Lipase

The most important thing to know

ZENPEP may increase your chance of having a rare bowel disorder called fibrosing colonopathy especially if taken at a high dose for a long time in children with cystic fibrosis. This condition is serious and may require surgery. The risk of having this condition may be reduced by following the dosing instructions that your doctor gave you.

Call your doctor right away if you have any unusual or severe: Stomach area (abdominal) pain Bloating Trouble passing stool (having bowel movements) Nausea, vomiting, or diarrhea Take ZENPEP exactly as prescribed by your doctor.

How to take it

Take ZENPEP exactly as your doctor tells you. Contact your doctor if you continue to have signs and symptoms of malabsorption (not absorbing nutrients from food) such as abdominal pain, abdominal distention, bloating, fatty stools, or weight loss. Your dose may need to be changed. You should not switch ZENPEP with any other pancreatic enzyme product without first talking to your doctor.

Do not take more capsules in a day than the number your doctor tells you (total daily dose). Always take ZENPEP with a meal or snack. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose. ZENPEP capsules should be swallowed whole. Do not crush or chew the ZENPEP capsules or its contents and do not hold the capsule contents in your mouth.

Crushing or chewing the ZENPEP capsules may cause irritation in your mouth or change the way ZENPEP works in your body. Giving ZENPEP to Adults and Children 12 Months of Age and Older: Swallow ZENPEP capsules whole and take them with enough liquid (water or juice) to swallow them right away. If you have trouble swallowing capsules, open the capsules and sprinkle the entire contents on a small amount of acidic soft food such as applesauce, bananas or pears.

Ask your doctor about other foods you can mix with ZENPEP. If you sprinkle ZENPEP on food, swallow it right after you mix it. Do not store ZENPEP that is mixed with food. Swallow the ZENPEP and food mixture right away followed with water or juice. Make sure the medicine is swallowed completely. If you forget to take ZENPEP, call your doctor or wait until your next meal and take your usual number of capsules.

Do not make up for missed doses. Take your next dose at the usual time. Giving ZENPEP to Infants (Children from Birth to 12 Months of Age): The 2 ways to give ZENPEP to infants (children from birth to 12 months of age), which are described below: a) Giving with an Acidic Soft Food Before each breastfeeding session or each time you give 120 mL of formula, carefully open the capsule and sprinkle the entire contents of the capsule in a small amount of acidic soft food (such as, store bought preparations of applesauce, bananas or pears) Mix the capsule contents evenly through the food.

Be careful not to crush the ZENPEP capsule contents while mixing. Give the entire mixture to the infant right away. Do not store the ZENPEP mixture or save for later use. Do not mix the ZENPEP capsule contents directly into a bottle of breast milk or formula. Give your infant enough formula or breastfeed your infant right away to completely swallow the ZENPEP food mixture.

Look into your infant's mouth to make sure that all of the medicine has been swallowed. Throw away the empty ZENPEP capsule. b) Giving Directly Into the Infant's Mouth Before Breastfeeding or Formula Feeding Before each breastfeeding session or each time you give 120 mL of formula, carefully open the ZENPEP capsule and sprinkle the capsule contents directly into the infant's mouth.

Do not mix the ZENPEP capsule contents directly into a bottle of breast milk or formula. Give your infant additional breast milk or formula right after ZENPEP to completely swallow the ZENPEP capsule contents. Look in your infant's mouth to make sure that all the medicine has been swallowed. Throw away the empty ZENPEP capsule.

If a dose is missed, give the next dose with the next feeding. What are possible side effects of ZENPEP? ZENPEP may cause serious side effects, including: Irritation of the inside of your mouth. This can happen if ZENPEP is not swallowed completely. Increase in blood uric acid levels (hyperuricemia). This may happen in people with gout, kidney problems, or those who take high doses of pancrelipase, the active ingredient in ZENPEP.

Call your doctor if you have pain, stiffness, redness or swelling of your joints. Severe allergic reactions. Severe allergic reactions have happened in people taking

Who should not take it

ZENPEP is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes. ZENPEP contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas. ZENPEP is safe and effective in adults and children. Before taking ZENPEP, tell your doctor about all your medical conditions, including if you: are allergic to pork (pig) products.

have a history of blockage of your intestines, or scarring or thickening of your bowel wall (fibrosing colonopathy). have gout, kidney disease, or high blood uric acid (hyperuricemia). have trouble swallowing capsules. have any other medical condition. are pregnant or plan to become pregnant. are breastfeeding or plan to breastfeed.

It is not known if ZENPEP passes into your breast milk. Talk to your doctor about the best way to feed your baby if you take ZENPEP. Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Know the medicines you take. Keep a list of them and show it to your doctor and pharmacist when you get a new medicine.