Uceris is an extended release corticosteroid tablet that reduces inflammation in the body.

Uceris extended release tablets are a prescription medicine used to help get active, mild to moderate ulcerative colitis (UC) under control (induce remission) in adults.

It is not known if Uceris extended release tablets are safe and effective in children.

When taking Uceris avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using Uceris.

Call your doctor if you have signs of too much corticosteroid in your body, such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Take Uceris exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Take Uceris in the morning with a full glass of water. You may take this medicine with or without food.

You should not stop using Uceris suddenly. Follow your doctor's instructions about tapering your dose.

Do not crush, break, or dissolve a Uceris extended release tablet. Swallow the tablet whole.

Your dosage needs may change if you have surgery, are ill, or are under stress. Do not change your doses or medication schedule without advice from your doctor.

If you take this medicine long-term, you may need frequent medical tests.

Call your doctor if your symptoms do not improve, or if they get worse.

Store tightly closed at room temperature, away from moisture and heat.

Usual Adult Dose for Ulcerative Colitis:

Extended-release tablets:
Initial dose: 9 mg orally once a day in the morning
Duration of therapy: Up to 8 weeks

Comments:
-Avoid grapefruit juice for the duration of therapy.

Use: For the induction of remission in patients with active, mild to moderate ulcerative colitis.

You should not use Uceris if you are allergic to budesonide or any of the ingredients in Uceris extended release tablets.

To make sure Uceris is safe for you, tell your doctor if you have ever had::

• tuberculosis;

• any type of infection caused by bacteria, virus, fungus, or parasites especially chickenpox or measles;

• high blood pressure;

• a weak immune system (caused by disease or by using certain medicines);

• osteoporosis or low bone mineral density;

• a stomach ulcer;

• eczema;

• plan to have a surgery;

• any allergies;

• diabetes, cataracts, or glaucoma (in you or a family member); or

• liver disease.

Steroids can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have. Tell your doctor about any illness or infection you had within the past several weeks.

Tell your doctor if you are pregnant or plan to become pregnant, or breastfeeding or plan to breastfeed.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

High doses or long-term use of steroid medicine can lead to thinning skin, easy bruising, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Grapefruit may interact with budesonide and cause side effects. Avoid consuming grapefruit products.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using Uceris.

Get emergency medical help if you have signs of an allergic reaction to Uceris: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Uceris may cause serious side effects. Call your doctor at once if you have:

• increased adrenal gland hormones - hunger, weight gain, swelling, skin discoloration, slow wound healing, sweating, acne, increased body hair, tiredness, mood changes, muscle weakness, missed menstrual periods, sexual changes;

• decreased adrenal gland hormones - nausea, vomiting, stomach pain, loss of appetite, feeling tired or light-headed, muscle or joint pain, skin discoloration, craving salty foods; or

• signs of infection - fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding.

Budesonide can affect growth in children. Tell your doctor if your child is not growing at a normal rate while using this medicine.

Common Uceris side effects may include:

• headache, dizziness;

• indigestion, nausea, vomiting, stomach pain, bloating, gas, constipation;

• feeling tired;

• high blood pressure;

• back pain, muscle cramps, joint pain;

• swelling of the face, lower legs, ankles, and feet;

• pain and burning when you urinate;

• acne;

• thicker or increased hair on your body and face;

• cold symptoms such as stuffy nose, sneezing, sore throat; or

• decreased adrenal gland hormones.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Ask a doctor or pharmacist before using Uceris with any other medicines, especially:

• stomach acid reducers.

This list is not complete. Other drugs may interact with budesonide, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.