ACECLOFENAC MONOGRAPH PDF

Each film-coated tablet contains mg of Aceclofenac. Aceclofenac film- coated tablets are indicated for the relief of pain and inflammation in osteoarthritis . Page 1 of PRODUCT MONOGRAPH. Pr. VOLTAREN*. VOLTAREN* SR. ( diclofenac sodium). 50 mg Enteric-Coated Tablets. 75 and Aceclofenac is a non-steroidal anti-inflammatory drug (NSAID) with marked anti- inflammatory and analgesic properties. It is reported to have a higher.

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Musculoskeletal and connective tissue disorders. In patients with systemic lupus erythematosus SLE and mixed connective tissue disorders there may be an increased risk of aseptic meningitis see section 4. 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.

Aceclofenac

Thus, it is advisable to avoid use of Aceclofenac in case of varicella. The principal target organ was the gastro-intestinal tract. Clinical trial and epidemiological data suggest that use of some NSAIDs particularly at high doses and in long term treatment may be associated with a small increased risk of arterial thrombotic events for example myocardial infarction or stroke. Melaena Gastrointestinal haemorrhage Gastrointestinal ulceration.

The lowest effective dose should be used and renal function monitored regularly. The mean plasma elimination half-life is around 4 hours. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease See section 4. Management of acute poisoning with NSAIDs aceclogenac consists of supportive and symptomatic measures.

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If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. This site uses cookies. Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so.

Aceclofenac 100 mg film-coated Tablets

Date of revision of the text. The patient’s need for aceclfenac relief and response to therapy should be re- evaluated periodically. Pruritus Rash Dermatitis Urticaria. GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

Aceclofenac – Drug Monograph –

There is insufficient data available on the consequences of Aceclofenac in humans. Other analgesics including cyclooxygenase-2 selective inhibitors: Aceclofenac Tablets may reversibly inhibit platelet aggregation see anticoagulants under ‘Interactions’.

The importance of prostaglandins in maintaining renal blood flow should be taken into monovraph in patients with impaired cardiac or renal function, liver dysfunction, those being treated with diuretics or recovering from major surgery. General disorders and administration site conditions. Avoid concomitant use of two or more NSAIDs including aspirin as this may increase the risk of adverse effects see section 4.

Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus due to decreased synthesis of prostacyclin in the kidney.

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Aceclofenac mg film-coated Tablets – Summary of Product Characteristics (SmPC) – (eMC)

Not all omnograph sizes may be marketed. Increased risk of gastrointestinal ulceration or bleeding see section 4. The risk is believed to increase with dose and duration of therapy. The use of Aceclofenac Tablets may impair female fertility and is not recommended in women attempting to conceive.

Less frequently, gastritis has been observed.

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. Marketing authorisation number s 9. Clinical trial and epidemiological data suggest that use of some NSAIDs particularly at high doses and in long term treatment may be associated with an increased risk of arterial thrombotic events for example myocardial infarction or stroke see section 4.

Renal insufficiency Nephrotic syndrome Renal failure.

The results from preclinical studies conducted with monpgraph are consistent with those expected for NSAIDs. If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur eosinophilia, rashAceclofenac Tablets should be discontinued.