Uniren Gel Special Precautions

Concomitant use of oral NSAIDs should be cautioned as the incidence of untoward effects, particularly systemic side effects, may increase.
Uniren Gel should not be co-administered with other products containing Diclofenac.
Uniren Gel should be applied only to intact, non- diseased skin and not to skin wounds or open injuries.
It should not be used with occlusion.
It should not be allowed to come into contact with the eyes or mucous membranes, and should never be taken by mouth. Some possibility of gastrointestinal bleeding in those with a significant history of this condition has been reported in isolated cases.
Risk of Gastrointestinal Ulceration, Bleeding and Perforation with NSAIDs: Serious Gl toxicity such as bleeding, ulceration and perforation can occur at anytime, with or without warning symptoms, in patients treated with NSAID therapy. Although minor upper Gl 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 Gl tract symptoms.
Studies to date have not identified any subset of patients not at risk of developing peptic ulceration and bleeding. Patients with prior history of serious adverse 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 for fatal GI events.
Cardiovascular Thrombotic Events: Observational studies have indicated that non-selective NSAIDs may be associated with an increased risk of serious cardiovascular events, principally myocardial infarction, which may increase with dose or duration of use. Patients with cardiovascular disease or cardiovascular risk of an adverse cardiovascular event in patient taking NSAIDs, especially in those with cardiovascular risk factors. The lowest effective dose should be used for the shortest possible duration.
There is no consistent evidence that the concurrent use of Aspirin mitigates the possible increased risk of serious cardiovascular thrombotic events associated with NSAIDs use.
Hypertension: NSAIDs may lead to the onset of new hypertension or worsening the pre-existing hypertension and patients taking antihypertensive with NSAIDs may have an impaired anti-hypertensive response. Caution is advised when prescribing NSAIDs to patients with hypertension. Blood pressure should be monitored closely during initiation of NSAIDs treatment and at regular intervals thereafter.
Heart Failure: Fluid retention and edema have been observed in some patients taking NSAIDs, therefore caution is advised in patients with fluid retention or heart failure.
Gastrointestinal Events: All NSAIDs can cause gastrointestinal discomfort and rarely serious, potentially fatal gastrointestinal effects such as ulcers, bleeding and perforation which may increase with dose or duration of use, but can occur at any time without warning. Caution is advised in patients with risk factors for gastrointestinal events e.g. the elderly, those with a history of serious gastrointestinal events, smoking and alcoholism. When gastrointestinal bleeding or ulcerations occur in patients receiving NSAIDs, the drug should be withdrawn immediately. Doctors should warn patient about signs and symptoms of serious gastrointestinal toxicity.
The concurrent use of Aspirin and NSAIDs also increases the risk of serious gastrointestinal adverse events.
Severe Skin Reactions: NSAIDs may very rarely cause serious cutaneous adverse events such as exfoliative dermatitis, Toxic Epidermal Necrolysis (TEN) and Stevens-Johnson Syndrome (SJS), which can be fatal and occur without warning. These serious adverse events are idiosyncratic and are independent of dose or duration of use. Patients should be advised of the signs and symptoms of serious skin reactions and to consult their doctor at the first appearance of a skin rash or any other sign of hypersensitivity.