PATIENT INFORMATION

ENTOCORT EC (EN-toe-cort EE CEE)

(budesonide)

Capsules

Read the Patient Information that comes with ENTOCORT EC before you start taking it and each time you get a refill. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is ENTOCORT EC?

ENTOCORT EC is a prescription glucocorticosteroid medicine used in people with mild to moderate Crohn’s disease that affects part of the small intestine (ileum) and part of the large intestine (ascending colon):

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to treat active Crohn’s disease.

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to help keep symptoms from coming back for up to 3 months.

It is not known if ENTOCORT EC is safe and effective in children.

Who should not take ENTOCORT EC?

Do not take ENTOCORT EC if:

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you are allergic to budesonide or any of the ingredients in ENTOCORT EC. See the end of this leaflet for a complete list of ingredients in ENTOCORT EC.

What should I tell my healthcare provider before taking ENTOCORT EC?

Before you take ENTOCORT EC tell your healthcare provider if you:

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have liver problems

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are planning to have surgery

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have chicken pox or measles or have recently been near anyone with chicken pox or measles

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have or had a family history of diabetes, cataracts or glaucoma

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have or had tuberculosis

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have high blood pressure (hypertension)

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have decreased bone mineral density (osteoporosis)

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stomach ulcers

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any other medical condition

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are pregnant or plan to become pregnant. It is not known if ENTOCORT EC may harm your unborn baby.

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are breastfeeding or plan to breastfeed. ENTOCORT EC can pass into breast milk and may harm your baby. You and your healthcare provider should decide if you will take ENTOCORT EC or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. ENTOCORT EC and other medicines may affect each other causing side effects.

Especially tell your healthcare provider if you take:

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a glucocorticosteroid medicine

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medicines that suppress your immune system (immunosuppressant)

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ketoconazale or other medicines that affect how your liver works.

Ask your healthcare provider or pharmacist if you are not sure if your medicine is one listed above.

How should I take ENTOCORT EC?

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Take ENTOCORT EC exactly as your healthcare provider tells you.

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Your healthcare provider will tell you how many ENTOCORT EC capsules to take. Your healthcare provider may change your dose if needed.

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Take ENTOCORT EC in the morning.

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Take ENTOCORT EC capsules whole. Do not chew or crush ENTOCORT EC capsules before swallowing.

What should I avoid while taking ENTOCORT EC?

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Do not eat grapefruit or drink grapefruit juice while taking ENTOCORT EC. Eating grapefruit or drinking grapefruit juice can increase the level of ENTOCORT EC in your blood.

What are the possible side effects of ENTOCORT EC?

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Effects of having too much glucocorticosteroid medicine in your blood (hypercorticism). Long-time use of ENTOCORT EC can cause you to have too much glucocorticosteroid medicine in your blood. Tell your healthcare provider if you have any of the following signs and symptoms of hypercorticism:

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acne

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bruise easily

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rounding of your face (moon face)

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ankle swelling

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thicker or more hair on your body and face

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a fatty pad or hump between your shoulders (buffalo hump)

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pink or purple stretch marks on the skin of your abdomen, thighs, breasts and arms

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Adrenal suppression. When ENTOCORT EC is taken for a long period of time (chronic use), adrenal suppression can happen. This is a condition in which the adrenal glands do not make enough steroid hormones. Symptoms of adrenal suppression include: tiredness, weakness, nausea and vomiting and low blood pressure. Tell your healthcare provider if you are under stress or have any symptoms of adrenal suppression during treatment with ENTOCORT EC.

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Immune system effects and a higher chance of infections.
ENTOCORT EC weakens your immune system. Taking medicines that weaken your immune system makes you more likely to get infections. Avoid contact with people who have contagious diseases such as chicken pox or measles, while taking ENTOCORT EC.

Tell your healthcare provider about any signs or symptoms of infection during treatment with ENTOCORT EC, including:

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Worsening of allergies. If you take certain other glucocorticosteroid medicines to treat allergies, switching to ENTOCORT EC may cause your allergies to come back. These allergies may include eczema (a skin disease) or rhinitis (inflammation inside your nose). Tell your healthcare provider if any of your allergies become worse while taking ENTOCORT EC.

The most common side effects of ENTOCORT EC include:

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headache

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infection in your air passages (respiratory infection)

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back pain

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upset stomach

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dizziness

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abdominal pain

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excessive stomach or intestinal gas

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diarrhea

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sinus infection

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viral infection

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joint pain

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of ENTOCORT EC. For more information, ask your healthcare provider or pharmacist.

Call your healthcare provider for medical advice about side effects. You may report side effects to AstraZeneca at 1-800-236-9933 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

How should I store ENTOCORT EC?

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Store ENTOCORT EC at 59°F to 86°F (15°C to 30°C).

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Keep ENTOCORT EC in a tightly closed container.

Keep ENTOCORT EC and all medicines out of reach from children.

General information about ENTOCORT EC.

Medicines are sometimes prescribed for purposes other than those listed in Patient Information leaflets. Do not use ENTOCORT EC for a condition for which it was not prescribed. Do not give ENTOCORT EC to other people, even if they have the same symptoms you have. It may harm them.

This Patient Information leaflet summarizes the most important information about ENTOCORT EC. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about ENTOCORT EC that is written for health professionals.

For more information go to.www.ENTOCORTEC.com or call 1-800-236-9933.

What are the ingredients in ENTOCORT EC?

Active ingredient: budesonide

Inactive ingredients: ethylcellulose, acetyltributyl citrate, methacrylic acid copolymer type C, triethyl citrate, antifoam M, polysorbate 80, talc, and sugar spheres.

The capsule shell contains: gelatin, iron oxide, and titanium dioxide.

Distributed by:

AstraZeneca LP

Wilmington, DE 19850

This Patient Information has been approved by the U.S. Food and Drug Administration.

Revised: December 2011

ENTOCORT is a trademark of the AstraZeneca group of companies.

© AstraZeneca 2010, 2011