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Important Safety Information

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(R) 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(R) Patch and other treatment options before deciding to use FLECTOR(R) Patch.

FLECTOR(R) Patch is contraindicated in patients with known hypersensitivity to diclofenac. FLECTOR(R) 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.

Use the lowest effective dose for the shortest duration consistent with individual patient treatment goals.

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

NSAIDs, including FLECTOR(R) Patch, can cause serious skin adverse events such as exfoliative dermatitis, Stevens
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