Uses

This medication is used to treat the signs and symptoms of rheumatoid arthritis, osteoarthritis, juvenile idiopathic arthritis, 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. See also Warning section.

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.

How To Use

Read the Medication Guide provided by your pharmacist before you start using this medication and each time you get a refill. If you have any questions regarding the information, consult your doctor or pharmacist.

Take this medication 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 this drug. 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 this medication.

The dosage is based on your medical condition and response to treatment. In children, the dosage is also based on weight. To reduce your risk of stomach bleeding and other side effects, take this medication 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 this medication regularly in order to get the most benefit from it. Remember to use it at the same times each day. It may take up to 2 weeks of taking this drug until you get the full benefit.

Tell your doctor if your condition lasts or gets worse. The risk of side effects goes up over time. Ask your doctor how long you should take this medication.

Side Effects

See also Warning section.

Upset stomach, heartburn, diarrhea, drowsiness, or dizziness may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor 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.

This medication may raise your blood pressure. Check your blood pressure regularly and tell your doctor if the results are high.

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
• symptoms of a low magnesium blood level (such as muscle spasms, irregular heartbeat, seizures)
• hearing changes (such as ringing in the ears)
• signs of lupus (such as rash on nose and cheeks, new or worsening joint pain)
• symptoms of heart failure (such as swelling ankles/feet, unusual tiredness, unusual/sudden weight gain)

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:

• nausea/vomiting that doesn't stop
• dark urine
• yellowing eyes/skin

This medication may rarely cause a severe intestinal condition due to a bacteria called C. difficile. This condition may occur during treatment or weeks to months after treatment has stopped. Tell your doctor right away if you develop:

• diarrhea that doesn't stop
• abdominal or stomach pain/cramping
• blood/mucus in your stool

If you have these symptoms, do not use anti-diarrhea or opioid products because they may make symptoms worse.

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:

• fever
• swollen lymph nodes
• rash/blisters
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing
• signs of 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 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

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)
• lupus

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 a change in the amount of urine.

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Limit alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

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.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

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.

Older adults may be at greater risk for bone loss and fractures (see above), stomach/intestinal bleeding, kidney problems, heart attack, stroke, and C. difficile infection while using this drug (see Side Effects section).

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks. Tell your doctor if you are pregnant or if you plan to become pregnant. This medication may harm an unborn baby and cause problems with normal labor/delivery. It is not recommended for use in pregnancy from 20 weeks until delivery. If your doctor decides that you need to use this medication between 20 and 30 weeks of pregnancy, you should use the lowest effective dose for the shortest possible time. You should not use this medication after 30 weeks of pregnancy.

Naproxen passes into breast milk. It is unknown if esomeprazole passes into breast milk. Consult your doctor before breast-feeding.

Drug Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• aliskiren
• ACE inhibitors (such as captopril, lisinopril)
• angiotensin II receptor blockers (such as valsartan, losartan)
• corticosteroids (such as prednisone)
• lithium
• mavacamten
• methotrexate (especially high-dose treatment)
• rifampin
• St John's wort
• "water pills" (diuretics such as furosemide)

This medication 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. Esomeprazole decreases stomach acid, so it may change how well these products work. Some affected products include atazanavir, erlotinib, levoketoconazole, nelfinavir, pazopanib, rilpivirine, certain azole antifungals (itraconazole, ketoconazole, posaconazole), among others.

Check all prescription and nonprescription medicine labels carefully since many medications contain pain relievers/fever reducers (aspirin, NSAIDs such as celecoxib, ibuprofen, or ketorolac). These drugs are similar to naproxen 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 81-162 milligrams a day), you should continue taking the aspirin unless your doctor instructs you otherwise. Daily use of naproxen may decrease aspirin's ability to prevent heart attack/stroke. Talk with your doctor about the risks and benefits. Ask about other medications that can be used to treat pain/fever.

This product may interfere with certain laboratory tests, possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this product.

Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 9-1-1. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: severe stomach pain, coffee ground-like vomit, trouble breathing, extreme drowsiness, loss of consciousness, seizures.

Notes

Do not share this medication with others.

Lab and/or medical tests (such as blood pressure, complete blood count, liver/kidney function) should be done while you are taking this medication. If you are taking this medication regularly for a long time, magnesium and vitamin B-12 levels may also be checked. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose

If you miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose. Use your next dose at the regular time. Do not double the dose to catch up.

Storage

Store at room temperature away from light and moisture. 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.