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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Show table of contents Hide table of contents 1. Aceclofenac mg film-coated Tablets 2.

Aceclofenac | C16H13Cl2NO4 – PubChem

Swallow the tablet whole with a glass of water. The use of Aceclofenac Tablets should therefore be avoided in pregnancy and lactation unless the potential benefits to the other outweigh the possible risks to the foetus. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. Pharmaceutical form mg: General disorders and administration site conditions.

Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly. Thus, it is advisable to avoid use of Aceclofenac in case of varicella. Aceclofenac film-coated tablets are supplied for oral administration and should be swallowed whole with a sufficient quantity of liquid. Gastrointestinal bleeding, ulceration and perforation: Undesirable effects such as dizziness, vertigo, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs.

Aceclofenac mg film-coated Tablets. Aceclofenac Tablets mg are packed in aluminium -aluminium blister packs. Less frequently, gastritis has been observed. This site uses cookies.

In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period. Aceclofenac is both structurally related and metabolised to diclofenac for which a greater amount of clinical and epidemiological data consistently point towards an increased risk of general arterial thrombotic events myocardial infarction or stroke, particularly at high doses and in long treatment.

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Renal and liver function should be closely monitored. Specific therapies such as forced diuresis, dialysis or haemoperfusion are probably of no help in eliminating NSAIDs due to their high rate of protein binding and extensive metabolism. Continue to take your tablets for as long as your doctor recommends.

M01A B16 The mode of action of aceclofenac is largely based on the inhibition to prostaglandin synthesis. During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.

Qualitative and quantitative composition 3. Visual disturbances, optic neuritis, headaches, paraesthesia, reports of aseptic meningitis especially in patients with existing auto-immune disorders, such as systemic lupus erythematosus, mixed connective tissue diseasewith symptoms such as stiff neck, headache, nausea, vomiting, fever or disorientation See section 4.

Good urine output should be ensured. The recommended dose is mg daily, taken as two separate mg doses, one tablet in the morning and one in the evening.

During the first and second trimester of pregnancy, Aceclofenac should not monigraph given unless clearly necessary. Close monitoring of patients on combined anti-coagulants and Aceclofenac Tablets therapy should be undertaken.

Aceclofenac is a potent inhibitor of the enzyme cyclo-oxygenase, which is involved in the production of prostaglandins. The importance of prostaglandins in maintaining renal blood flow should be taken into account in patients with impaired cardiac or renal function, liver dysfunction, those being treated with diuretics or recovering from major surgery.

Other adverse reactions reported less commonly include: 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.

Musculoskeletal and connective tissue disorders. Renal function should be monitored in these patients see also section 4.

Neurological and special senses: Name of the medicinal product 2. Flatulence Gastritis Constipation Vomiting Mouth ulceration.

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Aceclofenac 100 mg film-coated Tablets

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: To view the changes to a medicine you must sign up and log in. No changes in the pharmacokinetics of aceclofenac have been detected in the elderly.

When GI bleeding monograpb ulceration occurs in patients receiving aceclofenac, the treatment should be withdrawn. Avoid concomitant use of two or more NSAIDs including aspirin as this may increase the risk of adverse effects see section 4.

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.

Effects on renal function are usually reversible on withdrawal of Aceclofenac. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac Tablets should be considered.

Pruritus Rash Monobraph Urticaria. Given the route of administration and the pharmaceutical form, an overdose with injectable Aceclofenac is unlikely. Depression Acecclofenac dreams Insomnia. Anti-platelet agents and selective serotonin reuptake inhibitors SSRIs: Paediatric population There mlnograph no clinical data on the use of Aceclofenac in children and therefore it is not recommended for use in children under 18 years of age.

In patients with systemic lupus erythematosus SLE and mixed connective tissue disorders there may be an increased risk of aseptic meningitis see section 4. Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. For a full list of excipients, see section 6. The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided see section 4.

Mobograph The recommended dose is mg daily, taken as two separate mg doses, one tablet in the morning and one in the evening.