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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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.

Qualitative and quantitative composition 3. Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function. Marketing authorisation holder 8. GI bleeding, ulceration or perforation, which can be fatal, has monogtaph reported with all NSAIDs at any time during treatment, with or without warning symptoms or a previous history of serious GI events.

Aceclofenac | C16H13Cl2NO4 – PubChem

Never change the dose of your medicine without talking to your doctor first. Cardiovascular and cerebrovascular effects: 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.

Patients with a history of GI toxicity, particularly when elderly, should report any unusual abdominal symptoms especially GI bleeding particularly in the initial stages of treatment. Cardiovascular, Renal and Hepatic Impairment: Find out more here. Undesirable effects such as dizziness, vertigo, drowsiness, fatigue and visual disturbances minograph possible after taking NSAIDs. Hepatic insufficiency There is some evidence that the dose of Aceclofenac should be reduced in patients with hepatic impairment and it is suggested that an initial daily dose of mg be used.

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Within the system organ classes, undesirable effects are listed under headings of frequency, using the following categories: Show table of contents Hide table monnograph contents 1. Hypersensitivity to Aceclofenac or to any of the excipients. Oedema Fatigue Cramps in legs. Patients should be adequately hydrated and consideration should be given to xceclofenac of renal function after initiation of concomitant therapy, and periodically thereafter.

The volume of distribution is approximately 25 L. The elderly, who are more likely to be aceclofenqc from impaired renal, cardiovascular or hepatic function and receiving concomitant medication, are at increased risk of serious consequences of adverse reactions. Anaphylactic reaction including shock Hypersensitivity. No unexpected findings were recorded.

Paraesthesia Tremor Somnolence Headache Dysgeusia abnormal taste. Company contact details Accord Healthcare Limited. Clinical trial and epidemiological data suggest that use of some Monorgaph particularly at high doses and in long term treatment may be associated with an increased risk of arterial thrombotic events for example myocardial infarction or stroke see section 4.

Aceclofenac Tablets may reversibly inhibit platelet aggregation see anticoagulants under ‘Interactions’. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless the potential benefit to the patient outweighs the potential nonograph to the foetus.

Data from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early pregnancy.

Hepatitis may occur without prodromal symptoms. 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.

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

Close medical surveillance is imperative in patients with: The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal see section 4. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: Flatulence Gastritis Constipation Vomiting Mouth ulceration.

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Neurological and special senses: Last updated on eMC: Method of administration Swallow the tablet whole with a glass of water. Anti-platelet agents and selective serotonin reuptake inhibitors SSRIs: The administration of an NSAID may cause a dose dependent reduction mojograph prostaglandin formation and precipitate renal failure.

Aceclofenac 100 mg film-coated Tablets

Renal function should be monitored in these patients see also section 4. Any unused product or waste material should be disposed of in accordance with local requirements. The results from preclinical studies conducted with aceclofenac are consistent with those expected for NSAIDs.

Patients should be treated symptomatically as required. Close monitoring of patients on combined anti-coagulants and Aceclofenac Tablets therapy should be undertaken.

Aceclofenac is a non-steroidal agent with marked anti-inflammatory and analgesic properties. Severe heart failure, hepatic failure and renal failure see section 4. The blisters are further pack in to carton along with leaflet in pack sizes of 10, 20, 30, 40, 60 and tablets per pack. Pruritus Rash Dermatitis Urticaria. Given the route of administration and the pharmaceutical form, an overdose with injectable Aceclofenac is unlikely.

When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored. Aceclofenac Tablets mg are packed in aluminium -aluminium blister packs. Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus due to decreased synthesis of prostacyclin in the kidney.

The combination should be avoided unless frequent monitoring of lithium and digoxin levels can be performed. Minograph temporary discontinuation of Aceclofenac should be considered in women having difficulties to conceive or undergoing investigations for infertility.

Less frequently, gastritis has been observed.