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What is the most important information I should know about tolmetin?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use tolmetin. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal. These gastrointestinal effects can occur without warning at any time while you are taking tolmetin. Older adults may have an even greater risk of these serious gastrointestinal side effects.

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

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to tolmetin (such as ibuprofen, ketoprofen, or naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, ketoprofen, or naproxen. Do not drink alcohol while taking tolmetin. Alcohol can increase the risk of stomach bleeding caused by tolmetin.

What is tolmetin?

Tolmetin is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing hormones that cause inflammation and pain in the body.

Tolmetin is used to treat pain, inflammation, and stiffness caused by arthritis.

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

What should I discuss with my healthcare provider before taking tolmetin?

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal. These gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you have ever had an allergic reaction to tolmetin, aspirin, or other NSAIDs.

Before taking tolmetin, tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, or blood clot;

• heart disease, congestive heart failure, high blood pressure;

• a history of stomach ulcers or bleeding;

• liver or kidney disease;

• asthma;

• polyps in your nose;

• a bleeding or blood clotting disorder; or

• if you smoke.

If you have any of these conditions, you may need a dose adjustment or special tests to safely take tolmetin.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking tolmetin during the last 3 months of pregnancy may result in birth defects. Do not take tolmetin during pregnancy unless your doctor has told you to. Tolmetin can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

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