Country: Իռլանդիա
language: անգլերեն
source: HPRA (Health Products Regulatory Authority)
Montelukast sodium
Merck Sharp & Dohme Ireland (Human Health) Limited
R03DC; R03DC03
Montelukast sodium
10 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Leukotriene receptor antagonists; montelukast
Not marketed
2004-03-31
PACKAGE LEAFLET: INFORMATION FOR THE USER SINGULAIR® AR 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, 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 Singulair AR is and what it is used for 2. What you need to know before you take Singulair AR 3. How to take Singulair AR 4. Possible side effects 5. How to store Singulair AR 6. Contents of the pack and other information 1. WHAT SINGULAIR AR IS AND WHAT IT IS USED FOR WHAT SINGULAIR AR IS Singulair AR is a leukotriene receptor antagonist that blocks substances called leukotrienes. HOW SINGULAIR AR WORKS Leukotrienes cause allergy symptoms. By blocking leukotrienes, Singulair AR improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis). WHEN SINGULAIR AR SHOULD BE USED Your doctor has prescribed Singulair AR for the relief of your seasonal allergy symptoms. Singulair AR is used for the treatment of adults and adolescents 15 years of age and older WHAT ARE SEASONAL ALLERGIES? Seasonal allergies (also known as hay fever or seasonal allergic rhinitis) are an allergic response often caused by airborne pollens from trees, grasses and weeds. The symptoms of seasonal allergies typically may include: stuffy, runny, itchy nose; sneezing; watery, swollen, red, itchy eyes. 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE SINGULAIR AR Tell your doctor about any medical problems or allergies you have now or have had. DO NOT TAKE SINGULAIR AR if you are allergic to montelukast or any of the other ingredients of this medicine (li read_full_document
Health Products Regulatory Authority 14 May 2020 CRN009RQ4 Page 1 of 7 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT SINGULAIR ALLERGY 10mg film-coated tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One film-coated tablet contains montelukast sodium, which is equivalent to 10 mg montelukast. Excipients with known effect: This medicine contains 89.3 mg lactose monohydrate 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 Film-coated tablet Beige, rounded square, film-coated, size 7.9 mm x 7.9 mm with 117 engraved on one side. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS The relief of symptoms of seasonal allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose for adults and adolescents 15 years of age and older is one 10 mg tablet daily. General recommendations Singulair Allergy contains montelukast, the same active ingredient in Singulair. Singulair Allergy should not be used concomitantly with other products containing the same active ingredient, montelukast. Singulair Allergy may be taken with or without food. Singulair Allergy should be taken once daily each day for the duration of prescribed therapy. The time of administration for seasonal allergic rhinitis may be individualized to suit patient needs. No dosage adjustment is necessary for the elderly, or for patients with renal insufficiency, or mild to moderate hepatic impairment. There are no data on patients with severe hepatic impairment. The dosage is the same for both male and female patients. _Paediatric population_ Do not give Singulair Allergy 10 mg film‑coated tablets to children and adolescents less than 15 years of age. The safety and efficacy of Singulair Allergy 10 mg film‑coated tablets in patients younger than 15 years of age have not been established. 5 mg chewable tablets are available for paediatric patients 6 to 14 years of age. 4 read_full_document