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Important Safety Information and Indication

Nonsteroidal anti-inflammatory drugs (NSAIDs) increase the risk of a heart attack or stroke that can lead to death. This risk may happen early in the treatment and may increase with increasing doses and longer use of NSAIDs

FLECTOR Patch should never be used right before or after a heart surgery called “coronary artery bypass graft (CABG)”

NSAIDs increase the risk of bleeding, ulcers, and tears of the esophagus, stomach, and intestines. These can happen anytime during use without symptoms and may cause death. The risk of getting an ulcer or bleeding increases in elderly patients and patients with a past history of stomach ulcers, or stomach or intestinal bleeding

Avoid taking NSAIDs after a recent heart attack unless your healthcare provider tells you to. You may have an increased risk of another heart attack if you take NSAIDs after a recent heart attack

The risk of getting an ulcer or bleeding increases with: taking medicines called “corticosteroids,” “anticoagulants,” “SSRIs,” or “SNRIs”; longer use; smoking; drinking alcohol; bleeding problems; advanced liver disease; and poor health

Do not use FLECTOR Patch if you’ve had an asthma attack, hives, or other allergic reaction with aspirin or other NSAIDs

FLECTOR Patch should not be applied to broken or damaged skin due to any cause, such as cuts, burns, infected wounds, or rashes with oozing fluid

Before using FLECTOR Patch, tell your healthcare provider about the following:

  • All of your medical conditions, including if you have liver or kidney problems, high blood pressure, or asthma; and if you’re pregnant or plan to become pregnant, breastfeeding or plan to breastfeed. FLECTOR Patch should not be used after 29 weeks of pregnancy
  • All other medications (prescription and nonprescription) you are taking. Do not take other medicines without talking to your healthcare provider first

Do not take oral NSAIDs while on FLECTOR Patch

Serious side effects include new or worse high blood pressure, heart failure, liver problems including liver failure, kidney problems including kidney failure, anemia, and 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 provider 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 that 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

INDICATION

FLECTOR Patch is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions

Please see Full Prescribing Information, including BOXED WARNING and Patient Medication Guide.

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