MOBIFLEX Film-coated tablet Ref.[8301] Active ingredients: Tenoxicam

For oral administration.

To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.4).

Adults

A single daily dose of 20mg Mobiflex should be taken at the same time each day. Mobiflex Tablets are for oral administration with water or other fluid.

Higher doses should be avoided as they do not usually achieve significantly greater therapeutic effect but may be associated with a higher risk of adverse events.

In acute musculoskeletal disorders treatment should not normally be required for more than 7 days, but in severe cases it may be continued up to a maximum of 14 days.

Elderly

The elderly are at increased risk of the serious consequences of adverse reactions. They are also more likely to be receiving concomitant medication or to have impaired hepatic, renal or cardiovascular function. If an NSAID is considered necessary the lowest effective dose should be used and for the shortest possible duration. The patient should be monitored regularly for GI bleeding during NSAID therapy.

Children

There are insufficient data to make a recommendation for administration of Mobiflex to children.

Use in renal and hepatic insufficiency

Because of the high plasma protein-binding of tenoxicam, caution is required when plasma albumin concentrations are markedly reduced (e.g. in nephrotic syndrome) or when bilirubin concentrations are high.

There is insufficient information to make dosage recommendations for Mobiflex in patients with pre-existing hepatic impairment.

Symptoms

In general, symptoms of NSAID overdosage usually include nausea, vomiting, epigastric pain, rarely diarrhoea, gastrointestinal bleeding, tinnitus, headache, blurred vision and dizziness. There have been isolated reports of more serious toxicity after ingestion of substantial quantities; they include seizures, excitation, drowsiness hypotension, apnoea, coma electrolyte imbalance and renal failure. Exacerbation of asthma is a possible effect.

Management

Patients should be treated symptomatically as required. In case of overdosage, discontinuation of the drug, and the administration of activated charcoal, gastric lavage, antacids and proton-pump inhibitors may be indicated. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. There are no specific antidotes. The benefit of gastric decontamination is uncertain. Dialysis does not significantly clear NSAIDs from the blood stream. Good urine output should be ensured – maintain adequate hydration. Renal and liver function should be closely monitored. Patients should be observed for at least four hours after ingestion of potentially toxic amounts. Frequent or prolonged convulsions should be treated with intravenous diazepam. Other measures may be indicated by the patient’s clinical condition.

Shelf life: 5 years.

Do not store above 30°C.

Do not store above 30°C.

No special requirements.