国家: 英国
语言: 英文
来源: MHRA (Medicines & Healthcare Products Regulatory Agency)
Montelukast sodium
CST Pharma Ltd
R03DC03
Montelukast sodium
5mg
Chewable tablet
Oral
No Controlled Drug Status
Valid as a prescribable product
BNF: 03030200; GTIN: 5055946802664
PACKAGE LEAFLET: INFORMATION FOR THE USER SINGULAIR ® PAEDIATRIC 5MG CHEWABLE TABLETS (MONTELUKAST SODIUM) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START TAKING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU OR YOUR CHILD. • 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 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 or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4. • The name of this medicine is SINGULAIR Paediatric 5mg chewable tablets but will be referred to as Singulair or Singulair Paediatric throughout the remainder of this leaflet. • Singulair Paediatric 5mg chewable tablets are also available in other strengths. WHAT IS IN THIS LEAFLET 1) What Singulair Paediatric is and what it is used for 2) What you need to know before you take Singulair Paediatric 3) How to take Singulair Paediatric 4) Possible side effects 5) How to store Singulair Paediatric 6) Contents of the pack and other information 1) WHAT SINGULAIR PAEDIATRIC IS AND WHAT IT IS USED FOR WHAT SINGULAIR PAEDIATRIC IS Singulair Paediatric is a leukotriene receptor antagonist that blocks substances called leukotrienes. HOW SINGULAIR PAEDIATRIC WORKS Leukotrienes cause narrowing and swelling of airways in the lungs. By blocking leukotrienes, Singulair Paediatric improves asthma symptoms and helps control asthma. WHEN SINGULAIR PAEDIATRIC SHOULD BE USED Your doctor has prescribed Singulair Paediatric to treat asthma, preventing your asthma symptoms during the day and night. • Singulair Paediatric is used for the treatment of paediatric patients 6 to 14 years of age who are not adequately controlled on their medication and need additional therapy. • Singulair Paediatric may also be use 阅读完整的文件
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Singulair Paediatric 5 mg chewable tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One chewable tablet contains montelukast sodium, which is equivalent to 5 mg montelukast. Excipients with known effect: This medicine contains 1.5 mg aspartame (E 951) per tablet. This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially ‘sodium-free’. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Chewable tablet. Pink, round, biconvex, diameter 9.5 mm with SINGULAIR engraved on one side and MSD 275 on the other. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Singulair is indicated in 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 β -agonists provide inadequate clinical control of asthma. Singulair may also be an alternative treatment option to low-dose inhaled corticosteroids for 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). Singulair 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 paediatric patients 6-14 years of age is one 5 mg chewable tablet daily to be taken in the evening. If taken in connection with food, Singulair should be taken 1 hour before or 2 hours after food. No dosage adjustment within this age group is necessary. General recommendations_ _ The therapeutic effect of Singulair on parameters of asthma control occurs within one day. Patients should be advised to continue taking Singulair even if their asthma is under control, as well as during periods of worsening asthma. No dosage adjustmen 阅读完整的文件