Vimovo Consumer (continued)
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 this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication 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, symptoms of a low magnesium blood level (such as unusually fast/slow/irregular heartbeat, persistent muscle spasms, seizures).
This drug may rarely cause serious (possibly fatal) liver disease. Stop taking this medication and get medical help right away if you have any symptoms of liver damage, including: persistent nausea/vomiting, dark urine, yellowing eyes/skin.
This medication 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.
Rarely, proton pump inhibitors (such as esomeprazole) have caused vitamin B-12 deficiency. The risk is increased if they are taken every day for a long time (3 years or longer). Tell your doctor right away if you develop symptoms of vitamin B-12 deficiency (such as unusual weakness, sore tongue, or numbness/tingling of the hands/feet).
A very serious allergic reaction to this drug 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, kidney problems (such as change in the amount of urine).
This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.
In the US -
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.
Read the Vimovo (naproxen and esomeprazole magnesium delayed release tablets) Side Effects Center for a complete guide to possible side effects
PRECAUTIONS: 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 this medication, tell your doctor or pharmacist your medical history, especially of: asthma (including a history of worsening breathing 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, 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.
This drug 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.
This medication 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 this drug, especially stomach bleeding and kidney problems.
Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication 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.
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