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IMPORTANT RISK INFORMATION

Do not take ASACOL HD if you are:

allergic to salicylates or aminosalicylates, such as aspirin or medications that contain aspirin

allergic to any of the ingredients of ASACOL HD

Before taking ASACOL HD, tell your healthcare provider if you:

have or have had kidney problems

are allergic to sulfasalazine

have or have had heart-related allergic reactions, such as inflammation of the heart muscle (myocarditis) or inflammation of the lining of the heart (pericarditis)

take any iron-containing supplements

have or have had liver problems

are pregnant, nursing, or are planning to become pregnant or to breastfeed

have any other medical conditions

Tell your healthcare provider about all medications you are taking, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking ASACOL HD with nonsteroidal anti-inflammatory drugs (NSAIDs) may cause kidney problems. Taking ASACOL HD with azathioprine or 6-mercaptopurine may cause blood problems. Ask your healthcare provider if you are not sure if you are taking one of these medicines.

What are the possible side effects of ASACOL HD?

ASACOL HD may cause serious side effects, including:

Kidney Problems. Your healthcare provider may check to see how your kidneys are working before taking ASACOL HD.

Acute Intolerance Syndrome and Other Allergic Reactions. Some people who use ASACOL HD can have allergic-type reactions, including acute intolerance syndrome. Other allergic reactions can cause heart problems, including an inflammation of the sac around the heart (pericarditis), blood problems, and problems with other organs in the body, including the kidneys, liver, and lungs. When this happens, it is usually in people who have had an allergic reaction to sulfasalazine. Stop using ASACOL HD and contact your healthcare provider right away if you get any of these symptoms: cramping, stomach (abdominal) pain, bloody diarrhea, fever, headache, chest pain, a decrease in the amount of your urine, shortness of breath, eye inflammation, fatigue, and rash.

Liver Failure. This can happen in people who have a history of liver problems and have taken other medicines that contain mesalamine. Tell your healthcare provider right away if you get any of these symptoms while using ASACOL HD: yellowing of your eyes, itchy skin, feeling very tired, flu-like symptoms, nausea, or vomiting.

Serious Skin Reactions. Some people who use ASACOL HD can have severe skin reactions. Stop using ASACOL HD and tell your healthcare provider right away if you develop any of the following signs or symptoms of a severe skin reaction, including blisters or peeling of your skin, mouth sores, blisters on your lips or around your mouth or eyes, high fever or flu-like symptoms, enlarged lymph nodes, or skin rash.

Sun Sensitivity. ASACOL HD can make your skin sensitive to the sun if you have skin conditions such as atopic dermatitis and atopic eczema. Try to limit your time in the sun. You should use sunscreen and wear a hat and clothes that cover your skin if you have to be in the sunlight.

Kidney Stones. Drink plenty of fluids when using ASACOL HD to decrease your chance of getting kidney stones. Call your healthcare provider right away if you get any of these symptoms: severe pain in your side or your back or blood in your urine.

The most common side effects of ASACOL HD include:

Headache, nausea, nasopharyngitis (common cold), stomach (abdominal) pain, and worsening of UC.

Tell your healthcare provider if you have any side effect that bothers you or does not go away. These are not all the possible side effects of ASACOL HD.

The following statement will be included within certain pieces at the discretion of regulatory:

Inform patients that if they are switching from a previous oral mesalamine therapy to ASACOL HD, they should discontinue their previous oral mesalamine therapy and follow the dosing instructions for ASACOL HD.

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.

If you are having difficulty paying for your medicine, AbbVie may be able to help.
Visit AbbVie.com/myAbbVieAssist to learn more.

The product information provided on this page is intended only for residents of the United States. The products discussed on this page may have different product labeling outside of the United States.

The health information described on this page is provided for educational purposes only and is not intended to substitute for discussions with a healthcare provider.