If your doctor previously prescribed Asacol for you, you can feel confident transitioning to DELZICOL because both medicines contain the same active ingredient (and have been shown to be equivalent).1,3
DELZICOL® (mesalamine) delayed-release capsules is a prescription medication approved for the treatment of mildly to moderately active ulcerative colitis (UC) in patients 12 years of age and older and for the maintenance of remission of UC in adults.
You should take DELZICOL at least 1 hour before a meal or 2 hours after a meal. Do not open, crush, break, or chew the capsules. Swallow whole with water. Call your doctor if you or your child cannot swallow the capsule whole.
ASACOL® HD (mesalamine) delayed-release tablets are available only by prescription for the treatment of moderately active UC in adults.
DELZICOL delayed-release capsules have been shown to be equivalent to ASACOL® (mesalamine) delayed-release tablets. You should not substitute two DELZICOL 400 mg capsules for one ASACOL® HD (mesalamine) 800 mg tablet unless directed by your doctor.
IMPORTANT RISK INFORMATION
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.
Reports of kidney problems have been reported with mesalamine-containing products like DELZICOL. Tell your doctor if you have or have had problems with your kidneys. Your doctor may check to see how your kidneys are working before starting DELZICOL and periodically while taking DELZICOL.
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 tell you to stop taking DELZICOL.
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 (myocarditis) and inflammation of the lining of the heart (pericarditis). If you have a history of these conditions, tell your doctor as DELZICOL may increase your chance 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, 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. Side effects in children were similar.
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 about DELZICOL, and also available at www.DELZICOL.com.
To report a side effect from one of our products, please call the Actavis Drug Safety Department at 1-800-272-5525.
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.