ESOMEPRAZOLE AND NAPROXEN

(ee soe MEP ra zole and na PROX en) Brand: Vimovo

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

• The naproxen in this medication may reason life-threatening heart or circulation problems such as heart onslaught or stroke, especially if you use it long term. Do not use this medication just till or after heart bypass surgery (coronary artery bypass graft, or CABG).

• Get abnormal medical help if you have chest pain, weakness, shortness of breath, slurred speech, or problems with vision or balance.

• Naproxen may also reason 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 while you are taking esomeprazole and naproxen, especially in older adults.

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

• Taking naproxen during the recent 3 months of pregnancy may result in birth defects. Do not take esomeprazole and naproxen during pregnancy unless your doctor has told you to.

What is esomeprazole and naproxen?

• Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It works by reducing substances in the body that reason inflammation, pain, and fever.

• Esomeprazole is a proton exhaust inhibitor. It decreases the amount of acid produced in the stomach.

• The combination of esomeprazole and naproxen is used to treat symptoms of osteoarthritis, rheumatoid arthritis, and ankylosing spondylitis. The esomeprazole in this medicine helps reduce the risk of stomach ulcers in people who may be at risk for them while receiving treatment with an NSAID.

• Esomeprazole and naproxen may also be used for purposes not listed in this medicine guide.

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

• You must not use this medicine if you are allergic to esomeprazole (Nexium) or naproxen (Aleve, Anaprox, Naprosyn, and others), or if you have ever had a severe allergic reaction to aspirin or another NSAIDs. Do not use esomeprazole and naproxen just till or after heart bypass surgery (coronary artery bypass graft, or CABG).

• The naproxen in this medication may reason life-threatening heart or circulation problems such as heart onslaught or stroke, especially if you use it long term.

• To create certain you can safely take esomeprazole and naproxen, speak your doctor if you have any of these another conditions:

· liver or kidney disease;

· heart malady, tall blood pressure, fluid retention, or a history of stroke, heart onslaught, or congestive heart failure;

· low levels of magnesium in your blood;

· a bleeding or blood clotting mess, such as hemophilia;

· a history of stomach ulcer, stomach bleeding, or intestinal mess (Crohn's malady, ulcerative colitis);

· asthma, or a history of allergic reaction to aspirin, especially aspirin triad syndrome; or

· if you smoke.

• Taking esomeprazole may magnify your risk of bone fracture in the hip, wrist, or spine. This effect has occurred mostly in people who have taken the medicine long term or at tall doses, and in those who are age 50 and older. It is not clear whether esomeprazole is the actual reason of an heighten risk of fracture. Speak your doctor if you have osteoporosis or osteopenia (low bone mineral density).

• FDA pregnancy category D. Speak your doctor if you are pregnant or plan to become pregnant during treatment. Taking naproxen during the recent 3 months of pregnancy may result in birth defects. Do not take esomeprazole and naproxen during pregnancy unless your doctor has told you to.

• Naproxen can pass into breast milk and may harm a nursing child. You must not breast-feed while taking esomeprazole and naproxen.

How must I take esomeprazole and naproxen?

• Take exactly as predesigned by your doctor. Do not take in larger or less amounts or for longer than recommended. Follow the directions on your prescription label. Esomeprazole and naproxen is generally taken 2 times every day, at least 30 minutes till a meal. Follow your doctor's instructions.

• Do not crush, chew, or interrupt an enteric coated pill. Swallow it intact. The enteric coated pill has a particular coating to protect your stomach. Breaking the pill will hurt this coating.

• To be certain this medicine is not causing deleterious effects, your blood may need to be tested often. Your blood pressure and kidney or liver function may also need to be tested. You may also need eye exams if you have any changes in your vision. Visit your doctor regularly.

• This medicine can reason unusual results with determined medical trials. Speak any doctor who treats you that you are using esomeprazole and naproxen.

• Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

• Take the missed doze as soon as you remember. Skip the missed doze if it is nearly time for your following scheduled doze. Do not take extra medication to create up the missed dose.

What happens if I overdose?

• Search abnormal medical attention or call the Poison Help line at 1-800-222-1222.

