Flector Patches contain diclofenac epolamine, a nonsteroidal anti-inflammatory drug (NSAID). Diclofenac epolamine works by reducing substances in the body that cause pain and inflammation.

Flector patches are used to treat pain caused by minor sprains, strains, or bruising.

Flector patches are for use in adults and children at least 6 years old.

Before using Flector, tell your doctor if you are allergic to any drugs, or if you have heart disease, congestive heart failure, high blood pressure, a history of heart attack or stroke, a history of stomach ulcer or bleeding, liver or kidney disease, a blood clotting disorder, asthma or polyps in your nose, or if you smoke.

Diclofenac can increase your risk of fatal heart attack or stroke, especially if you use it long term or take high doses, or if you have heart disease. Do not use Flector just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Get emergency medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance while using Flector Patches.

While the risk of absorbing diclofenac into your bloodstream is low, an NSAID may cause life-threatening heart or circulation problems such as heart attack or stroke, especially if you use it long term.

Flector may also cause serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning while you are using Flector, especially in older adults.

Call your doctor at once if you have symptoms of stomach bleeding such as black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Use Flector Patches exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

Using extra patches will not make the medicine more effective, and could cause dangerous side effects.

Apply the topical system directly to the area of pain. The patch can be worn for up to 12 hours and then removed. Apply a new patch at that time if pain continues.

Do not apply Flector on an open skin wound, or on areas of eczema, infection, skin rash, or burn injury.

Wash your hands after applying or removing a patch.

If the patch does not stick well, you may place medical tape around the edges. You may also use a mesh netting sleeve to hold a patch in place on your skin. Do not cover the patch with a bandage or other covering that does not allow air to pass through.

After removing a patch, fold it in half, sticky side in, and throw it away in a place where children or pets cannot get to it. Keep both used and unused patches out of the reach of children or pets.

If you use Flector patch long-term, you may need frequent medical tests.

Store at room temperature away from moisture and heat. Reseal the storage envelope each time you remove a patch from it.

Diclofenac can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Diclofenac may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using this medicine, especially in older adults.

You should not use Flector if you are allergic to diclofenac (Voltaren, Cataflam, Cambia, Solaraze, Pennsaid, and others), or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

To make sure Flector is safe for you, tell your doctor if you have:

• a heart attack, stroke, or blood clot;

• liver or kidney disease;

• high blood pressure;

• stomach ulcers or bleeding;

• asthma; or

• if you smoke.

If you are pregnant, you should not use Flector unless your doctor tells you to. Using a NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Diclofenac may interfere with ovulation, which can temporarily affect fertility (ability to have children) in women.

It may not be safe to breastfeed while using Flector patches. Ask your doctor about any risk.

Apply a Flector patch as soon as you remember, and wear it for 12 hours before applying a new one. Do not use extra patches to make up the missed dose. Do not wear a Flector patch for longer than 12 hours.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Do not wear a Flector patch while taking a bath or shower or while swimming.

Avoid getting a patch near your eyes, nose, or mouth. If this does happen, rinse with water. Call your doctor if you have eye irritation that lasts longer than 1 hour.

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin or other NSAIDs.

Ask a doctor or pharmacist before using other medicines for pain, fever, swelling, or cold/flu symptoms. They may contain ingredients similar to diclofenac (such as aspirin, ibuprofen, ketoprofen, or naproxen).

Get emergency medical help if you have signs of an allergic reaction to Flector (runny or stuffy nose, hives, wheezing, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Stop using Flector and seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include skin rash, fever, swollen glands, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using Flector and call your doctor at once if you have:

• a skin rash, no matter how mild;

• shortness of breath (even with mild exertion);

• swelling or rapid weight gain;

• signs of stomach bleeding - bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• liver problems - nausea, upper stomach pain, itching, tired feeling, flu-like symptoms, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

• kidney problems - little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or

• low red blood cells (anemia) - pale skin, unusual tiredness, feeling light-headed or short of breath, cold hands and feet.

Common Flector side effects may include:

• heartburn, gas, stomach pain, nausea, vomiting;

• diarrhea, constipation; or

• mild itching, burning, redness, or other skin irritation where the patch was worn.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Ask your doctor before using Flector if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with diclofenac. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.