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

Treats pain, arthritis, ankylosing spondylitis, and juvenile idiopathic arthritis. This medicine contains an NSAID and a proton pump inhibitor (PPI).

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 medicine to use. Do not use more than directed.
• Take this medicine at least 30 minutes before a meal.
• Swallow the tablet whole with water. Do not break, crush, chew, or dissolve it.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.

Drugs and Foods to Avoid:

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

• Do not use any other NSAID medicine unless your doctor tells you to. Some examples of other NSAIDs are aspirin, celecoxib, diclofenac, diflunisal, ibuprofen, or salsalate.
• Do not use this medicine together with medicines containing rilpivirine.
• Some foods and medicines can affect how naproxen/esomeprazole works. Tell your doctor if you are using any of the following:
  • Cholestyramine, cilostazol, clopidogrel, cyclosporine, diazepam, digoxin, erlotinib, ketoconazole, lithium, methotrexate, mycophenolate mofetil, pemetrexed, probenecid, rifampin, St John's wort, tacrolimus, or voriconazole
  • Blood pressure medicines (ACE inhibitors, ARBs, beta blockers)
  • Blood thinner (including dicumarol, heparin, warfarin)
  • Diuretic (water pill)
  • Iron supplements
  • Medicine to treat depression (including SNRIs, SSRIs)
  • Medicine to treat HIV infection (including atazanavir, nelfinavir, saquinavir, ritonavir)
  • Steroid medicine
• Do not drink alcohol while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding. Do not use this medicine during the later part of your pregnancy, unless your doctor says it is okay.
• Tell your doctor if you have kidney disease, liver disease, asthma, bleeding problems, Crohn disease, ulcers or other stomach problems, lupus, osteoporosis, heart failure, high blood pressure, any heart or blood vessel problems, or a recent heart attack. Tell your doctor if you drink alcohol.
• This medicine may cause the following problems:
  • Increased risk of blood clots, heart attack, stroke, or heart failure
  • Stomach or bowel problems (including bleeding, ulcers, or perforation)
  • Liver problems
  • High blood pressure
  • Kidney problems, including acute tubulointerstitial nephritis
  • Serious skin reactions, including exfoliative dermatitis, Stevens-Johnson syndrome, toxic epidermal necrolysis, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS)
  • Increased risk of broken bones in the hip, wrist, or spine (more likely if used several times per day or longer than 1 year)
  • Lupus
  • Fundic gland polyps (abnormal growth in the upper part of your stomach)
• This medicine can cause diarrhea. Call your doctor if the diarrhea becomes severe, does not stop, or is bloody. Do not take any medicine to stop diarrhea until you have talked to your doctor. Diarrhea can occur 2 months or more after you stop taking this medicine.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine may cause a delay in ovulation for women and may affect their ability to have children. If you plan to have children, talk with your doctor before using this medicine.
• This medicine may make you dizzy or drowsy. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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
• Bloody, black, or tarry stools, vomiting of blood or material that looks like coffee grounds
• Chest pain that may spread, trouble breathing, unusual sweating, fainting
• Dark urine or pale stools, nausea, vomiting, loss of appetite, stomach pain, yellow skin or eyes
• Dry mouth, increased thirst, confusion, numbness and tingling around the mouth, fingertips, or feet
• Fever, swelling in the body, unusual weight gain, change in how much or how often you urinate, bloody or cloudy urine
• Joint pain, rash on your cheeks or arms that gets worse in the sun
• Numbness or weakness in your arm or leg, or on one side of your body
• Seizures, dizziness, tremors, fast or uneven heartbeat, muscle spasms or cramps
• Severe diarrhea that does not go away, stomach cramps, weight loss
• Sudden or severe headache, problems with vision, speech, or walking
• Unusual bleeding, bruising, tiredness, or weakness

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

• Mild diarrhea, stomach upset
• Trouble having an erection

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