Apriso affects a substance in the body that causes inflammation, tissue damage, and diarrhea.

Apriso is used to treat mild to moderate ulcerative colitis in patients 18 years of age and older.

Apriso is used to prevent the symptoms of ulcerative colitis from recurring.

Stop using Apriso and call your doctor at once if you have severe stomach pain, stomach cramping, bloody diarrhea (may occur with fever, headache, and skin rash).

Take Apriso exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using mesalamine.

You may take Apriso with or without food.

Drink plenty of liquids to help prevent kidney stones.

Swallow the capsule whole and do not open, chew, or break it. Tell your doctor if you have trouble swallowing the capsule.

Call your doctor if your ulcerative colitis symptoms do not improve, or if they get worse.

This medicine can affect the results of certain medical tests. Tell any doctor who treats you that you are using Apriso.

You may need frequent blood tests to check your blood cells or kidney function.

Store at room temperature away from moisture and heat.

Usual Adult Dose for Ulcerative Colitis -- Maintenance:

Apriso 375 mg extended release capsules: 1.5 g (4 capsules) orally once a day in the morning

Comments:
Do not co-administer Apriso 375 mg extended release capsules with antacids.

Use: Maintenance of remission of ulcerative colitis in adults.

You should not use Apriso if you are allergic to mesalamine, aspirin, sulfasalazine, or salicylates (such as Disalcid, Doans Pills, Dolobid, Kaopectate, Nuprin Backache, Pepto-Bismol, Tricosal, Trilisate, and others).

To make sure Apriso is safe for you, tell your doctor if you have ever had:

• a kidney stone or kidney disease;

• liver disease;

• a blockage in your stomach or intestines (such as pyloric stenosis); or

• a skin condition such as eczema.

Apriso capsules contain phenylalanine. Tell your doctor if you have phenylketonuria (PKU).

Tell your doctor if you are pregnant or plan to become pregnant. It is not known whether mesalamine will harm an unborn baby. However, having untreated or uncontrolled ulcerative colitis during pregnancy may cause complications such as low birth weight or premature birth. The benefit of treating ulcerative colitis may outweigh any risks to the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risk. If you are breastfeeding, tell your doctor if you notice diarrhea in the nursing baby.

Do not give this medicine to a child. Apriso is not approved for use in anyone younger than 18 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

If you have a skin condition such as eczema, mesalamine could make you sunburn more easily. Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.

Ask your doctor before using an antacid, and use only the type your doctor recommends. Some antacids can make it harder for your body to absorb mesalamine.

Get emergency medical help if you have signs of an allergic reaction to Apriso: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Stop using Apriso and call your doctor at once if you have:

• severe stomach pain, stomach cramping, bloody diarrhea;

• fever, headache, general ill feeling;

• rash, itching, eye redness;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, feeling light-headed, trouble breathing;

• signs of a kidney stone - severe pain in your side and back, frequent need to urinate, foul-smelling urine, dark or cloudy urine;

• kidney problems - increased or decreased urination, swelling, weight gain; or

• liver problems - loss of appetite, upper stomach pain, tiredness, easy bruising or bleeding, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Low white blood cell counts may be more likely in older adults.

Common Apriso side effects may include:

• burping, constipation, nausea, vomiting, stomach pain, diarrhea, gas;

• dizziness;

• cold symptoms such as stuffy nose, sneezing, sore throat;

• back pain;

• headache;

• rash; or

• abnormal liver function tests.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Apriso can harm your kidneys, especially if you also use certain medicines for infections, cancer, osteoporosis, organ transplant rejection, bowel disorders, high blood pressure, or pain or arthritis (including Advil, Motrin, and Aleve).

Tell your doctor about all your other medicines, especially:

• azathioprine or 6-mercaptopurine.

This list is not complete. Other drugs may interact with mesalamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.