This medication is used along with a proton pump inhibitor medicine to treat people who cannot digest food normally. The pancreas is an organ in your body that normally produces enzymes to help you digest food. Certain conditions, such as surgical removal of some or all of the pancreas, or chronic pancreatitis, can decrease the production or release of these enzymes into the bowel (intestine). Pancrelipase contains a mixture of digestive enzymes (from pig pancreas) to help breakdown and digest fats, starches, and proteins in food.

Read the Medication Guide and, if available, the Patient Information Leaflet provided by your pharmacist before you start taking pancrelipase and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth, usually with every meal and snack as directed by your doctor. Swallow this medication whole. Do not crush or chew the tablets or keep them in your mouth. Doing so can irritate the mouth/throat and change the way the medication works. Drink plenty of fluids while taking this medication unless your doctor tells you otherwise.

The dosage is based on your medical condition, diet, weight, and response to treatment. Do not take more tablets in a day than prescribed by your doctor. Your condition will not improve any faster, and your risk of side effects will increase.

Your doctor should also prescribe another medicine (proton pump inhibitor such as lansoprazole, omeprazole) to decrease stomach acid. This helps pancrelipase work better by preventing it from breaking down in your stomach.

Use this medication regularly and follow any diet recommendations from your doctor or nutritionist to get the most benefit.

Tell your doctor if your condition lasts or gets worse.

Nausea, vomiting, bloating, constipation, or anal itching may occur. If any of these effects last or get worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• severe stomach/abdominal pain

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork products; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• gout
• kidney disease
• high uric acid level in the blood (hyperuricemia)
• intestinal problems (such as blockage)

If you have diabetes, pancrelipase may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

Some products that may interact with this drug include:

• acarbose
• miglitol

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669.

Do not share this product with others.

Do not change brands or dosage forms of pancrelipase without consulting your doctor or pharmacist. Different products may contain different amounts of digestive enzymes.

If you miss a dose, take the next dose with your next meal or snack as directed. Do not double the dose to catch up.

Store at room temperature away from light and moisture. Do not store in the bathroom. Keep all medications away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company.