| As with all non-steroidal anti-inflammatory drugs (NSAIDs) Diclomax should only be given to the elderly after other forms of treatment have been carefully considered, as the elderly have an increased frequency of adverse reactions to NSAIDs especially gastro-intestinal bleeding and perforation which may be fatal (see section 4.2).Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, and GI and cardiovascular risks below).The use of Diclomax Retard with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided (see section 4.5). 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 section 4.3).All patients who are receiving long-term treatment with NSAIDs should be monitored as a precautionary measure, e.g. renal, hepatic function (elevation of liver enzymes may occur) and blood counts.If abnormal liver function tests persist or worsen, clinical signs or symptoms consistent with liver disease develop or if other manifestations occur (eosinophilia, rash), Diclomax should be discontinued.Cardiovascular and cerebrovascular effects: Appropriate monitoring and advice are required for patients with a history of hypertension and/or mild to moderate congestive heart failure as fluid retention and oedema have been reported in association with NSAID therapy.Clinical trial and epidemiological data suggest that use of diclofenac, particularly at high dose (150mg daily) and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke).Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with diclofenac after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking). Respiratory disorders: Cautions is required if administered to patients suffering from, or with a previous history of, bronchial asthma since NSAIDs have been reported to cause bronchospasm in such patients.Gastro-intestinal bleeding, ulceration and perforation: Diclomax should be used with caution in patients with gastro-intestinal disorders or haematological abnormalities, as GI bleeding, ulceration or perforation, which can be fatal, has been reported with NSAID therapy at any time during treatment, with or without warning symptoms or a previous history of serious GI events.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 4.3), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase GI risk (see below and section 4.5).Patients with a history of GI toxicity, particularly the elderly, should report any unusual abdominal symptoms (especially GI bleeding) particularly in the initial stages of treatment. Caution is advised in patients receiving concomitant medications that could increase the risk of ulceration or bleeding, such as corticosteroids, or anticoagulants such as warfarin or anti-platelet agents such as aspirin (see section 4.5).When GI bleeding or ulceration occurs in patients receiving Diclomax, the treatment should be withdrawn.NSAIDs should be given with care to patients with a history of gastro-intestinal disease (ulcerative colitis, Crohn's disease) as these conditions may be exacerbated (see section 4.8).Haematological: Diclomax, in common with other NSAIDs, can reversibly inhibit platelet aggregation.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 4.8).Dermatological: Serious skin reactions, some of them fatal, including exfoliative dermatitis, Stevens-Johnson syndrome and toxic epidermal necrolysis, have been reported very rarely in association with the use of NSAIDs (see section 4.8). Patients appear to be at highest risk for these reactions early in the course of therapy: the onset of reaction occurring in the majority of cases within the first month of treatment. Diclomax should be discontinued at the first appearance of skin rash, mucosal lesions or any other sign of hypersensitivity.Impaired Female fertility: The use of Diclomax 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 Diclomax should be considered. | |
