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:
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:
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 VIVUS, Inc. at 1-888-998-4887.