Mesalamine (By mouth)

Apriso, Asacol HD, Delzicol, Lialda, Pentasa

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

• Some medicines can affect how mesalamine works. Tell your doctor if you are also using azathioprine, mercaptopurine, an antacid, or an NSAID pain or arthritis medicine (including aspirin, celecoxib, diclofenac, ibuprofen, naproxen).

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.
• Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days.
• Swallow the capsule or tablet whole. Do not open, break, crush, or chew it.
• Delayed-release capsule or tablet: 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 onto soft foods (including applesauce or yogurt). Swallow the mixture right away without chewing.
• Carefully follow all directions if you are changing from one brand of this medicine to another brand. Different brands may have different instructions.
• Part of the medicine may pass into your stools. Tell your doctor if this happens repeatedly.
• 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.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088

Mesalamine (me-SAL-a-meen)

Treats and prevents flare-ups of ulcerative colitis.

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
• Blistering, peeling, red skin rash
• Bloody diarrhea, severe cramping, stomach pain, fever, headache
• 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:

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

• 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), skin problems (including atopic dermatitis, atopic eczema), or a history of stomach problems (including 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 (including myocarditis, pericarditis)
  • Liver problems
• Tell your doctor if you have phenylketonuria (PKU). The Apriso™ extended-release capsules contain aspartame, which may cause unwanted effects in patients with this condition.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• 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.