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Ultresa delayed-release capsules

Generic Name: pancrelipase (PAN-kree-LYE-pase)
Brand Name: Ultresa

Ultresa delayed-release capsules are used for:

Improving food digestion in patients who cannot digest food properly because they have a pancreas problem (exocrine pancreatic insufficiency) caused by cystic fibrosis or certain other conditions.

Ultresa delayed-release capsules are a digestive enzyme combination. It works by helping the body to digest protein, starch, and fat.

Do NOT use Ultresa delayed-release capsules if:

  • you are allergic to any ingredient in Ultresa delayed-release capsules

Contact your doctor or health care provider right away if any of these apply to you.

Before using Ultresa delayed-release capsules:

Some medical conditions may interact with Ultresa delayed-release capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances (including pork proteins)
  • if you have gout or high uric acid levels
  • if you have a history of kidney problems, high blood sugar, or diabetes
  • if you have a history of pancreas problems, stomach or bowel problems (eg, blockage, scarring, thickening, short bowel syndrome, Crohn disease), or if you have had bowel surgery
  • if you have trouble swallowing capsules

Some MEDICINES MAY INTERACT with Ultresa delayed-release capsules. However, no specific interactions with Ultresa delayed-release capsules are known at this time.

Ask your health care provider if Ultresa delayed-release capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Ultresa delayed-release capsules:

Use Ultresa delayed-release capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Ultresa delayed-release capsules comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Ultresa delayed-release capsules refilled.
  • Take Ultresa delayed-release capsules by mouth with each meal or snack as directed by your doctor. Be sure not to take more capsules in a day than the number your doctor tells you to take.
  • Swallow Ultresa delayed-release capsules whole with enough liquid to swallow it completely. Do not break, crush, chew, or hold Ultresa delayed-release capsules in your mouth before swallowing. Doing so may increase the risk of mouth or tongue irritation from Ultresa delayed-release capsules. Contact your doctor if you experience mouth or tongue irritation while taking Ultresa delayed-release capsules.
  • If the patient is an infant (up to 12 months old), open the capsule and sprinkle the contents into the infant's mouth or over a small amount of acidic soft food (eg, applesauce, pureed bananas or pears) at room temperature. These should be the kind found in baby food jars bought at the store. Do NOT mix Ultresa delayed-release capsules directly in breast milk or formula. If sprinkled onto food, give the mixture to the infant right away. After giving Ultresa delayed-release capsules, follow it with breast-milk or formula. Be sure that none of the medicine is crushed, chewed, or left in the mouth.
  • If the patient is an adult or child older than 12 months old who cannot swallow the capsule whole, you may open it and sprinkle the contents over a small amount of acidic soft food (eg, applesauce, yogurt) at room temperature. Swallow the entire mixture right away, followed by a glass of water or juice. Be sure that none of the medicine is crushed, chewed, or left in the mouth. Check with your doctor if you are unsure which foods you may mix with Ultresa delayed-release capsules. Do not store the mixture or any unused portion of a capsule for future use.
  • Do not divide the capsule contents into smaller amounts.
  • If you miss a dose of Ultresa delayed-release capsules, skip the missed dose and take the next dose with the next meal or snack as directed. Do not take 2 doses at once or take a dose without a snack or a meal.

Ask your health care provider any questions you may have about how to use Ultresa delayed-release capsules.

Important safety information:

  • Do NOT take more or less than the recommended dose without checking with your doctor.
  • Do not switch between Ultresa delayed-release capsules and another pancreatic enzyme medicine without first checking with your doctor.
  • Diabetes patients -Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Ultresa delayed-release capsules may increase the risk of developing a rare, serious condition called fibrosing colonopathy. When this occurs, it is usually with high doses over a long period of time. It has been most commonly reported in children with cystic fibrosis. Contact your doctor right away if you experience unusual or severe nausea, vomiting, or stomach pain; stomach bloating; or severe or persistent loose stools, constipation, or diarrhea.
  • Ultresa delayed-release capsules comes from pork (pig) pancreas tissue. There is an extremely rare risk of developing a viral disease from this product. No cases of viral disease from pork pancreas products have been identified.
  • Caution is advised when using Ultresa delayed-release capsules in CHILDREN; they may be more sensitive to its effects, especially fibrosing colonopathy.
  • PREGNANCY and BREAST-FEEDING: It is not known if Ultresa delayed-release capsules can cause harm to the fetus. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ultresa delayed-release capsules while you are pregnant. It is not known if this medicine is found in breast milk. If you are or will be breast-feeding while you use Ultresa delayed-release capsules, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Ultresa delayed-release capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; gas; headache; nausea; nosebleeds; stomach pain; throat pain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); mouth or tongue sores or irritation; painful, swollen joints; severe or persistent loose stools, diarrhea, or constipation; severe or unusual nausea, vomiting, or stomach pain; stomach bloating.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately.

Proper storage of Ultresa delayed-release capsules:

Store Ultresa delayed-release capsules at room temperature, between 68 and 77 degrees F (20 and 25 degrees C). Store in the original container with the lid tightly closed and away from heat, moisture, and light. Do not remove any moisture control packs that may come in the bottle. Do not store in the bathroom. Keep Ultresa delayed-release capsules out of the reach of children and away from pets.

General information:

  • If you have any questions about Ultresa delayed-release capsules, please talk with your doctor, pharmacist, or other health care provider.
  • Ultresa delayed-release capsules are to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.
  • Check with your pharmacist about how to dispose of unused medicine.

This information should not be used to decide whether or not to take Ultresa delayed-release capsules or any other medicine. Only your health care provider has the knowledge and training to decide which medicines are right for you. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about Ultresa delayed-release capsules. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to Ultresa delayed-release capsules. This information is not specific medical advice and does not replace information you receive from your health care provider. You must talk with your health care provider for complete information about the risks and benefits of using Ultresa delayed-release capsules.

Issue Date: June 3, 2015

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.