When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction (including asthma) to sulindac, aspirin, or other NSAID medicines, such as ibuprofen, naproxen, Advil®, Aleve®, Bextra®, Celebrex®, or Motrin®. Do not use this medicine right before or right after having a coronary artery bypass graft (CABG), a type of heart surgery.

How to Use This Medicine:
Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• It is best to take this medicine with food or milk.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are also using aspirin, a blood thinner (such as warfarin, Coumadin®), or a steroid medicine (such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, or Orapred®). Tell your doctor if you are using methotrexate (Trexall®), or a diuretic or "water pill" (such as furosemide, hydrochlorothiazide [HCTZ], torsemide, Demadex®, or Lasix®).
• Make sure your doctor knows if you are using cyclosporine (Neoral®, Sandimmune®), diflunisal (Dolobid®), dimethyl sulfoxide (RIMSO-50®), lithium (Eskalith®), or a diabetes medicine (such as glyburide, metformin, Actos®, or Glucotrol®).
• Make sure your doctor knows if you are using a blood pressure medicine such as candesartan, irbesartan, enalapril, lisinopril, losartan, olmesartan, valsartan, Accupril®, Atacand®, Avapro®, Benicar®, Cozaar®, Diovan®, Hyzaar®, Lotrel®, or Zestril®.
• Do not use any other NSAID medicine unless your doctor says it is okay. Some other NSAIDs are aspirin, diclofenac, ibuprofen, naproxen, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, or Voltaren®.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding. Do not use this medicine during the later part of a pregnancy unless your doctor tells you to.
• Make sure your doctor knows if you have a history of ulcers or other stomach problems. Tell your doctor if you have kidney disease, liver disease, anemia, aspirin-sensitive asthma, bleeding problems, eye or vision problems, systemic lupus erythematosus (SLE), pancreas problems, high blood pressure, congestive heart failure (CHF), or heart or circulation problems.
• This medicine may raise your risk of having a heart attack or stroke. This is more likely in people who already have heart disease. People who use this medicine for a long time might also have a higher risk.
• This medicine may cause bleeding in your stomach or intestines. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, if you are over 60 years old, if you are in poor health, or if you are using certain other medicines (a steroid medicine or a blood thinner).
• This medicine may cause a serious type of allergic reaction called anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you have a rash; itching; hoarseness; trouble breathing; trouble swallowing; or any swelling of your hands, face, or mouth while you are using this medicine.
• Serious skin reactions can occur with this medicine. Check with your doctor right away if you have blistering, peeling, or loosening of the skin; red skin lesions; severe acne or skin rash; sores or ulcers on the skin; or fever or chills while you are using this medicine.
• Liver problems may occur while you are using this medicine. Stop using this medicine and check with your doctor right away if you are having more than one of these symptoms: abdominal pain or tenderness; clay-colored stools; dark urine; decreased appetite; fever; headache; itching; loss of appetite; nausea and vomiting; skin rash; swelling of the feet or lower legs; unusual tiredness or weakness; or yellow eyes or skin.
• Pancreatitis may occur while you are using this medicine. Tell your doctor right away if you have sudden and severe stomach pain, chills, constipation, nausea, vomiting, fever, or lightheadedness.
• Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want you to have your eyes checked by an ophthalmologist (eye doctor).
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Blood tests may be needed to check for unwanted effects.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, or red skin rash.
• Bloody or black, tarry stools.
• Change in how much or how often you urinate.
• Chest pain, shortness of breath, or coughing up blood.
• Dark-colored urine or pale stools.
• Flu-like symptoms.
• Itching.
• Numbness or weakness in your arm or leg, or on one side of your body.
• Pain in your lower leg (calf).
• Rapid weight gain.
• Severe stomach pain.
• Shortness of breath, cold sweat, and bluish-colored skin.
• Skin rash or blisters with fever.
• Sudden or severe headache, problems with vision, speech, or walking.
• Sudden and severe stomach pain, nausea, vomiting, fever, and lightheadedness.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Vomiting blood or something that looks like coffee grounds.
• Yellowing of your skin or the whites of your eyes.

If you notice these less serious side effects, talk with your doctor:

• Dizziness or headache.
• Mild nausea, constipation, diarrhea, or stomach pain.
• Problems with your vision.

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088