Indication

 

DELZICOL® (mesalamine) delayed-release capsules are available only by prescription for the treatment of mildly to moderately active ulcerative colitis (UC) and for the maintenance of remission of UC in adults.


ASACOL® (mesalamine) delayed-release tablets are for the treatment of mildly to moderately active ulcerative colitis (UC) and the maintenance of remission of UC.

DELZICOL® (mesalamine) delayed-release capsules have been shown to be equivalent to ASACOL® (mesalamine) delayed-release tablets.

 

Important Safety Information about DELZICOL® (mesalamine) delayed-release capsules


You should not take DELZICOL® if you are allergic to salicylates (including mesalamine, aspirin, or aspirin-containing products) or to any of the ingredients of DELZICOL®. Please tell your doctor if you think you are.


Reports of problems with kidney function have been associated with mesalamine-containing products like DELZICOL®. Tell your doctor if you have or have had problems with your kidneys. It is recommended that all patients have their kidney function checked before starting DELZICOL® and periodically while on therapy.


Products that contain mesalamine, like DELZICOL®, have been associated with a condition that may be difficult to distinguish from an ulcerative colitis flare-up. Symptoms include cramping, stomach ache and bloody diarrhea, and sometimes fever, headache, and rash. If you experience any of these symptoms, talk to your doctor immediately. Your doctor may decide to discontinue your medication.


Tell your doctor if you are allergic to sulfasalazine, as you may also be allergic to DELZICOL® or drugs that contain or are converted to mesalamine. Some patients taking DELZICOL® or mesalamine-containing products have reported heart-related allergic reactions, such as inflammation of the heart muscle and inflammation of the lining of the heart. Tell your doctor if you have or have had a history of myocarditis or pericarditis as this may increase your likelihood of having these types of reactions.


Reports of liver failure have been associated with mesalamine-containing products like DELZICOL® in patients that have or have had liver disease. Tell your doctor if you have a problem with your liver.


Tell your doctor if you have a stomach blockage (pyloric stenosis), as this may delay the release of medication.


In clinical trials, common side effects reported included stomach pain, belching, pain, headache, back pain, diarrhea, rash, upset stomach, runny nose, flu symptoms, weakness or tiredness, flatulence, vomiting, fever, joint pain, constipation, and gastrointestinal bleeding.


Before starting DELZICOL®, tell your doctor about all medications you are taking. Mesalamine may increase the risk of kidney problems when used with non-steroidal anti-inflammatory drugs (NSAIDs) (eg, ibuprofen, naproxen). Mesalamine may increase the risk of blood disorders when used with azathioprine and 6-mercaptopurine.


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.



DELZICOL® is a registered trademark of Warner Chilcott Company, LLC.

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