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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Hypromellose 15 cps Macrogol Titanium dioxide E Each film-coated tablet contains mg of Aceclofenac. The patient’s need for symptomatic relief and response to therapy should be re- evaluated periodically.

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. Method of administration Swallow the tablet whole with a glass of water.

Good urine output should be ensured. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: 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.

There is no information on the secretion of Aeclofenac to breast milk, there was however no notable transfer of radio labelled 14C Aceclofenac to the milk of lactating rats. Renal function should be monitored in these patients see also section 4. Swallow the tablet whole with a glass of water.

During the first and second trimester of pregnancy, Aceclofenac should not be given unless clearly necessary. When Aceclofenac was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected.

Aceclofenac Tablets may reversibly inhibit platelet aggregation see anticoagulants under ‘Interactions’. Patients appear to be at highest risk of these reactions early in the course of therapy, the onset of the reaction occurring in the majority of cases within the first month of treatment. 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.

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Caution 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.

Caution should be advised in patients receiving concomitant medications which could increase the risk of ulceration or bleeding, such as oral corticosteroids, anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin see section 4. Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn’s disease See section 4. Stomatitis Intestinal perforation Exacerbation of Crohn’s disease and colitis Ulcerative Haematemesis Gastrointestinal haemorrhage Gastric ulcer Pancreatitis.

There are no clinical data on the use of Aceclofenac in acecolfenac and therefore it is not recommended for use in children under 18 years of age. Depression Abnormal dreams Mknograph. Therefore, the aecclofenac should be administered with caution, especially in the elderly.

Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms see section 4. Paediatric population There are no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years of acsclofenac.

Blood urea increased Blood creatinine increased. Musculoskeletal and connective tissue disorders.

Aceclofenac | C16H13Cl2NO4 – PubChem

Back to top Accord Healthcare Limited contact details. Renal and liver function should be closely monitored. The results from preclinical studies conducted with aceclofenac are consistent with those expected for NSAIDs. Patients should be treated symptomatically as required. Aceclofenac circulates mainly as unchanged drug. Date of revision of the text. In view of the known effects of NSAIDs on the foetal cardiovascular aceclodenac 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.

There is insufficient data available on the consequences of Aceclofenac in humans. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.

NSAIDs should not be used during the first two trimesters of pregnancy or moongraph unless the potential benefit to the patient outweighs the potential risk to the foetus.

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Aceclofenac

Pharmaceutical form mg: Sign Up Log In Cancel. M01A B16 The mode of action of aceclofenac is largely acceclofenac on the inhibition to prostaglandin synthesis. Gastrointestinal bleeding, ulceration and perforation: The lowest effective dosage should be used see section 4.

Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity. Other adverse reactions reported less commonly include: Enter medicine name or company Start typing to retrieve search suggestions.

Effects on renal function are usually reversible on withdrawal of Aceclofenac Tablets. Approximately two- thirds of the administered dose is excreted via the urine, mainly as hydroxymetabolites. Patients with mild acedlofenac moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function.

Aceclofenac should not be prescribed during pregnancy, mojograph during the last trimester of pregnancy, unless there are compelling reasons for doing so. Peptic ulcers, perforation or GI bleeding, sometimes fatal, particularly in the elderly, may occur see section 4. Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus due to decreased synthesis aceclofemac prostacyclin in the kidney.

Aceclofenac 100 mg film-coated Tablets

Given the route of administration and the pharmaceutical form, an overdose with injectable Aceclofenac is unlikely. Aceclofenac film-coated tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis.

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 reactions.

Congenital abnormalities have been reported in association with NSAID administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. Hepatitis may occur without prodromal symptoms.