Naproxen/esomeprazole (By mouth)

Introduction

Esomeprazole Magnesium (es-oh-MEP-ra-zole mag-NEE-zee-um), Naproxen (na-PROX-en)

Treats pain caused by arthritis or ankylosing spondylitis. This medicine is a combination of a nonsteroidal anti-inflammatory drug (NSAID) and a proton pump inhibitor (PPI) that helps protect against ulcers in your stomach or intestines.

Brand Name(s)

Vimovo

When This Medicine Should Not Be Used

How to Use This Medicine

Delayed Release Tablet

• Your doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to.
• It is best to take this medicine on an empty stomach.Take this medicine 30 minutes before a meal.
• Delayed-release tablet: Swallow the tablet whole with water. Do not break, crush, chew, or dissolve it.
• Your doctor may tell you to take vitamin D and calcium supplements while you are using this medicine.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you also use rifampin (Rifadin®, Rimactane®), St John's wort, a blood thinner (such as warfarin, Coumadin®), a steroid medicine (such as cortisone, dexamethasone, hydrocortisone, methylprednisolone, prednisolone, prednisone, Decadron®, Medrol®, or Orapred®), or a diuretic or water pill (such as bumetanide, chlorothiazide, ethacrynic acid, furosemide, hydrochlorothiazide [HCTZ], indapamide, metolazone, torsemide, Bumex®, Demadex®, Diuril®, Edecrin®, Lasix®, Lozol®, or Zaroxolyn®).
• Do not use any other NSAID medicine unless your doctor tells you to. Some examples of other NSAIDs are aspirin, diclofenac, ibuprofen, Advil®, Aleve®, Celebrex®, Ecotrin®, Motrin®, Naprosyn®, or Voltaren®.
• Make sure your doctor knows if you also use cholestyramine (Questran®), cilostazol (Pletal®), cyclosporine (Gengraf®, Neoral®, Sandimmune®), diazepam (Valium®), digoxin (Lanoxin®), erlotinib (Tarceva®), iron supplements, ketoconazole (Nizoral®), lithium (Eskalith®), methotrexate (Rheumatrex®), probenecid (Benemid®), tacrolimus (Prograf®), or voriconazole (Vfend®).
• Tell your doctor if you use blood pressure medicine (such as atenolol, enalapril, lisinopril, losartan, metoprolol, olmesartan, propranolol, valsartan, Accupril®, Cozaar®, Diovan®, Inderal®, Lotensin®, Lotrel®, Monopril®, Prinivil®, Toprol®, or Zestril®), medicine to treat depression (such as fluoxetine, paroxetine, Celexa®, Lexapro®, Paxil®, or Zoloft®), diabetes medicine that you take by mouth (such as glyburide, Glucotrol®, or Glucovance®), medicine for seizures (such as phenytoin, Dilantin®), or medicine to treat HIV infection (such as atazanavir, nelfinavir, saquinavir, Fortovase®, Invirase®, Reyataz®, or Viracept®).

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding. Do not use this medicine during the later part of pregnancy, unless your doctor tells you to.
• Make sure your doctor knows if you have seizures, a history of low magnesium levels in your blood, Crohn disease, or ulcers or other stomach problems. Tell your doctor if you have kidney disease, liver disease, anemia, asthma, bleeding problems, osteoporosis, congestive heart failure (CHF), fluid retention or swelling, high blood pressure, or any other heart or circulation problems.
• Naproxen may increase your risk of heart attack or stroke. This is more likely in people who already have heart disease or who use this medicine for a long time. Get emergency help right away if you have any symptoms of a heart attack or stroke. Some possible symptoms are chest pain or discomfort, uneven heartbeat, pain that spreads to your arm or jaw, unusual sweating, feeling faint, trouble breathing, slurred speech, or weakness on one side of your body.
• Naproxen may cause bleeding in your stomach or intestines. This is more likely if you have had a stomach ulcer in the past, if you smoke or drink alcohol regularly, are older than 60 years of age, are in poor health, or use certain medicines (such as steroids or a blood thinner).
• Stop using this medicine and tell your doctor right away if you have seizures, dizziness, a fast or pounding heartbeat, or muscle spasms. These may be symptoms of hypomagnesemia (low magnesium in the blood). This is more likely to occur if you take this medicine longer than 1 year or if you take it with digoxin or certain diuretics (water pills).
• Tell your doctor right away if you have diarrhea that does not go away, stomach pain, and fever while taking this medicine. These may be symptoms of Clostridium difficile colitis (also called C diff). C diff is an inflammation of your large intestine that causes diarrhea. You have a higher risk of this condition if you also use antibiotics, are elderly, or have other health conditions.If you have severe diarrhea, ask your doctor before taking any medicine to stop the diarrhea.
• Serious allergic reactions can occur during treatment with this medicine. Check with your doctor right away if you have any of the following symptoms: blistering, peeling, or loose skin, chills, cough, diarrhea, fever, itching, joint or muscle pain, red skin rash, sore throat, sores, ulcers, or white spots in the mouth or on the lips, or unusual tiredness or weakness.
• Check with your doctor right away if you have any symptoms of liver problems, such as dark urine or pale stools, nausea, vomiting, loss of appetite, pain in your upper stomach, or yellow skin or eyes.
• This medicine may increase your risk of broken bones in the hip, wrist, and spine. This is more likely if you are older than 50 years of age, if you receive high doses of this medicine, or if you use it for longer than 1 year.
• Make sure any doctor or dentist who treats you knows that you are using this medicine. This medicine may affect the results of certain medical tests.
• This medicine may make you dizzy or drowsy. Do not drive, use machines, or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.You may need blood or other lab tests to check for side effects.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Blistering, peeling, red skin rash, sometimes with a fever
• Bloody, black, or tarry stools
• Change in how much or how often you urinate, bloody or cloudy urine
• Chest pain, trouble breathing, or coughing up blood
• Dark-colored urine or pale stools
• Fast, slow, pounding, or uneven heartbeat
• Nausea, vomiting, loss of appetite, or pain in your upper stomach
• Numbness or weakness in your arm or leg, or on one side of your body
• Seizure, tremors, muscle spasms or cramps
• Severe diarrhea that does not go away, stomach pain, and fever
• Sudden or severe headache, problems with vision, speech, or walking
• Unexplained weight gain, swelling in your hands, ankles, or feet
• Unusual bleeding, bruising, or weakness
• Vomiting of blood or something that looks like coffee grounds

If you notice these less serious side effects, talk with your doctor:

• Diarrhea, constipation, heartburn, indigestion, gas, or stomach pain
• Dizziness or drowsiness
• Mild skin rash or itching

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088