Naproxen OTC Treatment Report

Precautions

Instructions

Side Effects

Interactions

Taking an NSAID can increase your risk of life-threatening heart or circulation problems, including heart attack or stroke. This risk will increase the longer you use an NSAID. Do not use this medicine just before or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

NSAIDs can also increase your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and gastrointestinal effects can occur without warning at any time while you are taking an NSAID. Older adults may have an even greater risk of these serious gastrointestinal side effects.

Do not use this medication if you are allergic to naproxen, or if you have a history of allergic reaction to aspirin or other NSAIDs.

Before taking naproxen, tell your doctor if you are allergic to any drugs, or if you have:

• a history of heart attack, stroke, or blood clot;
• heart disease, congestive heart failure, high blood pressure;
• a history of stomach ulcers or bleeding;
• liver or kidney disease;
• asthma;
• polyps in your nose;
• a bleeding or blood clotting disorder; or
• if you smoke.

If you have any of these conditions, you may not be able to use naproxen, or you may need a dosage adjustment or special tests during treatment.

FDA pregnancy category C. This medication may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the last 3 months of pregnancy may result in birth defects. Do not take naproxen during pregnancy unless your doctor has told you to.

Naproxen can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give this medicine to a child younger than 2 years old without the advice of a doctor.

Do not use any other over-the-counter cold, allergy, or pain medication without first asking your doctor or pharmacist. Many medicines available over the counter contain aspirin or other medicines similar to naproxen (such as ibuprofen or ketoprofen). If you take certain products together you may accidentally take too much of this type of medication. Read the label of any other medicine you are using to see if it contains aspirin, ibuprofen, or ketoprofen.

Do not drink alcohol while taking naproxen. Alcohol can increase the risk of stomach bleeding caused by naproxen.

Avoid prolonged exposure to sunlight. Naproxen may increase the sensitivity of the skin to sunlight. Use a sunscreen and wear protective clothing when exposure to the sun is unavoidable.

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Since naproxen is sometimes taken as needed, you may not be on a dosing schedule. If you are taking the medication regularly, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.

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Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop taking naproxen and seek medical attention or call your doctor at once if you have any of these serious side effects:

• chest pain, weakness, shortness of breath, slurred speech, problems with vision or balance;
• black, bloody, or tarry stools;
• coughing up blood or vomit that looks like coffee grounds;
• swelling or rapid weight gain;
• urinating less than usual or not at all;
• nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
• bruising, severe tingling, numbness, pain, muscle weakness; or
• fever, headache, neck stiffness, chills, increased sensitivity to light, purple spots on the skin, and/or seizure (convulsions).

Less serious side effects may include:

• upset stomach, mild heartburn or stomach pain, diarrhea, constipation;
• bloating, gas;
• dizziness, headache, nervousness;
• skin itching or rash;
• blurred vision; or
• ringing in your ears.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

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Tell your doctor if you are taking an antidepressant such as citalopram (Celexa), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), sertraline (Zoloft), or venlafaxine (Effexor). Taking any of these drugs with naproxen may cause you to bruise or bleed easily.

Before taking naproxen, tell your doctor if you are taking any of the following drugs:

• a blood thinner such as warfarin (Coumadin);
• lithium (Eskalith, Lithobid);
• methotrexate (Rheumatrex, Trexall);
• diuretics (water pills) such as furosemide (Lasix);
• steroids (prednisone and others);
• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as diclofenac (Cataflam, Voltaren), etodolac (Lodine), flurbiprofen (Ansaid), indomethacin (Indocin), ketoprofen (Orudis), ketorolac (Toradol), mefenamic acid (Ponstel), meloxicam (Mobic), nabumetone (Relafen), piroxicam (Feldene), and others; or
• an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others.

If you are using any of these drugs, you may not be able to use naproxen or you may need dosage adjustments or special tests during treatment.

There may be other drugs not listed that can affect naproxen. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Aflaxen, Aleve, Aleve Caplet, Aleve Easy Open Arthritis, Aleve Gelcap, Anaprox, Anaprox-DS, EC-Naprosyn, Midol Extended Relief, Naprelan '375', Naprelan '500', Naprosyn, naproxen, Comfort Pac with Naproxen, Leader Naproxen Sodium, Naprelan '750', and Naproxen Sodium DS

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