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 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 if you’ve had an asthma attack, hives, or other allergic reaction with aspirin or other NSAIDs.
FLECTOR 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, tell your healthcare provider about the following:
- All of your medical conditions, including if you have liver or kidney problems, high blood pressure, asthma, if you’re pregnant or plan to become pregnant, and are breastfeeding or plan to breastfeed. FLECTOR 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.
Serious side effects include new or worse high blood pressure; heart failure; liver problems, including liver failure; kidney problems, including kidney failure or 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 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 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 were skin reactions, including itching, inflamed skin, or burning at the site of treatment; stomach discomfort or intestinal problems, including nausea, altered taste, or upset stomach; and nervous disorders, including headache, tingling of the skin, or sleepiness.
Avoid contact of FLECTOR with eyes, nose, or mouth, and wash hands after applying, handling, or removing FLECTOR. FLECTOR still contains medicine even after use. Keep FLECTOR out of the reach of children and pets. If a child or pet puts FLECTOR in their mouth, seek medical help immediately.
Other information about NSAIDs: aspirin can cause bleeding in the brain, stomach, and intestines and ulcers in the stomach and intestines.
FLECTOR is indicated for the topical treatment of acute pain due to minor strains, sprains, and contusions in adults and pediatric patients 6 years and older.