ACECLOFENAC MONOGRAPH PDF

May 23 2020
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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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Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms especially GI bleeding particularly in the initial stages of treatment.

To be taken preferably with or after food.

Aceclofenac 100 mg film-coated Tablets

Never change the dose of your medicine without talking to your doctor first. No changes in the pharmacokinetics of aceclofenac have been detected in the elderly. The most commonly-observed adverse events are gastrointestinal in nature. Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus due to decreased synthesis of prostacyclin in the kidney.

The blisters are further pack in to carton along with leaflet in pack sizes of 10, 20, 30, 40, 60 and tablets per pack. Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. Exceptionally, occurrence of serious cutaneous and soft tissues infections complications during varicella has been reported in association with NSAID treatment.

The principal target organ was the gastro-intestinal tract. Name of the medicinal product 2. Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. 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 monograp.

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The combination should be avoided unless frequent monitoring of lithium and digoxin acecloefnac can be performed. 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.

Patients should be treated symptomatically as required. The aluminium foil is 0. Less frequently, gastritis has been observed.

Aceclofenac | C16H13Cl2NO4 – PubChem

Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use of aceclofenac, see section 4. This information is intended for use by health professionals. Within the system organ classes, undesirable effects are listed under headings of frequency, using the moograph categories: In view of the known effects of NSAIDs on the foetal cardiovascular system risk of closure of the ductus arteriosus and on the possible risk of persistent pulmonary hypertension of the new born, use in the last trimester of pregnancy is contraindicated.

Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Asthma, rhinitis, angioedema or urticaria in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided aceclfenac section 4. Pancreatitis has been reported very rarely. By continuing to browse the site you are agreeing to our policy on the use of cookies.

Peak plasma concentrations are reached approximately 1. Effects on renal function are usually reversible on withdrawal of Aceclofenac Tablets. To view the changes to a medicine you must sign up and log in.

Aceclofenac

History of active bleedings or bleeding disorders NSAIDS are contraindicated in patients monoggraph have previously shown hypersensitivity reactions e. Back to top Accord Healthcare Limited contact details. Qualitative and quantitative composition Each film-coated tablet contains mg of Aceclofenac.

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Aceclofenac circulates mainly as unchanged drug. Several NSAID drugs inhibit the renal clearance of lithium, resulting in increased serum concentrations of both.

Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. Aceclofenac Tablets mg are aceclofena in aluminium -aluminium blister packs. Hypersensitivity to Aceclofenac or to any of the excipients. If abnormal liver function tests persist or worsen, clinical signs or symptoms acecllfenac with liver disease develop or if other manifestations occur eosinophilia, rashAceclofenac Tablets should be discontinued.

Qualitative and quantitative composition 3. Aceclofenac mg film-coated Tablets. Monoggaph is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. Aceclofenac should also be administered with caution and under close medical surveillance to patients with congestive heart failure, significant risk factors for cardiovascular events and history of cerebrovascular bleeding.

There is no information on the use of Aceclofenac during pregnancy. If affected, patients should not drive or operate machinery. Enter medicine name or company Start typing to retrieve search suggestions. During the third nonograph of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: The possible interaction between NSAIDs and methotrexate should be born in mind also when low doses of methotrexate are used, especially in patients with decreased renal function.

Other adverse reactions reported less commonly include: Find out more here.

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