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naproxen and pseudoephedrine

Pronunciation: na PROX en and soo doe e FED rin

Brand: Aleve Cold and Sinus, Aleve Sinus & Headache, Aleve-D Sinus & Cold, Sudafed PSE

What is the most important information I should know about naproxen and pseudoephedrine?

Do not use this medicine if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Naproxen and pseudoephedrine can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen and pseudoephedrine may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen and pseudoephedrine, especially in older adults.

What is naproxen and pseudoephedrine?

Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). Pseudoephedrine is a decongestant.

Naproxen and pseudoephedrine is a combination medicine used to treat stuffy nose, sinus congestion, headache, fever, and minor aches and pains caused by the common cold or flu.

Naproxen and pseudoephedrine may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before taking naproxen and pseudoephedrine?

Naproxen and pseudoephedrine can increase your risk of fatal heart attack or stroke, even if you don't have any risk factors. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG).

Naproxen and pseudoephedrine may also cause stomach or intestinal bleeding, which can be fatal. These conditions can occur without warning while you are using naproxen and pseudoephedrine, especially in older adults.

You should not use this medicine if you are allergic to naproxen or pseudoephedrine, or if you have ever had an asthma attack or severe allergic reaction after taking aspirin or an NSAID.

Ask a doctor or pharmacist if this medicine is safe to use if you have:

  • heart disease, high blood pressure, high cholesterol, diabetes, or if you smoke;
  • a history of heart attack, stroke, or blood clot;
  • a history of stomach ulcers or bleeding;
  • asthma;
  • a thyroid disorder;
  • enlarged prostate, urination problems;
  • liver or kidney disease; or
  • fluid retention.

Taking naproxen during the last 3 months of pregnancy may harm the unborn baby. Do not use naproxen and pseudoephedrine without a doctor's advice if you are pregnant.

Ask a doctor before using this medicine if you are breast-feeding.

Naproxen and pseudoephedrine is not approved for use by anyone younger than 12 years old.

How should I take naproxen and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. Use the lowest dose that is effective in treating your condition.

Swallow the tablet whole and do not crush, chew, or break it.

Take this medicine with a full glass of water.

Take with food or milk if this medicine upsets your stomach.

If you need to have any type of surgery, tell the surgeon ahead of time if you have taken a cold medicine within the past few days.

Call your doctor if you have a fever lasting longer than 3 days, or if your symptoms do not improve after 7 days of taking this medicine.

Store at room temperature away from moisture and heat.

What happens if I miss a dose?

Since cold medicine is used when needed, you may not be on a dosing schedule. Skip any missed dose if it's almost time for your next dose. Do not use two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking naproxen and pseudoephedrine?

Avoid drinking alcohol. It may increase your risk of stomach bleeding.

Avoid taking aspirin while you are taking naproxen and pseudoephedrine.

Ask a doctor or pharmacist before using other cough or cold medicines that may contain similar ingredients.

What are the possible side effects of naproxen and pseudoephedrine?

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning in your eyes, skin pain, red or purple skin rash that spreads and causes blistering and peeling).

Get emergency medical help if you have signs of a heart attack or stroke: chest pain spreading to your jaw or shoulder, sudden numbness or weakness on one side of the body, slurred speech, leg swelling, feeling short of breath.

Stop using this medicine and call your doctor at once if you have:

  • severe dizziness, anxiety, or nervousness;
  • shortness of breath (even with mild exertion);
  • swelling or rapid weight gain;
  • the first sign of any skin rash, no matter how mild;
  • signs of stomach bleeding --bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;
  • liver problems --loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
  • kidney problems --little or no urination, swelling in your feet or ankles, feeling tired or short of breath; or
  • low red blood cells (anemia) --pale skin, feeling light-headed or short of breath, rapid heart rate, trouble concentrating.

Common side effects may include:

  • indigestion, heartburn, stomach pain, nausea;
  • diarrhea, constipation;
  • warmth, tingling, or redness under your skin;
  • sleep problems (insomnia); or
  • feeling restless or excited.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect naproxen and pseudoephedrine?

Ask your doctor before using naproxen and pseudoephedrine if you take an antidepressant. Taking certain antidepressants with an NSAID may cause you to bruise or bleed easily.

Ask a doctor or pharmacist before using naproxen and pseudoephedrine with any other medications, especially:

  • lithium;
  • methotrexate;
  • a blood thinner (warfarin, Coumadin, Jantoven);
  • heart or blood pressure medication, including a diuretic or "water pill"; or
  • steroid medicine (such as prednisone).

This list is not complete. Other drugs may affect naproxen and pseudoephedrine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about naproxen and pseudoephedrine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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