Nazione: Malesia
Lingua: inglese
Fonte: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
MONTELUKAST SODIUM; Levocetirizine Dihydrochloride
Glenmark Pharmaceuticals (Malaysia) Sdn. Bhd.
MONTELUKAST SODIUM; Levocetirizine Dihydrochloride
14 Tablets
Glenmark Pharmaceuticals Limited
1 _Consumer Medication Information Leaflet (RiMUP) _ _ _ GLENCET M FILM-COATED TABLETS Montelukast and Levocetirizine Dihydrochloride Tablets (10mg + 5mg) WHAT IS IN THIS LEAFLET 1. What Glencet M is used for 2. How Glencet M works 3. Before you take Glencet M 4. How to take Glencet M 5. While you are using it 6. Side Effects 7. Storage and Disposal of Glencet M 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT GLENCET M IS USED FOR Glencet M contains the active ingredients Montelukast sodium and Levocetirizine dihydrochloride. Glencet M is used for the treatment of relief of symptoms associated with seasonal allergic rhinitis.. HOW GLENCET M WORKS Montelukast is a leukotriene receptor antagonist that blocks substances called leukotrienes. Leukotrienes cause narrowing and swelling of airways in the lungs and also cause allergy symptoms. By blocking leukotrienes, montelukast improves seasonal allergy symptoms (also known as hay fever or seasonal allergic rhinitis). Levocetirizine is a potent and selective antihistamine which blocks the action of substance called histamine which is produced in the body during an allergic reaction. BEFORE YOU TAKE GLENCET M _-When you must not use it _ a) If you are allergic to montelukast, levocetirizine dihydrochloride, cetirizine, hydroxyzine or any of the other ingredients of this medicine. b) if you have a severe impairment of kidney function (severe renal failure with creatinine clearance below 10 ml/min) c) if you have rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption. _-_ _ _ _Before you start to use it _ _ _ Talk to your doctor or pharmacist before taking Glencet M _ _ _ _CHILDREN AND ADOLESCENTS The use of Glencet M is not recommended in children less than 18 years since this product has not been studied. _ _ _-Taking other medicines _ Tell your doctor or pharmacist if you are taking or have recently taken or might take any other medicines including those obtained Leggi il documento completo
PANTONE BLACK PROCESS C SUPERSEDES ARTWORK CODE PE55457 PANTONE SHADE ICONGRAPHICS CODE: PHARMACODE: Group Normal renal function Mildly decreased renal function Moderatelydecreasedrenal function Severelydecreasedrenal function End stage renal disease (ESRD) 60 - < 90 30 - < 60 15 < 30 (not requiring dialysis) 1 tablet once every 3 days Contra-indicated 1 tablet once every 2 days eGFR (ml/min) ≥ 90 1 tablet once daily 1 tablet once daily Dosage and frequency < 15 (requiring dialysis treatment) 35 mm _For the use only of a registered Medicinal Practitioner or_ _ a hospital or a Laboratory_ SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE SPACE FOR PHARMACODE INFORMATION FOR THE PHYSICIAN 1. NAME OF THE MEDICINAL PRODUCT GLENCET M (Montelukast 10mg + Levocetirizine dihydrochloride 5mg) Film-coated Tablets 2. Q U A L I T A T I V E A N D Q U A N T I T A T I V E COMPOSITION Each film coated tablet contains: Montelukast sodium equivalent to Montelukast 10 mg Levocetirizine Dihydrochloride 5 mg Colours: Ferric Oxide Yellow USPNF, Ferric Oxide Red USPNF & Titanium Dioxide USP 3. PHARMACEUTICAL FORM Yellow, round, biconvex, film coated tablets plain on both sides. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS GLENCET M (Montelukast 10mg +Levocetirizine dihydrochloride 5mg) Film-coated Tablets are indicated for the relief of symptoms associated with seasonal allergic rhinitis. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults (≥18 years of age): The recommended dose is one tablet to be taken orally, in the evening. The tablets should be swallowed whole with or without food. PAEDIATRIC AND ADOLESCENT (<18 YEARS OF AGE): Since this product has not been studied in the adolescent and paediatric population this medicinal product is not recommended in this age group. PATIENTS WITH RENAL IMPAIRMENT: No dose adjustment is needed in patients with mild renal impairment (creatinine clearance >79 ml/min). For patients with moderate to severe renal impairment (creatinine clearance <79 ml/min - >10ml/min), this pro Leggi il documento completo