Country: Malta
Language: English
Source: Medicines Authority
MONTELUKAST
Mylan Ireland Limited Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
R03DC03
MONTELUKAST 5 mg
CHEWABLE TABLET
MONTELUKAST 5 mg
POM
DRUGS FOR OBSTRUCTIVE AIRWAY DISEASES
Withdrawn
2012-02-01
Page 1 of 7 PACKAGE LEAFLET: INFORMATION FOR THE PATIENT MONTELUKAST MYLAN 5 MG montelukast FOR CHILDREN 6 TO 14 YEARS OLD READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START GIVING/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, ask your doctor, pharmacist or nurse. _ _ − 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 yours or your child’s − If you or your child get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4 WHAT IS IN THIS LEAFLET 1. What Montelukast Mylan 5 mg is and what it is used for 2. What you need to know before you give/take Montelukast Mylan 5 mg 3. How to give/take Montelukast Mylan 5 mg 4. Possible side effects 5. How to store Montelukast Mylan 5 mg 6. Contents of the pack and other information 1. WHAT MONTELUKAST MYLAN 5 MG IS AND WHAT IT IS USED FOR Montelukast Mylan 5 mg contains montelukast, which 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 5 mg improves asthma symptoms and helps control asthma. Your doctor has prescribed Montelukast Mylan 5 mg to treat asthma, preventing your _ _ or your child’s _ _ asthma symptoms during the day and night. • Montelukast Mylan 5 mg is used for the treatment of patients who are not adequately controlled on their medication and need additional therapy. • Montelukast Mylan 5 mg 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. • Montelukast Mylan 5 mg also helps prevent the narrowing of airways triggered Read the complete document
Page 1 of 11 1. NAME OF THE MEDICINAL PRODUCT Montelukast Mylan 5 mg 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains montelukast sodium, which is equivalent to 5 mg montelukast. Excipient with known effect: Each chewable tablet contains 2 mg aspartame (E 951). For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Chewable Tablet A white to off-white, round, biconvex tablet (7.2mm in diameter) debossed with “M” on one side and “MS2” on the other side. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Montelukast Mylan 5 mg is indicated in the treatment of asthma as add-on therapy in those 6 to 14 years 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 5 mg may also be an alternative treatment option to low-dose inhaled corticosteroids for 6 to 14 years 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 5 mg is also indicated in the prophylaxis of asthma for 6 to 14 years old patients in which the predominant component is exercise-induced bronchoconstriction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The dosage for paediatric patients 6-14 years of age is one 5 mg chewable tablet daily to be taken in the evening. No dosage adjustment within this age group is necessary. _ _ _General recommendations. _ The therapeutic effect of montelukast on parameters of asthma control occurs within one day. Patients should be advised to continue taking Montelukast Mylan 5 mg even if their asthma is under control, as well as during periods of worsening asthma. No dosage adjustment is necessary for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no d Read the complete document