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|Indomethacin Sustained-Release Capsules

Indomethacin Sustained-Release Capsules

Indomethacin Sustained-Release Capsules is used for:

Treating moderate to severe rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is used to treat certain types of bursitis and tendonitis. It may also be used for other conditions as determined by your doctor.

Indomethacin Sustained-Release Capsules is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Indomethacin Sustained-Release Capsules if:

• you are allergic to any ingredient in Indomethacin Sustained-Release Capsules
• you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, ibuprofen, celecoxib)
• you have recently had or will be having bypass heart surgery
• you are taking diflunisal, another NSAID (eg, ibuprofen), or triamterene
• you are in the last 3 months of pregnancy

Contact your doctor or health care provider right away if any of these apply to you.

Before using Indomethacin Sustained-Release Capsules:

Some medical conditions may interact with Indomethacin Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have a history of kidney or liver disease, diabetes, or stomach or bowel problems (eg, bleeding, perforation, ulcers, inflammation)
• if you have a history of swelling or fluid buildup, depression, mental or mood problems, seizures, Parkinson disease, asthma, growths in the nose (nasal polyps), or mouth inflammation
• if you have high blood pressure, a blood disorder, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases
• if you have poor health, dehydration or low fluid volume, low blood sodium levels, or high blood potassium levels, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Indomethacin Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Anticoagulants (eg, warfarin), corticosteroids (eg, prednisone), diflunisal, heparin, other NSAIDs (eg, ibuprofen), salicylates (eg, aspirin), or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased
• Potassium-sparing diuretics (eg, spironolactone, triamterene) because the risk of kidney problems or increased blood potassium levels may be increased
• Cyclophosphamide because low blood sodium levels may occur
• Probenecid because it may increase the risk of Indomethacin Sustained-Release Capsules"s side effects
• Cyclosporine, digoxin, lithium, methotrexate, quinolones (eg, ciprofloxacin), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Indomethacin Sustained-Release Capsules
• Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), angiotensin receptor blockers (eg, losartan), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Indomethacin Sustained-Release Capsules

This may not be a complete list of all interactions that may occur. Ask your health care provider if Indomethacin Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Indomethacin Sustained-Release Capsules:

Use Indomethacin Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Indomethacin Sustained-Release Capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Indomethacin Sustained-Release Capsules refilled.
• Take Indomethacin Sustained-Release Capsules by mouth with food. This may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor if you have persistent stomach upset.
• Swallow Indomethacin Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• You may take Indomethacin Sustained-Release Capsules with antacids if it upsets your stomach.
• Take Indomethacin Sustained-Release Capsules with a full glass of water (8 oz/240 mL) as directed by your doctor.
• If you miss a dose of Indomethacin Sustained-Release Capsules and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use this medicine.

Important safety information:

• Indomethacin Sustained-Release Capsules may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Indomethacin Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Serious stomach ulcers or bleeding can occur with the use of Indomethacin Sustained-Release Capsules. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Indomethacin Sustained-Release Capsules with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
• Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Indomethacin Sustained-Release Capsules is an NSAID. Before you start taking any new medicine, read the ingredients. If it also has an NSAID (eg, ibuprofen) in it, check with your doctor. If you are not sure, check with your doctor or pharmacist.
• Do not take aspirin while you are using Indomethacin Sustained-Release Capsules unless your doctor tells you to.
• Indomethacin Sustained-Release Capsules may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Indomethacin Sustained-Release Capsules.
• Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be done to monitor your progress or to check for side effects. Be sure to keep all doctor and lab appointments.
• Use Indomethacin Sustained-Release Capsules with caution in the ELDERLY; they may be more sensitive to its effects, including stomach bleeding, kidney problems, confusion, or mental changes.
• Indomethacin Sustained-Release Capsules should be used with extreme caution in CHILDREN younger than 15 year old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: This medicine may harm the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Indomethacin Sustained-Release Capsules while you are pregnant. Indomethacin Sustained-Release Capsules is found in breast milk. Do not breast-feed while you are taking Indomethacin Sustained-Release Capsules.

Possible side effects of Indomethacin Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset.

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); blood in the urine; bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; rectal bleeding; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; unusual vaginal bleeding; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include confusion; decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe headache; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Store Indomethacin Sustained-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Indomethacin Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Indomethacin Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Indomethacin Sustained-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Indomethacin Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.