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NAPROXEN
NAPROXEN ENTERIC COATED TABLET - ORAL

Important Note

The following information is intended to supplement, not substitute for, the expertise and judgment of your physician, pharmacist or other healthcare professional. It should not be construed to indicate that use of the drug is safe, appropriate, or effective for you. Consult your healthcare professional before using this drug.

NAPROXEN ENTERIC COATED TABLET - ORAL

(nah-PROX-en)

COMMON BRAND NAME(S): EC-Naprosyn

Uses

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID), which relieves pain and swelling (inflammation). It is used to treat arthritis and other painful conditions. This drug works by blocking the enzyme in your body that makes prostaglandins. Decreasing prostaglandins helps to reduce pain and swelling. Enteric-coated tablets of naproxen are a delayed-release form of the drug. They are not intended to be used for conditions that require immediate pain relief such as acute gout, menstrual pain, tendonitis or bursitis. A quicker-acting dosage form should be used for these conditions.

How To Use

Take this medication by mouth with or without food. Swallow the tablet whole. Do not break, crush or chew the tablets. Take with a full glass (8 oz or 240 ml) unless your doctor directs you otherwise. Do not lie down for at least 30 minutes after taking this drug. Do not take this medication with antacids or other drugs that decrease stomach acid. The dosage is based on your medical condition and response to therapy. In certain conditions (e.g., arthritis), it may take up to two weeks, taken regularly, before the full benefits of this drug take effect.

Side Effects

Upset stomach, nausea, vomiting, heartburn, headache, diarrhea, constipation, drowsiness, and dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: stomach pain, swelling of the hands or feet, sudden or unexplained weight gain, ringing in the ears (tinnitus). Tell your doctor immediately if any of these unlikely but serious side effects occur: vision changes, rapid or pounding heartbeat, easy bruising or bleeding. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: change in amount of urine, severe headache, very stiff neck, mental/mood changes, persistent sore throat or fever. This drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. If you notice any of the following unlikely but very serious side effects, stop taking naproxen and consult your doctor or pharmacist immediately: black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. This drug may rarely cause serious (possibly fatal) liver disease. If you notice any of the following highly unlikely but very serious side effects, stop taking naproxen and consult your doctor or pharmacist immediately: yellowing eyes and skin, dark urine, unusual/extreme tiredness. An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, severe dizziness, trouble breathing. If you notice other effects not listed above, contact your doctor or pharmacist.

Precautions

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: severe kidney disease, allergies to aspirin or other NSAIDs (e.g., ibuprofen, celecoxib). Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney disease, liver disease, poorly controlled diabetes, stomach problems (e.g., bleeding, ulcers), heart disease (e.g., congestive heart failure), high blood pressure, swelling (edema, fluid retention), dehydration, blood disorders (e.g., anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps), history of an allergic reaction with symptoms of lip/tongue/throat swelling (angioedema), any allergies in addition to those listed above. This drug may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase your risk for stomach bleeding. Consult your doctor or pharmacist for more information. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths or sunlamps. Use a sunscreen and wear protective clothing when outdoors. Caution is advised when using this drug in the elderly because they may be more sensitive to the side effects of the drug, especially stomach bleeding and kidney effects. This medication should be used only when clearly needed during the first 6 months of pregnancy. It is not recommended for use during the last 3 months of pregnancy due to the potential for fetal harm and interference with normal labor/delivery. Discuss the risks and benefits with your doctor. This drug passes into breast milk. While there have been no reports of harm to nursing infants, consult your doctor before breast-feeding.

Drug Interactions

Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription products you may use, especially of: alendronate, other medications for arthritis (e.g., aspirin, methotrexate), "blood thinners" (e.g., warfarin), corticosteroids (e.g., prednisone), cyclosporine, high blood pressure drugs (including ACE inhibitors such as captopril, angiotensin II receptor antagonists such as losartan, and beta-blockers such as metoprolol), lithium, other NSAIDs (e.g., ibuprofen, celecoxib), probenecid, stomach/ulcer medication (e.g., antacids, sucralfate, H2-blockers such as famotidine, proton pump inhibitors such as omeprazole), "water pills" (diuretics such as furosemide, hydrochlorothiazide, triamterene). This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use this drug. Check all prescription and nonprescription medicine labels carefully since many contain pain relievers/fever reducers (NSAIDs such as aspirin or ibuprofen) which are similar to this drug. Aspirin, as prescribed by your doctor for reasons such as heart attack or stroke prevention (usually these dosages are 81-325 mg per day), should be continued. Consult your doctor or pharmacist for more details. Do not start or stop any medicine without doctor or pharmacist approval.

Overdose

If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include: severe stomach pain, coffee ground-like vomit, unusually fast or slow heartbeat, trouble breathing, extreme drowsiness, loss of consciousness, or seizures.

Notes

Do not share this medication with others. Laboratory and/or medical tests may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you are prescribed this drug on a regular schedule (not just "as needed") and you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature between 59 and 86 degrees F (15-30 degrees C) away from light and moisture. Do not store in the bathroom. Keep all medicines away from children and pets.