ULTRESA- pancrelipase lipase, pancrelipase protease and pancrelipase amylase capsule, delayed release 
Aptalis Pharma US, Inc

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MEDICATION GUIDE

ULTRESA® (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 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 ULTRESA exactly as prescribed by your doctor. Do not take more or less ULTRESA than directed by your doctor.

What is ULTRESA?

ULTRESA is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.

ULTRESA capsules contain a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

What should I tell my doctor before taking ULTRESA?

Before you take ULTRESA, tell your doctor about all of your medical conditions, including if you:

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and 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 ULTRESA?

Giving ULTRESA to infants (up to 12 months of age):

  1. Give ULTRESA right before each feeding of formula or breast milk.
  2. Do not mix ULTRESA capsule contents directly into formula or breast milk.
  3. Open the capsule and sprinkle the contents on a small amount of soft acidic food such as applesauce, pureed bananas or pears. These foods should be the kind found in baby food jars that you buy at the store, or other foods recommended by your doctor. You may also sprinkle the capsule contents directly into your infant’s mouth and immediately give formula or breast milk to ensure your infant has swallowed the medicine completely.
  4. If you sprinkle the ULTRESA on food, give the ULTRESA and food mixture to your infant right away. Do not store ULTRESA that is mixed with food. Throw away any unused portion of capsule contents.
  5. Give your infant enough formula or breast milk to completely swallow the ULTRESA capsule contents or the ULTRESA and food mixture.
  6. Look in your infant's mouth to make sure that all of the medicine has been swallowed.
  7. If you miss giving your infant a dose of ULTRESA, wait and give the prescribed dose of ULTRESA right before the next feeding of formula or breast milk. Do not give 2 doses at one time.

Giving ULTRESA to children and adults:

  1. You should not divide the capsule contents into small amounts to give small doses of ULTRESA.
  2. Swallow ULTRESA capsules whole and take them with enough liquid to swallow them right away.
  3. If you have trouble swallowing capsules, open the capsule and sprinkle the contents on a small amount of soft acidic food including applesauce or yogurt. Ask your doctor about other foods you can mix with ULTRESA.
  4. If you sprinkle ULTRESA on food, swallow it right after you mix it and drink plenty of water or juice to make sure the medicine is swallowed completely. Do not store ULTRESA that is mixed with food. Throw away any unused portion of capsule contents.
  5. If you miss a dose of ULTRESA, wait until your next meal or snack and take your prescribed dose. Take your next dose at your usual time. Do not take two doses at one time.

What are the possible side effects of ULTRESA?

ULTRESA may cause serious side effects, including:

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

The most common side effects of ULTRESA include:

Other possible side effects:

ULTRESA 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 possible side effects of ULTRESA. 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. / Forest Laboratories, LLC at 1-800-472-2634.

How should I store ULTRESA?

Keep ULTRESA and all medicines out of the reach of children.

General information about the safe and effective use of ULTRESA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ULTRESA for a condition for which it was not prescribed. Do not give ULTRESA 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 ULTRESA. If you would like more information, talk to your doctor. You can ask your doctor or pharmacist for information about ULTRESA that is written for health professionals.

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

What are the ingredients in ULTRESA?

Active ingredient: lipase, protease, amylase.

Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate.

Capsule shell ingredients:
ULTRESA 4,000 USP units of lipase; 8,000 USP units of protease; 8,000 USP units of amylase contains hypromellose, titanium dioxide, FD&C Blue 1, red iron oxide, and capsule imprint ink.

ULTRESA 13,800 USP units of lipase; 27,600 USP units of protease; 27,600 USP units of amylase contains gelatin, titanium dioxide, yellow iron oxide, and capsule imprint ink.

ULTRESA 20,700 USP units of lipase; 41,400 USP units of protease; 41,400 USP units of amylase contains gelatin, titanium dioxide, black iron oxide, and capsule imprint ink.

ULTRESA 23,000 USP units of lipase; 46,000 USP units of protease; 46,000 USP units of amylase contains gelatin, titanium dioxide, yellow iron oxide, black iron oxide, and capsule imprint ink.

The black radial imprinting on the capsule contains Iron oxide black as colorant, shellac, and propylene glycol. It may also contain strong ammonia solution, and potassium hydroxide.

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

Marketed by:

Aptalis Pharma US, Inc

100 Somerset Corporate Boulevard
Bridgewater, NJ 08807

Manufactured by:
Aptalis Pharma S.r.L.
Pessano, Italy 20060

Revised: 09/2014

ULTRESA® is a registered trademark of Aptalis Pharma US, Inc. or its affiliates.

© 2014 APTALIS PHARMA US, INC.

Revised: 9/2014
Aptalis Pharma US, Inc