ACECLOFENAC MONOGRAPH PDF

Fenrizragore Aceclofenac should not aceclofena prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. Pharmaceutical form mg: Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms see section 4. Aceclofenac mg film-coated Tablets Do not crush or chew the tablets. No changes in the pharmacokinetics of aceclofenac have been detected in the elderly. Dyspepsia Abdominal pain Nausea Diarrhoea.

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Close monitoring of patients on combined anticoagulants and Aceclofenac therapy should be undertaken. Contraindications 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 hypersensitive to these drugs.

Side Effects 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. Precautions Aceclofenac should not be administered to patients with active or suspected peptic ulcer or gastro-intestinal bleeding.

Overdose Effects There are no human data available on the consequences of Aceclofenac over dosage. If over dosage is observed, therapeutic measures should be taken according to symptoms; supportive and symptomatic treatment should be given for complications such as hypotension, gastro-intestinal irritation, respiratory depression, and convulsions. Storage Conditions Keep at a cool and dry place, protected from light and moisture.

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