylan 4mg improves asthma symptoms and helps control asthma. Your doctor has prescribed Montelukast Mylan 4mg to treat asthma, preventing your_ _asthma symptoms during the day and night. • Montelukast Mylan 4mg 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 Mylan 4mg 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 Lees het volledige document
PAGE 1 OF 10 SUMMARY OF PRODUCT CHARACTERISTICS PAGE 2 OF 10 1. NAME OF THE MEDICINAL PRODUCT Montelukast Mylan 4 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 4mg chewable tablet: One chewable tablet contains montelukast sodium, which is equivalent to 4 mg montelukast. Excipients: Each chewable tablet contains 2.0 mg Aspartame (E 951). For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable Tablet 4mg Chewable Tablets: A white to off-white coloured, oval, biconvex tablets debossed with “M” on one side and “MS1” on other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Montelukast Mylan 4mg 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 beta-agonists provide inadequate clinical control of asthma. Montelukast Mylan 4mg 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 Mylan 4mg 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 _Method of administration: _ For oral use. This medicinal product should be given to a child under adult supervision. The dosage for paediatric patients 2-5 years of age is on Lees het volledige document