DONA 1500 Milligram Powder for Oral Solution

Land: Irland

Språk: engelsk

Kilde: HPRA (Health Products Regulatory Authority)

Aktiv ingrediens:

GLUCOSAMINE SULFATE, SODIUM CHLORIDE

Tilgjengelig fra:

Meda Health Sales Ireland Limited

ATC-kode:

M01AX05

INN (International Name):

GLUCOSAMINE SULFATE, SODIUM CHLORIDE

Dosering :

1500 Milligram

Legemiddelform:

Powder for Oral Solution

Resept typen:

Product not subject to medical prescription

Terapeutisk område:

Other antiinflammatory and antirheumatic agents, non-steroids

Autorisasjon status:

Authorised

Autorisasjon dato:

2016-01-08

Informasjon til brukeren

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.
WARNINGS 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 an intolerance to some sugars.
• If you are on a controlled sodium diet.
The pre

Preparatomtale

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 sulfate
1500 mg
sodium chloride
384 mg
Excipients with known effect:
One sachet contains 2.5 mg aspartame, 151 mg sodium and 2028.5mg
sorbitol
For the 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.
_OLDER PEOPLE:_
No specific studies have been performed in older people, but according
to clinical experience dosage adjustment is not
required when treating otherwise healthy, older patients.
_PATIENT WITH IMPAIRED RENAL AND/OR LIVER FUNCTION:_
In patients with impaired renal and/or liver function no dose
recommendations can be given, since no studies have been