Naproxen/Esomeprazole, Oral

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KEY POINTS

• This medicine is taken by mouth to treat symptoms of arthritis and to decrease the risk for gastric ulcers from taking NSAIDs. Take it exactly as directed.
• NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG).
• This medicine may also cause other unwanted side effects. Tell your healthcare provider if you have any side effects that are serious, continue, or get worse.
• Tell all healthcare providers who treat you about all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take.

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What are other names for this medicine?

Type of medicine: nonsteroidal anti-inflammatory drug (NSAID); proton pump inhibitor

Generic and brand names: naproxen/esomeprazole, oral; Vimovo

What is this medicine used for?

This medicine is a combination of a nonsteroidal anti-inflammatory drug (NSAID) with a medicine to prevent stomach acid. It is used to provide relief from the symptoms of arthritis and ankylosing spondylitis, and to decrease the risk for gastric ulcers from taking NSAIDs.

This medicine may be used to treat other conditions as determined by your healthcare provider.

What should my healthcare provider know before I take this medicine?

Before you take this medicine, be sure to tell your healthcare provider if you have ever had:

• An allergic reaction to any medicine
• A blockage in the intestines, Crohn's disease, or ulcerative colitis
• A heart attack or recent heart surgery
• A stroke or transient ischemic attack (TIA)
• Asthma
• Bleeding problems or blood disorders such as anemia
• Heart failure or problems with swelling in ankles, feet, or hands
• High blood pressure
• Kidney or liver disease
• Low levels of magnesium in your blood
• Osteoporosis
• Trouble urinating
• Stomach or intestinal ulcers or bleeding

Tell your provider if you take steroids such as prednisone or medicine that reduces the chance of blood clots forming such as warfarin (Coumadin) or clopidogrel (Plavix). Also, tell your healthcare provider if you are on a low-sodium diet.

Females of childbearing age: Tell your healthcare provider if you are pregnant or breast-feeding. This medicine is not recommended for use in late pregnancy because it may harm the baby. Do not breast-feed while taking this medicine without your healthcare provider's approval.

How do I use it?

Read the Medication Guide when you start taking this medicine and each time you get a refill. Take this medicine exactly as your healthcare provider prescribes. Do not take more or take it longer than prescribed. Ask your healthcare provider or pharmacist about anything you do not understand.

Check the label on the medicine for directions about your specific dose. Take this medicine with a full glass (8 ounces) of water. Take this medicine at least 30 minutes before a meal. Do not break, crush, or chew the tablets. Swallow them whole.

Check with your healthcare provider before using this medicine in children under age 18.

If you are taking aspirin to prevent a heart attack or stroke, talk with your healthcare provider before you take this NSAID medicine. NSAIDs may make aspirin less effective. Your healthcare provider can tell you how much time you should allow between taking aspirin and taking this NSAID medicine.

What if I miss a dose?

If you miss a dose, take it as soon as you remember unless it is almost time for the next scheduled dose. In that case, skip the missed dose and take the next one as directed. Do not take double doses. If you are not sure of what to do if you miss a dose, or if you miss more than one dose, contact your healthcare provider.

What if I overdose?

If you or anyone else has intentionally taken too much of this medicine, call 911 or go to the emergency room right away. If you pass out, have seizures, weakness or confusion, or have trouble breathing, call 911. If you think that you or anyone else may have taken too much of this medicine, call the poison control center. Do this even if there are no signs of discomfort or poisoning. The poison control center number is 800-222-1222.

Symptoms of an acute overdose may include: unusual bruising or bleeding, black or tarry bowel movements, confusion, fast heartbeat, flushing, unusual sweating, headache, dizziness, drowsiness, nausea, gas, numbness, pain in the upper stomach, ringing in the ears, shallow or trouble breathing, trouble moving your body, tremors, decreased urination, trouble urinating, vomiting, weakness, coma.

What should I watch out for?

Warning: This medicine may cause ulcers and bleeding in the stomach and intestines at any time during treatment. This may happen without warning symptoms. You may be at higher risk if you smoke, are over the age of 65 or in poor health, drink alcohol, or take this medicine for a long time. If you have stomach pain, or bloody or black tarry bowel movements, stop taking this medicine and contact your healthcare provider right away.

You may have swelling of the ankles, feet, or hands while taking this medicine. If this becomes bothersome, contact your healthcare provider.

This medicine has been linked with increased risk for high blood pressure. NSAIDs may increase the chance of a heart attack or stroke that can lead to death. This chance increases if you:

• Use NSAIDs for a long time
• Have heart disease

Talk with your healthcare provider about this.

This medicine should not be used right before or after a heart surgery called coronary artery bypass graft (CABG). Talk with your healthcare provider about this.

This medicine may cause an allergic reaction in people who have asthma or who have had allergic reactions to aspirin or other pain medicines. If you develop hives, itching, a rash, tightness in your chest, or trouble breathing, stop taking this medicine and contact your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.

This medicine may cause or worsen diarrhea. If you develop severe diarrhea or diarrhea that lasts more than 2 or 3 days while taking this medicine, or for several weeks after you stop taking this medicine, contact your healthcare provider right away. Do not take medicine to treat diarrhea without your provider's approval.

