DONA 1500MG POWDER FOR ORAL SOLUTION 1500 Milligram Powder for Oral Solution

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLUCOSAMINE SULFATE SODIUM CHLORIDE

Available from:

Rottapharm Ltd

INN (International Name):

GLUCOSAMINE SULFATE SODIUM CHLORIDE

Dosage:

1500 Milligram

Pharmaceutical form:

Powder for Oral Solution

Prescription type:

Product not subject to medical prescription

Authorization status:

Authorised

Authorization date:

0000-00-00

Patient Information leaflet

_DGsmaf110613AF09/DGsmaf010713AF09 _

PACKAGE LEAFLET: INFORMATION FOR THE USER 

DONA
®
 1500 MG POWDER FOR ORAL SOLUTION 
Glucosamine Sulfate  

_READ ALL OF THIS LEAFLET CAREFULLY BECAUSE IT CONTAINS IMPORTANT
INFORMATION FOR _
_YOU. _
_This medicine is available without prescription. However, you still
need to take DONA _
_carefully to get the best results from it.  _
o
  _Keep this leaflet. You may need to read it again. _
o
  _Ask your pharmacist if you need more information or advice. _
o
  _You must contact a doctor if your symptoms worsen or do not
improve after 30 _
_days. _
o
  _If any of the side effects gets serious, or if you notice any
side effects not listed _
_in this leaflet, please tell your doctor or pharmacist. _
_ _
_ _
_In this leaflet: _
_1.  What Dona is and what it is used for _
_2.  Before you take Dona _
_3.  How to take Dona _
_4.  Possible side effects _
_5.  How to store Dona  _
_6. Further _
_information _

1. 
WHAT DONA IS AND WHAT IT IS USED FOR 

Dona contains glucosamine sulfate which belongs to a group
of medicines called non-
steroidal anti-inflammatory and anti-rheumatic agents. 
Dona is used for the relief of symptoms in mild to moderate
osteoarthritis of the knee, as 
diagnosed by your doctor. 

2. 
BEFORE YOU TAKE DONA 

DO NOT TAKE DONA: 
•  If you are allergic (hypersensitive) to glucosamine or any of
the other ingredients of 
Dona. 
•  If you suffer from a genetic metabolic disorder
(phenylketonuria). 
•  If you are allergic to shellfish, as glucosamine is obtained
from shellfish. 

TAKE SPECIAL CARE WITH DONA 
Consult your doctor before taking Dona: 
2 
•  If you have diabetes; in this case closer monitoring of blood
sugar levels and where 
relevant insulin requirements may be necessary at the beginning of the
treatment 
and periodically during treatment with Dona. 
•  If you suffer from asthma; when starting on glucosamine,
you should be aware

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:
Glucosamine sulfate sodium chloride
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
Relief of symptoms in mild to moderate osteoarthritis of the knee, as diagnosed by a doctor.
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 by
the patient’s healthcare practitioner.
Patients should seek medical advice if their symptoms deteriorate after commencing treatment with
glucosamine.
_ELDERLY:_
No specific studies have been performed in elderly, but according to clinical experience dosage adjustment is
not required when treating otherwise healthy, elderl