Relief of symptoms in mild to moderate osteoarthritis of the knee.

Posology:
Unless otherwise prescribed by the doctor, the usual dosage is:
1 sachet daily.
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 reconsidered.
Additional information on special populations:
Children and Adolescents:
Glucosamine should not be used in children and adolescents below the age of 18
years, since efficacy and safety of the use have not been established.

Elderly:
No specific studies have been performed in the elderly, but according to clinical
experience dosage adjustment is not required when treating otherwise healthy
elderly patients.
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 performed.
Method of administration
The contents of one sachet (dissolved in a glass of water) should be taken preferably
at meals.

Glucosamine should not be used in children and adolescents below the age of 18
years since safety and efficacy of use have not been established.
A doctor must be consulted to rule out the presence of joint diseases for which other
treatment should be considered.
Caution is advised when treating patients with impaired glucose tolerance. Closer
monitoring of blood sugar levels and, where relevant, insulin requirements may be
necessary at the beginning of treatment and at regular intervals during treatment.
In patients having a known risk factor of cardiovascular disease monitoring of blood
lipid levels is recommended, since hypercholesterolemia has been observed in a few
cases in patients treated with glucosamine.
Exacerbation of asthma symptoms triggered after initiation of glucosamine treatment
has been described in one report (these symptoms resolved after withdrawal of
glucosamine). Therefore, asthmatic patients starting on glucosamine should be
aware of potential worsening of symptoms.
Contains aspartame as a source of phenylalanine and may therefore be harmful for
patients with phenylketonuria. Patients with rare hereditary problems of fructose
intolerance should not take dona® 1500 mg, Powder for Oral Solution.

One sachet contains 6.6 mmol (151 mg) of sodium. To be taken into consideration
by patients on a controlled sodium (low in sodium/salt) diet.

There are limited data on possible drug interactions with glucosamine, but
increments in the INR parameter have been reported with oral vitamin K antagonists.
Patients treated with oral vitamin K antagonists should therefore be closely monitored
at the time of initiation or termination of glucosamine therapy.Concomitant treatment
with glucosamine may enhance absorption and consequently serum concentrations
of tetracyclines. However, clinical relevance of this interaction is probably limited.
Given the fact that only limited data is available on potential glucosamine interactions,
particular attention should be given to any modified response to or modified serum
concentration levels of concomitantly used medicinal products.

Pregnancy
There is only limited amount of data from the use of glucosamine in pregnant women.
From animal studies only insufficient data is available. dona® 1500 mg, Powder for
Oral Solution, should not be used during pregnancy.
Lactation
It is not known whether or not glucosamine is excreted in human milk. Use of
glucosamine during lactation is not recommended as there is no data available on
the safety for the newborn.

Studies on the effects on the ability to drive and use machines have not been
performed. If dizziness or drowsiness is experienced, driving a car or operating
machinery is not recommended.

Evaluation of the undesirable effects is based on the following frequency
information:
Very common: ≥ 1/10
Common: ≥ 1/100 to < 1/10
Uncommon: ≥ 1/1 000 to < 1/100
Rare: ≥ 1/10 000 to < 1/1 000
Very rare: ≤ 1/10 000
Not known: (Frequency cannot be estimated from the available data).
The most common side effects associated with treatment with glucosamine are
nausea, abdominal pain, dyspepsia, flatulence, constipation, diarrhoea, headache,
tiredness and somnolence. The reported undesirable effects are usually mild and
transitory.

In diabetic patients, blood sugar monitoring may be adversely affected. The
frequency is not known.
Isolated spontaneous cases of hypercholesterolemia have been reported; however,
a causal relationship has not been established.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorization of the medicinal product is
important.
It allows continued monitoring of the benefit/risk balance of the medicinal product.
Healthcare
professionals are asked to report any suspected adverse reactions via

The National Pharmacovigilance and Drug Safety Centre (NPC)
Fax: +966-11-205-7662
Call NPC at +966-11-2038222, Ext 2317-2356-2340
Reporting hotline: 19999
E-mail: npc.drug@sfda.gov.sa
Website: www.sfda.gov.sa/npc

No cases of overdosage have been reported.

Pharmaco-therapeutic group: Other anti-inflammatory and anti-rheumatic agents,
non-steroids.
ATC code: M01AX05
Glucosamine is an endogenous substance and a normal constituent of the
polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans. In vitro
and in vivo studies have shown that glucosamine stimulates the synthesis of
physiological glycosaminoglycans and proteoglycans by chondrocytes, and of hyaluronic
acid by synoviocytes.
The mechanism of action of glucosamine in humans is unknown. The period to the
onset of action cannot be assessed.

Glucosamine is a relatively small molecule (molecular weight: 179) which is easily
dissolved in water and soluble in hydrophilic organic solvents.
The available information on the pharmacokinetics of glucosamine is limited. Absolute
bioavailability is unknown. The volume of distribution is approximately 5 liters, and the
half-life after intravenous administration is approximately 2 hours. Approximately 38%
of an intravenous dose is excreted in the urine as unchanged substance.

Non-clinical safety data revealed no special hazard of glucosamine sulfate for
humans based on conventional studies of repeat-dose toxicity, toxicity to
reproduction and development and genotoxicity.
Studies on the carcinogenic potential are not available.
Preclinical results from in vitro studies and in vivo studies have shown that
intravenous administration of high glucosamine doses reduces insulin secretion,
probably by inhibiting glucokinase in the beta cells, and induces insulin resistance in
peripheral tissues. The clinical relevance of these findings is unknown.

Aspartame, Sorbitol (Ph. Eur.), Citric acid, Macrogol 4000

Not applicable.

Do not store above 30°C.
Keep medicines out of the sight and reach of children.

Each sachet consists of three-layered material made of paper, aluminium and
polyethylene.
Packs containing 30 sachets with powder for oral solution.

No special requirements.