Pancrelipase

Pancrelipase is made up of three types of enzymes: lipases, proteases, and amylases.

Pancrelipase is used to replace these enzymes when the body does not produce enough. This shortage can happen due to certain medical conditions, such as cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

Pancrelipase may also be used after the surgical removal of the pancreas.

Pancrelipase may also be used for reasons not mentioned in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Do not take more than your recommended dose or use this medicine more often than prescribed.

Your dose needs may change if you switch to a different brand, strength, or form of this medicine. Avoid medication errors by using exactly as directed on the label, or as prescribed by your doctor.

Doses are based on weight. Your dose may change if you gain or lose weight.

Your doctor may need to adjust the dose of pancrelipase based on the amount of fatty foods in your diet.

Take pancrelipase with meals or snacks.

Read and carefully follow the Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you don't understand these instructions.

Swallow the tablet or capsule whole with a full glass of water or juice and do not crush, chew, or break it.

If you cannot swallow a capsule whole, open it and mix the medicine with soft food such as applesauce, bananas, or pears. Swallow the mixture right away without chewing. Do not mix the medicine with infant formula or breast milk. Do not save the mixture for later use.

Swallow pancrelipase right away and do not keep the pill or mixture in your mouth. Pancrelipase can irritate the inside of your mouth.

Pancrelipase can also be given through a feeding tube.

Some conditions are treated with a combination of pancrelipase and stomach acid medicine such as dexlansoprazole, esomeprazole, lansoprazole, omeprazole, rabeprazole, and others. Use all medications as directed.

Your doctor will need to check your progress on a regular basis and your blood may need to be tested often.

Call your doctor if your symptoms do not improve, or if they get worse.

Follow all storage instructions provided with pancrelipase. Your pharmacist can provide more information about how to store this medicine.

Call your doctor right away if you have symptoms of a rare but serious bowel disorder, such as severe or unusual stomach pain, bloating, constipation, nausea, vomiting, or diarrhea.

Tell your doctor if you have or have ever had:

• an allergy to pork products;
• gout or high levels of uric acid in the blood;
• a blockage or scarring of your intestines;
• trouble swallowing pills;
• lactose intolerance;
• any other medical condition; or
• kidney disease.

Pancrelipase is made from the pancreas of pigs. Blood and plasma are tested and treated to lower the risk of containing infectious agents, but there is still a small chance it could transmit a viral infection. Ask your doctor about your individual risk.

It is not known if pancrelipase will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

Ask a doctor if it is safe to breastfeed while using pancrelipase.

Do not give this medicine to a child without medical advice.

Get emergency medical help if you have signs of an allergic reaction: hives, difficulty breathing, swelling of your face, lips, tongue, or throat.

A rare but serious bowel disorder may happen during treatment with pancrelipase. Call your doctor right away if you have symptoms such as: severe or unusual stomach pain, bloating, constipation, nausea, vomiting, or diarrhea.

Pancrelipase may cause serious side effects. Call your doctor immediately if you have:

• joint pain, swelling, stiffness, or redness.

Pancrelipase can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using pancrelipase.

Common side effects of pancrelipase may include:

• stomach pain or upset, gas, nausea, vomiting;
• feeling full after eating a small amount;
• gallstones or bile duct stones;
• diarrhea, frequent or abnormal bowel movements;
• anal itching;
• bruising;
• headache, dizziness;
• runny or stuffy nose, cough, sore throat; or
• changes in your blood sugar.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Skip the missed dose and take your next dose at the usual time. Do not take two doses at once.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Other drugs may impact pancrelipase, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform your doctor about all other medicines you are taking.

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