Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
GLUCOSAMINE SULFATE GLUCOSAMINE SULPHATE SODIUM CHLORIDE
Clonmel Healthcare Ltd
1500 Milligram
Film Coated Tablet
2011-07-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Arthrimel 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 tablets Off-white, oblong-shaped, film-coated tablet 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Arthrimel tablets are indicated for the treatment of osteoarthritis of low to moderate degree. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _Administration:_ Arthrimel tablets should be swallowed whole. _Adults and the elderly_: One Arthrimel 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, Arthrimel tablets should not be used in persons under the age of 18 years. 4.3 CONTRAINDICATIONS Known sensitivity to glucosamine (or any of its derivatives), sulfates or any of the other ingredients in Arthrimel tablets (listed in section 6.1). IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 25/07/2011_ _CRN 2055022_ _page number: 1_ 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE WARNINGS Arthrimel tablets contain lactose monohydrate, patients with Read the complete document