NAPROXEN - naproxen tablet 
Polygen Pharmaceuticals LLC

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SPL MEDGUIDE

 

Medication Guide

for

Non-steroidal Anti-Inflammatory Drugs (NSAIDs)

(See the end of this Medication Guide for a list of prescriptionNSAID 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:
  • heart attack
  • stroke
  • high blood pressure
  • heart failure from body swelling (fluid retention)
  • 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
Other side effects include:
  • 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)

NSAID medicines that need a prescription


Generic Name
Trade Name
Celecoxib
Celebrex®
Diclofenac
Cataflam®, Voltaren®, ArthrotecTM (combined with misoprostol)
Diflunisal
Dolobid®
Etodolac
Lodine®, Lodine® XL
Fenoprofen
Nalfon®, Nalfon® 200
Flurbiprofen
Ansaid®
Ibuprofen
Motrin®, Tab-Profen®, Vicoprofen®* (combined with hydrocodone), CombunoxTM (combined with oxycodone)
Indomethacin
Indocin®, Indocin® SR, Indo-LemmonTM, IndomethaganTM
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.

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 PolyGen Pharmaceuticals LLC at 1-888-291-7337 and/ or to FDA at 1-800-FDA-1088


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

R304/13

Manufactured for:

PolyGen Pharmaceuticals LLC


Edgewood, NY 11717, USA


Manufactured by:

Marksans Pharma Ltd.

Verna, Goa-403 722, India

Revised: 06/2013
 
Polygen Pharmaceuticals LLC