WHAT IS Indocin/Indomethacin?

Indocin/Indomethacin is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Indocin/Indomethacin works by reducing hormones that cause inflammation and pain in the body.

Indocin/Indomethacin is used to treat pain or inflammation caused by many conditions such as arthritis, gout, ankylosing spondylitis, bursitis, or tendinitis.

Indocin/Indomethacin may also be used for purposes not listed in this medication guide.

WHAT IS THE MOST IMPORTANT INFORMATION I SHOULD KNOW ABOUT Indocin/Indomethacin?

This medicine can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use Indocin/indomethacin. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

Seek emergency medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

This medicine can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking Indocin/indomethacin. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

Do not drink alcohol while taking Indocin/indomethacin. Alcohol can increase the risk of stomach bleeding caused by Indocin/indomethacin. Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar toindomethacin (such as Motrin/ibuprofen, ketoprofen, or Anaprox/naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, Motrin/ibuprofen, ketoprofen, or Anaprox/naproxen.

WHAT HAPPENS IF I OVERDOSE?

Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of an Indocin/indomethacin overdose may include nausea, vomiting, stomach pain, drowsiness, black or bloody stools, coughing up blood, shallow breathing, fainting, or coma.

WHAT HAPPENS IF I MISS A DOSE?

If you are taking Indocin/indomethacin on a regular schedule, take the missed dose as soon as you remember. However, if it is almost time for the next dose, skip the missed dose and take only the next regularly scheduled dose. Do not take a double dose.

If you are taking Indocin/indomethacin as needed, take the missed dose if it is needed, then wait the recommended or prescribed amount of time before taking another dose.

HOW SHOULD I TAKE Indocin/Indomethacin?

Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take Indocin/indomethacin with food or milk to lessen stomach upset. Do not crush, chew, break, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking or opening the pill would cause too much of the drug to be released at one time. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one.

If you take Indocin/indomethacin for a long period of time, your doctor may want to check you on a regular basis to make sure this medication is not causing harmful effects. Do not miss any scheduled visits to your doctor.

This medication can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Indocin/indomethacin.

Store Indocin/indomethacin at room temperature away from moisture and heat. Do not allow the liquid medicine to freeze.

WHAT OTHER DRUGS WILL AFFECT Indocin/Indomethacin?

Before taking Indocin/indomethacin, tell your doctor if you are taking any of the following drugs:

• diflunisal (Dolobid);
• Probalan/probenecid ( Benemid );
• a blood thinner such as Coumadin/warfarin ( Coumadin );
• diuretics (water pills) such as Lasix/furosemide ( Lasix );
• Lithobid/lithium ( Eskalith , Lithobid );
• Sandimmune/cyclosporine ( Gengraf , Neoral , Sandimmune );
• Rheumatrex/methotrexate ( Rheumatrex , Trexall);
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as Cataflam xr/diclofenac ( Voltaren ), etodolac (Lodine), flurbiprofen (Ansaid), Motrin/ibuprofen (Advil, Motrin ), ketoprofen (Orudis), Toradol/ketorolac ( Toradol ), Ponstel/mefenamic acid ( Ponstel ), Mobic/meloxicam ( Mobic ), Relafen/nabumetone ( Relafen ), Anaprox/naproxen ( Aleve , Naprosyn), Feldene/piroxicam ( Feldene ), and others;
• Lanoxin/digoxin (digitalis, Lanoxin );
• steroids (Deltasone/prednisone and others); or
• a beta-blocker such as Tenormin/atenolol ( Tenormin ), bisoprolol (Zebeta), Trandate/labetalol (Normodyne, Trandate ), Toprol/metoprolol ( Lopressor , Toprol ), nadolol (Corgard), Inderal/propranolol ( Inderal , InnoPran), Betapace/sotalol ( Betapace ), timolol (Blocadren), and others.

If you are using any of these drugs, you may not be able to use Indocin/indomethacin or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect Indocin/indomethacin. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Indocin/Indomethacin SIDE EFFECTS

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking Indocin/indomethacin and seek medical attention or call your doctor at once if you have any of these serious side effects:

• coughing up blood or vomit that looks like coffee grounds;
• bruising, severe tingling, numbness, pain, muscle weakness.
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; or
• swelling or rapid weight gain;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools;
• urinating less than usual or not at all;

Keep taking Indocin/indomethacin and talk to your doctor if you have any of these less serious side effects:

• skin rash, itching;
• bloating, gas;
• upset stomach, mild heartburn, diarrhea, constipation;
• dizziness, nervousness, headache;
• ringing in your ears.
• blurred vision; or

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome.

WHAT SHOULD I AVOID WHILE TAKING Indocin/Indomethacin?

Do not drink alcohol while taking Indocin/indomethacin. Alcohol can increase the risk of stomach bleeding caused by Indocin/indomethacin. Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to Indocin/indomethacin (such as Motrin/ibuprofen, ketoprofen, or Anaprox/naproxen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, Motrin/ibuprofen, ketoprofen, or Anaprox/naproxen. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). Indocin/Indomethacin can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

What is the shelf life of the pills?

• The expiry date is mentioned on each blister. It is different for different batches. The shelf life is 2 years from the date of manufacture and would differ from batch to batch depending on when they were manufactured.