• Overdose symptoms may include feeling weak or weary, nausea, vomiting, stomach pain or discomfort, severe dizziness or drowsiness, bleeding, uncontrolled muscle movements, weak or shallow breathing, or loss of coordination.

What must I avoid while taking esomeprazole and naproxen?

• Ask a doctor or pharmacist till using any another pain or arthritis medication. Much medicines accessible over the counter contain naproxen or similar medicines (such as aspirin, ibuprofen, or ketoprofen). Taking determined commodity together can reason you to get too many of a determined drug. Check the label to see if a medication contains naproxen or other NSAID.

• This medicine can reason diarrhea, which may be a sign of a new infection. If you have diarrhea that is watery or bloody, stop taking esomeprazole and naproxen and call your doctor. Do not use anti-diarrhea medication unless your doctor tells you to.

• Ask your doctor till using an antidepressant such as citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac, Sarafem, Symbyax), fluvoxamine (Luvox), paroxetine (Paxil), or sertraline (Zoloft). Taking any of these drugs with an NSAID may magnify your risk of stomach bleeding.

• Avoid drinking alcohol. It may magnify your risk of stomach bleeding.

What are the possible side effects of esomeprazole and naproxen?

• 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 using esomeprazole and naproxen and call your doctor at once if you have a serious side effect such as:

· pale skin, light bruising, unusual bleeding, or any bleeding that will not stop;

· chest pain or hard feeling, pain spreading to the hand or shoulder, nausea, sweating, common ill feeling;

· sudden numbness or weakness, especially on one side of the body;

· sudden headache, confusion, problems with vision, speech, or balance;

· pain, swelling, warmth, or redness in one or both legs;

· low magnesium (dizziness, confusion, quick or uneven heart course, jerking muscle movements, jittery feeling, muscle cramps, muscle weakness or limp feeling, cough or choking feeling, seizure);

· urinating smaller than normal or not at all;

· swelling, rapid weight gain, feeling short of breath (even with mild exertion);

· diarrhea that is watery or bloody;

· black, bloody, or tarry stools, coughing up blood or vomit that looks like coffee grounds;

· nausea, upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

· severe skin reaction -- fever, sore throat, swelling in your person or tongue, burning in your eyes, skin pain, followed by a red or purple skin rash that spreads (especially in the person or upper body) and causes blistering and peeling.

• Smaller serious side effects may include:

· constipation, mild diarrhea; or

· mild stomach pain.

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

What another drugs will affect esomeprazole and naproxen?

• Esomeprazole must not be taken together with atazanavir (Reyataz) or nelfinavir (Viracept). Speak your doctor if you are taking either of these medications to treat HIV or AIDS.

• Speak your doctor about all another medicines you use, especially:

· clopidogrel (Plavix) or cilostazol (Pletal);

· cholestyramine (Prevalite, Questran);

· digoxin (digitalis, Lanoxin);

· lithium (Eskalith, Lithobid, others);

· methotrexate (Rheumatrex, Trexall);

· probenecid (Benemid);

· rifampin (Rifadin, Rifater, Rifamate);

· St. John's wort;

· tacrolimus (Prograf);

· an iron supplement;

· a blood thinner such as warfarin (Coumadin, Jantoven);

· steroids (prednisone and others);

· a diuretic (water pill) such as furosemide (Lasix);

· antifungal medicine such as ketoconazole (Nizoral) or voriconazole (Vfend);

· aspirin or another NSAIDs such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn, Naprelan, Treximet), celecoxib (Celebrex), diclofenac (Arthrotec, Voltaren), indomethacin (Indocin), meloxicam (Mobic), and others; or

· heart or blood pressure medicine such as atenolol (Tenormin, Tenoretic), benazepril (Lotensin), carvedilol (Coreg), fosinopril (Monopril), lisinopril (Prinivil, Zestril), metoprolol (Dutoprol, Lopressor, Toprol), propranolol (Inderal, InnoPran), ramipril (Altace), and others.

• This list is not complete and another drugs may interact with esomeprazole and naproxen. Speak your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal commodity. Do not start a new medicine without telling your doctor.

Where can I get more information?

• Your pharmacist can provide more information about esomeprazole and naproxen.

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.

Disclaim: Each effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses external of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way must be construed to indicate that the drug or drug combination is safety, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the help of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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