NAPROXEN AND PSEUDOEPHEDRINE

(na PROX en and soo doe e FED rin) Brand: Aleve Cool and Sinus, Aleve Sinus & Headache

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What is the most significant information I must know about naproxen and pseudoephedrine?

Always ask a doctor till giving a cough or cool medication to a child. Death can occur from the misuse of cough and cool medicines in very young children.

• Do not use naproxen and pseudoephedrine if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days.

Naproxen can magnify your risk of life-threatening heart or circulation problems, including heart onslaught or stroke. Do not use this medication just till or after having heart bypass surgery (also called coronary artery bypass graft, or CABG).

• Search abnormal medical help if you have symptoms of heart or circulation problems, such as chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

Naproxen can also magnify your risk of serious effects on the stomach or intestines, including bleeding or perforation (forming of a hole). These conditions can be fatal and can occur without warning at any time while you are taking naproxen.

• Call your doctor at once if you have symptoms of bleeding in your stomach or intestines. This includes black, bloody, or tarry stools, or coughing up blood or vomit that looks like coffee grounds.

• Do not take more of this medicine than is recommended. An overdose of naproxen can reason hurt to your stomach or intestines.

What is naproxen and pseudoephedrine?

Naproxen is in a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs). Naproxen works by reducing hormones that reason inflammation and pain in the body.

Pseudoephedrine is a decongestant that shrinks blood vessels in the nasal passages. Dilated blood vessels can reason nasal congestion (stuffy nose).

• The combination of naproxen and pseudoephedrine is used to treat stuffy nose, sinus congestion, cough, and pain or fever caused by the general cool or flu.

Naproxen and pseudoephedrine may also be used for purposes another than those listed in this medicine guide.

What must I discuss with my healthcare provider till taking naproxen and pseudoephedrine?

• Do not use a cough or cool medication if you have used an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Serious, life-threatening side effects can occur if you take a cough or cool medication till the MAO inhibitor has cleared from your body.

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

• NSAIDs can also magnify 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 medicine if you are allergic to naproxen and pseudoephedrine, or if you have a history of allergic reaction to aspirin or another NSAIDs.

• Till taking naproxen and pseudoephedrine, speak your doctor if you are allergic to any drugs, or if you have:

· a history of heart onslaught, stroke, or blood clot;

· heart malady, congestive heart failure, tall blood pressure;

· a history of stomach ulcers or bleeding;

· liver or kidney disease;

· asthma;

· diabetes;

· a thyroid disorder;

· polyps in your nose;

· a bleeding or blood clotting mess; or

· if you smoke.

• If you have any of these conditions, you may not be able to use naproxen and pseudoephedrine, or you may need a dosage adjustment or particular trials during treatment.

• This medicine may be deleterious to an unborn child. Taking naproxen during the recent 3 months of pregnancy may result in birth defects. Do not take naproxen and pseudoephedrine during pregnancy unless your doctor has told you to.

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

How must I take naproxen and pseudoephedrine?

• Use this medicine exactly as directed on the label, or as it has been predesigned by your doctor. Do not use the medicine in larger amounts, or use it for longer than recommended. Cool medication is generally taken only for a short time before your symptoms clear up.

Always ask a doctor till giving a cough or cool medication to a child. Death can occur from the misuse of cough and cool medicines in very young children.

• Do not crush, chew, or interrupt an extended-release tablet. Swallow the pill intact. The extended-release pill is specially made to release medication slowly in the body. Breaking the pill would reason too many of the drug to be released at one time.

• Call your doctor if you have a fever lasting longer than 3 days, if you have new symptoms, or if your condition does not improve after taking this medicine for 7 days.

• If you need to have any type of surgery, speak the surgeon onward of time if you have taken a cool medication within the past little days.

• Store naproxen and pseudoephedrine at room temperature away from moisture and heat.

What happens if I miss a dose?

• Since cool medication is generally taken only as needed, you may not be on a dosing schedule. If you are taking the medicine regularly, take the missed doze as soon as you remember. If it is nearly time for your following doze, skip the missed doze and take the medication at your following regularly scheduled time. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention if you think you have used too many of this medicine.

• Symptoms of a naproxen and pseudoephedrine overdose may include nausea, vomiting, stomach pain, dizziness, feeling restless or nervous, blurred vision, sweating, breathing problems, or seizure (convulsions).

What must I avoid while taking naproxen and pseudoephedrine?

• Do not use any another over-the-counter cough, cool, or pain medicine without first asking your doctor or pharmacist. Naproxen and pseudoephedrine are contained in much medicines accessible over the counter. If you take determined commodity together you may accidentally take too many of either medicine. Read the label of any another medication you are using to see if it contains naproxen or pseudoephedrine.

• Avoid drinking alcohol while taking naproxen and pseudoephedrine. If you drink more than 3 alcoholic beverages a day, naproxen may magnify your risk of stomach bleeding.

What are the possible side effects of naproxen and pseudoephedrine?

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

• Stop taking naproxen and pseudoephedrine and search 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;

· quick, pounding, or uneven heartbeat;

· severe dizziness, anxiety, restless feeling, or nervousness;

· light bruising or bleeding, unusual weakness, fever, chills, body aches, flu symptoms;

· heighten blood pressure (severe headache, blurred vision, trouble concentrating, chest pain, numbness, seizure);

· urinating smaller than normal or not at all;

· skin rash, bruising, severe tingling, numbness, pain, muscle weakness; or

· fever, headache, neck stiffness, chills, heighten sensitivity to easy, purple spots on the skin, and/or seizure (convulsions).

• Hold taking naproxen and pseudoephedrine and conversation to your doctor if you have any of these smaller serious side effects:

· upset stomach, nausea, heartburn, diarrhea, constipation;

· bloating, gas, loss of appetite;

· warmth, tingling, or redness under your skin;

· dizziness, headache, feeling excited or restless;

· sleep problems (insomnia);

· skin rash or itching;

· skin itching or rash; or

· ringing in your ears.

• Side effects another than those listed here may also occur. Conversation to your doctor about any side effect that seems unusual or that is especially bothersome. You may message side effects to FDA at 1-800-FDA-1088.

What another drugs will affect naproxen and pseudoephedrine?

• Till taking naproxen and pseudoephedrine, speak your doctor if you are taking any of the next drugs:

· a blood thinner such as warfarin (Coumadin);

· diuretics (water pills), or blood pressure medications;

· steroids (prednisone and others);

· aspirin or another 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;

· an ACE inhibitor such as benazepril (Lotensin), captopril (Capoten), fosinopril (Monopril), enalapril (Vasotec), lisinopril (Prinivil, Zestril), ramipril (Altace), and others;

· a beta-blocker such as atenolol (Tenormin), carteolol (Cartrol), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal), sotalol (Betapace), timolol (Blocadren), and others; or

· antidepressants such as amitriptyline (Elavil), clomipramine (Anafranil), imipramine (Janimine, Tofranil), and others.

• If you are using any of these drugs, you may not be able to use naproxen and pseudoephedrine or you may need dosage adjustments or particular trials during treatment.

• There may be another drugs not listed that can affect naproxen and pseudoephedrine. Speak your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal commodity, and drugs predesigned by another doctors. Do not start using a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist has information about naproxen and pseudoephedrine written for health professionals that you may read.

Remember, hold this and all another medicines out of the reach of children, never share your medicines with others, and use this medicine only for the indication prescribed.

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