Vimovo (as a combination product containing Esomeprazole, Naproxen)

Esomeprazole is used to treat gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach). Esomeprazole is used to treat the symptoms of GERD, allow the esophagus to heal, and prevent further damage to the esophagus. Esomeprazole is also used to decrease the chance that people who are taking nonsteroidal anti-inflammatory drugs (NSAIDs) will develop ulcers (sores in the lining of the stomach or intestine). It is also used with other medications to treat and prevent the return of stomach ulcers caused by a certain type of bacteria (H. pylori). Esomeprazole is also used to treat conditions in which the stomach produces too much acid such as Zollinger-Ellison syndrome. Esomeprazole is in a class of medications called proton pump inhibitors. It works by decreasing the amount of acid made in the stomach.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Esomeprazole may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• nausea
• gas
• constipation
• dry mouth

Some side effects can be serious. If you experience any of these symptoms, call your doctor immediately, or get emergency medical help:

• blisters or peeling skin
• hives
• rash
• itching
• difficulty breathing or swallowing
• swelling of the face, throat, tongue, lips, eyes, hands, feet, ankles, or lower legs
• hoarseness
• irregular, fast, or pounding heartbeat
• excessive tiredness
• dizziness
• lightheadedness
• muscle spasms
• uncontrollable shaking of a part of the body
• seizures
• severe diarrhea with watery stools
• stomach pain
• fever

People who take proton pump inhibitors such as esomeprazole may be more likely to fracture their wrists, hips, or spine than people who do not take one of these medications. The risk is highest in people who take high doses of one of these medications or take them for one year or longer. Talk to your doctor about the risk of taking esomeprazole.

Esomeprazole may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include the following:

• confusion
• drowsiness
• blurred vision
• fast heartbeat
• nausea
• sweating
• flushing
• headache
• dry mouth

Keep all appointments with your doctor and the laboratory. Your doctor may order certain laboratory tests before and during your treatment, especially if you have severe diarrhea..

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

• Vimovo^® (containing Esomeprazole, Naproxen)