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 any other bowel problems.
• If you have an infection.
• If you have TB (tuberculosis), talk with your doctor.
• If you take any drugs (prescription or OTC, natural products, vitamins) that must not be taken with this medicine (Uceris), like certain drugs that are used for HIV, infections, or depression. There are many drugs that must not be taken with this medicine (Uceris). Your doctor or pharmacist can tell you if you are taking a drug that must not be taken with this medicine (Uceris).

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.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• You may have more chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu.
• If you have high blood sugar (diabetes), talk with your doctor. This medicine may raise blood sugar.
• Check your blood sugar as you have been told by your doctor.
• Have a bone density test as you have been told by your doctor. Talk with your doctor.
• Have your eye pressure checked if you are on this medicine (Uceris) for a long time. Talk with your doctor.
• Talk with your doctor if you come into contact with anyone who has chickenpox or measles and you have not had chickenpox, measles, or the vaccines for them.
• Avoid grapefruit and grapefruit juice.
• When changing from an oral steroid to another form of a steroid, there may be very bad and sometimes deadly side effects. Signs like weakness, feeling tired, dizziness, upset stomach, throwing up, not thinking clearly, or low blood sugar may happen. Call your doctor right away if you have any of these signs. If you have a bad injury, have surgery, or any type of infection, 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 may need extra steroids.
• This medicine is not approved for use in children. Talk with the doctor.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using this medicine (Uceris) while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your 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.

• This medicine is for rectal use only. Do not take this medicine (Uceris) by mouth.
• Before using this medicine (Uceris), use the bathroom to empty your bowels.
• Warm the can before use by holding it in your hands and shaking it for 10 to 15 seconds.
• If you need more lubricant for the applicator, you may use petrolatum or petroleum jelly.
• You can use this medicine (Uceris) while standing, lying down, or sitting.
• If you are using this medicine (Uceris) in the evening, use right before bedtime. After using this medicine (Uceris), try to avoid emptying your bowels until the next morning.
• This medicine may catch on fire. Do not use near an open flame or while smoking.
• Use as you have been told, even if your signs get better.

What do I do if I miss a dose?

• Use 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 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.
• Signs of Cushing's disease like weight gain in the upper back or belly, moon face, very bad headache, or slow healing.
• 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.
• Skin changes (pimples, stretch marks, slow healing, hair growth).
• Swelling of the ankles.
• Any unexplained bruising or bleeding.
• Change in eyesight.
• Bone or joint pain.

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:

• Upset stomach.

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. Do not refrigerate or freeze.
• Protect from heat or open flame. Do not puncture or burn even if it seems empty.
• 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.