Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM
ACCORD HEALTHCARE SDN.BHD.
MONTELUKAST SODIUM
28 Tablets; 28tablet Tablets
INTAS PHARMACEUTICALS LIMITED
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ 1 MONTAS (MONTELUKAST PAEDIATRIC CHEWABLE TABLETS) Montelukast Sodium (4mg, 5mg) WHAT IS IN THIS LEAFLET 1. What MONTAS is used for 2. How MONTAS works 3. Before you use MONTAS 4. How to take MONTAS 5. While you are using MONTAS 6. Side effects 7. Storage and disposal of MONTAS 8. Product description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT MONTAS IS USED FOR MONTAS (montelukast sodium) is used to treat: • Asthma, including preventing your asthma symptoms during the day and night. MONTAS also prevents the narrowing of airways triggered by exercise. • Allergic rhinitis (seasonal and perennial), including daytime and nighttime symptoms: nasal congestion, runny nose, nasal itching, and sneezing; nasal congestion upon awakening, difficulty going to sleep, and nighttime awakenings; tearing, itchy, red, and puffy eyes. HOW MONTAS WORKS MONTAS is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in your lungs. Blocking leukotrienes improves asthma symptoms and helps prevent asthma attacks. Leukotrienes also cause allergy symptoms. Blocking leukotrienes improves allergic rhinitis (seasonal and perennial, also known as outdoor and indoor nasal allergies). BEFORE YOU USE MONTAS _- When you must not use it _ _ _ • Do not take MONTAS if you or your child is allergic to any of its components. USE IN PREGNANCY Women who are pregnant or intend to become pregnant should consult their doctor before taking MONTAS. USE IN BREAST-FEEDING It is not known if MONTAS appears in breast milk. You should consult your doctor before taking MONTAS if you are breast-feeding or intend to breast-feed. - _ Before you start to use it_ _ _ _ _ Tell your doctor (or health care provider) about any medical problems or allergies you or your child has now or has had. - _Taking other medicines_ _ _ In general, MONTAS does not interfere with other medicines that you or your child may be Přečtěte si celý dokument
PACKAGE INSERT MONTAS (Montelukast Paediatric Chewable Tablets 4 mg / 5 mg) NAME AND STRENGTH OF ACTIVE INGREDIENT MONTAS 4: Each uncoated tablet contains: Montelukast Sodium Ph.Eur. 4.16 mg eq. to Montelukast 4 mg MONTAS 5: Each uncoated tablet contains: Montelukast Sodium Ph.Eur. 5.20 mg eq. to Montelukast 5 mg PRODUCT DESCRIPTION MONTAS 4: Pink coloured, mottled, oval, biconvex, uncoated tablet, debossed “M4” on one side and plain on other side. MONTAS 5: Pink coloured, mottled, round, biconvex, uncoated tablet, debossed “M5” on one side and plain on other side. PHARMACODYNAMICS & PHARMACOKINETICS _Pharmacodynamic effects_ Montelukast is a selective and active leukotriene receptor antagonist. Montelukast inhibits bronchoconstriction due to antigen challenge. Montelukast is a selective leukotriene receptor antagonist of the cysteinyl leukotriene CysLT 1 receptor. The cysteinyl leukotrienes (LTC 4, LTD 4, LTE 4) are products of arachidonic acid metabolism that are released from various cells, including mast cells and eosinophils. They bind to cysteinyl leukotriene receptors (CysLT) found in the human airway. Binding of cysteinyl leukotrienes to leukotriene receptors has been correlated with the pathophysiology of asthma, including airway edema, smooth muscle contraction, and altered cellular activity associated with the inflammatory process, factors that contribute to the signs and symptoms of asthma. It binds to cysteinyl leukotrienes (CysLT) type-1 receptors found in human airway (smooth muscle cells and macrophages), which prevents airway edema, smooth muscle contraction and other respiratory inflammation. The leukotrienes are also released from the nasal mucosa after allergen exposure where montelukast sodium may inhibit symptoms of allergic rhinitis. Montelukast binding to the CysLT1 receptor is high-affinity and selective, preferring the CysLT1 receptor to other pharmacologically important airway receptors, such as the prostanoid, cholinergic, or beta-adrenergic receptor. Montelukast in Přečtěte si celý dokument