Naproxen (Page 5 of 6)

HOW SUPPLIED

Naproxen Tablets, USP:

500 mg: white, capsule-shaped, biconvex, debossed with “IP 190” on obverse and “500” on the reverse. Packaged in bottles:

20

NDC

60429-135-20

60

NDC

60429-135-60

180

NDC

60429-135-18

Store at 15°-30°C (59°-86°F) in well-closed containers; dispense in light-resistant containers.

Rx only

Manufactured by: Amneal Pharmaceuticals of NY, Hauppauge, NY 11788

Marketed/Packaged by: GSMS Inc. Camarillo, CA 93012

Rev. 10-2008

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”
drinking alcohol
longer use
older age
smoking
having poor health

NSAID medicines should only be used:

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

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
slurred speech
chest pain
swelling of the face or throat
weakness in one part or side of your body

Stop your NSAID medicine and call your healthcare provider right away if you have any of the following symptoms:

nausea
vomit blood
more tired or weaker than usual
there is blood in your bowel movement or it is black and sticky like tar
itching
unusual weight gain
your skin or eyes look yellow
skin rash or blisters with fever
stomach pain
swelling of the arms and legs, hands and feet
flu-like 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)

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 (overthe-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, 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-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.

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