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Symbicort

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Symbicort

PATIENT INFORMATION

MEDICATION GUIDE

SYMBICORT (budesonide and formoterol fumarate dihydrate) 80/4.5
(budesonide 80 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol

SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5
(budesonide 160 mcg and formoterol fumarate dihydrate 4.5 mcg) Inhalation Aerosol

Read the Medication Guide that comes with SYMBICORT (budesonide and formoterol fumarate dihydrate) 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 (budesonide and formoterol fumarate dihydrate) ?

  • SYMBICORT (budesonide and formoterol fumarate dihydrate) contains 2 medicines:
    • Budesonide (the same medicine found in PULMICORT FLEXHALER®), an inhaled corticosteroid medicine. Inhaled corticosteroids help to decrease inflammation in the lungs. Inflammation in the lungs can lead to asthma symptoms.
    • Formoterol (the same medicine found in FORADIL® AEROLIZER®), a long-acting beta2-agonist medicine or LABA. LABA medicines are used in patients with chronic obstructive pulmonary disease (COPD) and asthma. LABA medicines help the muscles around the airways in your lungs stay relaxed to prevent asthma symptoms, such as wheezing and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe. In severe cases, wheezing can stop your breathing and may lead to death if not treated right away.
  • In patients with asthma, LABA medicines such as formoterol (one of the medicines in SYMBICORT (budesonide and formoterol fumarate dihydrate) ) may increase the chance of death from asthma problems. In a large asthma study, more patients who used another LABA medicine died from asthma problems compared with patients who did not use that LABA medicine. Talk with your healthcare provider about this risk and the benefits of treating your asthma with SYMBICORT (budesonide and formoterol fumarate dihydrate) .
  • SYMBICORT (budesonide and formoterol fumarate dihydrate) does not relieve sudden symptoms. Always have an inhaled short-acting beta2-agonist medicine with you to treat sudden symptoms. If you do not have this type of medicine, contact your healthcare provider to have one prescribed for you.
  • Do not stop using SYMBICORT (budesonide and formoterol fumarate dihydrate) unless told to do so by your healthcare provider because your symptoms might get worse.
  • SYMBICORT (budesonide and formoterol fumarate dihydrate) should be used only if your healthcare provider decides that another asthma-controller medicine alone does not control your asthma or that you need two asthma-controller medicines.
  • Call your healthcare provider if breathing problems worsen over time while using SYMBICORT (budesonide and formoterol fumarate dihydrate) . You may need different treatment.
  • Get emergency medical care if:
    • Breathing problems worsen quickly, and
    • You use your short-acting beta2-agonist medicine, but it does not relieve your breathing problems.

What is SYMBICORT (budesonide and formoterol fumarate dihydrate) ?

SYMBICORT (budesonide and formoterol fumarate dihydrate) combines an inhaled corticosteroid medicine, budesonide (the same medicine found in PULMICORT FLEXHALER), and a long-acting beta2-agonist medicine (LABA), formoterol (the same medicine found in FORADIL AEROLIZER).

Asthma

SYMBICORT (budesonide and formoterol fumarate dihydrate) is used long-term, two times each day to control symptoms of asthma, and prevent symptoms such as wheezing in patients age 12 year and older.

SYMBICORT (budesonide and formoterol fumarate dihydrate) contains formoterol (the same medicine found in FORADIL AEROLIZER). Because LABA medicines such as formoterol may increase the chance of death from asthma problems, SYMBICORT (budesonide and formoterol fumarate dihydrate) is not for patients with asthma who:

    • are well controlled with another asthma-controller medicine such as a low to medium dose of an inhaled corticosteroid medicine
    • only need short-acting beta2-agonist medicines once in awhile

The safety and effectiveness of SYMBICORT (budesonide and formoterol fumarate dihydrate) in asthma patients 6 to < 12 years of age has not been established.

Chronic Obstructive Pulmonary Disease (COPD)

COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both. SYMBICORT (budesonide and formoterol fumarate dihydrate) 160/4.5 mcg is used long term, two times each day to help improve lung function for better breathing in adults with COPD.

Who should not use SYMBICORT (budesonide and formoterol fumarate dihydrate) ?

Do not use SYMBICORT (budesonide and formoterol fumarate dihydrate) :

  • to treat sudden severe symptoms of asthma or COPD.
  • if you are allergic to any of the ingredients in SYMBICORT (budesonide and formoterol fumarate dihydrate) . See the end of the Medication Guide for a list of ingredients in SYMBICORT (budesonide and formoterol fumarate dihydrate) .

What should I tell my healthcare provider before using SYMBICORT (budesonide and formoterol fumarate dihydrate) ?

