Pancrelipase (By mouth)

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your doctor knows if you are taking iron supplements or vitamins that contain iron.

Warnings While Using This Medicine

• Make sure your doctor knows if you are pregnant or breastfeeding, or if you or your child have severe pancreas disease, kidney problems, gout, hyperuricemia (high uric acid in the blood), hyperuricosuria (high uric acid in the urine), or a bowel problem called fibrosing colonopathy (blocked intestines, or a scarred or thick bowel wall). Tell your doctor if you or your child have trouble swallowing capsules.
• This medicine is made from the pancreas of pigs. The risk of getting a virus from medicines made of pig organs has been greatly reduced in recent years. This is the result of required testing for certain viruses, and testing during manufacture of these medicines. Although the risk of transmitting certain viruses to people who will use the medicine is low, talk with your doctor if you or your child have concerns.
• This medicine may cause a serious type of allergic reaction, including anaphylaxis. Anaphylaxis can be life-threatening and requires immediate medical attention. Call your doctor right away if you or your child have itching; hives; hoarseness; trouble with breathing; trouble with swallowing; or any swelling of your hands, face, or mouth while you or your child are using this medicine.
• Your doctor will need to check your progress at regular visits while you are using this medicine. Be sure to keep all appointments.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Joint pain or swelling.
• Severe stomach pain.

If you notice these less serious side effects, talk with your doctor:

• Cough.
• Diarrhea, constipation, nausea, vomiting, or gas.
• Dizziness.
• Headache.
• Stomach upset or cramps.

Introduction

Amylase (AM-i-lase), Lipase (LYE-pase), Protease (PROE-tee-ase)

An enzyme that helps digest foods for patients who have cystic fibrosis and digestive disorders.

Brand Name(s)

Lipram-Pn20, Lipram-Pn16, Lipram 4500, Lipram-Pn10, Lapase, Dygase, Pangestyme EC, Zenpep, Creon, Pancreaze, Pancrelipase

When This Medicine Should Not Be Used

How to Use This Medicine

Capsule, Delayed Release Capsule, Long Acting Capsule, Powder, Tablet, Coated Tablet

• Your doctor will tell you how much of this medicine to use and how often. Your dose may need to be changed several times in order to find out what works best for you. Do not use more medicine or use it more often than your doctor tells you to.
• Drink a full glass of water with your medicine and plenty of fluids during the day.
• Take this medicine with meals and snacks as directed by your doctor.
• If the capsule opens, keep the powder away from your nose to avoid breathing in the powder. It can be very irritating to your lungs.
• Swallow the capsule or tablet whole. Do not let it dissolve in your mouth.
• Do not chew or crush the delayed-released capsule. Swallow it whole. If the capsule is too big to swallow, open it and put the contents in soft food (such as applesauce, pureed bananas or pears). Swallow the mixture right away without crushing or chewing it. Do not mix the capsule with alkaline foods or liquids, such as milk, breast milk, or formula.
• When the delayed-released capsule is given to infants, the contents of the capsule may be put directly into the mouth or mixed with a small amount of soft food (such as applesauce, pureed bananas or pears) and given before each feeding.
• Take the powder with meals. Keep the powder away from your nose to avoid breathing in the powder. It can be very irritating to your lungs.
• Carefully follow your doctor's instructions about any special diet.
• Use only the brand of this medicine that your doctor prescribed. Different brands may not work the same way.
• This medicine should come with a Medication Guide. Read and follow these instructions carefully. Ask your doctor or pharmacist if you have any questions. Ask your pharmacist for the Medication Guide if you do not have one.

If a dose is missed:

• If you miss a dose or forget to use your medicine, use it as soon as you can. If it is almost time for your next dose, wait until then to use the medicine and skip the missed dose. Do not use extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Store the delayed-release capsules in a tightly-closed container to protect them from moisture. Putting desiccant pouches in the container may also help to keep the capsules from getting moist.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your medicine with anyone.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088