Budesonide Oral capsule, gastro-resistant pellets

What is this medicine?

BUDESONIDE (bue DES oh nide) is a corticosteroid. It is used in the treatment of Crohn's disease, which is an inflammatory bowel disease.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• any active infection
• immune system problems
• liver disease
• an unusual or allergic reaction to budesonide, other corticosteroids, medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Do not chew, crush, or break open the capsules. If you are only taking this medicine once a day, take it in the morning. Take your doses at regular intervals. Do not take your medicine more often than directed. Do not stop taking this medicine except on the advice of your doctor or health care professional.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• mifepristone

This medicine may also interact with the following medications:

• anastrozole
• antacids
• cimetidine
• grapefruit juice
• ketoconazole

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

This medicine may increase your risk of getting an infection. Stay away from people who are sick. Tell your doctor or health care professional if you are around anyone with measles or chickenpox.

You may need to avoid receiving certain vaccines or may need to have changes in the vaccination schedules to ensure adequate protection from certain diseases. Make sure to tell your doctor or health care professional that you are taking this medicine before receiving any vaccine.

If you are going to have surgery, tell your doctor or health care professional that you are taking this medicine.

This medicine can affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.

Alcohol, grapefruit, and grapefruit juice can increase the risk of getting serious side effects while you are taking this medicine. Avoid grapefruit, grapefruit juice, and alcoholic drinks while taking this medicine.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
• changes in vision
• fever, sore throat, sneezing, cough, or other signs of infection, wounds that will not heal
• frequent passing of urine
• increased thirst
• mental depression, mood swings, mistaken feelings of self-importance or of being mistreated
• pain in hips, back, ribs, arms, shoulders, or legs
• severe stomach pain
• swelling of feet or lower legs
• unusually weak or tired
• vomiting

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• headache
• increased appetite
• nausea
• skin problems, acne, thin and shiny skin

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.