KEEPING IT COOL WITH SPIKE

5.2.12

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Uses of DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed release capsules

Persistent heartburn two or more days a week, despite treatment and diet changes, could be acid reflux disease (ARD). Prescription DEXILANT capsules are used in adults for 4 weeks to treat heartburn related to ARD, for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE), and for up to 6 months to continue healing of EE and relief of heartburn. Individual results may vary. Most damage (erosions) heals in 4–8 weeks.

Important Safety Information

DEXILANT may not be right for everyone. Do not take DEXILANT if you are allergic to DEXILANT or any of its ingredients. Serious allergic reactions have been reported. Tell your doctor if you get any of the following symptoms with DEXILANT: rash, face swelling, throat tightness, or difficulty breathing. Symptom relief does not rule out other serious stomach conditions. People who are taking multiple daily doses of proton pump inhibitor (PPI) medicines for a long period of time may have an increased risk of fractures of the hip, wrist, or spine. Low magnesium levels can happen in some people who take a PPI medicine.

The most common side effects of DEXILANT were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%). DEXILANT and certain other medicines can affect each other. Before taking DEXILANT, tell your doctor if you are taking ampicillin, atazanavir, digoxin, iron, ketoconazole, or tacrolimus. If you are taking DEXILANT with warfarin, you may need to be monitored because serious risks could occur.

Talk to your doctor or healthcare professional. Please see full Prescribing Information for DEXILANT.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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