What is ulcerative colitis (UC)?

    Understanding UC

    UC is a chronic disease (it never fully goes away), and it causes inflammation and sores (ulcers) on the lining of the large intestine (colon). This causes frequent bowel movements and leads to symptoms such as:

    • Bloody diarrhea
    • Abdominal pain
    • Urgency (immediate need to find a toilet)

    UC can affect people at any age, but most are diagnosed between their late teens and early 30s. With UC, months can go by without any symptoms. These periods of time are known as "remission." However, symptoms can return or become “active,” and this is often called a UC flare.

    Researchers do not know the exact cause of UC, but the condition may involve an autoimmune response in which your body becomes defensive or “fights” certain substances inside of the colon—even if they are good for you or your colon.

    At this time, there is no cure for UC, but effective treatments are available to reduce symptoms and help get patients into remission, and keep them there for extended periods of time.

    INDICATION

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

    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.

    • 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
    Email: salixmc@dlss.com

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