•Instruct patients and caregivers that CREON should only be taken as directed by their healthcare professional.
•Instruct patients and caregivers that CREON should always be taken with food.
•Instruct patients who are unable to swallow intact capsules to sprinkle the contents of CREON on a small amount of acidic soft food, such as applesauce, at room temperature. Instruct these patients to swallow the CREON-soft food mixture immediately without crushing or chewing, and follow with water or juice to ensure complete ingestion and to avoid irritation of the oral mucosa.
•Tell patients that CREON or their contents should not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity.
17.2 Fibrosing Colonopathy
Advise patients and caregivers to follow dosing instructions carefully, as doses of pancreatic enzyme products exceeding 6,000 lipase units/kg of body weight per meal have been associated with colonic strictures in children below the age of 12 years.
17.3 Allergic Reactions
Advise patients and caregivers to contact their healthcare professional immediately if allergic reactions to CREON develop.
Manufactured by:
Solvay Pharmaceuticals GmbH
Hannover, Germany
Marketed By:
Solvay Pharmaceuticals, Inc.
Marietta, GA 30062
1055216 1E Rev Apr 2009
© 2009 Solvay Pharmaceuticals, Inc.
Relabeling and Repackaging by:
Physicians Total Care, Inc.
Tulsa, OK 74146
17.4 FDA-Approved Medication Guide
MEDICATION GUIDE
CREON® (krē 'ŏn)
(pancrelipase)
Delayed-Release Capsules
Read this Medication Guide before you or your child start taking CREON and each time you or your child get a prescription refilled. There may be new information. This information does not take the place of talking with your healthcare professional about your medical condition or your treatment.
What is the most important information I should know about CREON?
•CREON may increase your chance of having a rare bowel disorder called fibrosing colonopathy. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare professional gave you. Call your healthcare professional right away if you have any unusual or severe stomach area (abdominal) pain.
•Take CREON exactly as prescribed. Do not take more or less CREON than directed by your healthcare professional.
What is CREON?
CREON is a prescription pancreatic enzyme medicine used to improve food digestion in people who cannot digest food properly because they have exocrine pancreatic insufficiency. CREON contains a mixture of digestive enzymes (including lipases, proteases, and amylases) from pig pancreas.
CREON is safe and effective in children.
What should I tell my healthcare professional before taking CREON?
Tell your healthcare professional if you:
•are allergic to pork (pig) products.
•have a history of intestinal blockage or a condition called fibrosing colonopathy.
•have gout, kidney disease, or a condition called high blood uric acid (hyperuricemia).
•have trouble swallowing capsules.
•are pregnant or planning to become pregnant
