GLUSARTEL

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.

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.

Within the system organ classes, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: 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 (cannot be estimated from the available data) The most common adverse reactions associated with treatment with glucosamine are nausea, abdominal pain, dyspepsia, flatulence, diarrhoea and constipation.

The reported adverse reactions are usually mild and transitory. In the following table, adverse reactions have been grouped on the basis of “Internationally agreed Order of Importance” System Organ Class (SOC) MedDRA Classification.

In each SOC, undesirable effects were classified according to their occurrence frequency. In each frequency class the undesirable effects are reported according to a decreasing order of severity. g. Tachycardia Vascular disorders Flushing Respiratory, thoracic and mediastinal Asthma / Asthma aggravated Gastrointestinal disorders Diarrhoea Constipation Nausea Flatulence Abdominal pain Dyspepsia Vomiting Hepatobiliary disorders Jaundice Skin and subcutaneous tissue disorders Erythema Pruritus Rash Angioedema Urticaria General disorders and Tiredness Oedema/periphera l oedema administration site conditions Investigations Hepatic enzyme elevation Blood glucose increased Blood pressure increased International normalized ratio fluctuation * frequency cannot be estimated by the available data Sporadic, spontaneous cases of hypercholesterolemia have been reported, but causality has not been established.

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. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

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.

5 mg sorbitol. Patients with hereditary fructose intolerance (HFI) should not take this medicine. 5 mg aspartame in each sachet. Aspartame is a source of phenylalanine. It may be harmful if you have phenylketonuria (PKU), a rare genetic disorder in which phenylalanine builds up because the body cannot remove it properly.

6% of the WHO recommended maximum daily intake of 2 g sodium for an adult. Glucosamine should not be used in children and adolescents under the age of 18 years since safety and efficacy have not been established.

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