INDOMETHACIN- indomethacin capsule 
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SPL MEDGUIDE SECTION

INDOMETHACIN CAPSULES USP

Medication Guide for Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescription NSAID medicines.)

What is the most important information I should know about medicines called Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines may increase the chance of a heart attack or stroke that can lead to death. This chance increases:

NSAID medicines should never be used right before or after a heart surgery called a "coronary artery bypass graft (CABG)."

NSAID medicines can cause ulcers and bleeding in the stomach and intestines at any time during treatment. Ulcers and bleeding:

The chance of a person getting an ulcer or bleeding increases with:

NSAID medicines should only be used:

What are Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

NSAID medicines are used to treat pain and redness, swelling, and heat (inflammation) from medical conditions such as:

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?

Do not take an NSAID medicine:

Tell your healthcare provider:

What are the possible side effects of Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)?

   serious side effects include:Other side effects include:        
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid Retension)
  • kidney problems including kidney failure
  • bleeding and ulcers in the stomach and intestine
  • low red blood cells (anemia)
  • life-threatening skin reactions
  • life-threatening allergic reactions
  • liver problems including liver failure
  • asthma attacks in people who have asthma
  • stomach pain
  • constipation
  • diarrhea
  • gas
  • heartburn
  • nausea
  • vomiting
  • dizziness

Get emergency help right away if you have any of the following symptoms:

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

These are not all the side effects with NSAID medicines. Talk to your healthcare provider or pharmacist for more information about NSAID medicines. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other information about Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

Aspirin is an NSAID medicine but it does not increase the chance of a heart attack.Aspirin can cause bleeding in the brain, stomach, and intestines. Aspirin can also cause ulcers in the stomach and intestines.

Some of these NSAID medicines are sold in lower doses without a prescription (over-the-counter). Talk to your healthcare provider before using over-the-counter NSAIDs for more than 10 days.

NSAID medicines that need a prescription

Celecoxib                 Celebrex
Diclofenac                 Cataflam, Voltaren, Arthrotec (combined with  misoprostol)
Diflunisal                 Dolobid
Etodolac                 Lodine, Lodine XL
Fenoprofen                 Nalfon, Nalfon 200
Flurbiprofen                 Ansaid
Ibuprofen                 Motrin, Tab-Profen, Vicoprofen( (combined with                  hydrocodone), Combunox (combined with oxycodone)
Indomethacin                 Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen                 Oruvail
Ketorolac                 Toradol
MefenamicAcid                 Ponstel
Meloxicam                 Mobic
Nabumetone                 Relafen
Naproxen                 Naprosyn, Anaprox, Anaprox DS, EC-Naprosyn, Naprelan,                  Naprapac (copackaged with lansoprazole)
Oxaprozin                 Daypro
Piroxicam                 Feldene
Sulindac                 Clinoril
Tolmetin                 Tolectin, Tolectin DS, Tolectin 600

*Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for less than 10 days to treat pain. The OTC NSAIDS label warns that long term continuous use may increase the risk of heart attack or stroke.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Manufactured for:

Camber Pharmaceuticals, Inc

Piscataway, NJ 08854

By: Hetero Labs Limited

Jeedimetla, Hyderabad-500 055, India.

Revised: 4/2023
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