ZENPEP- pancrelipase capsule, delayed release
Read this Medication Guide before you start taking ZENPEP and each time you get a refill. There may be new information. This information does not take the place of talking to your doctor about your medical condition or treatment.
What is the most important information I should know about ZENPEP?
Take ZENPEP exactly as prescribed. Do not take more or less ZENPEP than directed by your doctor.
What is ZENPEP?
ZENPEP is a prescription medicine for people who cannot digest food normally because their pancreas does not make enough enzymes. ZENPEP may help your body use fats, proteins and sugars from food.
ZENPEP contains a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.
ZENPEP is safe and effective in children.
What should I tell my doctor before taking ZENPEP?
Before taking ZENPEP, tell your doctor about all your medical conditions, including if you:
Tell your doctor about all the medicines you take, including prescription and nonprescription medicines, vitamins, and dietary or 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.
How should I take ZENPEP?
Giving ZENPEP to children and adults
Giving ZENPEP to infants (children up to 12 months):
What are possible side effects of ZENPEP?
ZENPEP may cause serious side effects, including:
See “What is the most important information I should know about ZENPEP?”
Call your doctor right away if you have any of these symptoms.
The most common side effects of ZENPEP include
Other Possible Side Effects
ZENPEP and other pancreatic enzyme products are made from the pancreas of pigs, the same pigs people eat as pork. These pigs may carry viruses. Although it has never been reported, it may be possible for a person to get a viral infection from taking pancreatic enzyme products that come from pigs.
Tell your doctor if you have any side effect that bothers you or does not go away.
These are not all the possible side effects of ZENPEP. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
You may also report side effects to Aptalis Pharma at 1-888-936-7371.
How do I store ZENPEP?
Keep ZENPEP and all medicines out of the reach of children.
General information about ZENPEP
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZENPEP for a condition for which it was not prescribed. Do not give ZENPEP to other people, even if they have the same symptoms you have. It may harm them.
This Medication Guide summarizes the most important information about ZENPEP. If you would like more information, talk with your doctor. You can ask your pharmacist or doctor for information about ZENPEP that is written for health professionals. For more information, go to www.ZENPEP.com or call 1-888-ZENPEP1 (1-888-936-7371).
What are the ingredients in ZENPEP?
Active ingredient: lipase, protease, amylase
Inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hydrogenated castor oil, hypromellose phthalate, magnesium stearate, microcrystalline cellulose, talc, and triethyl citrate in hypromellose capsules.
The red radial imprinting on the 3,000 capsule strength contains, antifoam DC 1510, industrial methylated spirit, iron oxide red C.I. 77491-E172, n-butyl alcohol, shellac and soya lecithin.
The blue radial imprinting on the 5,000, 10,000, 15,000, 20,000, 25,000, and 40,000 capsule strengths contains dehydrated alcohol, FD&C Blue #2 aluminum lake C.I. 73015-E132, isopropyl alcohol, n-butyl alcohol, propylene glycol, shellac and strong ammonia solution.
Capsule shell ingredients:
3,000 USP units and 5,000 USP units of lipase contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, and water.
10,000 USP units of lipase contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, titanium oxide, water and yellow ferric oxide.
15,000 USP units of lipase contain carnauba wax or talc, carrageenan, hypromellose, potassium chloride, red ferric oxide, titanium oxide, and water.
20,000 USP units of lipase contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, water, and yellow ferric oxide.
25,000 USP units of lipase contain carnauba wax or talc, carrageenan, FD&C Blue #2, hypromellose, potassium chloride, titanium oxide, and water.
40,000 USP units of lipase contain FD&C Yellow #6, hypromellose, titanium oxide and water.
This Medication Guide has been approved by the U.S. Food and Drug Administration.
Aptalis Pharma S.r.l.
Via Martin Luther King, 13
20060, Pessano con Bornago
Aptalis Pharma US, Inc.
100 Somerset Corporate Boulevard
Bridgewater, NJ, 08807
©2014 Aptalis Pharma US, Inc.
Issued March 2014
03/2014 rev. 10