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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NSAIDs should be given with care to patients with a history of gastrointestinal disease ulcerative colitis, Crohn’s disease as these conditions may be exacerbated see section 4.


Effects on renal function are usually reversible on withdrawal of Aceclofenac. The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided see section 4.

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. GI bleeding, ulceration or perforation, which can be fatal, has been reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. 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.

Alternatively, in adults, gastric lavage should be considered within one hour of ingestion of a potentially life-threatening overdose. 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.


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 aceclofeanc inhibitors or antiplatelet agents such as aspirin aceclodenac section 4. 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.

Given the route of administration and the pharmaceutical form, an overdose with injectable Aceclofenac is unlikely. 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. Therefore, the combination should be administered with caution, especially in the elderly.

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

NEWT Guidelines – Drug Monographs – Aceclofenac

The results from preclinical studies conducted with aceclofenac are consistent with those expected for NSAIDs. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal see section 4.

Thus, it is advisable to avoid use of Aceclofenac in case of varicella. Epidemiological data has also found an increased risk of acute coronary syndrome and myocardial infarction associated with the use mnoograph aceclofenac, see section 4.

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Depression Abnormal dreams Insomnia. Respiratory, thoracic and mediastinal disorders. If Aceclofenac is used by a women attempting to conceive, or during the first the first and second trimester of pregnancy, the dose should be kept as low and duration of treatment as short as possible.


Oedema Fatigue Cramps in legs. There are insufficient data to exclude such a risk for aceclofenac.

Thus with Aceclofenac Tablets, consideration should be given to adjustment of the dosage of hypoglycaemic agents. To be taken preferably with or after food. Any unused product or waste material should be disposed of in accordance with local requirements.

If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration.

Healthcare aceclotenac are asked to report any suspected adverse reactions via the Yellow Card Scheme at: The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure.

Undesirable effects such as dizziness, vertigo, drowsiness, fatigue and visual disturbances are possible after taking NSAIDs. Date of revision of the text.

Aceclofenac 100 mg film-coated Tablets

This information is intended for qceclofenac by health professionals. Pruritus Rash Dermatitis Urticaria. History of active bleedings or bleeding disorders NSAIDS are contraindicated in patients who have previously shown hypersensitivity reactions e. Find out more here. Hypromellose 15 cps Macrogol Titanium dioxide E To view the changes to a medicine you must sign up and log in.