This medicine is a digestive enzyme combination used to improve 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.
Follow the directions for using this medicine provided by your doctor. This medicine has a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE by mouth with each meal or snack as directed by your doctor. SWALLOW THIS MEDICINE WHOLE with enough liquid to swallow it completely. Do not break, crush, chew, or hold this medicine in your mouth before swallowing. Doing so may increase the risk of mouth or tongue irritation from this medicine. Follow with a glass of water or juice. Contact your doctor if you experience mouth or tongue irritation while taking this medicine. IF THE PATIENT IS AN INFANT (up to 12 months), open the capsule and sprinkle the contents into the infant's mouth or over a small amount of applesauce at room temperature. DO NOT mix this medicine directly in breast milk or formula. If sprinkled onto applesauce, give the mixture to the infant right away. After giving this medicine, 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 WHO CANNOT SWALLOW THE CAPSULE WHOLE, open it and sprinkle the contents over a small amount of acidic soft food (such as applesauce) at room temperature. Mix the medicine with the food and swallow the entire mixture right away. Follow with 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 what foods you may mix with this medicine. STORE THIS MEDICINE at room temperature up to 77 degrees F (25 degrees C), in the original container, away from heat, moisture, and light. Brief storage between 77 and 104 degrees F (25 and 40 C) is permitted for up to 30 days. Do not store in the bathroom. KEEP THIS MEDICINE out of the reach of children and away from pets. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. DO NOT take 2 doses at once or take a dose without a snack or a meal.
Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including gout; high uric acid levels; a history of kidney problems; a history of pancreas problems or stomach or bowel problems (eg, blockage, scarring, short bowel syndrome, Crohn disease); allergies, including allergies to pork proteins; pregnancy; or breast-feeding. Tell your doctor if you have trouble swallowing capsules. USE OF THIS MEDICINE IS NOT RECOMMENDED if you have inflammation of the pancreas (pancreatitis) or a flare-up of long-term pancreas problems. Contact your doctor or pharmacist if you have any questions about taking this medicine.
SIDE EFFECTS that may occur while taking this medicine include decreased appetite, dizziness, frequent or abnormal bowel movements, gas, headache, irritability, sore throat or cough, stomach pain, or vomiting. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience painful, swollen joints; severe or persistent loose stools, diarrhea, or constipation; severe or unusual nausea, vomiting, or stomach pain; stomach bloating; symptoms of high blood sugar (eg, increased urination, thirst, or hunger; confusion; unusual drowsiness; fast breathing; flushing); or symptoms of low blood sugar (eg, anxiety, dizziness, drowsiness, fast heartbeat, headache, lightheadedness, tremors, unusual sweating, weakness). AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue. 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. You may report side effects to FDA at 1-800-FDA-1088.
IF OVERDOSE IS SUSPECTED, contact your local poison control center or emergency room immediately.
FOLLOW THE DIETARY PLAN provided by your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out. CHECK WITH YOUR PHARMACIST about how to dispose of unused medicine.