Cardiovascular risk

• NSAIDs may cause an increased risk of serious cardiovascular thrombotic events, myocardial infarction, and stroke, which can be fatal. This risk may increase with duration of use. Patients with cardiovascular disease or risk factors for cardiovascular disease may be at greater risk
• FLECTOR^® Patch is contraindicated for the treatment of peri-operative pain in the setting of coronary artery bypass graft (CABG) surgery

Gastrointestinal risk

• NSAIDs cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal. These events can occur at any time during use and without warning symptoms. Elderly patients are at greater risk for serious gastrointestinal events

Carefully consider the potential benefits and risks of FLECTOR^® Patch and other treatment options before deciding to use FLECTOR^® Patch. Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

FLECTOR^® Patch is contraindicated in patients with known hypersensitivity to diclofenac. FLECTOR^® Patch should not be given to patients who have experienced asthma, urticaria, or allergic-type reactions after taking aspirin or other NSAIDs. Severe, rarely fatal, anaphylactic-like reactions to NSAIDs have been reported in such patients.

FLECTOR^® Patch is contraindicated for the treatment of perioperative pain in the setting of coronary artery bypass graft (CABG) surgery.

FLECTOR^® Patch should not be applied to non-intact or damaged skin resulting from any etiology, eg, exudative dermatitis, eczema, infected lesion, burns or wounds.

Reports suggest that NSAIDs may diminish the antihypertensive effect of ACE inhibitors. This interaction should be given consideration in patients taking NSAIDs concomitantly with ACE inhibitors.

Clinical studies, as well as postmarketing observations, have shown that FLECTOR^® Patch may reduce the natriuretic effect of furosemide and thiazides in some patients.

Fluid retention and edema have been observed in some patients taking NSAIDs. FLECTOR^® Patch should be used with caution in patients with fluid retention or heart failure.

Treatment with FLECTOR^® Patch is not recommended in patients with advanced renal disease.

In late pregnancy, as with other NSAIDs, FLECTOR^® Patch should be avoided because it may cause premature closure of the ductus arteriosus.

NSAIDs, including FLECTOR^® Patch, can lead to onset of new hypertension or worsening of preexisting hypertension, either of which may contribute to the increased incidence of cardiovascular events.

NSAIDs, including FLECTOR^® Patch, can cause serious skin adverse events such as exfoliative dermatitis, Stevens-Johnson Syndrome (SJS), and toxic epidermal necrolysis (TEN), which can be fatal. These serious events may occur without warning. Patients should be informed about the signs and symptoms of serious skin manifestations and use of the drug should be discontinued at the first appearance of skin rash or any other sign of hypersensitivity.

When FLECTOR^® Patch is administered with aspirin, the binding of diclofenac to protein is reduced, although the clearance of free diclofenac is not altered. The clinical significance of this interaction is not known; however, as with other NSAIDs, concomitant administration of diclofenac and aspirin is not generally recommended because of the potential of increased adverse events.

Contact of FLECTOR^® Patch with eyes and mucosa, although not studied, should be avoided. If eye contact occurs, immediately wash out the eye with water or saline. Consult a physician if irritation persists for more than an hour.