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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The temporary discontinuation of Aceclofenac should be considered in women having difficulties to conceive or undergoing investigations for infertility.

The volume of distribution is approximately 25 L. Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Jonson syndrome, and toxic epidermal necrolysis, have been reporting very rarely in association with the use of NSAIDs see section 4.

Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign monobraph hypersensitivity. Hepatitis may occur without prodromal symptoms.

Cardiovascular and cerebrovascular effects: Name of the medicinal product 2. Company contact details Accord Healthcare Limited. Other measures may be indicated by the patient’s clinical condition.

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.

NEWT Guidelines – Drug Monographs – Aceclofenac

Hypromellose 15 cps Macrogol Titanium dioxide E This information is intended for use by health professionals. Flushing Hot flush vasculitis. Combination therapy with protective agents e. Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms see section 4.


Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function. Decreased elimination of methotrexate. Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function.

Aceclofenac 100 mg film-coated Tablets

When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored.

Effects on renal function are usually reversible on withdrawal of Aceclofenac Axeclofenac.

Patients should monobraph adequately hydrated and consideration should be given to monitoring of renal function after initiation of concomitant therapy, and periodically thereafter. These may consist of a non-specific allergic reactions and anaphylaxis b respiratory tract reactivity comprising asthma, aggravated asthma, bronchospasm or dyspnoea, or c assorted skin disorders, including rashes of various types, pruritus, urticaria, purpura, angiodema and, more rarely exfoliative and bullous dermatoses including epidermal necrolysis and erythema multiforme.

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

Any unused product or waste material should be disposed of in accordance with local requirements. To email a medicine you must monogfaph up and log in.

Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: No unexpected findings were recorded. Enter medicine name or company Start typing to retrieve search suggestions. There is insufficient data available on the consequences of Aceclofenac in humans. Management of acute poisoning with NSAIDs essentially consists of supportive and symptomatic measures.

Close monitoring of patients on combined anti-coagulants and Aceclofenac Tablets therapy should be undertaken. The combination should be avoided unless frequent monitoring of lithium and digoxin levels can be performed.


The mean plasma monogra;h half-life is around 4 hours. Undesirable effects such as dizziness, vertigo, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs.


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 aceclofehac, headache, nausea, vomiting, fever or disorientation See section 4.

However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk to the foetus. Adults The recommended dose is mg daily, taken as two separate mg doses, one tablet in the morning acedlofenac one in the evening.

The possible interaction between NSAIDs and acevlofenac should be born in mind also when low doses of methotrexate are used, especially in patients with decreased renal function. Pancreatitis has been reported very rarely. Flatulence Gastritis Constipation Vomiting Mouth ulceration.

Increased risk of gastrointestinal ulceration or bleeding see section 4. If affected, patients should not drive or operate machinery. 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.

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