ULTRESA may cause serious side effects, including:

◦See “What is the most important information I should know about ULTRESA?”
◦Irritation of the inside of your mouth. This can happen if ULTRESA is not swallowed completely.
◦Increase in blood uric acid levels. This may cause worsening of swollen, painful joints (gout) caused by an increase of uric acid levels in your blood..
◦Allergic reactions including trouble breathing, skin rash, itching, or swollen lips.
Call your doctor right away if you have any of these symptoms.

The most common side effects of ULTRESA include:

◦headache
◦throat pain
◦nose bleeds
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. at 1-800-472- 2634.

How should I store ULTRESA?

◦Store ULTRESA at room temperature between 68°F to 77°F (20°C to 25°C). Avoid heat.
◦ULTRESA capsules should be stored in a dry place in the original container.
◦After opening the bottle, keep it closed tightly between uses to keep your medicine dry (protect it from moisture).
◦The ULTRESA bottle contains a desiccant packet to help keep your medicine dry (protect it from moisture). Do not throw away or eat the desiccant packet.
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, gelatin, hydrogenated castor oil, hypromellose phthalate, iron oxides, magnesium stearate, microcrystalline cellulose, talc, titanium dioxide, triethyl citrate.

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

Marketed by:

Aptalis Pharma US, Inc

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