1 tablet contains Aceclofenac 100 mg

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: No clinical data on the use of Aceclofenac 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 is not altered in elderly patients; therefore it is not 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.

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: Diclotol® tablets should be swallowed whole with a sufficient quantity of liquid. These are to be taken preferably with or after food.

When Diclotol® 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 Special warnings and precautions for use).