Budesonide extended-release tablets

What is this medicine?

BUDESONIDE (bue DES oh nide) is a corticosteroid. It is used in the treatment of ulcerative colitis which is a type of inflammatory bowel disease.

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 cut, crush, or chew this medicine. Swallow whole. Take your dose in the morning. Do not take with grapefruit juice. You can take it with or without food. If it upsets your stomach, take it with food. 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.

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 emotions or moods

• eye pain

• signs and symptoms of high blood sugar such as being more thirsty or hungry or having to urinate more than normal. You may also feel very tired or have blurry vision.

• signs and symptoms of infection like fever or chills; cough; sore throat; pain or trouble passing urine

• slow growth in children (if used for longer periods of time)

• swelling of ankles, feet

• trouble sleeping

• weak bones (if used for longer periods of time)

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

• acne

• back pain

• dizziness

• gas

• headache

• nausea

• stomach pain

• tiredness

• upset stomach

• vomiting

What may interact with this medicine?

• antacids

• certain antibiotics like clarithromycin or erythromycin

• certain antivirals for HIV or hepatitis

• certain medicines for fungal infections like ketoconazole, itraconazole, or posaconazole

• cimetidine

• cyclosporine

• grapefruit juice

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.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.

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

• cataracts

• diabetes

• immune system problems

• glaucoma

• having surgery

• high blood pressure

• history of stomach ulcers

• liver disease

• osteoporosis

• an unusual or allergic reaction to budesonide, other corticosteroids, medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your healthcare professional for regular checks on your progress. Tell your healthcare professional if your symptoms do not start to get better or if they get worse. If you are taking this medicine over a prolonged period, carry an identification card with your name and address, the type and dose of your medicine, and your doctor's name and address.

This medicine may increase your risk of getting an infection. Tell your doctor or health care professional if you are around anyone with measles or chickenpox, or if you develop sores or blisters that do not heal properly.

If you are going to need surgery or other procedure, tell your healthcare professional that you are using this medicine.

This medicine may increase blood sugar. Ask your healthcare provider if changes in diet or medicines are needed if you have diabetes.