Cataflam is a nonsteroidal anti-inflammatory drug (NSAID). Diclofenac works by reducing substances in the body that cause pain and inflammation.

Cataflam is used to treat mild to moderate pain, or signs and symptoms of osteoarthritis or rheumatoid arthritis.

Cataflam is also used to treat menstrual cramps.

Cataflam 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. Even people without heart disease or risk factors could have a stroke or heart attack while taking this medicine. Do not use diclofenac just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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

Before taking this medicine

You should not use Cataflam if you are allergic to diclofenac, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

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).

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

• heart disease, high blood pressure;

• ulcers or bleeding in your stomach;

• asthma;

• liver or kidney disease; or

• if you smoke.

Taking diclofenac during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

Cataflam is not approved for use by anyone younger than 18 years old.

Take Cataflam exactly as directed on the label, or as prescribed by your doctor. Follow the directions on the label and read all medication guides. Your doctor may occasionally change your dose. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

For treatment of pain or primary dysmenorrhea the recommended dosage of Cataflam is 50 mg three times daily. In some patients an initial dose of 100 mg of Cataflam, followed by 50 mg doses, may provide better relief.

For the relief of osteoarthritis the recommended dosage is 100-150 mg/day in divided doses, i.e. 50 mg two or three times a day.

For the relief of rheumatoid arthritis the recommended dosage is 150-200 mg/day in divided doses, i.e. 50 mg three or four times a day.

Different formulations of diclofenac, Voltaren (diclofenac sodium tablets) and Cataflam (diclofenac potassium immediate-release tablets) are not necessarily equivalent in strength even if the milligram strength is the same.

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

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

You should not use Cataflam if you are allergic to diclofenac, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

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).

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

• heart disease, high blood pressure;

• ulcers or bleeding in your stomach;

• asthma;

• liver or kidney disease; or

• if you smoke.

Taking diclofenac during the last 3 months of pregnancy may harm the unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

Cataflam is not approved for use by anyone younger than 18 years old.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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

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

Avoid taking aspirin or other NSAIDs unless your doctor tells you to.

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 Cataflam (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 Cataflam 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, feeling short of breath.

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

• the first sign of any skin rash, no matter how mild;

• flu-like symptoms;

• heart problems - swelling, rapid weight gain, feeling short of breath;

• kidney problems - little or no urinating, painful or difficult urination, swelling in your arms or legs, feeling tired or short of breath;

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

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

Common Cataflam side effects may include:

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

• diarrhea, constipation;

• headache, dizziness, drowsiness;

• abnormal lab tests;

• itching, sweating;

• stuffy nose;

• increased blood pressure; or

• swelling or pain in your arms or legs.

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 Cataflam 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:

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

• other forms of diclofenac (Arthrotec, Flector, Pennsaid, Solaraze, Voltaren Gel);

• a blood thinner - warfarin, Coumadin, Jantoven; or

• other NSAIDs - aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), indomethacin, meloxicam, and others.

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