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Generic Name: pseudoephedrine/naproxen (SOO-doe-e-FED-rin/na-PROX-en)

Brand Name: Examples include Aleve Cold and Sinus and Sudafed Pressure + Pain 12 Hour

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

Pseudoephedrine/naproxen 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.

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Pseudoephedrine/naproxen is used for:

Temporarily relieving symptoms, such as sinus pressure, minor body aches and pain, headache, fever, and nasal and sinus congestion, due to colds, sinus problems, and flu. It may also be used for other conditions as determined by your doctor.

Pseudoephedrine/naproxen is an NSAID and decongestant combination. The NSAID works in the brain to help decrease pain. The decongestant works by constricting blood vessels and reducing swelling in the nasal passages, which relieves congestion and pressure.

Do NOT use pseudoephedrine/naproxen if:

  • you are allergic to any ingredient in pseudoephedrine/naproxen
  • you have had a severe allergic reaction (eg, severe rash, hives, trouble breathing, growths in the nose, dizziness) to aspirin or an NSAID (eg, celecoxib, ibuprofen)
  • you have recently had or will be having bypass heart surgery
  • you have severe high blood pressure, severe heart blood vessel disease, a rapid heartbeat, or severe heart problems
  • you are taking furazolidone or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the last 14 days
  • you are in the last 3 months of pregnancy
  • you are taking another medicine that contains naproxen

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

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Before using pseudoephedrine/naproxen:

Some medical conditions may interact with pseudoephedrine/naproxen. 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 adrenal gland problems (eg, an adrenal gland tumor), stomach or bowel problems (eg, bleeding, perforation, ulcers, persistent or returning stomach pain or heartburn), diabetes, glaucoma or increased eye pressure, an enlarged prostate or other prostate problems, seizures, thyroid problems, kidney problems, or liver problems
  • if you have high blood pressure, blood disorders, bleeding or clotting problems, heart problems (eg, heart failure, irregular heartbeat), a blood vessel disease (eg, arteriosclerosis), or if you are at risk of any of these diseases
  • if you have a history of swelling or fluid buildup, lupus, asthma, growths in the nose (nasal polyps), or mouth inflammation
  • 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; you smoke; or you have a history of alcohol abuse
  • if you are taking medicine for high blood pressure

Some MEDICINES MAY INTERACT with pseudoephedrine/naproxen. Tell your health care provider if you are taking any other medicines, especially any of the following:

  • Anticoagulants (eg, warfarin), antiplatelet medicines (eg, clopidogrel, prasugrel), aspirin, corticosteroids (eg, prednisone), factor Xa inhibitors (eg, enoxaparin), heparin, or selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), or other NSAIDs (eg, ibuprofen) because the risk of stomach bleeding may be increased
  • Digoxin, furazolidone, linezolid, MAOIs (eg, phenelzine), probenecid, tricyclic antidepressants (eg, amitriptyline), or urinary alkalinizers (eg, sodium bicarbonate) because they may increase the risk of pseudoephedrine/naproxen’s side effects
  • Bisphosphonates (eg, alendronate), bromocriptine, cyclosporine, droxidopa, 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 pseudoephedrine/naproxen
  • Angiotensin-converting enzyme (ACE) inhibitors (eg, enalapril), beta-blockers (eg, propranolol), diuretics (eg, furosemide, hydrochlorothiazide), guanadrel, guanethidine, mecamylamine, methyldopa, or reserpine because their effectiveness may be decreased by pseudoephedrine/naproxen

This may not be a complete list of all interactions that may occur. Ask your health care provider if pseudoephedrine/naproxen 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 pseudoephedrine/naproxen:

Use pseudoephedrine/naproxen as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Take pseudoephedrine/naproxen by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation. 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 pseudoephedrine/naproxen with a full glass of water (8 oz/240 mL) as directed by your doctor.
  • Swallow pseudoephedrine/naproxen whole. Do not break, crush, or chew before swallowing.
  • If you take antacids, cholestyramine, or sucralfate, ask your doctor or pharmacist how to take them with pseudoephedrine/naproxen.
  • If you miss a dose of pseudoephedrine/naproxen 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 and 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 pseudoephedrine/naproxen.

