Patients should be informed of the following information before initiating therapy with an NSAID and periodically during the course of ongoing therapy. Patients should also be encouraged to read the NSAID Medication Guide that accompanies each prescription dispensed.

  1. Flector® Patch, like other NSAIDs, may cause serious CV side effects, such as MI or stroke, which may result in hospitalization and even death. Although serious CV events can occur without warning symptoms, patients should be alert for the signs and symptoms of chest pain, shortness of breath, weakness, slurring of speech, and should ask for medical advice when observing any indicative sign or symptoms. Patients should be apprised of the importance of this follow-up (seeWARNINGS, Cardiovascular Effects).

  2. Flector® Patch, like other NSAIDs, may cause GI discomfort and, rarely, serious GI side effects, such as ulcers and bleeding, which may result in hospitalization and even death. Although serious GI tract ulcerations and bleeding can occur without warning symptoms, patients should be alert for the signs and symptoms of ulcerations and bleeding, and should ask for medical advice when observing any indicative sign or symptoms including epigastric pain, dyspepsia, melena, and hematemesis. Patients should be apprised of the importance of this follow-up (seeWARNINGS, Gastrointestinal Effects: Risk of Ulceration, Bleeding, and Perforation).

  3. Flector® Patch, like other NSAIDs, may cause serious skin side effects such as exfoliative dermatitis, SJS, and TEN, which may result in hospitalizations and even death. Although serious skin reactions may occur without warning, patients should be alert for the signs and symptoms of skin rash and blisters, fever, or other signs of hypersensitivity such as itching, and should ask for medical advice when observing any indicative signs or symptoms. Patients should be advised to stop the drug immediately if they develop any type of rash and contact their physicians as soon as possible.

  4. Patients should be instructed to promptly report signs or symptoms of unexplained weight gain or edema to their physicians (seeWARNINGS, Cardiovascular Effects).

  5. Patients should be informed of the warning signs and symptoms of hepatotoxicity (e.g., nausea, fatigue, lethargy, pruritus, jaundice, right upper quadrant tenderness, and "flu-like" symptoms). If these occur, patients should be instructed to stop therapy and seek immediate medical therapy.

  6. Patients should be informed of the signs of an anaphylactoid reaction (e.g. difficulty breathing, swelling of the face or throat). If these occur, patients should be instructed to seek immediate emergency help (seeWARNINGS).

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

  8. Patients should be advised not to use Flector® Patch if they have a aspirin-sensitive asthma. Flector® Patch, like other NSAIDs, could cause severe and even fatal bronchospasm in these patients (seePRECAUTIONS, Preexisting asthma). Patients should discontinue use of Flector® Patch and should immediately seek emergency help if they experience wheezing or shortness of breath.

  9. Patients should be informed that Flector® Patch should be used only on intact skin.

  10. Patients should be advised to avoid contact of Flector® Patch with eyes and mucosa. Patients should be instructed that if eye contact occurs, they should immediately wash out the eye with water or saline, and consult a physician if irritation persists for more than an hour.

  11. Patients and caregivers should be instructed to wash their hands after applying, handling or removing the patch.

  12. Patients should be informed that, if Flector® Patch begins to peel off, the edges of the patch may be taped down.

  13. Patients should be instructed not to wear Flector® Patch during bathing or showering. Bathing should take place in between scheduled patch removal and application (seeDOSAGE AND ADMINISTRATION).

  14. Patients should be advised to store Flector® Patch and to discard used patches out of the reach of children and pets. If a child or pet accidentally ingests Flector® Patch, medical help should be sought immediately (seePRECAUTIONS, Accidental Exposure in Children).