17 PATIENT COUNSELING INFORMATION
See Medication Guide

17.1 Dosing and Administration
Instruct patients and caregivers that ZENPEP should only be taken as directed by their healthcare professional. Patients should be advised that the total daily dose should not exceed 10,000 lipase units/kg body weight/day unless clinically indicated. This needs to be especially emphasized for patients eating multiple snacks and meals per day. Patients should be informed that if a dose is missed, the next dose should be taken with the next meal or snack as directed. Doses should not be doubled. [see Dosage and Administration (2)].
Instruct patients and caregivers that ZENPEP should always be taken with food. Patients should be advised that ZENPEP delayed-release capsules must not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity. Patients should swallow the intact capsules with adequate amounts of liquid at mealtimes. If necessary, the capsules contents can also be sprinkled on soft acidic foods. [see Dosage and Administration (2)].
Instruct patients to notify their healthcare professional if they are pregnant or are thinking of becoming pregnant during treatment with ZENPEP. [see Use in Specific Populations (8.1).]

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 (10,000 lipase units/kg body weight/day) have been associated with colonic strictures in children below the age of 12 years. [see Dosage and Administration (2)].

17.3 Allergic Reactions
Advise patients and caregivers to contact their healthcare professional immediately if allergic reactions to ZENPEP develop. [see Warnings and Precautions (5.5)].

ZENPEP® is subject of US Patent No. 7,658,918.

Manufactured by: Eurand S.p.A.
Via Martin Luther King, 13
20060, Pessano con Bornago
Milan, Italy

Marketed by:
Eurand Pharmaceuticals, Inc.
790 Township Line Road, Suite 250
Yardley, PA 19067

For further information, please call Eurand Medical Information Department toll-free at 1-800-716-6507.

©2010 Eurand Pharmaceuticals, Inc.
PKG-1028
04/10 rev. 1

MEDICATION GUIDE

ZENPEP® (ZEN-pep)
(pancrelipase)
Delayed-Release Capsules

Read this Medication Guide before you start taking ZENPEP and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.

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 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
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 healthcare professional.

What is ZENPEP?
ZENPEP is a prescription medicine for people who cannot digest food normally because their