DONA Capsules Hard 500 Milligram
Country: Ireland
Language: English
Source: HPRA (Health Products Regulatory Authority)
Summary of Product characteristics
(SPC)
19-04-2024
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Active ingredient:
CRYSTALLINE GLUCOSAMINE SULFATE
Available from:
Rottapharm Ltd
Dosage:
500 Milligram
Pharmaceutical form:
Capsules Hard
Authorization date:
2006-07-14
Summary of Product characteristics
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dona 500mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Crystalline glucosamine sulfate
628 mg
Equivalent to
glucosamine sulfate
500mg
Sodium chloride
128mg
The content of sodium in each capsule is 2.2 mmol.
For a full list of excipients, see section 6.1.
3 PHARMACEUTICAL FORM
Capsule, hard (Capsule)
Hard gelatine, snap-fit, red-red capsule (size 0), reporting the logo ROTTA printed in black ink on the body and the
head.
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
One capsule should be taken three times 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 the 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.
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 product.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 11/04/2012_
_CRN 2109751_
_page number: 1_
This medicinal product contains 50 mg sodium per dose. The daily sodium intake is 150 mg (equiva
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