Important Safety Information

What is the most important information I should know about PANCREAZE®?

PANCREAZE® may increase your chance of having a serious, rare bowel disorder called fibrosing colonopathy that may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your healthcare provider gave you. Take PANCREAZE® exactly as prescribed by your doctor. Do not take more or less PANCREAZE® than directed by your doctor.

Call your doctor right away if you have any unusual or severe stomach area (abdominal) pain, bloating, trouble passing stool (having bowel movements), nausea, vomiting, or diarrhea.

What should I tell my doctor before taking PANCREAZE®?

Tell your doctor if you:

  • are allergic to pork (pig) products
  • have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy)
  • have gout, kidney disease, or high blood uric acid (hyperuricemia)
  • have trouble swallowing capsules
  • have any other medical condition
  • are pregnant or plan to become pregnant
  • are breast-feeding or plan to breast-feed

Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

What are the possible side effects of PANCREAZE®?

PANCREAZE® may cause serious side effects, including:

  • A rare bowel disorder called fibrosing colonopathy
  • Irritation of the inside of your mouth. This can happen if PANCREAZE® is not swallowed completely
  • Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase in your blood uric acid levels
  • Allergic reactions including trouble with breathing, skin rashes, or swollen lips

Call your doctor right away if you have any of these symptoms.

Other possible side effects: PANCREAZE® 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.

The most common side effects include pain in your stomach (abdominal pain) and gas.

These are not all the side effects of PANCREAZE®. Talk to your doctor about any side effect that bothers you or does not go away. You may report side effects to the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Janssen Pharmaceuticals, Inc. at 1-800-526-7736.

How do I take PANCREAZE®?

  • Do not crush or chew the PANCREAZE® capsules or their contents, and do not hold the capsule or contents in your mouth. Take PANCREAZE® exactly as your doctor tells you. Read the Medication Guide for directions on how to give PANCREAZE® to adults and children (children older than 12 months)
  • Read the Medication Guide for directions on how to give PANCREAZE® to infants (children up to 12 months)

Please read the PANCREAZE® Medication Guide and PANCREAZE® Product Information and discuss any questions you have with your doctor.