Uses of Uceris:

• It is used to treat ulcerative colitis.
• It may be given to you for other reasons. Talk with the doctor.

What do I need to tell my doctor BEFORE I take Uceris?

• If you have an allergy to budesonide or any other part of this medicine (Uceris).
• If you are allergic to this medicine (Uceris); any part of this medicine (Uceris); or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have liver disease.
• If you are taking any of these drugs: Cyclosporine, erythromycin, indinavir, itraconazole, ketoconazole, ritonavir, or saquinavir.

This is not a list of all drugs or health problems that interact with this medicine (Uceris).

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine (Uceris) with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take Uceris?

• Tell all of your health care providers that you take this medicine (Uceris). This includes your doctors, nurses, pharmacists, and dentists.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• If you have high blood sugar (diabetes), you will need to watch your blood sugar closely.
• If you have been taking this medicine (Uceris) for many weeks, talk with your doctor before stopping. You may want to slowly stop this medicine (Uceris).
• Chickenpox and measles can be very bad or even deadly in some people taking steroid drugs like this medicine (Uceris). Avoid being near anyone with chickenpox or measles if you have not had these health problems before. If you have been exposed to chickenpox or measles, talk with your doctor.
• This medicine may lower how much natural steroid is in your body. If you have a fever, an infection, surgery, or you are hurt, talk with your doctor. You may need extra doses of oral steroids. These extra steroids will help your body deal with these stresses. Carry a warning card saying that there may be times when you need extra steroids.
• This medicine may cause weak bones (osteoporosis) with long-term use. Talk with your doctor to see if you have a higher chance of weak bones or if you have any questions.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Long-term use may raise the chance of cataracts or glaucoma. Talk with the doctor.
• Have your eye pressure checked if you are on this medicine (Uceris) for a long time. Talk with your doctor.
• Avoid grapefruit and grapefruit juice.
• Talk with your doctor before getting any vaccines. Use of some vaccines with this medicine (Uceris) may either raise the chance of an infection or make the vaccine not work as well.
• If you are 65 or older, use this medicine (Uceris) with care. You could have more side effects.
• This medicine may affect growth in children and teens in some cases. They may need regular growth checks. Talk with the doctor.
• Tell your doctor if you are pregnant, plan on getting pregnant, or are breast-feeding. You will need to talk about the benefits and risks to you and the baby.

How is this medicine (Uceris) best taken?

Use this medicine (Uceris) as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• Take in the morning if taking once a day.
• Take with or without food.
• Swallow whole. Do not chew, break, or crush.
• Keep taking this medicine (Uceris) as you have been told by your doctor or other health care provider, even if you feel well.

What do I do if I miss a dose?

• Take a missed dose as soon as you think about it.
• If it is close to the time for your next dose, skip the missed dose and go back to your normal time.
• Do not take 2 doses at the same time or extra doses.

What are some side effects that I need to call my doctor about right away?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of a weak adrenal gland like a very bad upset stomach or throwing up, very bad dizziness or passing out, muscle weakness, feeling very tired, mood changes, not hungry, or weight loss.
• Feeling very tired, weak, or touchy; trembling; having a fast heartbeat, confusion, sweating, or dizziness if you missed a dose or recently stopped this medicine (Uceris).
• Signs of high blood pressure like very bad headache or dizziness, passing out, or change in eyesight.
• Any unexplained bruising or bleeding.
• Black, tarry, or bloody stools.
• Throwing up blood or throw up that looks like coffee grounds.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• A fatty pad or hump between the shoulders.
• Round face.
• Feeling very tired or weak.
• Swelling of the ankles.
• Bone pain.
• Change in eyesight.

What are some other side effects of Uceris?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Headache.
• Signs of a common cold.
• Upset stomach or throwing up.
• Stomach pain or heartburn.
• Diarrhea.
• Feeling tired or weak.
• Gas.
• Back pain.
• Dizziness.
• Joint pain.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If OVERDOSE is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out Uceris?

• Store at room temperature.
• Keep lid tightly closed.
• Store in a dry place. Do not store in a bathroom.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Throw away unused or expired drugs. Do not flush down a toilet or pour down a drain unless you are told to do so. Check with your pharmacist if you have questions about the best way to throw out drugs. There may be drug take-back programs in your area.

Consumer Information Use and Disclaimer

• If your symptoms or health problems do not get better or if they become worse, call your doctor.
• Do not share your drugs with others and do not take anyone else's drugs.
• Some drugs may have another patient information leaflet. Check with your pharmacist. If you have any questions about this medicine (Uceris), please talk with your doctor, nurse, pharmacist, or other health care provider.
• If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.