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NAPROSYN® DRUG INFORMATION, ABOUT NAPROSYN®

IMPORTANT WARNING

The Food and Drug Administration (FDA) announced on April 7, 2005 that they are asking makers of all prescription nonsteroidal anti-inflammatory drugs (NSAIDs) to change the package insert to include a ''boxed'' or serious warning about the increased risk of cardiovascular events (including stroke and heart attack) and potentially life-threatening gastrointestinal (GI) bleeding which is associated with NSAID use. The information should say that people who have just had heart surgery should not take NSAIDs. The FDA has also asked makers of over-the-counter (OTC), nonprescription NSAIDs to include information on the label about possible cardiovascular events and gastrointestinal (GI) bleeding. In addition, skin reactions may occur in people taking these drugs. Talk to your doctor if you are taking one of these medications if you have questions or concerns about these potential dangers. For more information see the FDA website: http://www.fda.gov/cder/drug/infopage/COX2/default.htm.

WHAT IS NAPROSYN?

Naprosyn is used to relieve the pain, inflammation (swelling), tenderness and stiffness caused by gout, arthritis or other inflammatory conditions. It also is used to relieve other pain, including menstrual pain, muscle pain and pain after childbirth, surgery or dental work.

Naprosyn has other uses. Ask your doctor or pharmacist for more information.

HOW TO USE NAPROSYN

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Naprosyn is found in a regular tablet, an extended-release tablet or liquid to take by mouth. Usual doses are:

for arthritis - twice a day
for gout - every 8 hours
for pain - extended-release tablets, once a day OR regular tablets, every 6-8 hours, as needed

Follow the directions on the package or label carefully. Ask your doctor or pharmacist questions about any part you do not understand. Take Naprosyn exactly as directed. Do not take more or less and do not take it more often than prescribed by your doctor.

Liquid Naprosyn - shake well before each use to mix the medication evenly.

If you are taking Naprosyn without a prescription, do not take it for more than 3 days for fever or 10 days for pain unless advised by your doctor.

NAPROSYN DRUG INTERACTIONS and PRECAUTIONS

Before taking Naprosyn, tell your doctor:

about any prescription and nonprescription medications you are taking, especially:
- aspirin
- atenolol (Tenormin)
- diuretics ('water pills')
- cyclosporine (Neoral, Sandimmune)
- carteolol (Cartrol)
- lithium (Eskalith, Lithobid)
- labetalol (Normodyne, Trandate)
- medications for arthritis or diabetes
- metoprolol (Lopressor)
- methotrexate
- nadolol (Corgard)
- probenecid (Benemid)
- phenytoin (Dilantin)
- warfarin (Coumadin)
- vitamins
- Do not take acetaminophen or aspirin when using Naprosyn unless your doctor tells you to.
if you are allergic to Naprosyn, aspirin, other medications for pain or arthritis, or any other drugs
if you smoke or drink large amounts of alcohol
if you have or have ever had:
- high blood pressure
- heart, liver or kidney disease
- stomach problems
- other gastrointestinal disease
if you are having surgery, including dental surgery. Tell the surgeon or dentist that you are taking Naprosyn.

IMPORTANT NOTE:

This information is intended only to supplement the judgment and expertise of your physician, pharmacist or other healthcare provider. It should not be taken to indicate that use of this medicine is safe, effective or appropriate for you. Consult your physician before this medicine is used

Naprosyn may make you drowsy. Do not drive a car or operate machinery until you know how it will affect you.

Alcohol can add to the drowsiness caused by Naprosyn. Do not drink alcohol while taking this medicine.

NAPROSYN and PREGNANCY

Tell your doctor if you are pregnant or trying to get pregnant. If you become pregnant while taking Naprosyn, call your doctor.

NAPROSYN and BREAST FEEDING

Tell your doctor if you are breast feeding.

NAPROSYN SIDE EFFECTS

Although side effects from Naprosyn are not common, they may occur. inform your physician if any of these symptoms are severe or do not go away:

nervousness
headache
dizziness
stomach upset
vomiting
stomach pain or cramps
gas
constipation
diarrhea

If you experience any of the following serious Naprosyn side effects, call your doctor immediately:

black, tarry stools
bloody diarrhea
bloody vomit
ringing in the ears
blurred vision
itching
swelling of hands, feet, ankles, or lower legs
skin rash

DIETARY PRECAUTIONS

Naprosyn may cause an upset stomach. Take Naprosyn with food or milk.

MISSED DOSES

Take the missed Naprosyn dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed one and continue your regular dosing schedule. Do not take a double dose to make up for one that was missed.

NAPROSYN OVERDOSE

In case of an overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call your local emergency services at 911.

STORAGE

Keep Naprosyn in the original container, tightly closed, and out of reach of children. Store it at room temperature away from excess moisture and heat. Do not store in the bathroom. Throw away any Naprosyn that is outdated or no longer needed. Talk to your pharmacist about the proper disposal.

OTHER INFORMATION

Keep all appointments with your doctor and with the laboratory. Certain lab tests will be ordered by your doctor to check your response to Naprosyn.

Do not let anyone else take your Naprosyn. Ask your pharmacist any questions you have about refills of your prescription.

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