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: 7/2014

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Effective Time: 20140707

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