Creon DR 3000U Capsules (70 Count Bottle)

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PANCRELIPASE ENTERIC-COATED CAPSULE - ORAL

(PAN-kree-LYE-pase)

COMMON BRAND NAME(S): Creon, Ultrase, Zenpep, Zymase

USES: This medication contains digestive enzymes to help break down and digest fats, starch, and proteins in food. It is used in conditions where the pancreas cannot make or does not release enough digestive enzymes into the small intestines to digest the food (e.g., chronic pancreatitis, cystic fibrosis, cancer of the pancreas, post-pancreatectomy, post-gastrointestinal bypass surgery).

HOW TO USE: Some brands of this medication have a Medication Guide provided by your pharmacist. If one is available, read the Medication Guide before your start taking this medication and each time you get a refill. If you have any questions, consult your doctor or pharmacist. Take this medication by mouth with meals and snacks as directed by your doctor. Swallow the capsule whole. Do not crush or chew the capsules or keep the capsules in your mouth. Doing so can irritate the mouth and also change the way the medication works. If swallowing is difficult, then the capsule may be opened and the contents mixed in a small amount of liquid or soft food that does not need to be chewed (such as room-temperature applesauce). Do not mix the contents of the capsule with alkaline food or liquid (such as milk, ice cream, tea). Consult your doctor or pharmacist for more information about what foods/liquids (such as infant formula, breast milk) to avoid when mixing. Swallow the food or liquid right away, making sure not to chew the medication. Drink a glass of water or juice after swallowing the food to make sure all the medication is swallowed. Do not save the medication mixture for later. Dosage is based on your medical condition, diet, weight, and response to treatment. Do not take more capsules in a day than prescribed by your doctor. Your condition will not improve any faster, and your risk of side effects will increase. Drink plenty of fluids while taking this medication unless your doctor tells you otherwise. Use this medication regularly to get the most benefit from it. Take it with every meal or snack. If your doctor has recommended that you follow a special diet, it is very important to follow the diet to get the most benefit from this medication. Do not change brands or dosage forms of pancrelipase without consulting your doctor or pharmacist. Different products may contain different amounts of the digestive enzymes. Inform your doctor if your condition persists or worsens.

SIDE EFFECTS: Diarrhea, constipation, headache, abdominal pain/cramps/bloating, gas, cough, nausea, or vomiting may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly. Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects. Tell your doctor right away if any of these rare but very serious side effects occur: severe constipation, severe stomach/abdominal discomfort, frequent/painful urination, joint pain. A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing. This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist. In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch. In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before taking pancrelipase, tell your doctor or pharmacist if you are allergic to it; or to pork protein; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details. Before using this medication, tell your doctor or pharmacist your medical history, especially of: sudden/severe swelling of the pancreas (acute pancreatitis), sudden worsening of long-term disease of the pancreas, gout, kidney disease, high uric acid level in the blood (hyperuricemia), intestinal problems (such as blockage). If you have diabetes, pancrelipase may affect your blood sugar. Check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet. Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products). During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor. It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor\'s approval. Some products that may interact with this drug include: acarbose, miglitol.

OVERDOSE: If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

NOTES: Do not share this product with others.

MISSED DOSE: If you miss a dose, take the next dose with your next meal or snack as directed. Do not double the dose to catch up.

STORAGE: Store at room temperature away from light and moisture. Check the product package for more details on how to store your brand, or ask your pharmacist. Do not store in the bathroom. Keep all medicines away from children and pets. Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.

Information last revised October 2016. Copyright(c) 2016 First Databank, Inc.