PANCRELIPASE (pan cre LI pase) treats a condition where the pancreas does not make enough of the enzymes needed to digest food. It works by replacing those enzymes, so your body can break down food. This improves nutrition and decreases fatty bowel movements.

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Take with food. Do not crush or chew the contents of the capsule. If you or your child have trouble swallowing, you may open the capsule and sprinkle the contents on soft foods that do not require chewing such as applesauce, pureed bananas, or pears. Swallow the mixture right away followed with water or juice. Do not store the mixture. If you are giving this medication to an infant, you may sprinkle the contents directly into your child's mouth. Give the medication right before each feeding of formula or breast milk. Do not mix capsule contents directly into formula or breast milk. Make sure the medication is swallowed completely and that no medication is left in the mouth. Take your doses at regular intervals. Do not take your medication more often than directed.

A special MedGuide will be given to you by the pharmacist with each prescription and refill of delayed-release capsules (Creon, Zenpep, or Pancreaze). Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Do not refrigerate. Keep this medication in the original container. Protect from moisture. Keep the container tightly closed. Do not throw out the packet in the container. It keeps the medication dry. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, empty the medication out of the container. Mix it with cat litter, dirt, coffee grounds, or another unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Stomach pain, bloating, vomiting, bloody diarrhea, weight loss

Side effects that usually do not require medical attention (report to your care team if they continue or are bothersome):

• Cough
• Dizziness
• Irritation inside the mouth or throat
• Gas
• Stomach pain
• Vomiting

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• A history of intestinal blockage or a condition called 'fibrosing colonopathy'
• Abnormally high uric acid in the blood
• Diabetes
• Gout
• Kidney disease
• Trouble swallowing capsules
• An unusual or allergic reaction to pancrelipase, pancreatin, pork, pork protein, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

What may interact with this medication?

• Acarbose
• Antacids containing calcium or magnesium
• Iron
• Miglitol

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular check-ups. Talk to your care team before you change brands of this medication. Each brand has different amounts of enzymes.

You may need to be on a special diet while taking this medication. Also, ask your care team how much water you need to drink.

This medication may increase your chance of having a rare bowel disorder. The risk of having this condition may be reduced by following the dosing directions that your care team gives you. Call your care team right away if you have any unusual or severe stomach pain.

This medication may increase blood uric acid levels, for example, worsening of gout, or painful, swollen joints. Call your care team right away if you have any of these symptoms.

Be careful if you open the capsule. This medication can irritate the lungs if you breathe it in. Also, do not hold the medication in your mouth or chew it. This may cause mouth sores.

This medication may affect blood sugar levels. If you have diabetes, check with your care team before you change your diet or the dose of your diabetic medication.

Patients should inform their care team if they wish to become pregnant or think they might be pregnant.