Страна: Великобритания
Язык: английский
Источник: MHRA (Medicines & Healthcare Products Regulatory Agency)
Montelukast sodium
Torrent Pharma (UK) Ltd
R03DC03
Montelukast sodium
10mg
Oral tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03030200; GTIN: 5060623370367
PACKAGE LEAFLET: INFORMATION FOR THE USER MONTELUKAST 10 MG TABLETS For adolescents and adults from 15 years 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, 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 tablets are and what they are used for 2. What you need to know before you take Montelukast tablets 3. How to take Montelukast tablets 4. Possible side effects 5. How to store Montelukast tablets 6. Contents of the pack and other information 1. WHAT MONTELUKAST TABLETS ARE AND WHAT THEY ARE USED FOR WHAT MONTELUKAST TABLETS ARE Montelukast tablets are a leukotriene receptor antagonist that blocks substances called leukotrienes. HOW MONTELUKAST TABLETS WORKS Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, Montelukast tablets improve asthma symptoms, help control asthma and improve seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis). WHEN MONTELUKAST TABLETS SHOULD BE USED Your doctor has prescribed Montelukast tablets to treat asthma, preventing your asthma symptoms during the day and night. - Montelukast tablets are used for the treatment of adults and adolescents 15 years of age and older who are not adequately controlled on their medication and need additional therapy. - Montelukast tablets also help prevent the narrowing of airways triggered by exercise. - In those asthmatic patients in whom Montelukast tablets are indicated in asthma, Montelukast tablets can also provide symptomatic relief of seasonal allerg Прочитать полный документ
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Montelukast 10 mg tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each tablet contains 10.4 mg montelukast sodium which corresponds to 10 mg montelukast. Excipients with known effect: Montelukast 10 mg tablet contains 0.75 mg aspartame in each tablet. Montelukast 10 mg tablet contains less than 1 mmol (23 mg) of sodium per tablet. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Tablet Light brown coloured, round biconvex shaped, uncoated tablet, with breakline on both sides. The tablet can be divided into equal doses. 4.1 THERAPEUTIC INDICATIONS Montelukast is indicated in the treatment of asthma as add-on therapy in those patients from 15 years of age 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. In those asthmatic patients in whom Montelukast is indicated in asthma, Montelukast can also provide symptomatic relief of seasonal allergic rhinitis. 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 Posology The recommended dose for adults and adolescents 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 on parameters of asthma control occurs within one day. Montelukast tablets may be taken with or without food. Patients should be advised to continue taking Montelukast even if their asthma is under control, as well as during periods of worsening asthma. Montelukast should not be used concomitantly with other products containing the same active ingredient, montelukast. No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency, or mild to moderate hepatic im Прочитать полный документ