DONA 500 Milligram Capsules Hard

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

Active ingredient:

GLUCOSAMINE SULFATE SODIUM CHLORIDE

Available from:

Meda Health Sales Ireland Limited

ATC code:

M01AX05

INN (International Name):

GLUCOSAMINE SULFATE SODIUM CHLORIDE

Dosage:

500 Milligram

Pharmaceutical form:

Capsules Hard

Prescription type:

Product not subject to medical prescription

Therapeutic area:

Other antiinflammatory and antirheumatic agents, non-steroids

Authorization status:

Authorised

Authorization date:

2015-11-19

Patient Information leaflet

Package Leaflet: Information for the user
DONA 500MG CAPSULES
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
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 (hypersensitive) to glucosamine or any of the
other
ingredients of Dona.
• 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 are on a controlled sodium diet.
The presence of another joint disease, which would require alternative
treatment,
should be excluded.
If unusual signs or symptoms appear, or if any change

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:
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 the 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
Posology
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.
_OLDER PEOPLE:_
No specific studies have been performed in older patients, but
according to clinical experience dosage
adjustment is not required when treating otherwise healthy, older
patients.
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