Država: Irska
Jezik: engleski
Izvor: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULPHATE SODIUM CHLORIDE
FMC Pharma Ltd
GLUCOSAMINE SULPHATE SODIUM CHLORIDE
500 Milligram
Film Coated Tablet
Product subject to prescription which may be renewed (B)
Authorised
0000-00-00
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Glucosamine sulfate 500mg Film-coated Tablets 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 628mg glucosamine sulfate sodium chloride equivalent to 500 mg glucosamine sulfate or 393mg glucosamine. Excipients: Each tablet contains 50.6 mg (2.2 mmol) of sodium. Lactose monohydrate 60.0 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, 9x20mm. 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 _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 3 times daily. Or Three Glucosamine sulfate tablets to 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: _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 required when treating otherwise healthy, elderly patients. IRISH MEDICINES BOARD _______________________________ Pročitajte cijeli dokument