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|Naproxen Enteric-Coated Tablets

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Naproxen Enteric-Coated Tablets

Generic Name: Naproxen Enteric-Coated Tablets (na-PROX-en)
Brand Name: EC-Naprosyn

Naproxen Enteric-Coated Tablets is a nonsteroidal anti-inflammatory drug (NSAID). It may cause an increased risk of serious and sometimes fatal heart and blood vessel problems (eg, heart attack, stroke). The risk may be greater if you already have heart problems or if you take Naproxen Enteric-Coated Tablets for a long time. Do not use Naproxen Enteric-Coated Tablets right before or after bypass heart surgery.

Naproxen Enteric-Coated Tablets may cause an increased risk of serious and sometimes fatal stomach ulcers and bleeding. Elderly patients may be at greater risk. This may occur without warning signs.

Naproxen Enteric-Coated Tablets is used for:

Treating rheumatoid arthritis, osteoarthritis, juvenile arthritis, and ankylosing spondylitis. It may also be used for other conditions as determined by your doctor.

Naproxen Enteric-Coated Tablets is an NSAID. Exactly how it works is not known. It may block certain substances in the body that are linked to inflammation. NSAIDs treat the symptoms of pain and inflammation. They do not treat the disease that causes those symptoms.

Do NOT use Naproxen Enteric-Coated Tablets if:

you are allergic to any ingredient in Naproxen Enteric-Coated Tablets
you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or a nonsteroidal anti-inflammatory drug (NSAID) (eg, ibuprofen, celecoxib)
you have recently had or will be having bypass heart surgery
you are in the last 3 months of pregnancy
you are an taking H₂ blocker (eg, ranitidine) or sucralfate

Contact your doctor or health care provider right away if any of these apply to you.

Before using Naproxen Enteric-Coated Tablets:

Some medical conditions may interact with Naproxen Enteric-Coated Tablets. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have a history of kidney or liver disease, diabetes, or stomach problems (eg, bleeding, perforation, ulcers)
if you have a history of swelling or fluid buildup, asthma, growths in the nose (nasal polyps), or mouth inflammation
if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure), or blood vessel disease, or if you are at risk for any of these diseases
if you have poor health, dehydration or low fluid volume, or low blood sodium levels, you are on a low salt (sodium) diet, you drink alcohol, or you have a history of alcohol abuse

Some MEDICINES MAY INTERACT with Naproxen Enteric-Coated Tablets. Tell your health care provider if you are taking any other medicines, especially any of the following:

Anticoagulants (eg, warfarin), aspirin, corticosteroids (eg, prednisone), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine) because the risk of stomach bleeding may be increased
Probenecid because it may increase the risk of Naproxen Enteric-Coated Tablets???"s side effects
H₂ blockers (eg, ranitidine) or sucralfate because they may decrease Naproxen Enteric-Coated Tablets"s effectiveness
Cyclosporine, hydantoins (eg, phenytoin), lithium, methotrexate, quinolones (eg, ciprofloxacin), sulfonamides (eg, sulfamethoxazole), or sulfonylureas (eg, glipizide) because the risk of their side effects may be increased by Naproxen Enteric-Coated Tablets
Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), or diuretics (eg, furosemide, hydrochlorothiazide) because their effectiveness may be decreased by Naproxen Enteric-Coated Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Naproxen Enteric-Coated Tablets may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Naproxen Enteric-Coated Tablets:

Use Naproxen Enteric-Coated Tablets as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Naproxen Enteric-Coated Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naproxen Enteric-Coated Tablets refilled.
Take Naproxen Enteric-Coated Tablets by mouth. It may be taken with food if it upsets your stomach. Taking it with food may not lower the risk of stomach or bowel problems (eg, bleeding, ulcers). Talk with your doctor or pharmacist if you have persistent stomach upset.
Swallow Naproxen Enteric-Coated Tablets whole. Do not break, crush, or chew before swallowing.
Take Naproxen Enteric-Coated Tablets with a full glass of water (8 oz/240 mL) as directed by your doctor.
If you take antacids or cholestyramine, ask your doctor or pharmacist how to take them with Naproxen Enteric-Coated Tablets.
If you miss a dose of Naproxen Enteric-Coated Tablets and you are taking it regularly, take it as soon as possible. If it is almost time for your next dose, skip the missed dose. Go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Naproxen Enteric-Coated Tablets.

Important safety information:

Naproxen Enteric-Coated Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use this medicine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Serious stomach ulcers or bleeding can occur with the use of Naproxen Enteric-Coated Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking Naproxen Enteric-Coated Tablets with food will NOT reduce the risk of these effects. Contact your doctor or emergency room at once if you develop severe stomach or back pain; black, tarry stools; vomit that looks like blood or coffee grounds; or unusual weight gain or swelling.
Do NOT take more than the recommended dose or use for longer than prescribed without checking with your doctor.
Naproxen Enteric-Coated Tablets has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID in it too. If it does or if you are not sure, check with your doctor or pharmacist.
Do not take aspirin while you are using this medicine unless your doctor tells you to.
Do not switch between different forms of Naproxen Enteric-Coated Tablets (eg, tablets, suspension) unless your doctor tells you to. They may not provide the same amount of medicine to your body.
Naproxen Enteric-Coated Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Naproxen Enteric-Coated Tablets.
Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Naproxen Enteric-Coated Tablets. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Naproxen Enteric-Coated Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
Naproxen Enteric-Coated Tablets should be used with extreme caution in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: Naproxen Enteric-Coated Tablets may cause harm to the fetus. Do not use it during the last 3 months of pregnancy. If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Naproxen Enteric-Coated Tablets while you are pregnant. Naproxen Enteric-Coated Tablets should not be used during labor. Naproxen Enteric-Coated Tablets is found in breast milk. Do not breast-feed while taking Naproxen Enteric-Coated Tablets.

Possible side effects of Naproxen Enteric-Coated Tablets:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; diarrhea; dizziness; drowsiness; gas; headache; heartburn; nausea; stomach upset; stuffy nose.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; trouble breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody or black, tarry stools; change in the amount of urine produced; chest pain; confusion; dark urine; depression; fainting; fast or irregular heartbeat; fever, chills, or persistent sore throat; mental or mood changes; numbness of an arm or leg; one-sided weakness; red, swollen, blistered, or peeling skin; ringing in the ears; seizures; severe headache or dizziness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of hands, legs, or feet; unusual bruising or bleeding; unusual joint or muscle pain; unusual tiredness or weakness; vision or speech changes; vomit that looks like coffee grounds; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include decreased urination; loss of consciousness; seizures; severe dizziness or drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; vomit that looks like coffee grounds.

Proper storage of Naproxen Enteric-Coated Tablets:

Store Naproxen Enteric-Coated Tablets at room temperature, between 59 and 86 degrees F (15 and 30 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Naproxen Enteric-Coated Tablets out of the reach of children and away from pets.

General information:

If you have any questions about Naproxen Enteric-Coated Tablets, please talk with your doctor, pharmacist, or other health care provider.
Naproxen Enteric-Coated Tablets is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Naproxen Enteric-Coated Tablets. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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