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

Aceclofenac 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 was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected.

Undesirable effects may be minimized 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.

Paediatric population

There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years of age.

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 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 are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

Renal insufficiency

There is no evidence that the dosage of Aceclofenac needs to be modified in patients with mild renal impairment, but as with other NSAIDs caution should be exercised (see Section 4.4).

Hepatic insufficiency

There is some evidence that the dose of Aceclofenac 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

Swallow the tablet whole with a glass of water. Do not crush or chew the tablets. Never change the dose of your medicine without talking to your doctor first. Continue to take your tablets for as long as your doctor recommends.

There is insufficient data available on the consequences of Aceclofenac in humans.

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.

Given the route of administration and the pharmaceutical form, an overdose with injectable Aceclofenac is unlikely.

Specific therapies such as forced diuresis, dialysis or haemoperfusion are probably 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 NSAIDs essentially consists of supportive and symptomatic measures.

4 years.

“Store below 25°C”.

Aceclofenac Tablets 100 mg are packed in aluminium -aluminium blister packs.

The aluminium blister foil is soft temper, plain, one side bright, dull side lacquer laminated to 25 μm OPA, bright side lacquer laminated to 60 μm PVC.

The aluminium foil is 0.025 mm thick aluminium alloy hard temper foil with mat finish.

The blisters are further pack in to carton along with leaflet in pack sizes of 10, 20, 30, 40, 60 and 100 tablets per pack.

Not all pack sizes may be marketed.

Any unused product or waste material should be disposed of in accordance with local requirements.