Votan SR Special Precautions

Strict accuracy of diagnosis and close medical surveillance are imperative in patients with symptoms indicative of a gastrointestinal disorder, with a case history suggestive of gastrointestinal ulceration, with ulcerative colitis, or with Crohn's disease, as well as in patients suffering from severe impairment of hepatic function.
Owing to the importance of prostaglandins for maintaining renal blood flow, particular caution is called for when using Votan in cases of impaired cardiac or renal function, in patients being treated with diuretics, and in those recovering from major surgical operations.
In the rare instances where peptic ulceration or gastrointestinal bleeding occurs in patients receiving the medication, the drug should be withdrawn.
During prolonged treatment with Votan, as with other highly active non-steroidal anti-inflammatory agents, monitoring of renal and hepatic function, as well as blood counts, are indicated as precautionary measures.
Severe cutaneous reactions, including Stevens-Johnson syndrome and toxic epidermal necrolysis (Lyell's syndrome), have been reported with diclofenac sodium. Patients treated with diclofenac sodium should be closely monitored for signs of hypersensitivity reactions. Discontinue diclofenac sodium immediately if rash occurs.
Warning Risk of GI Ulceration, Bleeding, and Perforation with NSAIDs: Serious GI toxicity, such as bleeding, ulceration, and perforation, can occur at any time, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper GI problems (e.g. dyspepsia) are common, usually developing early in therapy, prescribers should remain alert for ulceration and bleeding in patients treated with NSAIDs, even in the absence of previous GI tract symptoms. Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with a prior history of serious GI events and other risk factors associated with peptic ulcer disease (e.g. alcoholism, smoking, and corticosteroid therapy) are at increased risk. Elderly or debilitated patients seem to tolerate ulceration or bleeding less than other individuals and account for most spontaneous reports of fatal GI events.
Cardiovascular effects: Treatment with NSAIDs, including diclofenac, particularly at high doses and in long term, may be associated with an increased risk of serious cardiovascular thrombotic events (including myocardial infarction and stroke).
Treatment with diclofenac is generally not recommended in patients with established cardiovascular disease (congestive heart failure, established ischemic heart disease, peripheral arterial disease) or uncontrolled hypertension. If needed, patients with established cardiovascular disease, uncontrolled hypertension, or significant risk factors for cardiovascular disease (e.g. hypertension, hyperlipidaemia, diabetes mellitus, and smoking) should be treated with diclofenac only after careful consideration and only at doses ≤100 mg daily when treatment continues for more than 4 weeks.
As the cardiovascular risks of diclofenac may increase with dose and duration of exposure, the lowest effective daily dose should be used for the shortest duration possible. The patient's need for symptomatic relief and response to therapy should be re-evaluated periodically, especially when treatment continues for more than 4 weeks.
Patients should remain alert for the signs and symptoms of serious arteriothrombotic events (e.g. chest pain, shortness of breath, weakness, slurring of speech), which can occur without warning. Patients should be instructed to see a physician immediately in case of such an event.
Gastrointestinal effects: NSAIDs, including diclofenac, may be associated with increased risk of gastrointestinal anastomotic leak. Close medical surveillance and caution are recommended when using diclofenac after gastrointestinal surgery.
Effects on ability to drive or use machines: Patients experiencing dizziness or other central nervous disturbances should refrain from driving a vehicle or operating machines.
Use in Children: Votan is not suitable for children.
Use in the Elderly: In patients of advanced age, caution is indicated on basic medical grounds.