GLUSAMIN Film Coated Tablet 750 Milligram

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

GLUCOSAMINE SULPHATE SODIUM CHLORIDE

Available from:

FMC Pharma Ltd

Dosage:

750 Milligram

Pharmaceutical form:

Film Coated Tablet

Authorization date:

2011-08-26

Summary of Product characteristics

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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Glusamin 750mg Film-coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 942mg glucosamine sulfate sodium chloride equivalent to 750mg glucosamine sulfate.
Excipients:
Each tablet contains 75.9mg (3.3 mmol) of sodium.
Lactose monohydrate 3.0mg
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
Glusamin tablets are indicated for the treatment of osteoarthritis of low to moderate degree.
4.2 Posology and method of administration
Administration:
Glusamin tablets should be swallowed whole.
Adults and the elderly:
One Glusamin tablet should be taken twice daily.
Or
Two Glusamin tablets to 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
                                
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