Uses of Naproxen and Esomeprazole:

• It is used to treat some types of arthritis.
• It is used to treat ankylosing spondylitis.
• It is used to treat or prevent NSAID-associated gastric ulcers in patients with a history of ulcers.

What do I need to tell my doctor BEFORE I take Naproxen and Esomeprazole?

• If you have an allergy to naproxen, esomeprazole, or any other part of naproxen and esomeprazole.
• If you have an allergy to aspirin or NSAIDs.
• If you are allergic to naproxen and esomeprazole; any part of naproxen and esomeprazole; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have ever had asthma caused by a salicylate drug like aspirin or a drug like this one like NSAIDs.
• If you have any of these health problems: Active bleeding, bleeding in the brain or GI (gastrointestinal) tract, other bleeding problems, heart failure (weak heart), kidney or liver problems, or a stomach or bowel ulcer.
• If you have had a recent heart attack.
• If you are taking any other NSAID, a salicylate drug like aspirin, or pemetrexed.
• If you are taking any of these drugs: Atazanavir, clopidogrel, nelfinavir, rifampin, rilpivirine, or St. John's wort.
• If you are having trouble getting pregnant or you are having your fertility checked.
• If you are pregnant or may be pregnant. Do not take naproxen and esomeprazole if you are in the third trimester of pregnancy. You may also need to avoid naproxen and esomeprazole at other times during pregnancy. Talk with your doctor to see when you need to avoid taking naproxen and esomeprazole during pregnancy.

This is not a list of all drugs or health problems that interact with naproxen and esomeprazole.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take naproxen and esomeprazole with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Naproxen and Esomeprazole?

• This medicine may raise the chance of hip, spine, and wrist fractures in people with weak bones (osteoporosis). The chance may be higher if you take naproxen and esomeprazole in high doses or for longer than a year, or if you are older than 50 years old.
• Rarely, low magnesium levels have happened in people taking drugs like this one for at least 3 months. Most of the time, this happened after 1 year of treatment. You will need to have blood work if you take naproxen and esomeprazole for a long time or with certain other drugs.
• Long-term treatment (for instance longer than 3 years) with drugs like this one has rarely caused low vitamin B-12 levels. Talk with the doctor.
• The chance of heart failure is raised with the use of drugs like this one. In people who already have heart failure, the chance of heart attack, having to go to the hospital for heart failure, and death is raised. Talk with the doctor.
• The chance of heart attack and heart-related death is raised in people taking drugs like this one after a recent heart attack. People taking drugs like this one after a first heart attack were also more likely to die in the year after the heart attack compared with people not taking drugs like this one. Talk with the doctor.
• Lupus has happened with naproxen and esomeprazole, as well as lupus that has gotten worse in people who already have it. Tell your doctor if you have lupus. Call your doctor right away if you have signs of lupus like a rash on the cheeks or other body parts, sunburn easy, muscle or joint pain, chest pain or shortness of breath, or swelling in the arms or legs.
• Liver problems have happened with drugs like this one. Sometimes, this has been deadly. Call your doctor right away if you have signs of liver problems like dark urine, feeling tired, not hungry, upset stomach or stomach pain, light-colored stools, throwing up, or yellow skin or eyes.
• This medicine may raise the chance of a severe form of diarrhea called C diff-associated diarrhea (CDAD). Call your doctor right away if you have stomach pain or cramps, very loose or watery stools, or bloody stools. Do not try to treat diarrhea without first checking with your doctor.
• If you are 65 or older, use naproxen and esomeprazole with care. You could have more side effects.
• NSAIDs like naproxen and esomeprazole may affect egg release (ovulation) in women. This may cause you to not be able to get pregnant. This goes back to normal when naproxen and esomeprazole is stopped. Talk with your doctor.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant. If you are pregnant or you get pregnant while taking naproxen and esomeprazole, call your doctor right away.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

How is this medicine (Naproxen and Esomeprazole) best taken?

Use naproxen and esomeprazole as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take naproxen and esomeprazole at least 30 minutes before meals.
• Swallow whole with some water or other drink.
• Do not chew, break, or crush.
• Tell all of your health care providers that you take naproxen and esomeprazole. This includes your doctors, nurses, pharmacists, and dentists.
• Take calcium and vitamin D as you were told by your doctor.
• Do not take more than what your doctor told you to take. Taking more than you are told may raise your chance of very bad side effects.
• Do not take naproxen and esomeprazole for longer than you were told by your doctor.
• Have your blood work checked if you are on naproxen and esomeprazole for a long time. Talk with your doctor.
• High blood pressure has happened with drugs like this one. Have your blood pressure checked as you have been told by your doctor.
• This medicine may affect certain lab tests. Tell all of your health care providers and lab workers that you take naproxen and esomeprazole.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• Use care if you have risks for soft, brittle bones (osteoporosis). Some of these risks include drinking alcohol, smoking, taking steroids, taking drugs to treat seizures, or having family members with osteoporosis. Talk with your doctor about your risks of osteoporosis.
• Talk with your doctor before you drink alcohol.
• If you smoke, talk with your doctor.
• If you have asthma, talk with your doctor. You may be more sensitive to naproxen and esomeprazole.
• If you are taking aspirin to help prevent a heart attack, talk with your doctor.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of low magnesium levels like mood changes, muscle pain or weakness, muscle cramps or spasms, seizures, shakiness, not hungry, very bad upset stomach or throwing up, or a heartbeat that does not feel normal.
• Signs of kidney problems like unable to pass urine, change in how much urine is passed, blood in the urine, or a big weight gain.
• Signs of bleeding like throwing up or coughing up blood; vomit that looks like coffee grounds; blood in the urine; black, red, or tarry stools; bleeding from the gums; abnormal vaginal bleeding; bruises without a cause or that get bigger; or bleeding you cannot stop.
• Signs of high potassium levels like a heartbeat that does not feel normal; feeling confused; feeling weak, lightheaded, or dizzy; feeling like passing out; numbness or tingling; or shortness of breath.
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Chest pain or pressure or a fast heartbeat.
• Weakness on 1 side of the body, trouble speaking or thinking, change in balance, drooping on one side of the face, or blurred eyesight.
• Shortness of breath, a big weight gain, or swelling in the arms or legs.
• Feeling very tired or weak.
• Bone pain.
• Ringing in ears.
• Change in eyesight.
• Low mood (depression).
• Feeling confused.
• Flu-like signs.
• A very bad skin reaction (Stevens-Johnson syndrome/toxic epidermal necrolysis) may happen. It can cause very bad health problems that may not go away, and sometimes death. Get medical help right away if you have signs like red, swollen, blistered, or peeling skin (with or without fever); red or irritated eyes; or sores in your mouth, throat, nose, or eyes.

What are some other side effects of Naproxen and Esomeprazole?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Stomach pain or heartburn.
• Diarrhea or constipation.
• Gas.
• Upset stomach or throwing up.
• Dizziness.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Naproxen and Esomeprazole?

• Store in the original container at room temperature.
• Store in a dry place. Do not store in a bathroom.
• Keep lid tightly closed.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time naproxen and esomeprazole is refilled. If you have any questions about naproxen and esomeprazole, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.