DICLOFENAC SODIUM- diclofenac sodium tablet, film coated, extended release 
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Medication Guide


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

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

Rx only

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

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)

NSAID medicines that need a prescription

  Generic Name  Tradename
 Celecoxib Celebrex
 Diclofenac Cataflam, Voltaren, Arthrotec (combined with misoprostol)
 Diflunisal Dolobid
 Etodolac Lodine, Lodine XL
 Fenoprofen Nalfon, Nalfon 200
 Flurbirofen Ansaid
 Ibuprofen Motrin, Tab-Profen, Vicoprofen* (combined with hydrocodone), Combunox (combined with oxycodone)
 Indomethacin Indocin, Indocin SR, Indo-Lemmon, Indomethagan
 Ketoprofen Oruvail
 Ketorolac Toradol
 Mefenamic Acid Ponstel
 Meloxicam Mobic
 Nabumetone Relafen
 Naproxen Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn, 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 NSAID 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 by:

Actavis Elizabeth LLC

200 Elmora Avenue

Elizabeth, NJ 07207 USA

40-9185

Revised — June 2012

Revised: 8/2013
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