Budesonide

Brand Name: Entocort

Why is this medicine prescribed?
Busdesonide (Entocort) is used for the treatment of mild to moderate ulcerative colitis (UC) or Crohn’s disease (CD). The enema preparation of budesonide is used to treat UC located in the rectum and lower part of the colon. The capsule preparation is used to treat CD located at the end of the small intestine and beginning of the colon.

How should this medicine be used?
The capsules should be swallowed whole and not be chewed, broken, or crushed before being swallowed.

The enema should be administered in the evening before going to bed. The enema consists of a dispersible tablet and solution.

How to prepare the enema:

1. Remove the nozzle from the bottle keeping the protective cap on.

2. Take a tablet from the aluminum foil pack, and put it into the bottle. Do not swallow the tablet.

3. Put the nozzle back on the bottle and make sure that the protective cap is firmly on. Shake the bottle vigorously for at least 10 seconds or until the tablet has dissolved and a slightly yellowish liquid has been formed. A plastic bag has been enclosed which you may use to protect your hand when you administer the enema.

4. Lie down on your left side. Shake the bottle again before removing the protective cap. Put your hand inside the plastic bag and grip the bottle. Empty the contents into the rectum. After use, remove the plastic bag from your hand by pulling it over the bottle.

5. Roll over on your stomach. Stay in this position for five minutes.

6. Choose a suitable position to sleep in. Try to retain the enema as long as possible, preferably overnight.

NOTE: After preparation, the budesonide is intended for immediate use.

After taking this medication for a long period of time additional side effects may occur. Call your doctor as soon as possible if you experience:

abdominal pain backache coughing muscle cramps or pain

depression mood or personality changes any other unusual effects

Use this medication exactly as directed, and ask your doctor or pharmacist to explain any part you do not understand. Do not change the amount or frequency prescribed by your doctor.

What special precautions should I follow?
Before taking this medication, talk to your doctor and pharmacist about:

Allergies	Pregnancy/Breastfeeding
if you are allergic to budesonide or any other drugs	if you are pregnant, plan to become pregnant, or are breast feeding, call your doctor
Other medications	Medical conditions
any prescription and non-prescription medications you are taking (including vitamins and herbal products)	any current or past medical conditions

What should I do if I forget to take a dose?
Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not double up a dose to make up for a missed dose.

What side effects can this medicine cause?
Like any medication, side effects from budesonide may occur. Tell your doctor if these symptoms are severe or persist:

headache acne increased appetite nausea or indigestion menstrual changes

nervousness or restlessness dizziness or lightheadedness thin, fragile skin thinning of hair

Contact your doctor as soon as possible if any of the following occur:

• decreased or blurred vision
• burning and itching of skin

What storage conditions are needed for this medicine?
Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets at room temperature and away from excess heat, light and moisture (not in the bathroom). Dispose properly of any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

What other information should I know?
Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your response to budesonide.