• You should not take APRISO extended-release capsules if you experience an allergic reaction to salicylates or aminosalicylates, or to any of the components of APRISO capsules.

• Kidney impairment has been reported in patients given products like APRISO (contain mesalamine or are converted to mesalamine). It is recommended that you have an evaluation of kidney function prior to treatment with APRISO therapy and periodically while on therapy. Talk to your doctor if you have any kidney problems before taking APRISO.

• Mesalamine has been associated with an acute intolerance syndrome that may be difficult to distinguish from a flare of your ulcerative colitis. Symptoms include cramping, acute abdominal (stomach) pain and bloody diarrhea, sometimes fever, headache, and rash. Talk to your doctor if you experience a worsening of these problems after you start treatment.

• If you have liver disease, talk to your doctor before taking APRISO. There have been reports of liver failure in patients with liver disease who have taken mesalamine.

• Some people who use APRISO can have serious skin reactions. Stop using APRISO and tell your doctor right away if you develop any signs or symptoms of a serious skin reaction.

• If you have pre-existing skin conditions, wear protective clothing and use a broad spectrum sunscreen when outdoors to avoid sun exposure.

• Drink plenty of fluids while taking APRISO to decrease the risk of developing kidney stones. Call your doctor if you have severe side or back pain or blood in the urine.

• In the clinical studies, the most common side effects occurring in at least 3% of patients taking APRISO were headache, diarrhea, upper abdominal (stomach) pain, nausea, nasopharyngitis (inflammation of the nasal passages), flu and flu-like illness, and inflammation of the sinuses.

• You should not take APRISO while taking antacids because the dissolving of APRISO granules depends on the acidity in your stomach.

• If you are 65 years old or older, talk to your doctor before taking APRISO. Blood cell count must be monitored closely if you are 65 or older and on mesalamine therapy.

• If you have phenylketonuria (PKU), please be aware that each APRISO capsule contains aspartame equivalent to 0.56 mg of phenylalanine, so that the recommended adult dosing provides an equivalent of 2.24 mg of phenylalanine per day.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch/ or call 1-800-FDA-1088.

For product information, adverse event reports, and product complaint reports, please contact:
Salix Product Information Call Center
Phone: 1-800-508-0024
Fax: 1-510-595-8183

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