For the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

Analgesic, Anti-Inflammatory

Adults : The recommended dose is 100 mg, twice daily. Children : There are no clinical data on the use of Aceclofenac in children. Elderly : The pharmacokinetics of Aceclofenac is not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.

Aceclofenac should not be administered to patients with active or suspected peptic ulcer or gastro-intestinal bleeding. It should not be given to patients with moderate to severe renal impairment. Close medical surveillance is also imperative in patients suffering from severe impairment of hepatic function. It should not be prescribed during pregnancy, unless there are compelling reasons for doing so. The lowest effective dosage should be used. Aceclofenac should not be administered to patients previously sensitive to Aceclofenac or in whom aspirin or NSAIDs precipitate attacks of asthma, acute rhinitis or urticaria or who are hypertensive to these drugs.

The majority of side-effects observed have been reversible and of a minor nature and include gastro-intestinal disorders (dyspepsia, abdominal pain, nausea and diarrhea) and occasional occurrence of dizziness. Dermatological complaints including pruritus and rash and abnormal hepatic enzyme levels and raised serum creatinine have occasionally been reported.

There is no information on the use of Aceclofenac during pregnancy. The regular use of NSAIDs during the last trimester of pregnancy may increase uterine tone and contraction. There is no information on the secretion of Aceclofenac to breast milk. The use of Aceclofenac should therefore be avoided in pregnancy and lactation unless the potential benefits to the mother outweigh the possible risks to the fetus.

Store below 30°C in a dry place protected from sunlight. Keep out of reach of children.