Budesonide Rectal Foam

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 Rectal

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
• High blood pressure
• Immune system problems
• Liver disease
• Osteoporosis
• Thyroid disease
• An unusual or allergic reaction to budesonide, corticosteroids, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is for rectal use only. Do not take by mouth. Wash hands before and after use. Follow the directions on the prescription label. Before using foam, use the bathroom to empty the bowels. Use foam in a standing, lying or sitting position (e.g., while using the toilet). When using foam in the evening, use right before bedtime and do not try to have a bowel movement again until the next morning. Prepare the canister for use as directed. Use a new applicator for each dose. Place the forefinger on the top of pump dome and then turn the canister upside down. Insert the applicator gently into the rectum as far as it is comfortable. The easiest way to use foam is to keep one foot on the floor and raise the other foot onto a firm surface such as a chair or stool. Use the forefinger to fully push down the pump dome one time and hold it for about 2 seconds in that position. Release finger pressure on the pump dome and hold the applicator in place for 10 to 15 seconds. Remove the applicator. The foam will still expand a little and may drop out of the applicator or anus. Remove the applicator from the canister. Place the used applicator in the plastic bag provided. Throw the plastic bag away in household trash. Do not use your medication more often than directed. Do not suddenly stop using your medication because you may develop a severe reaction. Your care team will tell you how much medication to use. If your care team wants you to stop using the medication, the amount that you use may be slowly lowered over time to avoid any side effects.

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, use it as soon as you can. If it is almost time for your next dose, use only that dose. Do not use double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Grapefruit juice
• Mifepristone

This medication may also interact with the following:

• Cimetidine
• Ketoconazole

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. Consult your care team you do not start to get better after several days of use. Do not use if there is blood in your stools. Report rectal bleeding, pain, burning, itching, blistering, or any other sign of irritation to your care team.

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 have surgery, tell your care team that you are using this medication.

This medication may increase blood sugar. Ask your care team 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). Do not refrigerate. The product is flammable. Avoid fire, flames, and smoking during and right after use. 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.