Pancrelipase is a combination of three enzymes (proteins): lipase, protease, and amylase. These enzymes are normally produced by the pancreas and are important in the digestion of fats, proteins, and sugars.

Pancrelipase is used to replace these enzymes when the body does not have enough of its own. Certain medical conditions can cause this lack of enzymes, including cystic fibrosis, chronic inflammation of the pancreas, or blockage of the pancreatic ducts.

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

Pancrelipase may also be used for purposes not listed in this medication guide.

Call your doctor at once if you have symptoms of a rare but serious bowel disorder: severe or unusual stomach pain, vomiting, bloating, diarrhea, or constipation.

Pancrelipase comes as a tablet, and a delayed-release capsule to take by mouth. It is taken with plenty of water with every meal or snack, usually 5 to 6 times per day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take pancrelipase exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Pancrelipase is sold under several different brand names, and there are differences among the brand name products. Do not switch to a different brand of pancrelipase without talking to your doctor.

Swallow the tablets and delayed-release capsules whole with plenty of water; do not split, chew, or crush them. Do not suck the tablets or capsules or hold them in your mouth. Be sure that none of the tablet is left in your mouth after you swallow it.

If you cannot swallow the delayed-release capsules whole, you can open the capsules and mix the contents with a small amount of a soft, acidic food such as applesauce. You may be able to mix the capsule contents with certain other foods. Ask your doctor or pharmacist for more information. Swallow the mixture right after you mix it without chewing or crushing the capsule contents. After you swallow the mixture, drink a full glass of water or juice right away to wash down the medication.

If you are giving the delayed release capsules to a baby, you may open the capsule, sprinkle the contents on a small amount of a soft, acidic food such as jarred baby applesauce, bananas or pears, and feed it to the baby right away. Do not mix the capsule contents with formula or breast-milk. You can also sprinkle the contents directly into the baby's mouth. After you give the baby pancrelipase, give plenty of liquid to wash down the medication. Then look in the baby's mouth to be sure that he or she has swallowed all of the medication.

The contents of the delayed-release capsule must be taken right after the capsule is opened. Do not open capsules or prepare mixtures of capsules and food before you are ready to use them. Discard any unused capsule contents or pancrelipase and food mixtures; do not save them for future use.

Your doctor will probably start you on a low dose of medication and gradually increase your dose depending on your response to treatment and the amount of fat in your diet. Be sure to tell your doctor how you are feeling and whether your bowel symptoms improve during your treatment. Do not change the dose of your medication unless your doctor tells you that you should.

Your doctor will tell you the maximum amount of pancrelipase you should take in one day. Do not take more than this amount of pancrelipase in one day even if you eat more than your usual number of meals and snacks. Talk to your doctor if you are eating additional meals and snacks.

Pancrelipase will help improve your digestion only as long as you continue to take it. Continue to take pancrelipase even if you feel well. Do not stop taking pancrelipase without talking to your doctor.

Your doctor or pharmacist will give you the manufacturer's patient information sheet (Medication Guide) when you begin treatment with pancrelipase and each time you refill your prescription. Read the information carefully and ask your doctor or pharmacist if you have any questions. You can also visit the Food and Drug Administration (FDA) website (http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed. Do not switch brands of this medicine without your doctor's advice.

Pancrelipase should be taken with a meal or snack.

Carefully follow all directions when giving this medicine to a child. Ask your doctor or pharmacist if you have any questions.

Do not crush, chew, or break a pancrelipase capsule or tablet. Swallow it whole with a full glass of water.

Do not hold the pill in your mouth. Pancrelipase can irritate the inside of your mouth.

If you cannot swallow a capsule whole, open it and mix the medicine with applesauce. Swallow the mixture right away without chewing. Do not mix the medicine with infant formula or breast milk.

Do not inhale the powder from a pancrelipase capsule, or allow it to touch your skin. It may cause irritation, especially to your nose and lungs.

Pancrelipase is sometimes given with a stomach acid reducer such as Nexium, Prevacid, Prilosec, or Protonix. Follow your doctor's instructions about taking all medicines needed to treat your condition.

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

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

Call your doctor if you have any worsening of a long-term pancreas problem.

You should not take pancrelipase if you are allergic to pork proteins.

Tell your doctor if you have ever had:

• kidney disease;

• gout;

• diabetes;

• a blockage or scarring in your intestines;

• trouble swallowing pills; or

• lactose intolerance.

Tell your doctor if you are pregnant or plan to get pregnant, or if you are breastfeeding or plan to breastfeed.

Do not give pancrelipase to a child without medical advice.

Take the missed dose with your next meal or snack. Do not take two doses at one time.

Get your prescription refilled before you run out of medicine completely.

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

Keep this medication in the container it came in, tightly closed, and out of reach of children. If your medication came with a desiccant packet (small packet that contains a substance that absorbs moisture to keep the medication dry), leave the packet in the bottle but be careful not to swallow it. Store this medication at room temperature and away from excess heat and moisture (not in the bathroom). Do not refrigerate this medication.

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Your doctor or nutritionist will prescribe a diet specific for your nutritional needs. Follow these directions carefully.

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

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

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

• joint pain or swelling; or

• symptoms of a rare but serious bowel disorder--severe or unusual stomach pain, vomiting, bloating, diarrhea, constipation.

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, gas, vomiting;

• diarrhea, frequent or abnormal bowel movements;

• rectal itching;

• 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.

Other drugs may affect pancrelipase, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to pancrelipase.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.