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Entocort EC Sustained-Release Capsules is used for:

Treating mild to moderate Crohn disease and maintaining remission for up to 3 months. It may also be used for other conditions as determined by your doctor.

Entocort EC Sustained-Release Capsules is a corticosteroid. It works by decreasing inflammation.

Do NOT use Entocort EC Sustained-Release Capsules if:

• you are allergic to any ingredient in Entocort EC Sustained-Release Capsules
• you are taking mifepristone

Contact your doctor or health care provider right away if any of these apply to you.

Before using Entocort EC Sustained-Release Capsules:

Some medical conditions may interact with Entocort EC Sustained-Release Capsules. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you have heart problems; diabetes; esophagus inflammation; stomach problems; intestinal problems; heart attack; ulcer; kidney problems; liver disease; osteoporosis; high blood pressure; glaucoma; cataracts; a herpes eye infection; a bacterial, fungal, parasitic, or viral infection; diarrhea; measles; tuberculosis; chicken pox; or shingles
• if you have had a positive TB skin test or have recently been vaccinated

Some MEDICINES MAY INTERACT with Entocort EC Sustained-Release Capsules. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Barbiturates (eg, phenobarbital), carbamazepine, hydantoins (eg, phenytoin), or rifampin because they may decrease Entocort EC Sustained-Release Capsules's effectiveness
• Clarithromycin, steroidal contraceptives (eg, birth control pills), or imidazole antifungals (eg, ketoconazole, itraconazole) because they may increase the risk of Entocort EC Sustained-Release Capsules's side effects
• Ritodrine or live vaccines because the risk of their side effects may be increased by Entocort EC Sustained-Release Capsules
• Hydantoins (eg, phenytoin) because their effectiveness may be decreased by Entocort EC Sustained-Release Capsules
• Mifepristone because risk of side effects may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Entocort EC Sustained-Release Capsules may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Entocort EC Sustained-Release Capsules:

Use Entocort EC Sustained-Release Capsules as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• An extra patient leaflet is available with Entocort EC Sustained-Release Capsules. Talk to your pharmacist if you have questions about this information.
• Take Entocort EC Sustained-Release Capsules by mouth with or without food. If stomach upset occurs, take with food to reduce stomach irritation.
• Swallow Entocort EC Sustained-Release Capsules whole. Do not break, crush, or chew before swallowing.
• Use Entocort EC Sustained-Release Capsules on a regular schedule to get the most benefit from it.
• Do not eat grapefruit or drink grapefruit juice while you use Entocort EC Sustained-Release Capsules.
• If you miss a dose of Entocort EC Sustained-Release Capsules, take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Entocort EC Sustained-Release Capsules.

Important safety information:

• Entocort EC Sustained-Release Capsules may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Take Entocort EC Sustained-Release Capsules with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Tell your doctor or dentist that you take Entocort EC Sustained-Release Capsules before you receive any medical or dental care, emergency care, or surgery.
• Entocort EC Sustained-Release Capsules may lower the ability of your body to fight infection. Avoid contact with people who have colds or infections. Tell your doctor if you notice signs of infection like fever, sore throat, rash, or chills.
• If you have not had chickenpox, shingles, or measles, avoid contact with anyone who does.
• Do not receive a live vaccine (eg, measles, mumps) while you are taking Entocort EC Sustained-Release Capsules. Talk with your doctor before you receive any vaccine.
• Diabetes patients - Entocort EC Sustained-Release Capsules may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests, including adrenal function assessment, may be performed while you use Entocort EC Sustained-Release Capsules. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Entocort EC Sustained-Release Capsules should not be used in CHILDREN; safety and effectiveness in children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Entocort EC Sustained-Release Capsules while you are pregnant. Entocort EC Sustained-Release Capsules is found in breast milk. Do not breast-feed while taking Entocort EC Sustained-Release Capsules.

Possible side effects of Entocort EC Sustained-Release Capsules:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Back pain; changes in menstrual cycle; dizziness; gas; headache; indigestion; nausea; nervousness; pain; respiratory tract infection; stomach pain; tiredness; tremor; trouble sleeping; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne; change in mood or behavior; chest pain; confusion; severe headache; sudden increase in weight; swelling of the ankles; unusual bruising; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Store Entocort EC Sustained-Release Capsules at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly closed container. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Entocort EC Sustained-Release Capsules out of the reach of children and away from pets.

General information:

• If you have any questions about Entocort EC Sustained-Release Capsules, please talk with your doctor, pharmacist, or other health care provider.
• Entocort EC Sustained-Release Capsules is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Entocort EC Sustained-Release Capsules. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.