643.
How should I store CREON?
•Store CREON at room temperature (up to 25°C or 77°F) for up to 12 weeks after the bottle is opened.
•If you store CREON at temperatures greater than room temperature (up to 40°C or 104°F), throw away after 30 days.
•Store CREON in the container you were given by the pharmacy.
•Keep the bottle closed tightly.
•Protect the bottle from moisture.
•Keep CREON and all medicines out of reach of children.
General information about the safe and effective use of CREON
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use CREON for a condition for which it was not prescribed. Do not give CREON to other people to take, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about CREON. If you would like more information, talk to your healthcare professional. You can ask your healthcare professional or pharmacist for information about CREON that is written for healthcare professionals. For more information, go to www.creon-us.com or call toll-free [1-800-241-1643].
What are the ingredients in CREON?
Active Ingredient: pancrelipase
Inactive Ingredients: cetyl alcohol, dimethicone, gelatin, hypromellose phthalate, polyethylene glycol, red iron oxide, sodium lauryl sulfate, titanium dioxide, triethyl citrate, and yellow iron oxide. In addition, the 6,000 strength contains FD&C Blue No. 2 and the 12,000 strength contains black iron oxide. The imprinting ink on the capsule contains dimethicone, 2-ethoxyethanol, shellac, soya lecithin, and titanium dioxide.
Additional information about pancreatic enzymes
CREON and other pancreatic enzyme products are made from pancreatic organs of pigs used for food. There is a theoretical risk of contracting a viral infection from pig-derived medicines, but no human illness has been reported.
The risk of fibrosing colonopathy, increased blood uric acid levels, and the theoretical risk of viral transmission is present with all pancreatic enzyme products including CREON.
You should report any change in condition or illness to your healthcare professional.
© 2009 Solvay Pharmaceuticals, Inc.
Manufactured for Solvay Pharmaceuticals, Inc., Marietta, GA 30062, U.S.A.
1055216 1E Rev Apr 2009
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Issued April 2009
image of pill in hand image of pill being twisted image of pill emptied into bowl image of child drinking PRINCIPAL DISPLAY PANEL
CREON (pancrelipase) Delayed-Release Capsules
12,000 USP
image of package label Creondelayed-release (pancrelipase) Creondelayed-release (pancrelipase)
PRODUCT INFORMATION
Product Code 54868-6067
Dosage Form CAPSULE, DELAYED RELEASE
Route Of Administration ORAL
INGREDIENTS
Name Type Strength Moiety UNII Preferred Substance
PANCRELIPASE Active 12000 USP'U In 1 PANCRELIPASE LIPASE 8MYC33932O PANCRELIPASE LIPASE
POLYETHYLENE GLYCOL Inactive 3WJQ0SDW1A POLYETHYLENE GLYCOL
TRIETHYL CITRATE Inactive 8Z96QXD6UM TRIETHYL CITRATE
DIMETHICONE Inactive 92RU3N3Y1O DIMETHICONE
CETYL ALCOHOL Inactive 936JST6JCN CETYL ALCOHOL
SHELLAC Inactive 46N107B71O SHELL |
