Pancrelipase Capsules

Included as part of the PRECAUTIONS section.

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

Before taking pancrelipase, tell your doctor if you have gout, kidney disease, a history of intestinal blockage, a sudden onset of pancreatitis, or worsening of chronic pancreatic disease.

Use pancrelipase regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.

Do not hold the tablets or capsule contents in your mouth. The medication may irritate the inside of your mouth.

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.

If you miss a dose of this medicine, skip the missed dose and wait until your next scheduled dose to take the medicine. Do not take extra medicine to make up the missed dose.

• Cystic Fibrosis
• Pancreatitis

• Tell all of your health care providers that you take this medicine (pancrelipase capsules). This includes your doctors, nurses, pharmacists, and dentists.
• Have your blood work checked. Talk with your doctor.
• Follow the diet plan that your doctor told you about.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• There is more than 1 brand of this medicine. One brand cannot safely be used for the other. The doctor will tell you about any needed change.
• Watch for gout attacks.
• This medicine is made from pork (pig) pancreas tissue. There is a very small risk of getting a viral disease from this medicine (pancrelipase capsules). No cases have happened. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Joint pain or swelling.
• Mouth or tongue irritation.
• This medicine may raise the chance of a rare bowel problem called fibrosing colonopathy. This bowel problem can be very bad and may lead to the need for surgery. Call your doctor right away if you have any abnormal or very bad stomach pain, bloating, trouble passing stools, upset stomach, throwing up, or loose stools (diarrhea).

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Keep a list of all your drugs (prescription, natural products, vitamins, OTC) with you. Give this list to your doctor.
• Talk with the doctor before starting any new drug, including prescription or OTC, natural products, or vitamins.
• This medicine comes with an extra patient fact sheet called a Medication Guide. Read it with care. Read it again each time this medicine (pancrelipase capsules) is refilled. If you have any questions about this medicine, please talk with the doctor, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Review Date: October 4, 2017

• It is used to help break down food when the pancreas is not working the right way.

• If you have an allergy to pancrelipase, pork, or any other part of this medicine (pancrelipase capsules).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Use this medicine (pancrelipase capsules) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take with meals and snacks.
• Swallow whole. Do not chew, crush, or hold this product in your mouth. If you do, you may get mouth irritation or it may change the way this medicine works. Talk with your doctor.
• Take each dose with lots of fluids to make sure you swallow all of the contents.
• To gain the most benefit, do not miss doses.
• Keep taking this medicine (pancrelipase capsules) as you have been told by your doctor or other health care provider, even if you feel well.
• You may sprinkle contents of capsule on applesauce. Do not chew. Swallow right away and follow with water or juice.
• After mixing, take your dose right away. Do not store for future use.
• Some products may be sprinkled on foods other than applesauce. Be sure you know what foods you can mix this medicine with.
• Some brands of this medicine (pancrelipase capsules) may be given down a certain type of feeding tube. Other brands must not be given down a feeding tube. Check with your pharmacist to see if you can give this medicine down a feeding tube.

Infants up to 12 months old:

• Give this medicine (pancrelipase capsules) every time you feed your child.
• Sprinkle the contents into the infant's mouth or over a small amount of applesauce. Some products may also be mixed with other foods found in baby food jars like bananas or pears. Be sure you know what foods you can mix this medicine with.
• Do not mix with baby formula or breast milk.
• Give the mixture right away. Do not store for use at a later time.
• Have your child drink baby formula or breast milk right after giving.
• Check inside your child's mouth after feeding to make sure your child swallowed the drug.

What do I do if I miss a dose?

• Skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

• Store at room temperature.
• Store in the original container. Do not take out the antimoisture cube or packet.
• Keep lid tightly closed.
• Protect from heat.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.