Indication
FLECTOR Patch contains diclofenac epolamine, a nonsteroidal anti-inflammatory drug (NSAID) and is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions.
Important Safety Information
- FLECTOR Patch, like other NSAIDs, may increase the chance of a heart attack or stroke that can lead to death. This chance increases with longer use of NSAID medicines, and in people who have heart disease or risk factors such as high blood pressure
- NSAID medicines, including FLECTOR Patch, should never be used right before or after a heart surgery called “coronary artery bypass graft” (CABG)
- FLECTOR Patch, like other NSAID medicines, can cause ulcers and bleeding in the stomach and intestines at any time during treatment. These can happen without symptoms and may cause death. The chance of a person getting an ulcer or bleeding increases with: taking blood-thinning medicines or medicines called steroids; longer use; smoking; drinking alcohol; older age; having poor health
Do not use FLECTOR Patch if you’ve had aspirin-sensitive asthma or allergic reactions from taking aspirin or other NSAIDs.
FLECTOR Patch should not be applied to broken or damaged skin due to any cause, such as cuts, burns, infected wound, or rash with oozing fluid.
Before using FLECTOR Patch, tell your healthcare professional about the following:
- Any and all other health or medical problems you may have, such as heart disease including high blood pressure or heart failure, history of ulcers or bleeding in the stomach or intestines, kidney or liver problems, asthma or allergic-type reactions, and skin reactions
- All other medications (prescription and nonprescription) you are taking. Do not take oral NSAIDs while on FLECTOR Patch. Do not take other medicines without your healthcare professional’s approval
- If you are breastfeeding
FLECTOR Patch should not be used late in pregnancy.
Serious side effects include life-threatening skin and allergic reactions. Get emergency help right away if you have any of the following symptoms: shortness of breath or trouble breathing, chest pain, weakness in one part or side of your body, slurred speech, or swelling of the face or throat.
Stop using FLECTOR Patch and call your healthcare professional right away if you have any of the following symptoms: nausea, more tired or weaker than usual, itching, your skin or eyes look yellow, stomach pain, flu-like symptoms, vomiting blood, bowel movement contains blood or is black and sticky like tar, unusual weight gain, skin rash or blisters with fever, or swelling of the arms, legs, hands, or feet.
FLECTOR Patch should be used exactly as prescribed at the lowest dose possible and for the shortest time needed.
The most common side effects seen with FLECTOR Patch were skin reactions (including itching, inflamed skin, burning) at the site of treatment, stomach discomfort or intestinal problems (including nausea, altered taste, upset stomach), and nervous disorders (including headache, tingling of the skin, sleepiness).
Avoid contact of FLECTOR Patch with eyes, nose, or mouth, and wash hands after applying, handling, or removing FLECTOR Patch. FLECTOR Patch still contains medicine even after use. Keep FLECTOR Patch out of the reach of children and pets. If a child or pet puts FLECTOR Patch in their mouth, seek medical help immediately. Children should not use FLECTOR Patch.
Other information about NSAIDs: aspirin can cause bleeding in the brain, stomach, and intestines and ulcers in the stomach and intestines.
Please see Full Prescribing Information, including boxed warning, and Patient Medication Guide.