DONA 500 Milligram Capsules Hard

Nchi: Ayalandi

Lugha: Kiingereza

Chanzo: HPRA (Health Products Regulatory Authority)

Viambatanisho vya kazi:

GLUCOSAMINE SULFATE SODIUM CHLORIDE

Inapatikana kutoka:

Rottapharm Ltd

INN (Jina la Kimataifa):

GLUCOSAMINE SULFATE SODIUM CHLORIDE

Kipimo:

500 Milligram

Dawa fomu:

Capsules Hard

Dawa ya aina:

Product not subject to medical prescription

Idhini hali ya:

Authorised

Idhini ya tarehe:

0000-00-00

Taarifa za kipeperushi

_DGsmaf110613AF09/DGsmaf010713AF09 _
PACKAGE LEAFLET: INFORMATION FOR THE USER 

DONA
®
 500 MG CAPSULES 
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 are allergic to shellfish, as glucosamine is obtained
from shellfish. 

TAKE SPECIAL CARE WITH DONA 
Consult your doctor before taking Dona: 
•  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. 
2 
•  If you suffer from asthma; when starting on glucosamine,
you should be aware of 
potential worsening of symptoms. 
•  If you have severe liver or kidney problems. 
•  If

Tabia za bidhaa

SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dona 500mg Capsules
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each capsule contains:
Glucosamine sulfate sodium chloride
628 mg
Equivalent to glucosamine sulfate
500 mg
Sodium chloride
128 mg
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
Relief of symptoms in mild to moderate osteoarthritis of the knee, as diagnosed by a doctor.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
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.
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 the elderly, but according to clinical experience dosage adjustment
is not required when treating