Before taking naproxen/esomeprazole, tell your doctor or pharmacist if you are allergic to either of them; or to aspirin or other NSAIDs (such as ibuprofen, celecoxib); or to other proton-pump inhibitors such as omeprazole, pantoprazole; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg, tell your doctor or pharmacist your medical history, especially of: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs), liver disease, stomach/intestinal/esophagus problems (such as bleeding, ulcers, recurring heartburn), heart disease (such as history of heart attack), high blood pressure, stroke, swelling (edema, fluid retention), low sodium blood levels, blood disorders (such as anemia), bleeding or clotting problems, asthma, growths in the nose (nasal polyps).
Kidney problems can sometimes occur with the use of NSAID medications, including naproxen. Problems are more likely to occur if you are dehydrated, have heart failure or kidney disease, are an older adult, or if you take certain medications (see also Drug Interactions section). Drink plenty of fluids as directed by your doctor to prevent dehydration and tell your doctor right away if you have any unusual change in the amount of urine.
Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.
Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg may cause stomach bleeding. Daily use of alcohol and tobacco, especially when combined with this medicine, may increase the risk of stomach bleeding. Consult your doctor or pharmacist for more information.
Proton pump inhibitors (such as esomeprazole) may increase your risk for bone fractures, especially with longer use, higher doses, and in older adults. Talk with your doctor or pharmacist about ways to prevent bone loss/fracture, such as by taking calcium (such as calcium citrate) and vitamin D supplements.
Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).
Older adults may be more sensitive to the effects of Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg, especially stomach bleeding and kidney problems.
Before using Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.
Naproxen passes into breast milk. It is unknown if esomeprazole passes into breast milk. Consult your doctor before breast-feeding.
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medications away from children and pets.
Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.
Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg is used to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis when there is a high risk for stomach bleeding/ulcer. This product contains 2 medications: esomeprazole and naproxen. This product should not be used to relieve sudden pain. The naproxen starts to work slower than other naproxen products because of a special coating (delayed-release).
If you are treating a chronic condition such as arthritis, ask your doctor about non-drug treatments and/or using other medications to treat your pain.
Naproxen is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain, swelling, and joint stiffness. Naproxen can cause stomach ulcers, especially in patients with a history of stomach ulcers. Esomeprazole is a proton pump inhibitor (PPI) that blocks acid production in the stomach. This combination provides the benefits of naproxen and may reduce the risk of ulcers or bleeding that can occur with naproxen use.
Read the Medication Guide provided by your pharmacist before you start using Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.
Take Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg by mouth as directed by your doctor, usually twice daily (in the morning and evening) at least 30 minutes before a meal. Take it with a full glass (8 ounces or 240 milliliters) of water unless your doctor directs you otherwise. Do not lie down for at least 10 minutes after taking Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg. Swallow the tablet whole. Do not break, chew, crush or dissolve the tablet. Doing so can destroy the slow release of the drug and may increase side effects. If needed, you can take antacids while using Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg.
The dosage is based on your medical condition and response to treatment. To reduce your risk of stomach bleeding and other side effects, take Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg at the lowest effective dose for the shortest possible time. Do not increase your dose, take it more frequently, or take it for longer than prescribed.
Use Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg regularly in order to get the most benefit from it. Remember to use Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg at the same times each day. It may take up to 2 weeks of taking Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg until you get the full benefit.
Tell your doctor if your condition persists or worsens.
Upset stomach, heartburn, diarrhea, drowsiness, or dizziness may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.
Remember that your doctor has prescribed Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg do not have serious side effects.
Tell your doctor right away if you have any serious side effects, including: easy bruising/bleeding, lightheadedness/fainting, signs of a lung infection (such as fever, cough, trouble breathing), difficult/painful swallowing, swelling of the hands/feet, sudden/unexplained weight gain, change in amount of urine, symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures).
Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg may rarely cause serious (possibly fatal) liver disease. Stop taking Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg and get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, dark urine, yellowing eyes/skin.
Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg may rarely cause a severe intestinal condition (Clostridium difficile-associated diarrhea) due to a type of bacteria. Do not use anti-diarrhea products or narcotic pain medications if you have any of the following symptoms because these products may make them worse. Tell your doctor right away if you develop: persistent diarrhea, abdominal or stomach pain/cramping, fever, blood/mucus in your stool.
A very serious allergic reaction to Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash/blisters, unexplained fever, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
Click here to view a more detailed list of Vimovo side effects.
If you miss a dose of Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.
The effects of some drugs can change if you take other drugs or herbal products at the same time. This can increase your risk for serious side effects or may cause your medications not to work correctly. These drug interactions are possible, but do not always occur. Your doctor or pharmacist can often prevent or manage interactions by changing how you use your medications or by close monitoring.
To help your doctor and pharmacist give you the best care, be sure to tell your doctor and pharmacist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products) before starting treatment with this product. While using this product, do not start, stop, or change the dosage of any other medicines you are using without your doctor's approval.
Some products that may interact with Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg include: aliskiren, ACE Inhibitors (such as captopril, lisinopril), angiotensin II receptor blockers (such as valsartan, losartan), corticosteroids (such as prednisone), lithium, methotrexate (especially high-dose treatment), pemetrexed, probenecid, rifampin, St John's wort.
Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg may increase the risk of bleeding when taken with other drugs that also may cause bleeding. Examples include anti-platelet drugs such as clopidogrel, "blood thinners" such as dabigatran/enoxaparin/warfarin, among others.
Some products need stomach acid so that the body can absorb them properly. These include atazanavir, digoxin, erlotinib, nelfinavir, rilpivirine, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others. Esomeprazole decreases stomach acid, so it may change how well these other products work. Before using esomeprazole, consult your doctor or pharmacist about the other medications you take and for advice on how to reduce or avoid these types of interactions.
Do not take other products containing naproxen or proton pump inhibitors such as omeprazole. Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib or ibuprofen). These drugs are similar to the naproxen in this product and may increase your risk of side effects if taken together. However, if your doctor has directed you to take low-dose aspirin to prevent heart attack or stroke (usually at dosages of 81-325 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Ask your doctor or pharmacist for more details.
This product can affect the results of certain lab tests. Make sure laboratory personnel and your doctors know you use Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg.
This document does not contain all possible drug interactions. Keep a list of all the products you use. Share this list with your doctor and pharmacist to lessen your risk for serious medication problems.
The naproxen in this combination medication may rarely cause blood clots to form, causing a heart attack or stroke. The risk may be greater if you have heart disease or increased risk for heart disease (for example, due to smoking, family history of heart disease, or conditions such as high blood pressure or diabetes), or with longer use. Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg should not be taken right before or after heart bypass surgery (CABG). Also, Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg may infrequently cause serious (rarely fatal) bleeding from the stomach or intestines. This can occur without warning symptoms and at any time during treatment. The risk of bleeding is greater in older adults. Esomeprazole decreases the risk of bleeding.
Stop taking Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg and get medical help right away if you notice any of the following rare but very serious side effects: chest/jaw/left arm pain, severe dizziness, weakness on one side of the body, vision changes, slurred speech, black stools, persistent stomach/abdominal pain, vomit that looks like coffee grounds. (See also Precautions section.)
Talk with your doctor or pharmacist about the risks and benefits of treatment with Vimovo (Naproxen/Esomeprazole Magnesium) 500/20mg.