Important safety information:

  • Pseudoephedrine/naproxen may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use pseudoephedrine/naproxen 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 pseudoephedrine/naproxen. Taking it in high doses or for a long time, smoking, or drinking alcohol increases the risk of these side effects. Taking pseudoephedrine/naproxen 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.
  • Talk to your doctor before you take pseudoephedrine/naproxen if you drink more than 3 drinks with alcohol per day.
  • Do not take diet or appetite control medicines while you are taking pseudoephedrine/naproxen without checking with you doctor.
  • Pseudoephedrine/naproxen has naproxen and pseudoephedrine in it. Before you start any new medicine, check the label to see if it has naproxen, any other NSAID (eg, ibuprofen), pseudoephedrine, or another decongestant in it too. If it does or if you are not sure, check with your doctor or pharmacist.
  • Do NOT take more than the recommended dose or use for longer than directed without checking with your doctor.
  • Contact your doctor if you have trouble swallowing, severe or persistent heartburn, or if it feels like the tablet is stuck in your throat.
  • If your congestion does not get better within 7 days or you have a fever that does not get better within 3 days, check with your doctor. If your symptoms get worse or if you have new symptoms, check with your doctor.
  • Tell your doctor or dentist that you take pseudoephedrine/naproxen before you receive any medical or dental care, emergency care, or surgery.
  • Do not take aspirin while you are taking pseudoephedrine/naproxen unless your doctor tells you to.
  • Pseudoephedrine/naproxen may interfere with certain lab tests. Be sure your doctor and lab personnel know that you take pseudoephedrine/naproxen.
  • Diabetes patients – Pseudoephedrine/naproxen may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
  • Use pseudoephedrine/naproxen with caution in the ELDERLY; they may be more sensitive to its effects, especially stomach bleeding and kidney problems.
  • Pseudoephedrine/naproxen should not be used in CHILDREN younger than 12 years old without first checking with the child’s doctor; safety and effectiveness in these children have not been confirmed.
  • PREGNANCY and BREAST-FEEDING: Pseudoephedrine/naproxen may cause harm to the fetus. Do not take pseudoephedrine/naproxen 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 taking pseudoephedrine/naproxen while you are pregnant. Pseudoephedrine/naproxen should not be taken during labor. Pseudoephedrine/naproxen is found in breast milk. Do not breast-feed while taking pseudoephedrine/naproxen.

Possible side effects of pseudoephedrine/naproxen:

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; excitability; gas; headache; heartburn; nausea; nervousness or anxiety; trouble sleeping; upset stomach; vomiting; weakness.

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

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue; wheezing); 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; hallucinations; loss of appetite; mood or mental changes; numbness of an arm or leg; one-sided weakness; pale stools; persistent trouble sleeping; red, swollen, blistered, or peeling skin; restlessness; ringing in the ears; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe or persistent stomach pain or nausea; severe vomiting; shortness of breath; sudden or unexplained weight gain; swelling of the hands, legs, or feet; tremor; 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 skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; confusion; decreased urination; hallucinations; loss of consciousness; seizures; severe dizziness, lightheadedness, or headache; severe drowsiness; severe nausea or stomach pain; slow or troubled breathing; unusual bleeding or bruising; unusually fast, slow, or irregular heartbeat; vomit that looks like coffee grounds.

Proper storage of pseudoephedrine/naproxen: Store pseudoephedrine/naproxen 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 pseudoephedrine/naproxen out of the reach of children and away from pets.

General information:

  • If you have any questions about pseudoephedrine/naproxen, please talk with your doctor, pharmacist, or other health care provider.
  • Pseudoephedrine/naproxen 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.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take pseudoephedrine/naproxen or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about pseudoephedrine/naproxen. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to pseudoephedrine/naproxen. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your healthcare provider for complete information about the risks and benefits of using pseudoephedrine/naproxen.

Issue Date: March 6, 2013 Database Edition Copyright © 2013 Wolters Kluwer Health, Inc.

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