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«MEDICATION GUIDE SYMBICORT 80/4.5 (budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol SYMBICORT 160/4.5 (budesonide 160 ...»



(budesonide 80 mcg and formoterol fumarate dihydrate

4.5 mcg) Inhalation Aerosol


(budesonide 160 mcg and formoterol fumarate dihydrate

4.5 mcg) Inhalation Aerosol

Read the Medication Guide that comes with

SYMBICORT before you start using it and each time you

get a refill. There may be new information. This

Medication Guide does not take the place of talking to

your healthcare provider about your medical condition or treatment.

What is the most important information I should know about SYMBICORT?

SYMBICORT can cause serious side effects,


1. People with asthma who take long-acting beta2adrenegic agonist (LABA) medicines such as formoterol (one of the medicines in SYMBICORT) have an increased risk of death from asthma problems. It is not known whether budesonide, the other medicine in SYMBICORT, reduces the risk of death from asthma problems seen with formoterol.

• Call your healthcare provider if breathing problems worsen over time while using SYMBICORT. You may need different treatment.

• Get emergency medical care if:

o breathing problems worsen quickly, and o you use your rescue inhaler medicine, but it does not relieve your breathing problems.

Reference ID: 2906451

2. SYMBICORT should be used only if your healthcare provider decides that your asthma is not well controlled with a long-term asthmacontrol medicine, such as an inhaled corticosteroid.

3. When your asthma is well controlled, your healthcare provider may tell you to stop taking SYMBICORT.

Your healthcare provider will decide if you can stop SYMBICORT without loss of asthma control. Your healthcare provider may prescribe a different longterm asthma-control medicine for you, such as an inhaled corticosteroid.

4. Children and adolescents who take LABA medicines may have an increased risk of being hospitalized for asthma problems.


SYMBICORT combines an inhaled corticosteroid medicine, budesonide (the same medicine found in PULMICORT FLEXHALER), and a long-acting beta2agonist medicine (LABA), formoterol (the same medicine found in FORADIL AEROLIZER).

• Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms.

• LABA medicines are used in patients with chronic obstructive pulmonary disease (COPD) and ast

–  –  –

Reference ID: 2906451 SYMBICORT is used to control symptoms of asthma, and prevent symptoms such as wheezing in adults and children ages 12 and older.

SYMBICORT contains formoterol (the same medicine found in FORADIL AEROLIZER). LABA medicines such as formoterol increase the risk of death from asthma problems. SYMBICORT is not for

adults and children with asthma who:

o are well controlled with an asthma-control medicine such as a low to medium dose of an inhaled corticosteroid medicine o have sudden asthma symptoms

–  –  –

Chronic Obstructive Pulmonary Disease (COPD) COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. SYMBICORT 160/4.5 mcg is used long term, 2 times each day to help improve lung function for better breathing in adults with COPD.

Who should not use SYMBICORT?

–  –  –

What should I tell my healthcare provider before using SYMBICORT?

Tell your healthcare provider about all of your health

conditions, including if you:

• have heart problems

• have high blood pressure

• have seizures

• have thyroid problems

• have diabetes

–  –  –

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements.

SYMBICORT and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your healthcare provider if you take antifungal and anti-HIV medicines.

Know all the medicines you take. Keep a list and show it to your healthcare provider and pharmacist each time you get a new medicine.

How do I use SYMBICORT?

See the step-by-step instructions for using SYMBICORT at the end of this Medication Guide. Do not use SYMBICORT unless your healthcare provider has taught you and you understand everything. Ask your healthcare provider or pharmacist if you have any questions.

• Use SYMBICORT exactly as prescribed. Do not use SYMBICORT more often than prescribed.

SYMBICORT comes in 2 strengths. Your healthcare provider has prescribed the strength that is best for you. Note the differences between SYMBICORT and your other inhaled medications, including the differences in prescribed use and physical appearance.

Reference ID: 2906451

• SYMBICORT should be taken every day as 2 puffs in the morning and 2 puffs in the evening.

–  –  –

• Do not spray SYMBICORT in your eyes. If you accidentally get SYMBICORT in your eyes, rinse your eyes with water, and if redness or irritation persists, consult your healthcare provider.

• Do not change or stop any medicines used to control or treat your breathing problems. Your healthcare provider will change your medicines as needed.

• While you are using SYMBICORT 2 times each day, do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason.

• Ask your healthcare provider or pharmacist if any of your other medicines are LABA medicines.

–  –  –

SYMBICORT can cause serious side effects

• See “What is the most important information I should know about SYMBICORT?”

–  –  –

• Serious allergic reactions including rash, hives, swelling of the face, mouth, and tongue, and breathing problems. Call your healthcare provider or get emergency medical care if you get any symptoms of a serious allergic reaction.

–  –  –

• Adrenal insufficiency. Adrenal insufficiency is a condition in which the adrenal glands do not make enough steroid hormones. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine.

–  –  –

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

These are not all the side effects of SYMBICORT. Ask your healthcare provider or pharmacist for more information.

Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDAYou may also report side effects to ASTRAZENECA at 1-800-236-9933.

–  –  –

General Information about SYMBICORT Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYMBICORT for a condition for which it was not prescribed. Do not give your SYMBICORT to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about SYMBICORT. If you would like more information, talk with your healthcare provider or pharmacist. You can ask your healthcare provider or pharmacist for information about SYMBICORT that was written for healthcare professionals. For more information, call 1-800-236-9933 or go to www.MySymbicort.com.

What are the ingredients in SYMBICORT?

Active ingredient: micronized budesonide and micronized formoterol fumarate dihydrate Inactive ingredients: hydrofluroalkane (HFA 227), povidone K25 USP, and polyethylene glycol 1000 NF

–  –  –

How to Use SYMBICORT Follow the instructions below for using SYMBICORT.

You will breathe-in (inhale) the medicine. If you have any questions, ask your doctor or pharmacist.

Preparing your inhaler for use

–  –  –

This Medication Guide has been approved by the U.S.

Food and Drug Administration.

SYMBICORT and PULMICORT FLEXHALER are trademarks of the AstraZeneca group of companies.

ADVAIR DISKUS, ADVAIR HFA, SEREVENT and DISKUS are trademarks of GlaxoSmithKline. FORADIL AEROLIZER is a trademark of Novartis Pharmaceuticals Corporation.

© AstraZeneca 2006, 2007, 2009, 2010

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