When This Medicine Should Not Be Used:
Do not use this medicine if you have had an allergic reaction to pancrelipase, pancreatin, or pork products.

How to Use This Medicine:
Capsule, Delayed Release Capsule, Long Acting Capsule, Powder, Tablet, Coated Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• Drink a full glass of water with your medicine and plenty of fluids during the day.
• Take this medicine with food as directed by your doctor.
• Viokace™ tablets are used in combination with medicines for stomach ulcers called proton pump inhibitors, such as esomeprazole, lansoprazole, omeprazole, Nexium®, Prevacid®, or Prilosec®.
• If the capsule opens, avoid breathing in the powder. It can be irritating to your lungs.
• Swallow the capsule or tablet whole. Do not let it dissolve in your mouth. Do not crush, break, or chew it.
• Swallow the delayed-released capsule whole. Do not chew or crush it. If the capsule is too big to swallow, open it and put the contents in soft acidic food (such as applesauce or yogurt). Swallow the mixture right away. Do not chew it. Do not mix the contents with alkaline foods or liquids, such as milk.
• When the delayed-released capsule is given to infants, it may be put directly into the mouth. It may also be opened and the contents mixed with a small amount of soft food (such as applesauce). Do not mix the contents with alkaline foods or liquids, such as breast milk or formula.
• Take the powder with meals. Avoid breathing in the powder. It can be irritating to your lungs.
• Carefully follow your doctor's instructions about any special diet.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you take iron supplements or vitamins that contain iron.

Warnings While Using This Medicine:

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you have kidney problems, gout, high uric acid in the blood or urine (hyperuricemia or hyperuricosuria), severe pancreas disease, or bowel problems. Tell your doctor if you have trouble swallowing capsules or a history of problems with blood sugar levels.
• Check with your doctor right away if you have unusual or severe stomach pain, constipation, nausea, or vomiting. These may be symptoms of a rare but serious bowel disorder called fibrosing colonopathy.
• Tell your doctor if you are lactose intolerant. Viokace™ tablets contain lactose, which can make this condition worse.
• This medicine is made from the pancreas of pigs. The risk of getting a virus from medicines made of pig organs has been greatly reduced in recent years. This is the result of required testing for certain viruses and testing during the making of these medicines. Although the risk is low, talk with your doctor if you have concerns.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Joint pain
• Severe stomach pain, bloating, constipation, diarrhea, nausea, or vomiting
• Swelling in your feet or lower legs

If you notice these less serious side effects, talk with your doctor:

• Cough
• Headache
• Mild diarrhea or upset stomach
• Nosebleeds

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088