DONA 1500MG POWDER FOR ORAL SOLUTION
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
09-05-2024
Some documents for this product are not currently available, you can send a request to our customer service and we will notify you as soon as we are able to obtain them.
Send request.
Send request.
Active ingredient:
GLUCOSAMINE SULFATE SODIUM CHLORIDE
Available from:
Rottapharm Ltd
Dosage:
1500 Milligram
Pharmaceutical form:
Powder for Oral Solution
Authorization date:
1998-04-03
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dona 1500mg Powder For Oral Solution.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Crystalline glucosamine sulfate
1884 mg
equivalent to: glucosamine sulfate
1500 mg
sodium chloride
384 mg
Excipients: Contains 2.5mg Aspartame and 2028.5mg Sorbitol.
For a full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution.
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
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.
Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief)
may not be experienced until after some weeks of treatment and in some cases even longer. If no relief of symptoms is
experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated.
_ELDERLY:_
No specific studies have been performed in elderly, but according to clinical experience dosage adjustment is not
required when treating otherwise healthy, elderly patients.
_PATIENT WITH IMPAIRED RENAL AND/OR LIVER FUNCTION:_
In patients with impaired renal and/or liver function no dose recommendations can be given, since no stud
Read the complete document
