Ultresa

Generic name:pancrelipase
Drug class:Digestive enzymes
Approval date: March 1, 2012
Company: Aptalis Pharma US, Inc.
Treatment for: Exocrine Pancreatic Insufficiency due to Cystic Fibrosis

FDA Approves Ultresa

The U.S. Food and Drug Administration (FDA) has approved Ultresa (pancrelipase) Delayed Release Capsules for the treatment of exocrine pancreatic insufficiency due to cystic fibrosis (CF) or other conditions.

Ultresa Medication Guide

Read this Medication Guide before you start taking Ultresa and each time you get a refill. There may be new information. This information does not take the place of talking with your doctor about your medical condition or treatment.

Warnings

Ultresa may increase your chance of having a rare bowel disorder called fibrosing colonopathy. 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 Ultresa exactly as prescribed by your doctor. Do not take more or less Ultresa than directed by your doctor.

What is Ultresa?

Ultresa is a prescription medicine used to treat people who cannot digest food normally because their pancreas does not make enough enzymes due to cystic fibrosis or other conditions.

Ultresa capsules contain a mixture of digestive enzymes including lipases, proteases, and amylases from pig pancreas.

Ultresa is safe and effective in children when taken as prescribed by your doctor.

Before taking this medicine

Before you take Ultresa, tell your doctor about all of your medical conditions, including if you:

• are allergic to pork (pig) products
• have a history of intestinal blockage, or scarring or thickening of your bowel wall (fibrosing colonopathy)
• have gout, kidney disease, or a condition called high blood uric acid (hyperuricemia)
• have trouble swallowing capsules
• have any other medical condition
• are pregnant or plan to become pregnant. It is not known if Ultresa will harm your unborn baby.
• are breastfeeding or plan to breastfeed. It is not known if Ultresa passes into your breast milk. You and your doctor should decide if you will take Ultresa or breastfeed.

Tell your doctor about all the medicines you take, including prescription and nonprescription 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.

How should I take Ultresa?

• Take Ultresa capsules exactly as your doctor tells you
• You should not switch Ultresa with any other ...