What is CREON^®?

USES

CREON^® is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis, swelling of the pancreas that lasts a long time (chronic pancreatitis), removal of some or all of the pancreas (pancreatectomy), or other conditions.

Important Information about CREON^®

• CREON may increase your chance of having a rare bowel disorder called fibrosing colonopathy. The risk of having this condition may be reduced by following the dosing instructions that your healthcare professional gave you.

• Do not crush or chew CREON capsules or its contents, and do not hold the capsule or capsule contents in your mouth. Crushing, chewing or holding the CREON capsules in your mouth may cause irritation in your mouth. Consult your medication guide for how to take CREON if you have trouble swallowing capsules. Always take CREON with a meal or snack and enough liquid to swallow CREON completely. Take CREON exactly as your doctor tells you to.

• Call your healthcare professional right away if you have unusual or severe: stomach pain, frequent or abnormal bowel movements, bloating, trouble passing stool, nausea, vomiting, diarrhea, worsening of gout, or painful, swollen joints, trouble with breathing, skin rashes, or swollen lips.

• The most common side effects include: increased (hyperglycemia) or decreased (hypoglycemia) blood sugars, pain in your stomach area (abdominal area), frequent or abnormal bowel movements, gas, vomiting, dizziness or sore throat and cough.

• CREON and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.

Refer to your medication guide and full prescribing information every time you refill your prescription because information may change. Tell your healthcare professional if you have any symptom or side effect that bothers you or that does not go away.

You are encouraged to report negative adverse effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. If you cannot afford your medication, contact: www.pparx.org or call the toll-free phone number (1-888-4PPA-NOW) for assistance.