SPL MEDGUIDE SECTION

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

skin rash or blisters with fever

unusual weight gain

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.

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

* 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.

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

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

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

LAB-0609-1.0