Страна: Німеччина
мова: німецька
Джерело: BfArM (Bundesinstitut für Arzneimittel und Medizinprodukte)
Montelukast-Natrium
Synthon B.V. (8010015)
R03DC03
Montelukast sodium
Kautablette
Teil 1 - Kautablette; Montelukast-Natrium (27913) 4,16 Milligramm
zum Einnehmen
verlängert
2012-05-31
Common Technical Document Montelukast (as sodium) 4 mg Chewable tablets Document number (version): M1.3.1_03.MUT.sod.oct4.018.03.Core Page 1 of 7 1.3.1 Package leaflet - Core PACKAGE LEAFLET: INFORMATION FOR THE USER [PRODUCT NAME] 4 MG CHEWABLE TABLETS montelukast READ ALL OF THIS LEAFLET CAREFULLY BEFORE 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, 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 [Product name] is and what it is used for 2. What you need to know before you use [Product name] 3. How to use [Product name] 4. Possible side effects 5. How to store [Product name] 6. Contents of the pack and other information 1. WHAT [PRODUCT NAME] IS AND WHAT IT IS USED FOR WHAT [PRODUCT NAME] IS Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. HOW [PRODUCT NAME] WORKS Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, [Product name] improves asthma symptoms and helps control asthma. _ _ WHEN [PRODUCT NAME] SHOULD BE USED Your doctor has prescribed [Product name] to treat your child’s asthma, preventing asthma symptoms during the day and night. • [Product name] is used for the treatment of 2 to 5 year old patients who are not adequately controlled on their medication and need additional therapy. • [Product name] 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 they are unable to use inhaled corticosteroids. • [Product Прочитайте повний документ
Common Technical Document Montelukast (as sodium) 4 mg Chewable tablets Document number (version): M1.3.1_01.MUT.sod.oct4.018.04.Core Page 1 of 13 1.3.1 Summary of Product Characteristics – Core 1 NAME OF THE MEDICINAL PRODUCT [Product name] 4 mg chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains montelukast sodium, which is equivalent to 4 mg montelukast. Excipient(s) with known effect This medicine contains 1.2 mg aspartame (E951) per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet Pink, capsule shaped, biconvex tablets (approximately 4 x 12 x 6 mm). The tablets are debossed with “M9UT” and “4” on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS4 mg chewable tablets are 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. Прочитайте повний документ4 mg chewable tablets 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). 4 mg chewable tablets are 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 Posology This medicinal product is to be given to a child under adult supervision. For children who have problems consuming a chewable tablet, a granule formulation is available. The recommended dose Common Technical Document Montelukast (as sodium) 4 mg Chewable tablets Document number (version): M1.3.1_01.MUT.sod.oct4.018.04.Core Page 2 of 13