INDICATION

    APRISO extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older.

    Frequently asked questions about APRISO

    General APRISO information

    What is APRISO and how does it work?

    APRISO is a prescription medicine that is used for the maintenance of remission of UC in patients 18 years of age and older.

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    Who should not take APRISO?

    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.

    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.

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    How often should I take APRISO?

    Four capsules, taken once a day, in the morning.

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    Do I have to take APRISO on an empty stomach or with food?

    You can take APRISO with or without food. It passes through the stomach without being fully absorbed.

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    Can I take other medications with APRISO?

    You should not take APRISO with antacids. It is always best to let your doctor know about any other medications you are currently taking, even if they are over-the-counter, nonprescription medications, or dietary supplements. Your doctor will tell you which other medications you may or may not take with APRISO.

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    What safety concerns should I know about?

    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.

    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.

    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.

    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 of age 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.

    Please click here for the Important Safety Information for APRISO and here for the full Prescribing Information.

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    INDICATION

    APRISO® (mesalamine) extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.

    IMPORTANT SAFETY INFORMATION—APRISO extended-release capsules

    • 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

    Please click here for full Prescribing Information for APRISO extended-release capsules. OR Please see full Prescribing Information for APRISO extended-release capsules.

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    INDICATION

    APRISO® (mesalamine) extended-release capsules are indicated for the maintenance of remission of ulcerative colitis in adults.

    IMPORTANT SAFETY INFORMATION—APRISO extended-release capsules

    • 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

    Please click here for full Prescribing Information for APRISO extended-release capsules. OR Please see full Prescribing Information for APRISO extended-release capsules.