ARTHRIEX

Administration:

This medicinal product should be swallowed whole. Tablets can be taken with or without food.

Adults and the elderly:

One Arthriex tablet should be taken once daily. Glucosamine is not indicated for the treatment of acute painful symptoms. Relief of symptoms (especially pain relief) may not be experienced until after several 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.

Additional information on special populations:

Children/adolescents: Safety and efficacy has not been established in children and adolescents, therefore, Arthriex tablets should not be used in persons under the age of 18 years. 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 No studies have been performed in patients with impaired renal and/or liver function.

The most common adverse reactions associated with treatment with glucosamine are nausea, abdominal pain, indigestion, constipation and diarrhoea. In addition, headache, tiredness, rash itching, and flushing have been reported. The reported adverse reactions are usually mild and transitory.

MedDRA System Organ Class Common (≥1/100 to <1/10) Uncommon (≥1/1,000 to <1/100) Rare (≥1/10,000 to <1/1000) Not known (cannot be estimated from the available data) Metabolism and nutrition disorders Diabetes mellitus inadequate control Hypercholesterolaemia Nervous system disorders Headache Tiredness - Dizziness Respiratory, thoracic and mediastinal disorders - - Asthma / Asthma aggravated Gastrointestinal disorders Nausea Abdominal pain Indigestion Diarrhoea Constipation Vomiting Skin and subcutaneous tissue disorders Rash Itching Flushing Angioedema Urticaria General disorders and administration site conditions Oedema/peripheral oedema Cases of Hypercholesterolemia, Asthma, (or Asthma aggravated) and Diabetes mellitus inadequate control have been reported, but causality has not been established.

Arthriex tablets may cause Hepatic enzyme elevation and rarely jaundice. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.

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A doctor must be consulted to rule out the presence of joint diseases for which other treatment should be considered. A doctor must be consulted if this medicine is intended for long term use. Continuous treatment beyond 3 years cannot currently be recommended as safety has not been established beyond this period.

As the risk of diabetogenic effects is unknown and until further evidence becomes available, caution should be exercised in patients with Diabetes or a predisposition for Diabetes. Therefore in patients with impaired glucose tolerance, pre-diabetics and diagnosed diabetics (Type I and II), monitoring of the blood glucose levels should be increased, as deemed necessary, before start of treatment, periodically during treatment and at the end of the treatment, as determined by the primary Healthcare Professional.

Where relevant, monitoring of insulin requirements is also recommended before start of treatment, periodically during treatment and at the end of the treatment under medical supervision. In patients with a known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended during treatment with Arthriex tablets since hypercholesterolemia has been observed in a few patients treated with glucosamine.

The results should be a factor in determining whether treatment is continued after 2-3 months. 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 asthma symptoms. Arthriex tablets contain lactose monohydrate, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

6 mmol. To be taken into consideration by patients on a controlled sodium diet.

1). Arthriex tablets must not be used in patients who are allergic to shellfish as the active ingredient is obtained from shellfish. Arthriex tablets contain soya lecithin. Persons allergic to soya or peanut should therefore not use this medicinal product.

5). Arthriex tablets should not be used in patients with impaired renal and/or liver function, as no dose recommendations can be given since no studies have been performed. 5). 6).