IMPORTANT WARNING:

Why is this medication prescribed?

Etodolac tablets, capsules, and extended-release (long-acting) tablets are used to relieve pain, tenderness, swelling, and stiffness caused by osteoarthritis (arthritis caused by a breakdown of the lining of the joints) and rheumatoid arthritis (arthritis caused by swelling of the lining of the joints). Etodolac tablets and capsules are also used to relieve pain from other causes. Etodolac is in a class of medications called NSAIDs. It works by stopping the body's production of a substance that causes pain, fever, and inflammation.

How should this medicine be used?

Etodolac comes as a tablet, a capsule, and an extended-release tablet to take by mouth. To treat arthritis, the tablet and capsule are usually taken two to three times a day and the extended-release tablet is usually taken once a day. To relieve pain from other causes, the tablets and capsules are usually taken every 6 to 8 hours. Take etodolac at around the same time(s) every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take etodolac exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the extended-release tablets whole; do not split, chew, or crush them.

If you are taking etodolac for arthritis, your doctor may start you on a high dose and decrease your dose once your symptoms are controlled. It may take 1-2 weeks for you to feel the full benefit of this medication.

Other uses for this medicine

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?

Before taking etodolac,

• tell your doctor and pharmacist if you are allergic to etodolac, aspirin or other NSAIDs such as ibuprofen (Advil, Motrin) and naproxen (Aleve, Naprosyn), any other medications, or any of the inactive ingredients in etodolac tablets, capsules, or extended-release tablets. Ask your pharmacist for a list of inactive ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: angiotensin-converting enzyme (ACE) inhibitors such as benazepril (Lotensin), captopril (Capoten), enalapril (Vasotec), fosinopril (Monopril), lisinopril (Prinivil, Zestril), moexipril (Univasc), perindopril (Aceon), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik); cyclosporine (Neoral, Sandimmune); digoxin (Lanoxin); diuretics ('water pills'); lithium (Eskalith, Lithobid); and methotrexate (Rheumatrex). Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had asthma, especially if you also have frequent stuffed or runny nose or nasal polyps (swelling of the lining of the nose); swelling of the hands, feet, ankles, or lower legs; or kidney or liver disease.
• tell your doctor if you are pregnant, especially if you are in the last few months of your pregnancy, you plan to become pregnant, or you are breast-feeding. If you become pregnant while taking etodolac, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking etodolac.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?

Etodolac may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• constipation
• diarrhea
• gas or bloating
• vomiting
• headache
• dizziness
• ringing in the ears
• runny nose
• sore throat
• blurred vision

Some side effects can be serious. If you experience any of the following symptoms, or those mentioned in the IMPORTANT WARNING section, call your doctor immediately. Do not take any more etodolac until you speak to your doctor.

• unexplained weight gain
• swelling of the eyes, face, lips, tongue, throat, hands, feet, ankles, or lower legs
• fever or chills
• blisters
• rash
• itching
• hives
• hoarseness
• difficulty breathing or swallowing
• yellowing of the skin or eyes
• excessive tiredness
• unusual bleeding or bruising
• lack of energy
• loss of appetite
• pain in the upper right part of the stomach
• flu-like symptoms
• pale skin
• fast heartbeat
• cloudy, discolored, or bloody urine
• difficult or painful urination
• back pain

Etodolac may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?

Keep this medication in the container it came in, tightly closed, and out of reach of children. Do not prepare doses of etodolac tablets in advance; keep the tablets in the original container until you are ready to take them. Store etodolac at room temperature and away from excess heat and moisture (not in the bathroom). Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

• lack of energy
• drowsiness
• upset stomach
• vomiting
• stomach pain
• bloody, black or tarry stool
• vomit that is bloody or looks like coffee grounds
• coma (loss of consciousness for a period of time)

What other information should I know?

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking etodolac.

If you have diabetes and you test your urine for ketones, you should know that etodolac may interfere with the results of this type of test. Talk to your doctor about how you should monitor your diabetes while you are taking etodolac.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

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