Budesonide Delayed-Release Capsules

What is this medication?

BUDESONIDE (bue DES oh nide) treats Crohn's disease. It may also be used to prevent flare-ups once your symptoms are controlled. 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): Entocort EC, TARPEYO

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes (high blood sugar)
• Eye disease, such as glaucoma, cataracts, or blurred vision
• Having or recent surgery
• High blood pressure
• Immune system problems
• Infection, such as tuberculosis (TB) or other bacterial, fungal, parasitic, or viral infections
• Liver disease
• Osteoporosis, weak bones
• Stomach ulcers, other stomach or intestine problems
• An unusual or allergic reaction to budesonide, other corticosteroids, medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth with water. Take it as directed on the prescription label at the same time every day. Do not cut, crush or chew this medication. Swallow the capsules whole. If you are taking Entocort EC, you may open the capsule and put the contents in 1 tablespoon of applesauce. Swallow the medication and applesauce right away. Do not chew the medication or applesauce. You can take it with or without food. If it upsets your stomach, take it with food. If you are taking Tarpeyo, take it on an empty stomach, at least 1 hour before food. Do not open Tarpeyo capsules. Keep taking it unless your care team tells you to stop.

Do not take with grapefruit juice.

Talk to your care team about the use of this medication in children. While it may be prescribed for children for selected conditions, precautions do apply.

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

What may interact with this medication?

Do not take this medication with any of the following:

• Metyrapone

This medication may also interact with the following:

• Antacids
• Certain antibiotics like clarithromycin or erythromycin
• Certain antivirals for HIV or hepatitis
• Certain medications for fungal infections like ketoconazole, itraconazole, or posaconazole
• Cimetidine
• Cyclosporine
• Grapefruit juice

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. Tell your care team if your symptoms do not start to get better or if they get worse.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick. If you have not had the measles or chickenpox vaccines, tell your care team right away if you are around someone with these viruses.

If you are going to need surgery or other procedure, 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.

This medication may cause cataracts or glaucoma, especially with long term use. You should have regular eye exams while taking this medication. Tell your care team if you have changes in your eyesight.

Using this medication for a long time may weaken your bones. The risk of bone fractures may be increased. Talk to your care team about your bone health.

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). Protect from moisture. Keep the container tightly closed. Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, take the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in a bag or container. Put it in the trash.

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.