DOLENIO Film-coated tablets Ref.[6845] Active ingredients: Glucosamine

A doctor should be consulted to rule out the presence of joint disease 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.

In patients with known risk factor for cardiovascular disease, monitoring of the blood lipid levels is recommended, since hypercholesterolemia has been reported in a few cases in patients treated with glucosamine.

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.

This medicinal product contains 2.240mmol (51.538 mg) of sodium per dose. To be taken into consideration by patients on a controlled sodium diet.

Increased effect of coumarin anticoagulants (e.g. warfarin) during concomitant treatment with glucosamine 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 concentrations 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 medical products.

Pregnancy

There are inadequate data concerning the use of glucosamine in pregnant women. From animal studies only insufficient data are available. Glucosamine should not be used during pregnancy.

Breast feeding

There is no data available on the excretion of glucosamine in breastmilk. The use of glucosamine during breast feeding is therefore not recommended as there is no data on the safety of the child.

No studies on the effects on the ability to drive or use machines have been performed.

If dizziness or drowsiness is experienced, car driving and the operating of machinery are not recommended.

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.

In the table below, all causality adverse events are listed by system organ class and frequency (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)).

Nervous system disorders

Common: Headache, Tiredness

Not known: Dizziness

Respiratory, thoracic and mediastinal disorders

Not known: Asthma/Asthma aggravated

Gastrointestinal disorders

Common: Nausea, Abdominal pain, Indigestion, Diarrhoea, Constipation

Not known: Vomiting

Skin and subcutaneous tissue disorders

Uncommon: Rash, Itching, Flushing

Not known: Angioedema, Urticaria

Metabolism and nutrition disorders

Not known: Diabetes mellitus inadequate control, Hypercholesterolaemia

General disorders and administration site conditions

Not known: Oedema/Peripheral oedema

Cases of Hypercholesterolemia, Asthma, aggravated and Diabetes mellitus inadequate control have been reported, but causality has not been established.

Dolenio may cause Hepatic enzyme elevation and rarely jaundice.

Patients with Diabetes mellitus

Blood glucose control worsened in patients with diabetes mellitus. Frequency not known.

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. Healthcare professionals are asked to report any suspected adverse reactions via Yellow Card Scheme. Website: www.mhra.gov.uk/yellowcard.

Not applicable.