Mesalamine is used to treat mild to moderate ulcerative colitis. Mesalamine is also used to prevent the symptoms of ulcerative colitis from recurring.

Some brands of mesalamine are for use only in adults, and some brands are for use in children who are at least 5 years old.

Mesalamine may also be used for purposes not listed in this medication guide.

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

Mesalamine comes as a delayed-release (releases the medication in the intestine where its effects are needed) tablet, a delayed-release capsule, and an extended-release (long acting; releases the medication throughout the digestive system) capsule to take by mouth. The delayed-release tablets (Lialda) are usually taken with food once a day by adults and children. The delayed-release tablets (Asacol HD) are usually taken on an empty stomach three times a day (1 hour before or 2 hours after meals) by adults. The extended-release capsules (Apriso) are usually taken with or without food once a day in the morning by adults. The extended-release capsules (Pentasa) are usually taken with or without food four times a day by adults. The extended-release capsules (Delzicol) are usually taken with or without food 2 to 4 times a day by adults and twice a day by children, preferably in the morning and afternoon.

Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take mesalamine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the delayed-release tablets, delayed-release capsules, and extended-release capsules whole; do not split, chew, or crush them. Be careful not to break the protective coating on the delayed-release tablets. If you cannot swallow the extended-release capsules (Pentasa), you may open the capsules and sprinkle the entire contents on a tablespoon of applesauce or yogurt. Swallow (without chewing) this mixture immediately after preparation. If you cannot swallow the delayed-release capsules (Delzicol), you may carefully open the capsules and swallow (without chewing) the entire contents of each capsule and then drink a glass of water to make sure you have swallowed all of the medicine.

Drink plenty of fluids while taking mesalamine.

Continue to take mesalamine until you finish your prescription, even if you feel better at the beginning of your treatment. Do not stop taking mesalamine without talking to your doctor.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

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

Take Asacol HD on an empty stomach, at least 1 hour before or 2 hours after a meal.

Lialda should be taken with a meal.

You may take Apriso with or without food.

Drink plenty of liquids to help prevent kidney stones.

Other brands of mesalamine can be taken with or without food. Follow your doctor's instructions or the directions on your medicine label.

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

If you cannot swallow a Pentasa capsule whole, open it and sprinkle the medicine into a spoonful of yogurt or applesauce. Swallow the mixture right away without chewing. Do not save it for later use.

Tell your doctor if you find undissolved mesalamine tablets in your stool.

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 mesalamine.

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

Store at room temperature away from moisture and heat.

You should not use mesalamine 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).

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.

Some forms of mesalamine 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 without medical advice. Some brands of mesalamine are not approved for use in anyone younger than 18 years old. Delzicol should not be given to a child younger than 5 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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat, light, and moisture (not in the bathroom).

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Unless your doctor tells you otherwise, continue your normal diet.

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: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Mesalamine may cause serious side effects. Stop using mesalamine 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 side effects of mesalamine 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.

Mesalamine 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 affect mesalamine, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

If you are taking mesalamine delayed-release tablets (Delzicol), you may notice the tablet shell or part of the tablet shell in your stool. Tell your doctor if this happens frequently.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests before and during your treatment.

Before having any laboratory test, tell your doctor and the laboratory personnel that you are taking mesalamine.

Do not let anyone else take your medicine. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.