DONA Powder for Oral Solution 1500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
18-04-2024
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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
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 to glucosamine. The powder for oral solution contains aspartame and is therefore contraindicated in
patients with phenylketonuria.
Crystalline glucosamine sulfate
1884mg
equivalent to:
glucosamine sulfate
1500mg
sodium chloride
384mg
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 26/08/2011_
_CRN 2095711_
_page number: 1_
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Since glucosamine is obtained from shellfish, patients who are allergic to shellfish should exercise caution in the use of
the
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