ACECLOFENAC Film-coated tablet Ref.[6050] Active ingredients: Aceclofenac

Posology

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

Adults

The recommended dose is 200 mg daily, taken as two separate 100 mg doses, one tablet in the morning and one in the evening.

Children

There are no clinical data on the use of Aceclofenac 100 mg Tablets in children and therefore it is not recommended for use in children.

Elderly

The elderly, who are more likely to be suffering from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, 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.

The pharmacokinetics of Aceclofenac 100 mg Tablets are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

Patients with renal impairment

There is no evidence that the dosage of Aceclofenac 100 mg Tablets needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see section4.4).

Patients with liver impairment

There is some evidence that the dose of Aceclofenac 100 mg Tablets should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of 100 mg be used.

Method of administration

Aceclofenac 100 mg Film-coated Tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid.

To be taken preferably with or after food. When Aceclofenac 100 mg Tablets was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected.

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

a) Symptoms

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

b) Therapeutic measure

Patients should be treated symptomatically as required.

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.

Specific therapies such as dialysis or haemoperfusion are probable of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism.

Good urine output should be ensured.

Renal and liver function should be closely monitored.

Patients should be observed for at least four hours after ingestion of potentially toxic amounts.

In case of frequent or prolonged convulsions, patients should be treated with intravenous diazepam.

Other measures may be indicated by the patient’s clinical condition.

Management of acute poisoning with oral aceclofenac essentially consists of supportive and symptomatic measures for complications such as hypotension, renal failure, convulsions, gastro-intestinal irritation, and respiratory depression.

3 years.

This medicinal product does not require any special storage conditions.

Aceclofenac 100 mg Film-Coated Tablets are packaged in Aluminium/aluminium blisters placed into cardboard boxes containing 20, 30, 40, 60, 90, 100 or 180 tablets.

Not all pack sizes may be marketed.

No special requirements.