NAPROXEN- naproxen tablet 
Cardinal Health

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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.)

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:

•
with longer use of NSAID medicines
•
in people who have heart disease

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:

•
can happen without warning symptoms
•
may cause death

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

•
taking medicines called “corticosteroids” and “anticoagulants”
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health

NSAID medicines should only be used:

•
exactly as prescribed
•
at the lowest dose possible for your treatment
•
for the shortest time needed

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:

•
different types of arthritis
•
menstrual cramps and other types of short-term pain

Who should not take a Non-Steroidal Anti-Inflammatory Drug (NSAID)?
Do not take an NSAID medicine:

•
if you had an asthma attack, hives, or other allergic reaction with aspirin or any other NSAID medicine
•
for pain right before or after heart bypass surgery

Tell your healthcare provider:

•
about all of your medical conditions.
•
about all of the medicines you take. NSAIDs and some other medicines can interact with each other and cause serious side effects. Keep a list of your medicines to show to your healthcare provider and pharmacist.
•
if you are pregnant. NSAID medicines should not be used by pregnant women late in their pregnancy.
•
if you are breastfeeding. Talk to your doctor.

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
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

  

•
stomach pain 
•
constipation
•
diarrhea
•
gas 
•
heartburn
•
nausea
•
vomiting
•
dizziness
Get emergency help right away if you have any of the following symptoms:

  

•
shortness of breath or trouble
breathing
•
chest pain
•
weakness in one part or side of your body

  

•
slurred speech
•
swelling of the face or
throat
Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

  

•
nausea
•
more tired or weaker than usual
•
itching
•
your skin or eyes look yellow
•
stomach pain
•
flu-like symptoms
•
vomit blood

  

•
there is blood in your bowel
movement or it is black and sticky 
like tar
•
unusual weight gain
•
skin rash or blisters with fever
•
swelling of the arms and legs,
hands and feet

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 or West-ward at 1-877-233-2001.

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
  
Generic Name
  
Tradename

  Celecoxib

  Celebrex®

  Diclofenac

  Cataflam®, Voltaren®, ArthrotecTM (combined with misoprostol) 

  Diflunisal

  Dolobid®

  Etodolac

  Lodine®, Lodine®XL 

  Fenoprofen

  Nalfon®, Nalfon200®

  Flurbirofen

  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-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 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.

All registered trademarks in this document are the property of their respective owners.

Distributed by:
Major Pharmaceuticals
Livonia, MI 48150  USA

Revised September 2009

Revised: 12/2017
Document Id: 35e1a9ed-a4be-4191-9208-1507a7391153
Set id: bd03ffa0-02a7-4b66-82f2-d080562d9f1c
Version: 3
Effective Time: 20171206
Cardinal Health