Indication

Asacol^® HD (mesalamine) delayed-release tablets are available only by prescription for the treatment of moderately active ulcerative colitis (UC).

 

Important Safety Information

You should not take Asacol^® HD if you are allergic to any of the ingredients or to salicylates, such as aspirin. Tell your doctor if you have liver problems, kidney problems, or a history of kidney disease. It is recommended that all patients have their kidney function tested prior to starting and periodically while on Asacol^® HD therapy. Worsening of UC symptoms can also occur. Serious side effects may occur. Asacol^® HD has not been studied in pregnant women. Talk to your doctor if you are pregnant, planning to become pregnant, or are breastfeeding because Asacol^® HD may not be right for you. If you have questions, please talk to your doctor.

Asacol^® HD is generally well tolerated. In clinical studies, some patients reported headache, upset stomach, sore throat, stomach pain, and worsening of UC symptoms.

You should not substitute one Asacol^® HD 800 mg tablet for two Asacol^® (mesalamine) delayed-release 400 mg tablets unless directed by your doctor.

Please see Full Prescribing Information.

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.

Asacol^® is a registered trademark of Medeva Pharma Suisse AG, used under license by Warner Chilcott Company, LLC.