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 mg film-coated Tablets 2. Qualitative and quantitative composition Each film-coated tablet contains mg of Aceclofenac. For a full list of excipients, see section 6.
Pharmaceutical form mg: To be taken preferably with or after food. When Aceclofenac was administered to fasting and fed healthy volunteers only the rate and not the extent of aceclofenac absorption was affected.
Undesirable effects may be minimized by using the lowest effective dose for the shortest duration necessary to control symptoms see section 4. The recommended dose is mg daily, taken as two separate mg doses, one tablet in the morning and one in the evening. There are 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.
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. If an NSAID is considered necessary, the lowest effective dose should be used and for the shortest possible duration. The pharmacokinetics of Aceclofenac are not altered in elderly patients, therefore it is not considered necessary to modify the dose or dose frequency.
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. 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.
Swallow the tablet whole with a glass of water. Do not crush or chew the tablets. Never change the dose of your medicine without talking to your doctor first. Continue to take your tablets for as long as your doctor recommends. History of active bleedings or bleeding disorders NSAIDS are contraindicated in patients who have previously shown hypersensitivity reactions e.
Asthma, rhinitis, angioedema or urticaria in response to ibuprofen, aspirin, or other non-steroidal anti-inflammatory drugs. Severe heart failure, hepatic failure and renal failure 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 lowest effective dosage should be used see section 4. The use of Aceclofenac with concomitant NSAIDs including cyclooxygenase- 2 selective inhibitors should be avoided see section 4. The elderly have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal 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.
Cardiovascular, Renal and Hepatic Impairment: The administration of an NSAID may cause a dose dependent reduction in prostaglandin formation and precipitate renal failure. Patients at greatest risk of this reaction are those with impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the elderly.
Renal function should be monitored in these patients see also section 4. 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. Effects on renal function are usually reversible on withdrawal of Aceclofenac Tablets. Patients with mild to moderate renal impairment should be kept under surveillance, since the use of NSAIDs may result in deterioration of renal function.
The lowest effective dose should be used and renal function monitored regularly. Effects on renal function are usually reversible on withdrawal of Aceclofenac. If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur eosinophilia, rashAceclofenac Tablets should be discontinued.
Close medical surveillance is necessary in patients suffering from mild to moderate impairment of hepatic function. Hepatitis may occur without prodromal symptoms. Cardiovascular and cerebrovascular effects: As the cardiovascular risks of aceclofenac may increase with dose and duration of exposure, the shortest duration possible and the lowest effective daily dose should be used.
The patient’s need for symptomatic relief and response to therapy should be re- evaluated periodically. Aceclofenac should also be administered with caution and under close medical surveillance to patients with congestive heart failure, significant risk factors for cardiovascular events and history of cerebrovascular bleeding.
Clinical trial and epidemiological data suggest that use of some NSAIDs particularly at high doses and in long term treatment may be associated with a small increased risk of arterial thrombotic events for example myocardial infarction or stroke.
There are insufficient data to exclude such a risk for aceclofenac. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular disease e. Gastrointestinal bleeding, ulceration and perforation: 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.
Close medical surveillance is imperative in patients with: The risk of GI bleeding, ulceration or perforation is higher with increasing NSAID doses, in patients with a history of ulcer, particularly if complicated with haemorrhage or perforation see section 4. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents e.
Aceclofenac mg film-coated Tablets – Summary of Product Characteristics (SmPC) – (eMC)
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.
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 serotonin-reuptake inhibitors or antiplatelet agents such as aspirin see section 4.
When GI bleeding or ulceration occurs in patients receiving aceclofenac, the treatment should be withdrawn. 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. SLE and mixed connective tissue disease: In patients with systemic lupus erythematosus SLE and mixed connective tissue disorders there may be an increased risk of aseptic meningitis see section 4.
The use of Aceclofenac Tablets may impair female fertility and is not recommended in women attempting to conceive. In women who have difficulties conceiving or who are undergoing investigation of infertility, withdrawal of Aceclofenac Tablets should be considered.
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 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. Aceclofenac should be discontinued at the first appearance of skin rash, mucosal lesions, or any other sign of hypersensitivity.
Exceptionally, varicella can trigger serious cutaneous and soft tissues infections complications. Thus, it is advisable to avoid use of Aceclofenac in case of varicella.
NEWT Guidelines – Drug Monographs – Aceclofenac
Aceclofenac Tablets may reversibly inhibit platelet aggregation see anticoagulants under ‘Interactions’. Avoid concomitant use of two or more NSAIDs including aspirin as this may increase the risk of adverse effects see section 4.
NSAIDs may reduce the effect of anti-hypertensives. The risk of acute renal insufficient, which is usually reversible, may be increased in some patients with compromised renal function e.
Therefore, the combination should be administered with caution, especially in the elderly. Patients should be adequately hydrated and consideration should be given to monitoring of renal function after initiation acelcofenac concomitant therapy, and periodically thereafter.
Although it was not shown to affect blood pressure control when co-administered with bendrofluazide, interactions with other diuretics cannot be ruled out. When concomitant administration with potassium-sparing diuretics is employed, serum potassium should be monitored.
Several NSAID drugs inhibit the renal clearance of lithium, resulting in increased serum concentrations of both. The combination should be avoided unless frequent monitoring of lithium and digoxin levels can be performed. Monogrraph elimination of methotrexate. The possible interaction between NSAIDs and methotrexate should be born in mind also when low doses of methotrexate are used, especially in patients with decreased renal function.
When minograph therapy has to be used, the renal function should be monitored. Increased risk of gastrointestinal ulceration or bleeding see section 4. NSAIDs may enhance the effects of anti-coagulants, such as warfarin see section 4. Close monitoring of patients on combined anti-coagulants and Aceclofenac Tablets therapy should be undertaken.
Animal acfclofenac indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Anti-platelet agents and selective serotonin reuptake inhibitors Aceckofenac Increased risk acfclofenac gastrointestinal bleeding see section 4. Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus due to decreased synthesis of prostacyclin in the kidney.
During combination therapy it is therefore important to carefully monitor renal function. Clinical studies have shown that diclofenac can be given together with oral antidiabetic agents without influencing their clinical effect. However, there have been isolated reports of hypoglycaemic and hyperglycaemic effects.
Aceclofenac 100 mg film-coated Tablets
Thus with Aceclofenac Tablets, consideration should be given to adjustment of the dosage of hypoglycaemic agents. There is no information on the use of Aceclofenac during pregnancy.
Monogrwph from epidemiological studies suggest an increased risk of miscarriage, cardiac malformation or gastroschisis after use of prostaglandin synthesis inhibitor in early pregnancy. The risk is believed to increase with dose and duration of therapy. In animals, administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation loss and embryo-foetal lethality. In addition, increased incidences of various malformations, including cardiovascular, have been reported in animals given a prostaglandin synthesis inhibitor during the organogenetic period.
During the first and second trimester mknograph pregnancy, Aceclofenac should not be given unless clearly necessary. 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. 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.
In view of the known effects of NSAIDs on the foetal cardiovascular system risk of 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. NSAIDs should not be used during the first two trimesters of pregnancy or labour unless monograpu potential benefit to the patient outweighs the potential risk to the foetus.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may expose the foetus to: