PERTZYE- pancrelipase capsule, delayed release
Digestive Care, Inc.
|This Medication Guide has been approved by the U.S. Food and Drug Administration.||Revised: 9/2022|
|What is the most important information I should know about PERTZYE?
PERTZYE may increase the risk of having a rare bowel disorder called fibrosing colonopathy, especially if taken at a high dose in children with cystic fibrosis who are less than 12 years of age. This condition is serious and may require surgery. The risk of having fibrosing colonopathy may be reduced by following the dosing instructions that your doctor gives you.
Call your doctor right away if you have any unusual or severe:
|Take PERTZYE exactly as prescribed by your doctor. Do not take more PERTZYE than your doctor tells you to.|
|What is PERTZYE?
|Before taking PERTZYE, tell your doctor about all of your medical conditions, including if you:
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 PERTZYE?
|What are the possible side effects of PERTZYE?
|Call your doctor right away if you have any of these symptoms.
The most common side effects of PERTZYE include:
|Other possible side effects:
PERTZYE 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.
These are not all of the possible side effects of PERTZYE. 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.
|How should I store PERTZYE?
|General information about the safe and effective use of PERTZYE.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use PERTZYE for a condition for which it was not prescribed. Do not give PERTZYE to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or doctor for information about PERTZYE that is written for health professionals.
|What are the ingredients in PERTZYE?
Active ingredients: lipase, protease, and amylase.
Inactive ingredients: sodium bicarbonate, sodium carbonate, cellulose acetate phthalate, sodium starch glycolate, diethyl phthalate, ursodiol, polyvinylpyrrolidone, and talc.
The hard gelatin capsule shells contain: gelatin and water.
The green imprinting ink on the 4,000 units of lipase; 14,375 units of protease; 15,125 units of amylase capsules contain: FD&C Blue #1, D&C Yellow #10, black iron oxide, dehydrated alcohol, isopropyl alcohol, butyl alcohol, propylene glycol, shellac and ammonium hydroxide.
The blue imprinting ink on the 8,000 units of lipase; 28,750 units of protease; 30,250 units of amylase capsules contain: FD&C Blue #1, ethanol, methanol, n-butyl alcohol, propylene glycol, shellac and ammonium hydroxide.
The red imprinting ink on the 16,000 units of lipase; 57,500 units of protease; 60,500 units of amylase capsules contain: FD&C Red #40, povidone, titanium dioxide, dehydrated alcohol, sodium hydroxide, butyl alcohol, propylene glycol, isopropyl alcohol, and shellac.
The purple imprinting ink on the 24,000 units of lipase; 86,250 units of protease; 90,750 units of amylase capsules contain: FD&C Blue #2, D&C Red #7, titanium dioxide, strong ammonia solution, propylene glycol, butyl alcohol, isopropyl alcohol, dehydrated alcohol, and shellac.
For more information, go to www.Pertzye.com or call 1-877-882-5950.
Digestive Care, Inc.
1120 Win Drive
Bethlehem, PA 18017
U.S. License No. 2184
Product of USA