Naproxen Sustained-Release Tablets

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Naproxen Sustained-Release Tablets


Generic Name: Naproxen Sustained-Release Tablets (na-PROX-en)
Brand Name: Naprelan

Naproxen Sustained-Release 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 Sustained-Release Tablets for a long time. Do not use Naproxen Sustained-Release Tablets right before or after bypass heart surgery.

Naproxen Sustained-Release 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 Sustained-Release Tablets is used for:

Treating rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis. It is used to treat tendonitis, bursitis, gout, menstrual cramps, or mild to moderate pain. It may also be used for other conditions as determined by your doctor.

Naproxen Sustained-Release 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 Sustained-Release Tablets if:

  • you are allergic to any ingredient in Naproxen Sustained-Release 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

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

Before using Naproxen Sustained-Release Tablets:

Some medical conditions may interact with Naproxen Sustained-Release 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 or bowel 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 Sustained-Release 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 Sustained-Release Tablets"s side effects
  • 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 Sustained-Release 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 Sustained-Release Tablets

This may not be a complete list of all interactions that may occur. Ask your health care provider if Naproxen Sustained-Release 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 Sustained-Release Tablets:

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

  • Naproxen Sustained-Release Tablets comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Naproxen Sustained-Release Tablets refilled.
  • Take Naproxen Sustained-Release 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.
  • Take Naproxen Sustained-Release Tablets with a full glass of water (8 oz/240 mL) as directed by your doctor.
  • If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with Naproxen Sustained-Release Tablets.
  • If you miss a dose of Naproxen Sustained-Release 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 Sustained-Release Tablets.

Important safety information:

  • Naproxen Sustained-Release Tablets may cause dizziness or drowsiness. These effects may be worse if you take it with alcohol or certain medicines. Use Naproxen Sustained-Release Tablets 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 Sustained-Release Tablets. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking this medicine 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 Sustained-Release Tablets has naproxen in it. Before you start any new medicine, check the label to see if it has naproxen or any other NSAID (eg, ibuprofen) 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 Naproxen Sustained-Release Tablets unless your doctor tells you to.
  • Do not switch between different forms of Naproxen Sustained-Release Tablets (eg, tablets, suspension) unless your doctor tells you to. They may not provide the same amount of medicine to your body.
  • Naproxen Sustained-Release Tablets may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take Naproxen Sustained-Release Tablets.
  • Lab tests, including kidney function, complete blood cell counts, and blood pressure, may be performed while you use Naproxen Sustained-Release 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 Sustained-Release Tablets with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
  • Naproxen Sustained-Release Tablets should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Naproxen Sustained-Release 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 Sustained-Release Tablets while you are pregnant. Naproxen Sustained-Release Tablets should not be used during labor. Naproxen Sustained-Release Tablets is found in breast milk. Do not breast-feed while taking Naproxen Sustained-Release Tablets.

Possible side effects of Naproxen Sustained-Release 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 Sustained-Release Tablets:

Store Naproxen Sustained-Release Tablets at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store away from heat, moisture, and light. Do not store in the bathroom. Keep Naproxen Sustained-Release Tablets out of the reach of children and away from pets.

General information:

  • If you have any questions about Naproxen Sustained-Release Tablets, please talk with your doctor, pharmacist, or other health care provider.
  • Naproxen Sustained-Release 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 Sustained-Release 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
Copyright © 2006 Wolters Kluwer Health, Inc.




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