Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID).

Diclofenac topical system (patch) is used to treat pain caused by minor sprains, strains, or bruising.

Diclofenac topical system is for use in adults and children at least 6 years old.

Diclofenac topical system may also be used for purposes not listed in this medication guide.

Diclofenac can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use diclofenac transdermal 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.

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 diclofenac topical system 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 diclofenac transdermal 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 this medicine 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.

Tell your doctor if you have ever had:

• 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 diclofenac topical system (patch) unless your doctor tells you to. Using an 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 this medicine. Ask your doctor about any risk.

Apply a 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 diclofenac 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 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 (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 diclofenac 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.

Diclofenac may cause serious side effects. Stop using diclofenac 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 side effects of diclofenac transdermal 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 diclofenac 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 affect 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.