国家: 爱尔兰
语言: 英文
来源: HPRA (Health Products Regulatory Authority)
Glucosamine sulfate
FMC Pharma Ltd
M01AX; M01AX05
Glucosamine sulfate
1500 milligram(s)
Film-coated tablet
Product subject to prescription which may be renewed (B)
Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine
Not marketed
2011-08-26
PACKAGE LEAFLET: INFORMATION FOR THE USER GLUCOSAMINE SULFATE 1500 MG FILM-COATED TABLETS GLUCOSAMINE SULFATE 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 Glucosamine sulfate is and what it is used for 2. What you need to know before you take Glucosamine sulfate 3. How to take Glucosamine sulfate 4. Possible side effects 5. How to store Glucosamine sulfate 6. Contents of the pack and other information 1. WHAT GLUCOSAMINE SULFATE IS AND WHAT IT IS USED FOR Glucosamine sulfate belongs to a group of medicines called other anti-inflammatory and anti- rheumatic agents, non steroids. Glucosamine sulfate 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 GLUCOSAMINE SULFATE DO NOT TAKE GLUCOSAMINE SULFATE - If you are allergic to: - Glucosamine or to any of the other ingredients of Glucosamine sulfate (listed in section 6) - Shellfish, since Glucosamine sulfate is manufactured from shellfish. - Peanut or soya, sincecontains soya lecithin. WARNINGS AND PRECAUTIONS TAKE SPECIAL CARE WITH GLUCOSAMINE SULFATE IF YOU - Suffer from impaired glucose tolerance. More frequent controls of your blood glucose levels may be necessary when starting treatment with Glucosamine sulfate - Have kidney or liver dysfuncti 阅读完整的文件
Health Products Regulatory Authority 02 February 2021 CRN009ZP8 Page 1 of 5 SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucosamine sulfate 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. Excipient(s) with known effect Each tablet contains 151.8 mg (6.6mmol) of sodium, 6.0 mg Lactose monohydrate and 0.72 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, 9.5x21mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Glucosamine sulfate 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 Glucosamine sulfate tablets should be swallowed whole. Tablets can be taken with or without food. _Adults and the elderly_: One Glucosamine sulfate tablet should be taken once daily. 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 reevaluated. Additional information on special populations: _Paediatric population_ 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 clinicalexperience dosage adjustment is not required when treating otherwise healthy, elderly patients. _Impaired renal and/or liver function_ In patients with impaired renal and/or liver function no dose recommendations can be given, since no studies have been performed. 4.3 CONTRAINDICATIONS Health Products Regulato 阅读完整的文件