ncrease 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.
What should I tell my doctor before taking ULTRESA?
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 breast-feeding 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 pancreatic enzyme product without first talking to your doctor.
◦Do not take more capsules in a day than the number your doctor tells you to take (total daily dose).
◦Always take ULTRESA with a meal or snack and plenty of fluid. If you eat a lot of meals or snacks in a day, be careful not to go over your total daily dose.
◦Your doctor may change your dose based on the amount of fatty foods you eat or based on your weight.
◦Do not crush or chew the ULTRESA capsules or their contents, and do not hold the capsule or contents in your mouth. Crushing, chewing or holding the ULTRESA capsules in your mouth may cause irritation in your mouth or change the way ULTRESA works in your body.
Giving ULTRESA to children and adults:
1.You should not divide the capsule contents into small amounts to give small doses of ULTRESA.
2.Swallow ULTRESA capsules whole and take them with enough liquid to swallow them right away.
3.If you have trouble swallowing capsules, open the capsule and sprinkle the contents on a small amount of soft acidic food including applesauce or yogurt. Ask your doctor about other foods you can mix with ULTRESA.
4.If you sprinkle ULTRESA on food, swallow it right after you mix it and drink plenty of water or juice to make sure the medicine is swallowed com