•100 capsules (NDC 0032-3016-13)
•250 capsules (NDC 0032-3016-28)
Storage and Handling

Creon must be stored at room temperature up to 25°C (77°F) and protected from moisture. Temperature excursions are permitted between 25°C to 40°C (77°F and 104°F) for up to 30 days. Product should be discarded if exposed to higher temperature and moisture conditions higher than 70%. After opening, keep bottle tightly closed between uses to protect from moisture.

Bottles of Creon 3,000 USP units of lipase must be stored and dispensed in the original container.

Do not crush Creon delayed-release capsules or the capsule contents.

Patient Counseling Information
See FDA-approved patient labeling (Medication Guide)

Dosing and Administration
•Instruct patients and caregivers that Creon 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 Creon should always be taken with food. Patients should be advised that Creon delayed-release capsules and the capsule contents 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 capsule contents can also be sprinkled on soft acidic foods [see Dosage and Administration (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 in children below the age of 12 years [see Dosage and Administration (2)].

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

Pregnancy and Breast Feeding
•Instruct patients to notify their healthcare professional if they are pregnant or are thinking of becoming pregnant during treatment with Creon [see Use in Specific Populations (8.1)].
•Instruct patients to notify their healthcare professional if they are breast feeding or are thinking of breast feeding during treatment with Creon [see Use in Specific Populations (8.3)].
Manufactured by:

Abbott Laboratories GmbH

Hannover, Germany

Marketed by:

AbbVie Inc.

North Chicago, IL 60064, U.S.A.

© 2012 AbbVie Inc.

1083531 March, 2013

MEDICATION GUIDE

Creon® (krē ′ŏn)

(pancrelipase)

Delayed-Release Capsules

Read this Medication Guide before you start taking Creon 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 Creon?

Creon may increase your c