ibuprofen and pseudoephedrine

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

Ibuprofen can increase your risk of fatal heart attack or stroke. Do not use this medicine just before or after heart bypass surgery (coronary artery bypass graft, or CABG). Ibuprofen may also cause stomach or intestinal bleeding, which can be fatal.

What is ibuprofen and pseudoephedrine?

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

Ibuprofen and pseudoephedrine is a combination medicine used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the common cold or flu.

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

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

Ibuprofen 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).

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

Do not use ibuprofen and pseudoephedrine if you have used an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, tranylcypromine, and others.

Do not give ibuprofen to a child younger than 12 years old.

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

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

If you are pregnant, you should not take ibuprofen and pseudoephedrine unless your doctor tells you to. Taking an NSAID during the last 20 weeks of pregnancy can cause serious heart or kidney problems in the unborn baby and possible complications with your pregnancy.

Ask a doctor before using this medicine if you are breastfeeding.

How should I take ibuprofen and pseudoephedrine?

Use exactly as directed on the label, or as prescribed by your doctor. An overdose of ibuprofen can damage your stomach or intestines.

If you need surgery, tell the surgeon ahead of time if you have taken this medicine within the past few days.

What happens if I miss a dose?

Since this 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?

Overdose symptoms may include vomiting, stomach pain, diarrhea, ringing in your ears, severe drowsiness, agitation, sweating, coughing up blood, weak or shallow breathing, fainting, or seizure (convulsions).

What should I avoid while taking ibuprofen 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 ibuprofen and pseudoephedrine?

• confusion, severe drowsiness, ringing in your ears, severe dizziness, feeling like you might pass out;
• fast, pounding, or uneven heartbeat;
• easy bruising or bleeding (nosebleeds, bleeding gums);
• a 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, stomach pain (upper right side), tiredness, itching, 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
• nerve problems --fever, headache, neck stiffness, chills, increased sensitivity to light, seizure (convulsions).

Common side effects may include:

• diarrhea, constipation;
• headache, dizziness, drowsiness, weakness;
• upset stomach, nausea, vomiting, loss of appetite;
• feeling anxious or excited;
• sleep problems (insomnia); or
• flushing (warmth, redness, or tingly feeling).

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 ibuprofen and pseudoephedrine?

Ask a doctor or pharmacist before using ibuprofen 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 ibuprofen 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 ibuprofen and pseudoephedrine.