This medicine is a 5-aminosalicylic acid (5-ASA) used to treat moderately active ulcerative colitis (inflammation of the colon). It may also be used for other conditions as determined by your doctor.
Follow the directions for using this medicine provided by your doctor. AN ADDITIONAL PATIENT INFORMATION LEAFLET may be available with this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. TAKE THIS MEDICINE BY MOUTH with or without food, or as directed by your doctor. If you are unsure how to take this medicine, contact your doctor or pharmacist. SWALLOW THIS MEDICINE WHOLE WITH LIQUID. Do not break, crush, or chew before swallowing. If you cannot swallow this medicine whole, contact your doctor. STORE THIS MEDICINE at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a tightly-closed container, away from heat, moisture, and light. KEEP THIS MEDICINE out of the reach of children and away from pets. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, take it as soon as possible or as directed by your doctor. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.
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 TAKE THIS MEDICINE if you are also taking probenecid or sulfinpyrazone. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking 6-mercaptopurine, anticoagulants (eg, warfarin), carbonic anhydrase inhibitors (eg, acetazolamide), nateglinide, repaglinide, spironolactone, sulfonylureas (eg, glipizide), or valproic acid. Tell your doctor if you are taking any medicines that may harm the kidney (eg, aminoglycoside antibiotics, such as gentamicin; amphotericin B; azathioprine; cyclosporine; nonsteroidal anti-inflammatory drugs / NSAIDs, such as ibuprofen; tacrolimus; vancomycin). Ask your doctor if you are unsure if any of your medicines might harm the kidney. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions, including a history of liver or kidney problems, certain stomach problems (eg, pyloric stenosis), pancreas problems (eg, pancreatitis), Kawasaki syndrome, rheumatic fever, heart problems (eg, inflammation of the sac around your heart), allergies, pregnancy, or breast-feeding. Tell your doctor if you have the flu or chickenpox, lung or breathing problems (eg, asthma), stomach or bowel ulcers, or urinary blockage. Tell your doctor if you have recently received a live vaccine (eg, varicella, influenza) or if you eat high-fat meals. USE OF THIS MEDICINE IS NOT RECOMMENDED if you are younger than 18 years of age and you have the flu or chickenpox, or you have received a varicella or influenza vaccine within the past 6 weeks. Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine.
SIDE EFFECTS that may occur during treatment include diarrhea; dizziness; gas; headache; indigestion; joint, muscle, or back pain; mild stomach pain; nausea; runny or stuffy nose; vomiting; or weakness. If they continue or are bothersome, check with your doctor. CONTACT YOUR DOCTOR IMMEDIATELY if you experience bloody diarrhea; blood in the urine; bloody or coffee ground-like vomit; burning, numbness, or tingling; change in the amount of urine produced; chest pain; confusion; dark urine; fast or irregular heartbeat; fever, cough, chills, or persistent sore throat; pale stools; persistent loss of appetite; severe or persistent headache or dizziness; severe or sudden stomach pain or cramping; severe stomach or back pain with nausea and vomiting; shortness of breath; sudden, unexplained weight gain; swelling of the hands, ankles, or feet; unusual bruising or bleeding; unusual tiredness or weakness; or yellowing of the skin or eyes. 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, throat, or tongue; or unusual hoarseness. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare 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. Symptoms of overdose may include confusion, diarrhea, dizziness, drowsiness, dry mouth or eyes, fast or difficult breathing, fever, headache, ringing in the ears, seizures, sluggishness, sweating, vomiting, or weakness.
DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.