Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID). Menthol provides a cooling sensation when applied to the skin.

DicloStream (for the skin) is a combination medicine used to treat osteoarthritis of the knee.

DicloStream may also be used for purposes not listed in this medication guide.

Diclofenac and menthol can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Diclofenac and menthol may also cause stomach or intestinal bleeding, which can be fatal.

Follow all directions on your prescription label and read all medication guides. Use the lowest dose that is effective in treating your condition.

Do not take by mouth. Topical medicine is for use only on the skin. Do not use on open wounds or irritated skin. Rinse with water if this medicine gets in your eyes or mouth.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

Do not apply this medicine to an open skin wound, or on areas of infection, rash, burn, or peeling skin.

After applying the medicine, wash and dry your hands. Wait until the medicine is completely dry before you cover the knee with clothing. Avoid showering/bathing the treated knee for at least 30 minutes after applying DicloStream.

Wait until the treated skin is completely dry before you apply sunscreen, insect repellant, lotion, or other skin products. Do not allow anyone else to touch the treated skin until it is completely dry.

Do not cover treated skin with a bandage or expose it to heat from a hot tub, heating pad, or sauna. Heat or bandaging can increase the amount of drug absorbed through your skin and may cause harmful effects.

If you use this medicine long-term, your blood pressure will need to be checked often. Your kidney and liver function may also need to be checked.

Store at room temperature away from moisture and heat. Keep the bottle tightly closed when not in use.

You should not use DicloStream if you are allergic to menthol or diclofenac (Voltaren, Cataflam, Flector, 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:

• heart problems, high blood pressure, or if you smoke;

• a heart attack, stroke, or blood clot;

• stomach ulcers, bleeding in your stomach or intestines;

• fluid retention;

• asthma; or

• kidney disease.

Diclofenac can affect ovulation and it may be harder to get pregnant while you are using this medicine.

If you are pregnant, you should not use DicloStream 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.

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

Apply the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not apply two doses at one time.

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

Overdose symptoms may include drowsiness, lack of energy, nausea, vomiting, or stomach pain.

Avoid getting DicloStream in your eyes. If contact does occur, rinse with water. Call your doctor if you have eye irritation that lasts longer than 1 hour.

Avoid exposing treated skin to heat, sunlight, or tanning beds.

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).

Avoid drinking alcohol. It may increase your risk of liver damage.

Avoid smoking, since it can also increase your risk of stomach bleeding.

If you are also taking low-dose aspirin to prevent heart attack or stroke, do not stop taking it or change your dose without your doctor's advice. Aspirin should be used for cardiovascular conditions only under the supervision of a doctor.

Get emergency medical help if you have signs of an allergic reaction (hives, 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 DicloStream and seek emergency medical attention 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, feeling short of breath.

Also call your doctor at once if you have:

• a skin rash, no matter how mild;

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

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

• liver problems--nausea, diarrhea, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

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

Serious side effects may be more likely in older adults.

Common side effects of DicloStream may include:

• skin dryness, redness, itching, or rash;

• blistering or hardening of the treated skin;

• numbness, tingling, burning pain;

• acne;

• flushing (sudden warmth, redness, or tingly feeling);

• stomach pain, constipation, diarrhea, gas, heartburn, nausea, vomiting; or

• dizziness.

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 and menthol if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Tell your doctor about all your other medicines, especially:

• cyclosporine;

• digoxin;

• lithium;

• methotrexate;

• pemetrexed;

• a blood thinner (warfarin, Coumadin, Jantoven);

• aspirin or other NSAIDs (ibuprofen, naproxen, Advil, Motrin, Aleve, celecoxib, indomethacin, meloxicam, and others;

• heart or blood pressure medication, including a diuretic or "water pill"; or

• steroid medicine (prednisone and others).

This list is not complete. Other drugs may affect diclofenac and menthol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.