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IMPORTANT RISK INFORMATION
AND USES

What is the most important information I should know about ZENPEP?

ZENPEP 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 fibrosing colonopathy may be reduced by following the dosing instructions your doctor gave you. 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.
Take ZENPEP exactly as prescribed. Do not take more or less ZENPEP than directed by your doctor.

What is ZENPEP®?

ZENPEP (pancrelipase) is a prescription medicine for people who cannot digest food normally because their pancreas does not make enough enzymes. ZENPEP may help your body use fats, proteins, and sugars from food. ZENPEP contains a mixture of digestive enzymes (lipases, proteases, and amylases) from pig pancreas. ZENPEP is safe and effective in children.

Please also see Medication Guide within the full Prescribing Information.

Before you take ZENPEP, 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 breastfeeding or plan to breastfeed.
About all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements.

How should I take ZENPEP?

Take ZENPEP exactly as your doctor tells you.
Do not crush or chew the ZENPEP capsule or its contents, and do not hold the capsule or contents in your mouth. This may cause irritation in your mouth or change the way ZENPEP works in your body. See Medication Guide and talk to your doctor for additional directions.

Side Effects

ZENPEP may cause serious side effects, including worsening of swollen, painful joints (gout) caused by an increase in blood uric acid levels and allergic reactions including trouble with breathing, skin rashes, or swollen lips. Call your doctor right away if you have any of these symptoms.
The most common side effects of ZENPEP include belly pain, gas, and headache.
ZENPEP 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.
Tell your doctor if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ZENPEP. For more information, ask your doctor or pharmacist.

Please also see Medication Guide within the full Prescribing Information.

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