When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to mesalamine or an aminosalicylate or salicylate medicine (such as aspirin).

How to Use This Medicine:
Delayed Release Capsule, Long Acting Capsule, Tablet, Delayed Release Tablet, Coated Tablet

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• Swallow the capsule or tablet whole. Do not open, break, crush, or chew it.
• Delayed-release capsule or tablets: Take it on an empty stomach, at least 1 hour before or 2 hours after a meal.
• Lialda® delayed-release tablet: Take with food.
• Pentasa® extended-release capsule: You may swallow the capsule whole, or open the capsule and sprinkle the contents on applesauce or yogurt. Swallow the mixture right away without chewing.
• Part of the medicine may pass into your stools. Tell your doctor if this happens repeatedly.
• Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. The medicine bottle might come with a small pouch (desiccant) inside it. Keep this pouch in the bottle to protect the medicine from moisture.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect how mesalamine works. Tell your doctor if you are also using any of the following:
  
  • Azathioprine
  • Mercaptopurine
  • Antacids
  • NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart disease (including a history of myocarditis or pericarditis), or a history of stomach problems (such as blockage, pyloric stenosis). Tell your doctor if you had an allergic reaction to sulfasalazine.
• This medicine may cause the following problems:
  
  • Mesalamine-induced acute intolerance syndrome
  • Kidney problems
  • Heart problems (myocarditis, pericarditis)
  • Liver failure in people who already have liver disease
• Tell your doctor if you have phenylketonuria (PKU). The Apriso™ extended-release capsules contain aspartame, which may be a problem for people who have PKU.
• Carefully follow all directions if you are changing from one brand of this medicine to another brand. Different brands may have different instructions.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Bloody diarrhea, severe cramping, stomach pain, fever, headache, rash
• Chest pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Decrease in how much or how often you urinate, difficult or painful urination
• Fast, slow, or pounding heartbeat

If you notice these less serious side effects, talk with your doctor:

• Mild constipation, diarrhea, gas, nausea, vomiting, or stomach upset

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088