Budesonide rectal foam

What is this medicine?

BUDESONIDE (bue DES oh nide) is a corticosteroid. It helps to reduce swelling, redness, and itching caused by ulcerative colitis.

How should I use this medicine?

This medicine 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 medicine more often than directed. Do not suddenly stop using your medicine because you may develop a severe reaction. Your doctor will tell you how much medicine to use. If your doctor wants you to stop using the medicine, the amount that you use may be slowly lowered over time to avoid any side effects.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue

• changes in vision

• cough

• fever or chills

• increased thirst

• mental depression, mood swings, mistaken feelings of self-importance, mistaken feelings of being mistreated

• nausea

• pain or trouble passing urine

• skin problems, acne, thin and shiny skin

• sore throat

• swelling of feet or lower legs

• unusual bruising or red pinpoint spots on the skin

• unusually weak or tired

• vomiting

• weight gain

• wounds that will not heal

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• diarrhea or constipation

• difficulty sleeping

• headache

• increased appetite

• increased sweating

• menstrual problems

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• grapefruit juice

• mifepristone

This medicine may also interact with the following medications:

• cimetidine

• ketoconazole

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.

Where should I keep my medicine?

Keep out of the reach of children.

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 medicine after the expiration date.

What should I tell my health care provider before I take this medicine?

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 medicines, foods, dyes, or preservatives

• pregnant or trying to get pregnant

• breast-feeding

What should I watch for while using this medicine?

Visit your doctor or health care professional for regular checks on your progress. Consult your doctor or health care professional 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 doctor or health care professional.

This medicine may increase your risk of getting an infection. Tell your doctor or health care professional 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 doctor or health care professional that you are using this medicine.

The medicine can increase your blood sugar. If you are a diabetic check with your doctor if you need help adjusting the dose of your diabetic medicine.