Important Safety Information

• Fibrosing colonopathy has been reported following treatment with pancreatic enzyme products. Do not exceed the recommended dosage of 2,500 lipase units/kg/meal (or 10,000 lipase units/kg/day) or 4,000 lipase units/g fat ingested/day in adult and pediatric patients greater than 12 months of age without further investigation.
• To avoid irritation of oral mucosa, care should be taken to ensure that CREON is not crushed, chewed, or retained in the mouth. CREON should always be taken with food.
• Pancreatic enzyme products contain purines that may increase blood uric acid levels. High dosages have been associated with hyperuricosuria and hyperuricemia. Consider monitoring blood uric acid levels in patients with gout, renal impairment, or hyperuricemia during treatment with CREON.
• There is theoretical risk of viral transmission with all pancreatic enzyme products, including CREON.
• Severe hypersensitivity reactions including anaphylaxis, asthma, hives, and pruritus have been reported with pancreatic enzyme products. Monitor patients with a known hypersensitivity reaction to proteins of porcine origin for hypersensitivity reactions during treatment with CREON.
• Adverse reactions that occurred in at least 2 cystic fibrosis patients (greater than or equal to 4%) receiving CREON were vomiting, dizziness, and cough.
• Adverse reactions that occurred in at least 1 chronic pancreatitis or pancreatectomy patient (greater than or equal to 4%) receiving CREON were hyperglycemia, hypoglycemia, abdominal pain, abnormal feces, flatulence, frequent bowel movements, and nasopharyngitis.

Please see full Prescribing Information.

US-CREO-230452