Asacol^® (mesalamine) Delayed-Release Tablets, available only by prescription from your doctor, is the only sulfa-free medication indicated to both:

• treat mild to moderate flare-ups of ulcerative colitis
• maintain remission of ulcerative colitis

Asacol is proven to treat mild to moderate flare-ups of ulcerative colitis. In a six-week clinical study of flare-ups, Asacol was evaluated for its ability to reduce ulcerative colitis symptoms, including rectal bleeding, number of bowel movements, and abdominal pain. After three weeks of therapy, rectal bleeding and number of bowel movements were reduced.

Asacol is also proven to maintain remission. In a six-month study, Asacol extended patients' time in remission when taken continuously at the maintenance dose, as compared to placebo (sugar pill).

Talk with your doctor to see if remission therapy is right for you. Responses to remission therapy can vary. In addition, drug therapy may cause side effects.

Ulcerative colitis rarely goes into permanent remission. The risk of flare-ups can be substantially reduced by continued use of Asacol at the maintenance dose as directed by your doctor.

You should not take Asacol if you have been told by a health care professional that you have an increased sensitivity, or hypersensitivity, to salicylates, such as aspirin, or to any of the components of the Asacol tablet. Talk to your doctor if you have any questions about increased sensitivity to salicylates or if your condition worsens while taking Asacol.

There are some important precautions you should be aware of regarding Asacol therapy, including:

General. If you have pyloric stenosis (a narrowing of the outlet from the stomach that causes contents of the stomach to remain there for a longer period of time), you should tell your doctor before using Asacol. Pyloric stenosis may keep the Asacol tablet from reaching the colon as quickly as it normally would.

Pregnant or nursing mothers. If you are pregnant, become pregnant, or are a nursing mother, talk with your doctor before using Asacol therapy.

Recommended periodic monitoring. Your doctor may require certain tests to check your kidney function before starting Asacol therapy and periodically while you continue Asacol therapy. These tests will make sure the medication is not harming your kidneys.

Kidney function. If you have a history of kidney impairment or kidney disease, you should tell your doctor before using Asacol, as it may worsen your kidney condition.

Worsening of the symptoms. Worsening of the symptoms of ulcerative colitis was reported in 3% of Asacol-treated people in clinical trials.

Reaction to sulfasalazine or mesalamine. Some people who have had a reaction to sulfasalazine may have a similar reaction to Asacol or other products containing mesalamine. Such a reaction may include worsening of ulcerative colitis symptoms (i.e., cramping, abdominal pain, and bloody diarrhea), and occasionally fever, headache, general discomfort, itching, rash, and conjunctivitis (an inflammation of part of the eye).

Talk with your doctor about your medical history and if you have any questions about your medication. It's also important to visit your doctor periodically to monitor your condition and discuss how your treatment plan is working for you.

For more information, please refer to the Precautions section of the

In clinical studies comparing people taking Asacol to those taking a sugar pill (placebo), there was no significant difference in the number of people reporting side effects. Please note, however, Asacol is a medication and side effects may occur with its use. In studies of flare-ups, some people taking Asacol reported headache, abdominal pain, general pain, rash, upset stomach, and worsening of ulcerative colitis symptoms. In a maintenance study, headache, runny nose, general pain, sore throat, infection, and nervousness were reported.

Some serious side effects may occur. Periodic visits to your doctor are important. Contact your doctor if you have any questions or if you are experiencing any side effects while taking Asacol.

Asacol has a favorable safety profile based on a six-month maintenance study and in clinical studies of flare-ups. Results included:

• No overall significant changes in kidney function, liver function, or blood cell tests. Since the potential for kidney problems exists, periodic monitoring by your doctor is recommended.
• The number of people withdrawing from studies as a result of side effects was low (less than 4%) and similar among people taking sugar pill (placebo). No one withdrew from this study as a result of an abnormal lab test.

Asacol tablets are designed with a special outer coating that targets the delivery of the medication to the colon where it is needed.

• This unique delivery system allows the tablet to travel in one piece through the digestive tract until it reaches the end of the small intestine and beginning of the colon.
• At this location, the tablet's special coating begins to dissolve and release the active ingredient, 5-ASA, for activity throughout the entire colon.
• The active ingredient acts right at the site to reduce inflammation of the inner lining of the colon and rectum.

When taking Asacol, be sure to swallow your tablets whole - do not break or chew them. Chewing breaks the special outer coating.

In clinical studies, a small percentage of people (2 to 3%) have reported passage in the stool of what appears to be whole tablets, fragments of tablets, or tablet shells. If this occurs repeatedly, contact your doctor.