Naproxen Sodium

Naproxen is used to relieve mild to moderate pain from various conditions. It reduces pain, swelling, and joint stiffness caused by arthritis. Reducing these symptoms helps you do more of your normal daily activities. This medication is known as a nonsteroidal anti-inflammatory drug (NSAID). This form of naproxen is absorbed more slowly into your bloodstream than other forms of naproxen. Therefore, this medication should not be taken to relieve sudden pain (e.g., from gout attacks, menstrual pain). Ask your doctor or pharmacist about other medications that can quickly relieve sudden pain from these conditions.

If you miss a dose, take 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.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start using naproxen and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist. Take this medication by mouth, usually once daily with a full glass of water (8 ounces or 240 milliliters) or as directed by your doctor. Do not lie down for at least 10 minutes after taking this drug. To prevent stomach upset, take this medication with food or milk. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing. Dosage is based on your medical condition and response to treatment. Your doctor will usually start you on the short-acting form of this medication and switch you over to this form of the medication if it provides the proper dose and if your pain/condition lasts for a long time. To reduce your risk of stomach bleeding and other side effects, take this medication at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for a longer time than prescribed. For ongoing conditions such as arthritis, continue taking this medication as directed. Discuss the risks and benefits with your doctor or pharmacist. Use this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. For certain conditions (e.g., arthritis), it may take up to 2 weeks of taking this drug regularly until you get the full benefit. Tell your doctor if your condition persists or worsens.

Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first. This drug should not be used with the following medications because very serious interactions may occur: ketorolac, cidofovir. If you are currently using either of these medications listed above, tell your doctor or pharmacist before starting this medication. Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: antacids, anti-platelet drugs (e.g., cilostazol, clopidogrel), birth control pills that contain drospirenone, bisphosphonates taken by mouth (e.g., alendronate), "blood thinners" (e.g., enoxaparin, heparin, warfarin), certain diabetes drugs (sulfonylureas such as tolazamide), corticosteroids (e.g., prednisone), cyclosporine, desmopressin, digoxin, diuretics/"water pills" (e.g., furosemide, hydrochlorothiazide, triamterene), high blood pressure drugs (including ACE inhibitors such as captopril, angiotensin II receptor blockers such as losartan, beta blockers such as metoprolol), lithium, methotrexate, pemetrexed, phenytoin, potassium, probenecid, SSRI antidepressants (e.g., fluoxetine, sertraline), tenofovir. Check all prescription and nonprescription medicine labels carefully for other pain/fever drugs (NSAIDs such as aspirin, celecoxib, ibuprofen). These drugs are similar to naproxen, so taking one of these drugs while also taking naproxen may increase your risk of side effects. Consult your doctor or pharmacist for more details. However, if your doctor has prescribed low doses of aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue to take the aspirin. Daily use of NSAIDs (e.g., ibuprofen) may decrease aspirin's ability to prevent heart attack/stroke. Consult your doctor or pharmacist for more details and to discuss other possible treatments (e.g., acetaminophen) for your pain/condition. This medication may interfere with certain laboratory tests (including urine 5-HIAA test), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug. This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Do not share this medication with others. This medication has been prescribed for your current condition only. Do not use it later for another condition unless told to do so by your doctor. A different medication may be necessary in that case. Laboratory and/or medical tests (e.g., blood pressure, complete blood count, liver/kidney function tests, electrolyte levels) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details. Non-drug treatment for arthritis that is approved by your doctor (e.g., weight loss if needed, strengthening and conditioning exercises) may help improve your flexibility, range of motion, and joint function. Consult your doctor for specific instructions.

If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe drowsiness/dizziness, persistent nausea/vomiting, ringing in the ears.

Before taking naproxen, tell your doctor or pharmacist if you are allergic to it; or to aspirin or other NSAIDs (e.g., ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), severe kidney disease, severe liver disease. Before using this medication, tell your doctor or pharmacist your medical history, especially of: stomach/intestinal problems (e.g., ulcers, diverticulosis, ulcerative colitis, Crohn's disease), kidney disease, liver disease, poorly controlled diabetes, heart disease (e.g., heart failure, history of heart attack), high blood pressure, stroke, swelling ankles/feet/hands, a severe loss of body water (dehydration), bleeding/clotting problems, blood disorders (e.g., anemia), asthma, growths in the nose (nasal polyps), heartburn, immune system diseases (e.g., lupus erythematosus). This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages. This medicine may cause stomach bleeding. Daily use of alcohol and tobacco may increase your risk for stomach bleeding, especially when combined with this medicine. Limit alcohol and stop smoking. Consult your doctor or pharmacist for more information. Before having surgery, tell your doctor or dentist that you are using this medication. This medication may make you more sensitive to the sun. Avoid prolonged sun exposure, tanning booths, and 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 its side effects, especially stomach bleeding and kidney effects. During the first 6 months of pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the last 3 months of pregnancy due to possible harm to the unborn baby 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.

Store at room temperature between 59-86 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. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

See also Warning section. Nausea, stomach upset, heartburn, diarrhea, constipation, headache, dizziness, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor immediately if any of these unlikely but serious side effects occur: frequent/painful urination, swelling ankles/feet/hands, sudden/unexplained weight gain, vision changes, hearing changes (e.g., ringing in the ears), difficult/painful swallowing, shortness of breath. Stop taking this medication and tell your doctor immediately if any of these rare but very serious side effects occur: mental/mood changes (e.g., depression), unexplained stiff neck, persistent/severe headache, change in the amount of urine, easy bruising/bleeding, fast/pounding heartbeat, signs of infection (e.g., fever, persistent sore throat), skin sores/blisters. This drug may rarely cause serious, possibly fatal liver disease. If you notice any of the following rare but very serious side effects, stop taking this medication and consult your doctor or pharmacist immediately: dark urine, yellowing eyes/skin, persistent nausea/vomiting, unusual tiredness. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Nonsteroidal anti-inflammatory drugs (including naproxen) may rarely increase the risk for a heart attack or stroke. This effect does not apply to low-dose aspirin. (See also Drug Interactions section.) The risk may be greater in people with heart disease or increased risk for heart disease (e.g., due to high blood pressure, diabetes) or with longer use. This drug should not be taken right before or after heart bypass surgery (CABG). Also, this drug may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This bleeding can occur without warning symptoms at any time during treatment. Stop taking this medication and seek immediate medical attention if you notice any of the following rare but very serious side effects: chest pain, severe dizziness, weakness on one side of the body, sudden vision changes, slurred speech, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. (See also Precautions section.) Talk with your doctor or pharmacist about the risks and benefits of treatment with this medication.