Budesonide Extended-Release Tablets

What is this medication?

BUDESONIDE (bue DES oh nide) treats ulcerative colitis. It works by decreasing inflammation in the digestive tract. It belongs to a group of medications called steroids.

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

COMMON BRAND NAME(S): UCERIS

What should I tell my care team before I take this medication?

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

• Any active infection
• Cataracts
• Diabetes
• Glaucoma
• Having surgery
• High blood pressure
• History of stomach ulcers
• Immune system problems
• Liver disease
• Osteoporosis
• An unusual or allergic reaction to budesonide, other corticosteroids, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with a glass of water. Follow the directions on the prescription label. Do not cut, crush, or chew this medication. 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 medication more often than directed. Do not stop taking this medication except on the advice of your care team.

Talk to your care team regarding the use of this medication 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 medication?

• Antacids
• Certain antibiotics like clarithromycin or erythromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections like ketoconazole, itraconazole, or posaconazole
• Cimetidine
• Cyclosporine
• Grapefruit juice

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 medication?

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

This medication may increase your risk of getting an infection. Tell your care team 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 care team that you are using this medication.

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

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Cushing syndrome—increased fat around the midsection, upper back, neck, or face, pink or purple stretch marks on the skin, thinning, fragile skin that easily bruises, unexpected hair growth
• High blood sugar (hyperglycemia)—increased thirst or amount of urine, unusual weakness or fatigue, blurry vision
• Increase in blood pressure
• Infection—fever, chills, cough, sore throat, wounds that don't heal, pain or trouble when passing urine, general feeling of discomfort or being unwell
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Mood and behavior changes—anxiety, nervousness, confusion, hallucinations, irritability, hostility, thoughts of suicide or self-harm, worsening mood, feelings of depression
• Swelling of the ankles, hands, or feet

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

• Acne
• General discomfort and fatigue
• Headache
• Nausea
• Weight gain

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 medication?

Keep out of the reach of children and pets.

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