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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Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease e. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Find out more here. Aeclofenac view of the known effects of NSAIDs on the foetal cardiovascular system risk mpnograph 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.

Hypersensitivity to Aceclofenac or to any of the excipients.

Effects on renal function are usually reversible on withdrawal of Aceclofenac Tablets. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. Therefore, the combination should be administered with caution, especially in the elderly.


Aceclofenac 100 mg film-coated Tablets

Within one hour of ingestion of a potentially toxic amount, activated charcoal should be considered. Aceclofenac film-coated tablets are indicated for the relief of pain and inflammation in osteoarthritis, rheumatoid arthritis and ankylosing spondylitis. Method of administration Swallow the tablet whole with a glass of water.

Marketing authorisation number s 9. Neurological and special senses: Aceclofenac was not considered to have any mutagenic activity in three in vitro studies and an in vivo study in the mouse.

Given the route of administration and the pharmaceutical form, an overdose with injectable Aceclofenac is unlikely. Caution is required if administered to patients suffering from, or with a previous acecloffenac of, bronchial asthma since NSAIDs have been reported to precipitate bronchospasm in such patients. Pancreatitis has been reported very rarely. Never change the dose of your medicine without talking to your doctor first.

The most commonly-observed adverse events are gastrointestinal in nature.

Hepatitis may aceclofenqc without prodromal symptoms. The mean plasma elimination half-life is around 4 hours. Aceclofenac mg film-coated Tablets 2. Thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.


Aceclofenac Tablets may reversibly inhibit platelet aggregation see anticoagulants under ‘Interactions’. Continue to take your tablets for as long as your doctor recommends. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter.


Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function.

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NEWT Guidelines – Drug Monographs – Aceclofenac

Paraesthesia Tremor Somnolence Headache Dysgeusia abnormal taste. Hypromellose 15 cps Macrogol Titanium dioxide E Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus due to decreased synthesis of prostacyclin in the kidney. Melaena Gastrointestinal haemorrhage Gastrointestinal ulceration. The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided see section 4.

Aceclofenac should not be prescribed during pregnancy, especially during the last trimester of pregnancy, unless there are compelling reasons for doing so. 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.

Name of the medicinal product 2. There is insufficient data available on the consequences of Aceclofenac in humans. Cardiovascular and cerebrovascular effects: