Pancrelipase

Pancrelipase capsules are used to improve digestion of food in infants, children, and adults who have pancreatic insufficiency (a condition in which the pancreas does not have enough pancreatic enzymes (substances needed to break down food so it can be digested) because they have a condition that affects the pancreas (a gland that produces several important substances including enzymes needed to digest food). Pancrelipase tablets are used along with another medication (proton pump inhibitor; PPI) to improve digestion of foods in adults who cannot digest food normally because they have chronic pancreatitis (swelling of the pancreas) or have had surgery to remove the pancreas. Pancrelipase is in a class of medications called enzymes. Pancrelipase acts in place of the enzymes normally made by the pancreas. It works to decrease fatty bowel movements and to improve nutrition by breaking down fats, proteins, and starches from food into smaller substances that can be absorbed from the intestine.

Pancrelipase comes as a tablet and a delayed-release (releases the medication in the intestine where its effects are needed) 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. Tablets or capsules that are not swallowed completely can cause irritation in your mouth or change the way pancrelipase works in your body.

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, 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. If you continue to experience any of the following symptoms of malabsorption (not absorbing nutrients from your food), call your doctor: stomach pain, bloating, fatty stools, or weight loss.

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 (https://www.fda.gov/Drugs/DrugSafety/ucm085729.htm) or the manufacturer's website to obtain the Medication Guide.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking pancrelipase,

• tell your doctor and pharmacist if you are allergic to pancrelipase, any other medications, pork products, or any of the ingredients in pancrelipase tablets or delayed release capsules.Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have ever had surgery on your intestine or a blockage, thickening, or scarring your intestine, and if you have or have ever had gout (sudden attacks of joint pain, swelling, and redness that occur when there is too much of a substance called uric acid in the blood), high levels of uric acid (a substance that forms when the body breaks down certain foods) in your blood,or kidney disease. If you will be taking pancrelipase tablets, also tell your doctor if you are lactose intolerant (have difficulty digesting dairy products).
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking pancrelipase, call your doctor.
• you should know that pancrelipase is made from the pancreas of pigs. There may be a risk that someone taking pancrelipase could become infected by a virus carried by pigs. However, this type of infection has never been reported.

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

Skip the missed dose and take your usual dose with your next meal or snack. Do not take a double dose to make up for a missed one.

Pancrelipase may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• headache
• cough
• sore throat
• dizziness
• bruising
• feeling full after eating a small amount
• gas
• irritation or itching around the anus

Some side effects can be serious. If you experience any of these symptoms or those listed in the HOW section, call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• difficulty breathing or swallowing
• hoarseness
• nausea
• vomiting
• diarrhea
• stomach pain or bloating
• difficulty having bowel movements
• pain, stiffness, redness, or swelling in joints, especially the big toe

Pancrelipase may cause other side effects. Call your doctor if you have any unusual problems while you are taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

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 (https://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. https://www.upandaway.org

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• pain or swelling in joints, especially the big toe
• diarrhea

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.

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