VIOKACE - pancrelipase lipase, pancrelipase protease and pancrelipase amylase tablet 
Aptalis Pharma US, Inc

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MEDICATION GUIDE

VIOKACETM (vye-oh-kase)

(pancrelipase)

tablets

Read this Medication Guide before you start taking VIOKACE 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 VIOKACE?

VIOKACE 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 doctor gave you.

Call your doctor right away if you have any unusual or severe:

Take VIOKACE exactly as prescribed by your doctor. Do not take more or less VIOKACE than directed by your doctor.

What is VIOKACE?

VIOKACE is a prescription medicine used with a proton pump inhibitor medicine (PPI) to treat adults who cannot digest food normally. Adults with swelling of the pancreas that lasts a long time (chronic pancreatitis), or who have had some or all of their pancreas removed (pancreatectomy) may not digest food normally because they do not make enough enzymes or because their enzymes are not released into the bowel (intestine).

VIOKACE contains a mixture of digestive enzymes (including lipases, proteases, and amylases) from pig pancreas.

It is not known if VIOKACE is safe and effective in children.  Use of VIOKACE in children may result in poor nutrition and slowing of growth. 

What should I tell my doctor before taking VIOKACE?

Before taking VIOKACE, tell your doctor about all your medical conditions, including if you:

Tell your doctor about all the medications you take, including prescription and nonprescription medicines, vitamins, or herbal supplements.

Know the medicines you take.  Keep a list of them and show it to your doctor and pharmacist when you get a new medicine. 

How should I take VIOKACE?

What are the possible side effects of VIOKACE?
VIOKACE may cause serious side effects, including:

Call your doctor right away if you have any of these symptoms.


The most common side effects of VIOKACE include:

Other Possible Side Effects:
VIOKACE 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 that does not go away. 

These are not all the side effects of VIOKACE.  For more information ask your doctor or pharmacist.

Call your doctor for medical advice about side effects.  You may report side effects to FDA at 1-800-FDA-1088.

You may also report side effects to Aptalis Pharma US, Inc. at 1-800-472-2634.

How should I store VIOKACE?

Keep VIOKACE and all medicines out of reach of children.

General information about the safe and effective use of VIOKACE
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use VIOKACE for a condition for which it was not prescribed. Do not give VIOKACE 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 VIOKACE. If you would like more information, talk to your doctor. You can ask your pharmacist or doctor for information about VIOKACE that is written for healthcare providers.

For more information, go to www.aptalispharma.com or call toll-free 1-800-472-2634.

What are the ingredients in VIOKACE?
Active Ingredient:
lipase, protease and amylase

Inactive Ingredients: colloidal silicon dioxide, crosscarmellose sodium, lactose monohydrate, microcrystalline cellulose, stearic acid and talc.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Marketed by:
Aptalis Pharma US, Inc
22 Inverness Center Parkway
Birmingham, Alabama 35242

Manufactured by:
Confab Laboratories, Inc.
St. Hubert, Canada

Issued 03/2012

© 2012 Aptalis Pharma US, Inc.

Revised: 04/2014
 
Aptalis Pharma US, Inc