Mesalamine (me-SAL-a-meen)

Treats and prevents flare-ups of ulcerative colitis.

Brand Name(s):

Apriso, Asacol, Delzicol, Lialda, Pentasa

When This Medicine Should Not Be Used:

How to Use This Medicine:

Delayed Release Capsule, Long Acting Capsule, Tablet, Delayed Release Tablet, Coated Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.
• 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.
• Asacol® delayed-release tablet:
  • You may take this medicine with or without food.
  • Drink extra fluids so you will urinate more often and help prevent kidney problems.
• 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.

Drugs and Foods to Avoid:

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

• Do not use Apriso® together with an antacid.
• Some medicines can affect how mesalamine works. Tell your doctor if you are also using azathioprine, mercaptopurine, an antacid, or NSAIDs (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, 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:
  • Kidney problems, including kidney stones
  • Mesalamine-induced acute intolerance syndrome
  • Heart problems, including myocarditis, pericarditis
  • Liver problems
  • Serious skin reactions, including Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP)
• 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.
• This medicine may make your skin more sensitive to sunlight. Wear sunscreen. Do not use sunlamps or tanning beds.
• 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.

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
• Blistering, peeling, red skin rash
• Bloody diarrhea, severe cramping, stomach pain, headache
• Change in how much or how often you urinate, difficult or painful urination, lower back or side pain
• Chest pain, trouble breathing
• Dark urine or pale stools, nausea, vomiting, loss of appetite, yellow skin or eyes
• Fast, slow, or pounding heartbeat
• Fever, chills, cough, stuffy or runny nose, sore throat, body aches

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

• Dizziness
• 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