When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to budesonide or to other components of the product.

How to Use This Medicine:
Foam

• Your doctor will tell you how much medicine to use. Do not use more than directed.
• To use: This medicine is to be applied on the anus. Do not take this medicine by mouth. Attach the applicator (provided in the package) to the can. Each applicator is coated with a lubricant. If additional lubrication is needed, you may use petrolatum or petroleum jelly. Warm the canister foam by shaking it in your hands for 10 to 15 seconds. You may use the rectal foam in a standing, lying, or sitting position (such as while using the toilet). Apply the foam in the morning and evening for the first 2 weeks. When applied in the evening, use it before bedtime. Try not to empty bowels until the next morning.
• Keep using this medicine for the full time of treatment, even if you begin to feel better after a few days. Do not miss any doses.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.
• Store the foam can at room temperature, away from heat and direct light. Do not keep this medicine inside a car where it could be exposed to extreme heat. Do not poke holes in the canister or throw it into a fire, even if the canister is empty.

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Some foods and medicines can affect budesonide works. Tell your doctor if you are using cyclosporine, erythromycin, indinavir, itraconazole, ketoconazole, ritonavir, or saquinavir.
• Do not eat grapefruit or drink grapefruit juice while you are using this medicine.

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease (including cirrhosis), high blood pressure, osteoporosis, stomach ulcers, tuberculosis, or a family history of cataracts, diabetes, or glaucoma. Tell your doctor if you have tuberculosis (TB) or another infection, or if you have allergies.
• You have a higher risk of adrenal gland problems if you use this medicine for a long time or use too much.
• You may get infections more easily while you use this medicine. Avoid people who are sick or have infections. Tell your doctor right away if you have been exposed to someone who has chicken pox or measles.
• This medicine may cause slow growth. If your child is using this medicine, the doctor will need to keep track of your child's height and weight.
• Do not stop using this medicine suddenly. Your doctor will need to slowly decrease your dose before you stop it completely.
• Tell any doctor or dentist who treats you that you are using this medicine. You may need to stop using this medicine several days before you have surgery or medical tests.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Color changes on the skin, dark freckles, easy bruising, muscle weakness
• Fever, chills, cough, sore throat, and body aches
• Lightheadedness, dizziness, or fainting
• Round, puffy face
• Thicker or more hair on your body and face

If you notice these less serious side effects, talk with your doctor:

• Headache
• Runny or stuffy nose, sneezing

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088