国: アイルランド
言語: 英語
ソース: HPRA (Health Products Regulatory Authority)
MONTELUKAST SODIUM
Pensa Pharma AB
MONTELUKAST SODIUM
10 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER Montelukast Pensa 10 mg film-coated tablets Montelukast READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START 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 doctor or pharmacist. • This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours. • If you get 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 Pensa is and what it is used for 2. What you need to know before you take Montelukast Pensa 3. How to take Montelukast Pensa 4. Possible side effects 5. How to store Montelukast Pensa 6. Contents of the pack and other information 1. WHAT MONTELUKAST PENSA IS AND WHAT IT IS USED FOR Montelukast Pensa is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Montelukast Pensa improves asthma symptoms, helps control asthma and improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis). Your doctor has prescribed Montelukast Pensa to treat asthma, preventing your asthma symptoms during the day and night. - Montelukast Pensa is used for the treatment of adults and adolescents from the age of 15 years who are not adequately controlled on their medication and need additional therapy. - In those asthmatic patients in whom Montelukast Pensa is indicated in asthma, Montelukast Pensa can also provide symptomatic relief of seasonal allergic rhinitis. - Montelukast Pensa also helps prevent the narrowing of airways triggered by exercise. Y 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Montelukast Pensa 10mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10.4 mg of montelukast sodium, which is equivalent to 10 mg of montelukast. Excipients with known effect: Each film-coated tablet contains 103.47 mg of lactose monohydrate. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet. The 10 mg film-coated tablets are peach color and biconvex with the code M10 engraved on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Montelukast Pensa 10 mg film-coated tablets is indicated in adults and adolescents from the age of 15 years for 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. In those asthmatic patients in whom montelukast is indicated in asthma, montelukast can also provide symptomatic relief of seasonal allergic rhinitis. Montelukast Pensa 10 mg film-coated tablets is also indicated in the prophylaxis of asthma in which the predominant component is exercise-induced bronchoconstriction. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology: The dosage for adults 15 years of age and older with asthma, or with asthma and concomitant seasonal allergic rhinitis, is one 10 mg tablet daily to be taken in the evening. _General recommendations_: The therapeutic effect of Montelukast Pensa on parameters of asthma control occurs within one day. Montelukast Pensa may be taken with or without food. Patients should be advised to continue taking Montelukast Pensa even if their asthma is under control, as well as during 完全なドキュメントを読む