• Let patients know that antacids may be used while taking NEXIUM.

• Advise patients to take NEXIUM at least one hour before a meal.

• For patients who are prescribed NEXIUM Delayed-Release Capsules, advise them not to chew or crush the capsules.

• Advise patients that, if they open NEXIUM Delayed-Release Capsules to mix the granules with food, the granules should only be mixed with applesauce. Use with other foods has not been eva luated and is not recommended.

• For patients who are advised to open the NEXIUM Delayed-Release Capsules before taking them or who are prescribed NEXIUM For Delayed-Release Oral Suspension, instruct them in the proper technique for administration [see Dosage and Administration (2)] and tell them to follow the dosing instructions in the PATIENT INFORMATION insert included in the package.

Advise patients to immediately report and seek care for any cardiovascular or neurological symptoms including palpitations, dizziness, seizures, and tetany as these may be signs of hypomagnesemia [see Warnings and Precautions (5.6)].

Distributed by:

AstraZeneca LP

Wilmington, DE 19850

FDA-APPROVED PATIENT LABELING
NEXIUM® (nex-e-um) (esomeprazole magnesium)

Delayed-Release Capsules and Delayed-Release Oral Suspension

Read the Patient Information that comes with NEXIUM before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

If you have any questions about NEXIUM, ask your doctor.

WHAT IS NEXIUM?

NEXIUM is a prescription medicine called a proton pump inhibitor (PPI).

NEXIUM is used in adults:

• for 4 to 8 weeks to treat the symptoms of gastroesophageal reflux disease (GERD). NEXIUM may also be prescribed to heal acid-related damage to the lining of the esophagus (erosive esophagitis), and to help continue this healing.

GERD is a chronic condition (lasts a long time) that occurs when acid from the stomach backs up into the esophagus (food pipe) causing symptoms, such as heartburn, or damage to the lining of the esophagus. Common symptoms include frequent heartburn that will not go away, a sour or bitter taste in the mouth, and difficulty swallowing.

• for up to 6 months to reduce the risk of stomach ulcers in some people taking pain medicines called non-steroidal anti-inflammatory drugs (NSAIDs).

• to treat patients with a stomach infection (Helicobacter pylori), along with the antibiotics amoxicillin and clarithromycin.

• for the long-term treatment of Zollinger-Ellison Syndrome. Zollinger-Ellison Syndrome is a rare condition in which the stomach produces a more than normal amount of acid.

For children and adolescents 1 to 17 years of age, NEXIUM may be prescribed for up to 8 weeks for short-term treatment of GERD.

NEXIUM is not recommended for children under the age of 1 year.

WHO SHOULD NOT TAKE NEXIUM?

Do not take NEXIUM if you:

• are allergic to any of the ingredients in NEXIUM. See the end of this leaflet for a complete list of ingredients in NEXIUM.

• are allergic to any other Proton Pump Inhibitor (PPI) medicine.

WHAT SHOULD I TELL MY DOCTOR BEFORE TAKING NEXIUM?

Tell your doctor about all your medical conditions, including if you:

have been told that you have low magnesium levels