This medicine may cause new or worsening high blood pressure. You may need to check your blood pressure regularly while you are taking this medicine. Talk with your healthcare provider about this.

This medicine may cause low levels of magnesium in your blood. Talk with your provider about how often you should have blood tests while taking this medicine. This is very important if you take digoxin because low magnesium can increase your risk of serious side effects. Low magnesium can happen in some people who take this medicine for at least 3 months. If this happens, it is usually after a year of treatment. Tell your healthcare provider right away if you have any of these symptoms of low magnesium levels:

• Seizures
• Dizziness
• Irregular or fast heart beat
• Shaking
• Muscle weakness
• Spasms of the hands, feet, or voice box
• Cramps or muscle aches

This medicine reduces the amount of acid in your stomach. Stomach acid is needed to absorb vitamin B12 properly. If you have taken this medicine for more than 3 years, talk with your provider about vitamin B12 deficiency.

This medicine may increase your risk for fractures of the hip, wrist, and spine, especially if you take high doses or take this medicine for longer than 1 year. Talk with your provider about this. Follow your healthcare provider's instructions about exercise, diet, and taking supplements.

Do not take other pain medicines or drink alcohol while you are taking this medicine unless your healthcare provider approves. They may increase the risk of stomach upset.

Check the labels of all nonprescription and prescription medicines you take. Taking other medicines that contain NSAIDs while you take this medicine may lead to an overdose. Ask your healthcare provider or pharmacist if you have any questions.

This medicine may make you dizzy or drowsy. Do not drive or operate machinery unless you are fully alert.

If you take this medicine for a long time, you may need to have blood tests regularly to see how this medicine affects you. Keep all appointments for these tests.

Adults over the age of 65 may be at greater risk for side effects. Talk with your healthcare provider about this.

Females: NSAIDs may affect your ability to get pregnant. This will go back to normal when this medicine is stopped. Talk with your healthcare provider about this.

If you need emergency care, surgery, lab tests, or dental work, tell the healthcare provider or dentist you are taking this medicine.

What are the possible side effects?

Along with its needed effects, your medicine may cause some unwanted side effects. Some side effects may be very serious. Some side effects may go away as your body adjusts to the medicine. Tell your healthcare provider if you have any side effects that continue or get worse.

Life-threatening (Report these to your healthcare provider right away. If you cannot reach your healthcare provider right away, get emergency medical care or call 911 for help.): Allergic reaction (hives, itching, rash, tightness in your chest or trouble breathing); extreme headache with stiff neck; seizures; sudden weakness, numbness, or tingling, especially on one side of your body; sudden or severe headache; sudden trouble with vision, speech, balance, or walking.

Serious (Report these to your healthcare provider right away.): Confusion; feeling faint; mouth or lip sores; hearing problems or ringing in your ears; dark urine; yellowing of your skin or eyes; loss of appetite; bloody or black tarry bowel movements; severe vomiting, stomach pain, or diarrhea; swelling in ankles, feet, or hands or any unexplained swelling; decreased urination or trouble urinating; severe or unusual tiredness or weakness; vision changes; unusual bruising or bleeding; chest pain; fast or irregular heartbeat; tremors; muscle cramps or spasms; shortness of breath; skin rash or blisters with fever; severe itching.

Other: Mild fever, chills, mild muscle pain, mild stomach pain, diarrhea, nausea, tiredness, gas, headache, dizziness, dry mouth, constipation, increased sweating.

What products might interact with this medicine?

When you take this medicine with other medicines, it can change the way this or any of the other medicines work. Nonprescription medicines, vitamins, natural remedies, and certain foods may also interact. Using these products together might cause harmful side effects. Talk to your healthcare provider if you are taking:

• ACE inhibitors such as benazepril (Lotensin), captopril, enalapril (Vasotec), fosinopril, lisinopril (Prinivil, Zestril), moexipril (Univasc), quinapril (Accupril), ramipril (Altace), and trandolapril (Mavik)
• Aliskiren (Tekturna) and aliskiren/hydrochlorothiazide (Tekturna HCT)
• Anagrelide (Agrylin)
• Angiotensin receptor blockers (ARBs) such as azilsartan (Edarbi), candesartan (Atacand), eprosartan (Teveten), irbesartan (Avapro), losartan (Cozaar), olmesartan (Benicar), telmisartan (Micardis), and valsartan (Diovan)
• Antibiotics such as cefditoren (Spectracef), ciprofloxacin (Cipro), levofloxacin (Levaquin), ofloxacin, and rifampin (Rifadin)
• Antidepressants such as amitriptyline, citalopram (Celexa), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), sertraline (Zoloft), and venlafaxine (Effexor)
• Antifungal medicines such as itraconazole (Sporanox), ketoconazole (Nizoral), posaconazole (Noxafil), and voriconazole (Vfend)
• Antiseizure medicines such as carbamazepine (Carbatrol, Epitol, Equetro, Tegretol), fosphenytoin (Cerebyx), and phenytoin (Dilantin, Phenytek)
• Aspirin and other salicylates
• Beta blockers such as acebutolol (Sectral), atenolol (Tenormin), carvedilol (Coreg), labetalol (Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), pindolol, and sotalol (Betapace, Sorine)
• Bile acid sequestrants such as cholestyramine (Prevalite), colesevelam (Welchol), and colestipol (Colestid)
• Cancer medicines such as bosutinib (Bosulif), dasatinib (Sprycel), erlotinib (Tarceva), gefitinib (Iressa), nilotinib (Tasigna), pemetrexed (Alimta), ponatinib (Iclusig), and pralatrexate (Folotyn)
• Corticosteroids such as betamethasone, cortisone, dexamethasone, fludrocortisone, hydrocortisone (A-Hydrocort, Cortef), methylprednisolone (Medrol, Solu-Medrol), prednisolone (Omnipred, Orapred, Prelone), prednisone (Prednisone Intensol), and triamcinolone (Aristospan, Kenalog)
• Diabetes medicines such as chlorpropamide, glimepiride (Amaryl), glipizide (Glucotrol), and glyburide (Glynase)
• Diazepam (Valium)
• Digoxin (Lanoxin)
• Diuretics (water pills) such as amiloride, bumetanide, chlorothiazide (Diuril), ethacrynic acid (Edecrin), furosemide (Lasix), hydrochlorothiazide (Microzide), spironolactone (Aldactone), and triamterene (Dyrenium)
• HIV medicines such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), lopinavir/ritonavir (Kaletra), nelfinavir (Viracept), rilpivirine (Edurant), and saquinavir (Invirase)
• Immunosuppressants such as cyclosporine (Gengraf, Neoral, Sandimmune), mycophenolate (CellCept, Myfortic), and tacrolimus (Astagraf, Prograf, Protopic)
• Iron supplements or multivitamins that contain iron, and iron medicines such as ferric carboxymaltose (Injectafer), ferric gluconate (Ferrlecit), ferumoxytol (Feraheme), and iron sucrose (Venofer)
• Ledipasvir/sofosbuvir (Harvoni)
• Lithium (Lithobid)
• Medicines that contain nonsteroidal anti-inflammatory medicines (NSAIDs) such as allergy, cold, or cough medicines or other pain or fever medicines
• Medicines to treat or prevent blood clots such as abciximab (ReoPro), argatroban, bivalirudin (Angiomax), cilostazol (Pletal), clopidogrel (Plavix), dabigatran (Pradaxa), dalteparin (Fragmin), dipyridamole (Persantine), enoxaparin (Lovenox), fondaparinux (Arixtra), lepirudin (Refludan), prasugrel (Effient), rivaroxaban (Xarelto), tirofiban (Aggrastat), and warfarin (Coumadin)
• Methotrexate (Otrexup, Rasuvo, Rheumatrex, Trexall)
• Natural remedies such as alfalfa, anise, bilberry, cat’s claw, celery, chamomile, chaparral, comfrey, dong quai, evening primrose, fenugreek, feverfew, fish oil, flaxseed, garlic, ginkgo, ginseng, glucosamine, grape seed, green tea, horse chestnut, kava, ma huang, pennyroyal, red clover, SAMe, St. John's Wort, turmeric, valerian, and willow
• Nonsteroidal anti-inflammatory medicines (NSAIDs) such as celecoxib (Celebrex), diclofenac (Cambia, Voltaren, Zipsor), ibuprofen (Advil, Motrin), indomethacin (Indocin), ketoprofen, ketorolac, nabumetone (Relafen), naproxen (Aleve, Anaprox, Naprelan), oxaprozin (Daypro), piroxicam (Feldene), and sulindac (Clinoril)
• Osteoporosis medicines such as alendronate (Fosamax), ibandronate (Boniva), and risedronate (Actonel, Atelvia)
• Paroxetine (Brisdelle, Paxil, Pexeva)
• Pentosan (Elmiron)
• Probenecid
• Propranolol (Hemangeol, Inderal, InnoPran)
• Sucralfate (Carafate)
• Sulfamethoxazole/trimethoprim (Bactrim, Septra)

Do not drink alcohol while taking this medicine. Also, do not take other pain medicines while you are taking this medicine without your healthcare provider's approval.

If you are not sure if your medicines might interact, ask your pharmacist or healthcare provider. Keep a list of all your medicines with you. List all the prescription medicines, nonprescription medicines, supplements, natural remedies, and vitamins that you take. Be sure that you tell all healthcare providers who treat you about all the products you are taking.

How should I store this medicine?

Store this medicine in the original container at room temperature. Keep the container tightly closed. Protect it from heat, high humidity, and bright light.

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This advisory includes selected information only and may not include all side effects of this medicine or interactions with other medicines. Ask your healthcare provider or pharmacist for more information or if you have any questions.

Ask your pharmacist for the best way to dispose of outdated medicine or medicine you have not used. Do not throw medicine in the trash.

Keep all medicines out of the reach of children.

Do not share medicines with other people.