Dona 1500 mg powder for oral solution

País: Irlanda

Idioma: inglés

Fuente: HPRA (Health Products Regulatory Authority)

Ingredientes activos:

Glucosamine sulfate sodium chloride

Disponible desde:

PCO Manufacturing Ltd.

Código ATC:

M01AX; M01AX05

Designación común internacional (DCI):

Glucosamine sulfate sodium chloride

Dosis:

1500 milligram(s)

formulario farmacéutico:

Powder for oral solution

tipo de receta:

Product not subject to medical prescription

Área terapéutica:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

Estado de Autorización:

Authorised

Fecha de autorización:

2014-09-12

Información para el usuario

_ _
_ _
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PACKAGE LEAFLET: INFORMATION FOR THE USER
DONA
®
1500 MG POWDER FOR ORAL
SOLUTION
glucosamine sulfate
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START TAKING
THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION
FOR YOU.

Always take this medicine exactly as described in this
leaflet or as your pharmacist has told you.

Keep this leaflet. You may need to read it again.

Ask your pharmacist if you need more information or
advice.

If you get any side effects, talk to your pharmacist. This
includes any possible side effects not listed in this
leaflet. See section 4.

You must talk to a doctor if you do not feel better or if
you feel worse after 30 days.
WHAT IS IN THIS LEAFLET:
1.
What Dona is and what it is used for
2.
What you need to know before you take Dona
3.
How to take Dona
4.
Possible side effects
5.
How to store Dona
6.
Contents of the pack and other 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.
WHAT YOU NEED TO KNOW BEFORE YOU TAKE DONA
DO NOT TAKE DONA:

If you are allergic to glucosamine or any of the other
ingredients of this medicine (listed in section 6).

If you are allergic to shellfish, as glucosamine is
obtained from shellfish.
WARNING AND PRECAUTIONS
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.

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 you have high cholesterol levels in your blood

If you have intolerance to some sugars.

If you are on a controlled sodium

Ficha técnica

Health Products Regulatory Authority
31 May 2021
CRN00CD9G
Page 1 of 2
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Dona 1500 mg powder for oral solution
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Each sachet contains:
Glucosamine Sulfate sodium chloride 1884 mg
equivalent to: glucosamine sulphate 1500 mg
sodium chloride 384 mg
Excipients with known effect: Each sachet contains aspartame (E951),
sodium and sorbitol (E420).
For the full list of excipients, see section 6.1
3 PHARMACEUTICAL FORM
Powder for oral solution.
_Product imported from Spain:_
A white, crystalline, odourless powder.
4 CLINICAL PARTICULARS
As per PA2010/022/002
5 PHARMACOLOGICAL PROPERTIES
As per PA2010/022/002
6 PHARMACEUTICAL PARTICULARS
6.1 LIST OF EXCIPIENTS
Aspartame (E951)
Sorbitol (E420)
Citric Acid
Macrogol 4000
6.2 INCOMPATIBILITIES
Not applicable.
6.3 SHELF LIFE
The shelf life expiry date of this product shall be the date shown on
the container and outer package of the product on the
market in the country of origin.
6.4 SPECIAL PRECAUTIONS FOR STORAGE
Do not store above 25°C.
Health Products Regulatory Authority
31 May 2021
CRN00CD9G
Page 2 of 2
6.5 NATURE AND CONTENTS OF CONTAINER
Single-dose sachets in a cardboard box containing 30 sachets.
6.6 SPECIAL PRECAUTIONS FOR DISPOSAL AND OTHER HANDLING
No special requirements
7 PARALLEL PRODUCT AUTHORISATION HOLDER
PCO Manufacturing Ltd.
Unit 10, Ashbourne Business Park
Rath
Ashbourne
Co. Meath
Ireland
8 PARALLEL PRODUCT AUTHORISATION NUMBER
PPA0465/401/001
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: 12
th
September 2014
10 DATE OF REVISION OF THE TEXT
May 2021