Dona 1500 mg Powder for oral solution

Maa: Irlanti

Kieli: englanti

Lähde: HPRA (Health Products Regulatory Authority)

Aktiivinen ainesosa:

Glucosamine sulfate; Sodium chloride; Glucosamine sulfate sodium chloride

Saatavilla:

Mylan IRE Healthcare Limited

ATC-koodi:

M01AX; M01AX05

INN (Kansainvälinen yleisnimi):

Glucosamine sulfate; Sodium chloride; Glucosamine sulfate sodium chloride

Annos:

1500 milligram(s)

Lääkemuoto:

Powder for oral solution

Prescription tyyppi:

Product not subject to medical prescription

Terapeuttinen alue:

Other antiinflammatory and antirheumatic agents, non-steroids; glucosamine

Valtuutuksen tilan:

Marketed

Valtuutus päivämäärä:

1998-04-03

Pakkausseloste

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.
o
Always take this medicine exactly as described in this leaflet or as
your pharmacist has
told you.
o
Keep this leaflet. You may need to read it again.
o
Ask your pharmacist if you need more information or advice.
o
If you get any side effects, talk to your pharmacist. This includes
any possible side effects
not listed in this leaflet. See section 4.
o
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 presence

Valmisteyhteenveto

Health Products Regulatory Authority
16 December 2020
CRN009ZTT
Page 1 of 7
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 1884mg
equivalent to: glucosamine sulfate 1500mg
sodium chloride 384mg
Excipients with known effect:
Each sachet contains 2.5 mg aspartame (E951), 2028.5 mg sorbitol
(E420) and 151 mg sodium.
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 re