국가: 아일랜드
언어: 영어
출처: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULFATE SODIUM CHLORIDE
FMC Pharma Ltd
GLUCOSAMINE SULFATE SODIUM CHLORIDE
1500 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
PACKAGE LEAFLET: INFORMATION FOR THE USER GLUSAMIN 1500 MG FILM-COATED TABLETS GLUCOSAMINE SULFATE READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING THIS MEDICINE. 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. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours. If any of the side effects get serious, or if you notice any side effect not listed in this leaflet, please tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Glusamin is and what it is used for 2. What you need to know before you take Glusamin 3. How to take Glusamin 4. Possible side effects 5. How to store Glusamin 6. Contents of the pack and other information 1. WHAT GLUSAMIN IS AND WHAT IT IS USED FOR Glusamin belongs to a group of medicines called other anti-inflammatory and anti-rheumatic agents, non steroids. Glusamin is used for the relief of symptoms of mild to moderate osteoarthritis of the knee. Osteoarthritis is a type of joint degeneration that generates symptoms such as stiffness (after sleep or long rest) and pain at motion (e.g. when climbing the stairs or walking along uneven surfaces). 2. WHAT YOU NEED TO KNOW BEFORE YOU TAKE GLUSAMIN DO NOT TAKE GLUSAMIN - If you are allergic (hypersensitive) to: - Glucosamine or to any of the other ingredients of Glusamin (see Section 6 “Further Information”) - Shellfish, since Glusamin is manufactured from shellfish. WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH GLUSAMIN IF YOU - Suffer from impaired glucose tolerance. More frequent controls of your blood glucose levels may be necessary when starting treatment with Glusamin - Have kidney or liver dysfunction, since no studies have been performed in such patients dose recommendations cannot 전체 문서 읽기
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glusamin 1500mg Film-Coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 1884mg glucosamine sulfate sodium chloride equivalent to 1500 mg glucosamine sulfate or 1178mg glucosamine. Excipients with known effect: Each tablet contains 151.8 mg (6.6mmol) of sodium. Lactose monohydrate 6.0 mg Lecithin soya (E322) For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Off-white oblong shaped film-coated tablet, 9.5 x 21mm 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glusamin tablets are indicated for relief of symptoms in mild to moderate osteoarthritis of the knee. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Method of Administration: Glusamin tablets should be swallowed whole. Tablets can be taken with or without food. _Adults and the elderly_: One Glusamin tablet should be taken once daily. Posology: Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after several weeks of treatment and in some cases even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated. Additional information on special populations: _Children/adolescents:_ Safety and efficacy has not been established in children and adolescents, therefore, Glucosamine sulfate tablets should not be used in persons under the age of 18 years. _Elderly_ No specific studies have been performed in the elderly, but according to clinical experience dosage adjustment is not HEALTH PRODUCTS REGULATORY AUTHORITY ________________________________________________________________________________________________________________________ _Date Printed 08/07/2014_ _CRN 212 전체 문서 읽기