Do not crush ULTRESA delayed-release capsule or the capsule contents.

17 PATIENT COUNSELING INFORMATION “See FDA-approved patient labeling (Medication Guide)”

17.1 Dosing and Administration ◦Instruct patients and caregivers that ULTRESA should only be taken as directed by their doctor. 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 ULTRESA should always be taken with food. Patients should be advised that ULTRESA delayed-release capsules must not be crushed or chewed as doing so could cause early release of enzymes and/or loss of enzymatic activity and irritation of the oral mucosa. 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) ].
◦Any unused portion of capsule contents should be discarded, and not used for subsequent dosing. The remaining exposed contents may lose potency and become less effective. [see Dosage and Administration (2) ]
◦Instruct patients that use of ULTRESA in children is limited by the available capsule dosage strengths and their ability to provide the recommended dose based on age and weight. Instruct patients that attempting to divide the capsule contents in small fractions to deliver small doses of lipase is not recommended. [see Dosage and Administration (2) ]
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 have been associated with colonic strictures (a rare bowel disorder) in children below the age of 12 years. [see Dosage and Administration (2) and Warnings and Precautions (5.1)].

17.3 Allergic ReactionsAdvise patients and caregivers to contact their doctor immediately if allergic reactions to ULTRESA develop.

17.4 Pregnancy and Breast Feeding◦Instruct patients to notify their physician if they are pregnant or are thinking of becoming pregnant during treatment with ULTRESA. [see Use in Specific Populations (8.1) ]
◦Instruct patients to notify their physician if they are breast feeding or are thinking of breast feeding during treatment with ULTRESA [see Use in Specific Populations (8.3) ]
Marketed by:

Aptalis Pharma US, Inc

22 Inverness Center Parkway
Birmingham, AL 35242 USA

Manufactured by:

Aptalis Pharma S.r.L.

Pessano, Italy 20060

ULTRESA and APTALIS are trademarks.

© 2012 APTALIS PHARMA US, INC.

MEDICATION GUIDEULTRESA™ (ul-tres-a)

(pancrelipase)

delayed-release capsules

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

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

ULTRESA may i