Pancrelipase (By mouth)

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, hyperuricemia, hyperuricosuria, severe pancreas disease, or fibrosing colonopathy. Tell your doctor if you have trouble swallowing capsules.
• 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, constipation, nausea, or vomiting
• Swelling in your feet or lower legs

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

• Diarrhea or upset stomach
• Headache
• Nosebleeds
• Sore throat

Introduction

Amylase (AM-i-lase), Lipase (LYE-pase), Protease (PROE-tee-ase)

Helps patients who have cystic fibrosis, pancreatitis, and digestive disorders digest foods.

Brand Name(s)

Lipram-Pn20, Lipram-Pn16, Lipram 4500, Lipram-Pn10, Lapase, Dygase, Pangestyme EC, Zenpep, Creon, Pancreaze, Pancrelipase

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule, Delayed Release Capsule, Long Acting Capsule, Powder, Tablet, Coated Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Drink a full glass of water with your medicine and plenty of fluids during the day.
• Take this medicine with meals and snacks as directed by your doctor.
• Viokace? tablet is used in combination with certain medicines for stomach ulcer 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 very 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.
• Do not chew or crush the delayed-released capsule. Swallow it whole. If the capsule is too big to swallow, open it and put the contents in soft food (such as applesauce or yogurt). Swallow the mixture right away. Do not chew it. Do not mix the capsule 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 or the contents mixed with a small amount of soft food (such as applesauce) before each feeding. Do not mix the capsule with alkaline foods or liquids, such as breast milk or formula.
• Take the powder with meals. Avoid breathing in the powder. It can be very irritating to your lungs.
• Carefully follow your doctor's instructions about any special diet.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the delayed-release capsules in a tightly closed container to protect them from moisture.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

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