Pronunciation: TOLE met in

Tolmetin 400 mg-MYL

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capsule, blue, imprinted with MYLAN 5200

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Tolmetin 400 mg-TEV

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capsule, red, imprinted with N 815, 400

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Tolmetin 600 mg-MYL

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oval, beige, imprinted with M313

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

Tolmetin 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 this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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

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 or inflammation caused by osteoarthritis or rheumatoid arthritis. Tolmetin is also used to treat juvenile rheumatoid arthritis in children who are at least 2 years old.

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

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

Tolmetin 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 this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

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

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

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

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
  • a history of heart attack, stroke, or blood clot;
  • a history of stomach ulcers or bleeding;
  • asthma;
  • liver or kidney disease; or
  • fluid retention.

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

Tolmetin can pass into breast milk and may harm a nursing baby. You should not breast-feed while using this medicine.

Tolmetin is not approved for use by anyone younger than 2 years old.

How should I take tolmetin?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger amounts or for longer than recommended. Use the lowest dose that is effective in treating your condition.

Take tolmetin on an empty stomach, at least 1 hour before or 2 hours after a meal.

It may take up to 1 week before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve.

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

This medicine can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using tolmetin.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

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.

What happens if I overdose?

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

What should I avoid while taking tolmetin?

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

Avoid taking aspirin while you are taking tolmetin.

Ask a doctor or pharmacist before using any cold, allergy, or pain medicine. Many medicines available over the counter contain aspirin or other medicines similar to tolmetin. Taking certain products together can cause you to get too much of this type of medication. Check the label to see if a medicine contains aspirin, ibuprofen, ketoprofen, or naproxen.

What are the possible side effects of tolmetin?

Get emergency medical help if you have signs of an allergic reaction: sneezing, runny or stuffy nose; wheezing or trouble breathing; hives; swelling of your face, lips, tongue, or throat.

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 tolmetin and call your doctor at once if you have:

  • changes in your vision;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • the first sign of any skin rash, no matter how mild;
  • 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 urinating, painful or difficult urination, swelling in your feet or ankles, feeling tired or short of breath;
  • low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating; or
  • severe skin reaction --fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects may include:

  • indigestion, stomach pain, nausea, vomiting;
  • diarrhea, gas;
  • headache, dizziness;
  • weakness; or
  • changes in weight.

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.

What other drugs will affect tolmetin?

Ask your doctor before using tolmetin if you take an antidepressant such as citalopram, escitalopram, fluoxetine (Prozac), fluvoxamine, paroxetine, sertraline (Zoloft), trazodone, or vilazodone. Taking any of these medicines with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist if it is safe for you to use tolmetin if you are also using any of the following drugs:

  • lithium;
  • methotrexate;
  • a blood thinner (warfarin, Coumadin, Jantoven);
  • heart or blood pressure medication, including a diuretic or "water pill"; or
  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may interact with tolmetin, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed in this medication guide.

Where can I get more information?

Your pharmacist can provide more information about tolmetin.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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