MOTIFENE Capsule, hard Ref.[50029] Active ingredients: Diclofenac

Posology

For oral administration.

The capsules should be swallowed whole with a liberal quantity of liquid.

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 Special warnings and precautions for use).

Adults

One capsule daily. Dose may be increased to two capsules daily if necessary. The first dose should be taken in the morning with breakfast and the second if required 8-12 hours later.

Paediatric population

The safety and efficacy of Motifene in children and adolescents below 18 years have not yet been established.

Older People (age 65 years or over)

Older people are at increased risk of the serious consequences of adverse reactions. 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.

Symptoms

Symptoms include headache, nausea, vomiting, epigastric pain, gastrointestinal bleeding, rarely diarrhoea, disorientation, excitation, coma, drowsiness, dizziness, tinnitus, fainting and occasionally convulsions. In cases of significant poisoning, acute renal failure and liver damage are possible.

Treatment

Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.

Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be closely monitored 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. Specific therapies such as forced diureses, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.

Supportive measures and symptomatic treatment should be given for complications such as hypotension, renal failure, convulsions, gastrointestinal disorder, and respiratory depression.

4 years.

Do not store above 25°C.

The capsules are blister packed in PVC/PDVC and aluminium foil and are packed into folding cardboard cartons.

Motifene is available in packs of 2, 4, 28 and 56 capsules.

Not all pack sizes may be marketed.

Not applicable.