Indomethacin Oral - SUSTAINED - RELEASE CAPSULE

Warnings
This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This side effect can occur without warning at any time during treatment with indomethacin. The elderly are at increased risk for serious stomach/intestinal bleeding.
Drugs related to indomethacin have rarely caused blood clots to form, resulting in serious (possibly fatal) heart attacks and strokes. This medication might also rarely cause similar problems. The risk of these serious side effects may increase if you have heart disease and with longer use of this medication. Talk to your doctor or pharmacist about the benefits and risks of treatment, as well as other possible medication choices.
Stop taking indomethacin and seek immediate medical attention if you notice any of the following rare but very serious side effects: black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds, chest pain, shortness of breath, weakness on one side of the body, sudden vision changes, slurred speech.
This medication should not be used right before or after heart bypass surgery.

Uses
Indomethacin is used to relieve pain, swelling, and joint stiffness caused by arthritis, gout, bursitis, and tendonitis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID).

OTHER USES:
This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.
This medication may also be used to relieve pain caused by inflammation of the pouch surrounding the heart and other conditions as prescribed by your doctor.

How to use Indomethacin Oral
Read the Medication Guide provided by your pharmacist before you start using indomethacin and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Shake the bottle well before each dose. Measure the dose out carefully with a medication spoon/cup. Take this medication by mouth with a full glass of water (8 ounces or 240 milliliters) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this drug. Take this medication either with food, right after meals, or with antacids to prevent stomach upset.
Dosage is based on your medical condition and response to therapy. In adults, do not use more than 200 milligrams per day. In children, dosage is also based on weight. The maximum dose for children is 4 milligrams per kilogram a day or 150 to 200 milligrams a day, whichever is less. To minimize side effect risks (e.g., stomach bleeding), use this medication at the lowest effective dose for the shortest possible length of time. Do not increase your dose or use it more often than prescribed. For ongoing conditions such as arthritis, continue using it as directed by your doctor. Discuss the risks and benefits with your doctor or pharmacist.
In certain conditions (e.g., arthritis), it may take up to 4 weeks of regular use before the full benefits of this drug take effect.
If you are taking this drug on an "as needed" basis (not on a regular schedule), remember that pain medications work best if they are used as the first signs of pain occur. If you wait until the pain has significantly worsened, the medicine may not work as well.
Inform your doctor if your condition worsens.

Before taking indomethacin, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, naproxen, celecoxib); or if you have any other allergies.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), severe kidney disease, recent heart bypass surgery (CABG).
Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, poorly controlled diabetes, stomach/intestine/esophagus problems (e.g., bleeding, ulcers), heart disease (e.g., congestive heart failure, history of heart attack), blood disorders (e.g., anemia), bleeding or clotting problems, high blood pressure, swelling (edema, fluid retention), a severe loss of body water (dehydration), stroke, mental/mood conditions (e.g., depression, psychoses), seizures, Parkinson's disease, high level of potassium in the blood, asthma, growths in the nose (nasal polyps).
Before having surgery, tell your doctor or dentist that you are using this medication.
This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery.
This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information.
This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and sunlamps. Use a sunscreen and wear protective clothing when outdoors.
The elderly may be more sensitive to the side effects of this drug, especially stomach/intestinal bleeding, kidney effects, and mental/mood changes.
Children may be more sensitive to the side effects of this drug, especially serious liver problems. Caution is advised when this drug is used in children. Discuss the risks and benefits of treatment with your doctor.
This medication should be used only when clearly needed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery. Discuss the risks and benefits with your doctor.
This drug passes into breast milk. Therefore, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.

Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US national poison hotline at 1-800-222-1222. Canadian residents should call their local poison control center directly. Symptoms of overdose may include severe stomach pain, vomit that looks like coffee grounds, extreme drowsiness, slow or shallow breathing, confusion, seizures.

NOTES:
Do not share this medication with others.
Laboratory and/or medical tests (e.g., complete blood count, liver and kidney function tests) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.
Non-drug treatment for arthritis that is approved by your doctor (e.g., weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

MISSED DOSE:
If you are prescribed this drug on a regular schedule (not just "as needed") and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

STORAGE:
Store at room temperature below 86 degrees F (30 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.
Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

See also Warning section.
Upset stomach, heartburn, headache, tiredness, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.
Tell your doctor immediately if any of these unlikely but serious side effects occur: stomach pain, swelling of the hands/feet, sudden/unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), mental/mood changes (e.g., confusion, hallucinations), fast/pounding heartbeat, persistent/severe headache, fainting, muscle weakness, uncontrollable movements.
Tell your doctor immediately if any of these rare but very serious side effects occur: change in the amount of urine, easy bruising/bleeding, signs of infection (e.g., fever, persistent sore throat), unexplained stiff neck, seizures.
This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following rare but very serious side effects, stop taking indomethacin and tell your doctor immediately: yellowing eyes/skin, dark urine, unusual/extreme tiredness, severe stomach/abdominal pain, persistent nausea/vomiting.
A very serious allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of a serious allergic reaction may include: rash, itching, swelling, severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

Your healthcare professionals (e.g., doctor or pharmacist) may already be aware of any possible drug interactions and may be monitoring you for it. Do not start, stop or change the dosage of any medicine before checking with them first.
This drug should not be used with the following medications because very serious interactions may occur: cidofovir, other NSAIDs (e.g., diflunisal, ketorolac), high doses of aspirin and related drugs (salicylates), a certain "water pill" (a diuretic called triamterene).
If you are currently using any of these medications listed above, tell your doctor or pharmacist before starting indomethacin.
Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: anti-platelet drugs (e.g., cilostazol, clopidogrel), oral bisphosphonates (e.g., alendronate), "blood thinners" (e.g., enoxaparin, heparin, warfarin), corticosteroids (e.g., prednisone), cyclosporine, desmopressin, digoxin, high blood pressure drugs (including ACE inhibitors such as captopril, angiotensin receptor blockers such as losartan, and beta-blockers such as metoprolol), lithium, methotrexate, pemetrexed, potassium supplements, probenecid, SSRI antidepressants (e.g., fluoxetine, sertraline), other "water pills" (diuretics such as furosemide, hydrochlorothiazide, spironolactone).
Check all prescription and nonprescription medicine labels carefully for other pain/fever drugs (NSAIDs such as aspirin, celecoxib, ibuprofen). These drugs are similar to this medication, so taking one of these drugs while also taking this medication may increase your risk of side effects. However, if your doctor has prescribed low doses of aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue to take the aspirin. Daily use of NSAIDs (e.g., ibuprofen) may decrease aspirin's ability to prevent heart attack/stroke. Consult your doctor or pharmacist for more details and to discuss other possible treatments (e.g., acetaminophen) for your pain/fever.
This medication can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug.
This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.