SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Glusartel 1500 mg powder for oral solution ▼

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Each sachet contains: 1884 mg glucosamine sulphate sodium chloride, corresponding to 1500 mg glucosamine sulphate or 1178 mg glucosamine.

For a full list of excipients, see section 6.1.

3 PHARMACEUTICAL FORM

Powder for oral solution. White, crystalline, odourless powder contained in singledose sachets.

4    CLINICAL PARTICULARS

4.1    Therapeutic indications

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

4.2    Posology and method of administration

1500 mg glucosamine sulphate (one sachet) to be taken once a day. The entire contents of one sachet should be fully dissolved in at least 250 ml of water (one glass) before drinking.

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 or sometimes even longer. If no relief of symptoms is experienced after 2-3 months, continued treatment with glucosamine should be re-evaluated.

Additional information on special populations

Glucosamine should not be used in children and adolescents below the age of 18 years (see 4.4).

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.

4.3 Contraindications

Known hypersensitivity to glucosamine or to any of the excipients.

Glusartel must not be given to patients who are allergic to shellfish, as the active ingredient is obtained from shellfish.

Glusartel must not be given to patients who suffer from phenylketonuria, since it contains aspartame, a source of phenylalanine.

4.4 Special warnings and precautions for use

A doctor must be consulted to rule out the presence of joint diseases for which other treatment should be considered.

In patients with impaired glucose tolerance, monitoring of the blood glucose levels and, where relevant, insulin requirements is recommended before start of treatment and periodically during treatment.

A report on exacerbated asthma symptoms triggered after initiation of glucosamine therapy has been described (symptoms resolved after withdrawal of glucosamine). Asthmatic patients starting on glucosamine should therefore be aware of potential worsening of symptoms.

Patients with rare hereditary problems of fructose intolerance should not take this medicine.

One sachet contains 6,6 mmol (151 mg) sodium. To be taken into consideration by patients on a controlled sodium diet.

Glucosamine should not be used in children and adolescents under the age of 18 years since safety and efficacy have not been established.

4.5 Interaction with other medicinal products and other forms of interaction

Data on possible drug interactions with glucosamine is limited, but increased INR with coumarin anticoagulants (warfarin and acenocoumarol) has been reported. Patients treated with coumarin anticoagulants should therefore be monitored closely when initiating or ending glucosamine therapy.

Concurrent treatment with glucosamine may increase the absorption and serum concentration of tetracyclines, but the clinical relevance of this interaction is probably limited.

Due to limited documentation on potential drug interactions with glucosamine, one should generally be aware of altered response or concentration of concurrently used medicinal products.

4.6 Pregnancy and lactation

Pregnancy

There are no adequate data from the use of glucosamine in pregnant women. From animal studies only insufficient data are available. Glusartel should not be used during pregnancy.

Breast Feeding

There are no data available on the excretion of glucosamine into human milk. The use of glucosamine during breastfeeding is therefore not recommended as there is no data on the safety for the newborn.

4.7 Effects on ability to drive and use machines

No studies on the effects on the ability to drive and use machines have been performed. If dizziness or drowsiness is experienced car driving and the operating of machinery is not recommended.

4.8 Undesirable effects

The most common adverse reactions associated with treatment with glucosamine are nausea, abdominal pain, dyspepsia, flatulence, diarrhoea and constipation. In addition, headache, somnolence, tiredness, rash, pruritus and erythema have been reported.

Organ System Class	Common from > to <1/10	Uncommon from >1/1,000 to <1/100	Rare from >1/10,000 to <1/1,000	Very rare <1/10,000	Unknown*
Immune system disorders					Allergic reaction
Nervous system disorders	Headache Somnolence Tiredness				Dizziness
Eye					Visual

disorders					disturbances
Gastrointes tinal disorders	Diarrhoea Constipation Nausea Flatulence Abdominal pain Dyspepsia
Skin and subcutaneous tissue disorders		Erythema Pruritis Rash			Hair loss

* frequency cannot be estimated by the available data

Sporadic, spontaneous cases of hypercholesterolemia have been reported, but causality has not been established.

4.9 Overdose

No case of overdose has been reported.

5    PHARMACOLOGICAL PROPERTIES

5.1    Pharmacodynamic properties

Pharmacotherapeutic group: Other anti-inflammatory and anti-rheumatic agents, nonsteroidal anti-inflammatory drugs. ATC code: M01AX05

Glucosamine is an endogenous substance, a normal constituent of the polysaccharide chains of cartilage matrix and synovial fluid glucosaminoglycans. In vitro and in vivo studies have shown 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 onset of response cannot be assessed.

5.2 Pharmacokinetic properties

Glucosamine is a relatively small molecule (molecular mass 179), which is easily dissolved in water and soluble in hydrophilic organic solvents. The available information on the pharmacokinetics of glucosamine is limited. The absolute bioavailability is unknown. The distribution volume is approximately 5 litres 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.

5.3 Preclinical safety data

D-glucosamine has low acute toxicity. Animal experimental data relating to toxicity during repeated administration, reproduction toxicity, mutagenicity and carcinogenicity is lacking for glucosamine.

Results from in vitro studies and in vivo studies in animals have shown that glucosamine reduces insulin secretion and induces insulin resistance, probably via glucokinase inhibition in the beta cells. The clinical relevance is unknown.

6 PHARMACEUTICAL PARTICULARS

6.1    List of excipients

Aspartame

Sorbitol

Citric acid anhydrous Macrogol 4000

6.2    Incompatibilities

Not applicable.

6.3    Shelf life

3 years

6.4    Special precautions for storage

Do not store above 30 °C.

Store in the original package.

6.5    Nature and contents of container

One sachet made of a three-layered material comprising paper, aluminium and polyethylene.

Pack-sizes of 4 (sample pack), 30 and 90 sachets. Not all pack-sizes may be marketed.