ARTHRIMEL Film Coated Tablet 750 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
26-04-2024
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Active ingredient:
GLUCOSAMINE SULFATE GLUCOSAMINE SULPHATE SODIUM CHLORIDE
Available from:
Clonmel Healthcare Ltd
Dosage:
750 Milligram
Pharmaceutical form:
Film Coated Tablet
Authorization date:
2011-07-15
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Arthrimel 750mg Film Coated Tablets
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each film-coated tablet contains 942mg glucosamine sulfate sodium chloride equivalent to 750 mg glucosamine
sulfate.
Excipients:
Each tablet contains 75.9 mg (3.3mmol) of sodium.
Lactose monohydrate 3.0 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 twice daily.
Or
Two Arthrimel 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 has not been established in children, therefore, Arthrimel tablets should not be used in persons
under the age of 18 years.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 25/07/2011_
_CRN 2055022_
_page number: 1_
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).
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
WARNINGS
Arthrimel ta
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