Quốc gia: Ai-len
Ngôn ngữ: Tiếng Anh
Nguồn: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULFATE
FMC Pharma Ltd
1500 Milligram
Film Coated Tablet
2011-07-22
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arthriaid 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. Excipients: Each tablet contains 151.8 mg (6.6mmol) of sodium. Lactose monohydrate 6.0 mg For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Film-coated tablet Off-white, oblong-shaped film-coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arthriaid tablets are indicated for the treatment of osteoarthritis of low to moderate degree. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Administration:_ Arthriaid tablets should be swallowed whole. _Adults and the elderly_: One Arthriaid tablet should be taken once daily. Efficacy of glucosamine has been demonstrated for periods of up to three months, with a residual effect evident for two months after drug withdrawal. The safety and efficacy of the product were also confirmed in pivotal clinical trials for treatment up to three years. Continuous treatment beyond 3 years cannot be recommended as the safety has not been established beyond this period. _Children:_ Safety and efficacy has not been established in children, therefore, Arthriaid tablets should not be used in persons under the age of 18 years. _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 Known sensitivity to glucosamine (or any of its derivatives), sulfates or any of the other ingredients in Arthriaid tablets (listed in section 6.1). IRISH MEDICINES BOARD ____________________________________________________________________________________________________________________ Đọc toàn bộ tài liệu