DONA Powder for Oral Solution 1500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
02-04-2023
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Active ingredient:
GLUCOSAMINE SULFATE
Available from:
PCO Manufacturing
Dosage:
1500 Milligram
Pharmaceutical form:
Powder for Oral Solution
Authorization date:
2007-01-05
Summary of Product characteristics
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Summary of Product Characteristics
1 NAME OF THE MEDICINAL PRODUCT
Dona 1500mg Powder for Oral Solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Excipients:
Aspartame
sorbitol
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution
Product imported from Greece, Italy and Spain.
A white, crystalline, odourless powder.
4 CLINICAL PARTICULARS
4.1 Therapeutic Indications
Treatment of the symptoms of osteoarthritis, i.e. pain and function limitation.
4.2 Posology and method of administration
Adults and the Elderly:
The contents of one sachet (dissolved in a glass of water) should be taken once daily, preferably at meals.
Pivotal proof of efficacy 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 and adolescents:
Glucosamine should not be used in children and adolescents below the age of 18 years (see 4.4).
4.3 Contraindications
Hypersensitivity
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