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
    • have liver problems
    • have osteoporosis
    • have an immune system problem
    • have eye problems such as increased pressure in the eye, glaucoma, or cataracts o are allergic to any medicines
    • are exposed to chicken pox or measles
    • are pregnant or planning to become pregnant. It is not known if SYMBICORT (budesonide and formoterol fumarate dihydrate) may harm your unborn baby.
    • are breastfeeding. Budesonide, one of the active ingredients in SYMBICORT (budesonide and formoterol fumarate dihydrate) , passes into breast milk. You and your healthcare provider should decide if you will take SYMBICORT (budesonide and formoterol fumarate dihydrate) while breast-feeding.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. SYMBICORT (budesonide and formoterol fumarate dihydrate) 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 (budesonide and formoterol fumarate dihydrate) ?

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

  • Use SYMBICORT (budesonide and formoterol fumarate dihydrate) exactly as prescribed. Do not use SYMBICORT (budesonide and formoterol fumarate dihydrate) more often than prescribed. SYMBICORT (budesonide and formoterol fumarate dihydrate) comes in two strengths. Your healthcare provider has prescribed the strength that is best for you. Note the differences between SYMBICORT (budesonide and formoterol fumarate dihydrate) and your other inhaled medications, including the differences in prescribed use and physical appearance.
  • SYMBICORT (budesonide and formoterol fumarate dihydrate) should be taken every day as two puffs in the morning and two puffs in the evening.
  • If you miss a dose of SYMBICORT (budesonide and formoterol fumarate dihydrate) , you should take your next dose at the same time you normally do. Do not take SYMBICORT (budesonide and formoterol fumarate dihydrate) more often or use more puffs than you have been prescribed.
  • Rinse your mouth with water and spit the water out after each dose (two puffs) of SYMBICORT (budesonide and formoterol fumarate dihydrate) . Do not swallow the water. This will help to lessen the chance of getting a fungus infection (thrush) in the mouth and throat.
  • Do not spray SYMBICORT (budesonide and formoterol fumarate dihydrate) in your eyes. If you accidentally get SYMBICORT (budesonide and formoterol fumarate dihydrate) 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 (budesonide and formoterol fumarate dihydrate) do not use other medicines that contain a long-acting beta2-agonist (LABA) for any reason, such as SEREVENT DISKUS (salmeterol xinafoate inhalation powder), ADVAIR DISKUS or ADVAIR HFA (fluticasone propionate and salmeterol), or formoterol containing products (FORADIL AEROLIZER, Brovana, Performist)
  • Make sure you always have a short-acting beta2-agonist medicine with you. Use your short-acting beta2-agonist medicine if you have breathing problems between doses of SYMBICORT (budesonide and formoterol fumarate dihydrate) .
  • Call your healthcare provider or get medical care right away if:
    • your breathing problems worsen with SYMBICORT (budesonide and formoterol fumarate dihydrate)
    • you need to use your short-acting beta2-agonist medicine more often than usual
    • your short-acting beta2-agonist medicine does not work as well for you at relieving symptoms
    • you need to use four or more inhalations of your short-acting beta2-agonist medicine for 2 or more days in a row
    • you use one whole canister of your short-acting beta2-agonist medicine in 8 weeks' time
    • your peak flow meter results decrease. Your healthcare provider will tell you the numbers that are right for you.
    • your symptoms do not improve after using SYMBICORT (budesonide and formoterol fumarate dihydrate) regularly for 1 week.

What are the possible side effects with SYMBICORT (budesonide and formoterol fumarate dihydrate) ?

  • SYMBICORT (budesonide and formoterol fumarate dihydrate) contains formoterol. In patients with asthma, LABA medicines such as formoterol may increase the chance of death from asthma problems. See “What is the most important information I should know about SYMBICORT (budesonide and formoterol fumarate dihydrate) ?”
  • Pneumonia and other lower respiratory tract infections. People with COPD have a higher chance of getting pneumonia and other lung infections. Inhaled corticosteroids may increase the chance of getting pneumonia. Call your healthcare provider if you notice any of these symptoms:

Other possible side effects with SYMBICORT (budesonide and formoterol fumarate dihydrate) include:

  • 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.
  • chest pain
  • increased blood pressure
  • a fast and irregular heartbeat
  • headache
  • tremor
  • nervousness
  • immune system effects and a higher chance for infections
  • eye problems including glaucoma and cataracts. You should have regular eye exams while using SYMBICORT (budesonide and formoterol fumarate dihydrate) .
  • lower bone mineral density. This may be a problem for people who already have a higher chance for low bone mineral density (osteoporosis).
  • slowed growth in children. A child's growth should be checked often.
  • thrush in the mouth and throat
  • throat pain

The most common side effects with SYMBICORT (budesonide and formoterol fumarate dihydrate) include:

Adults and children with asthma:

  • throat irritation
  • headache
  • upper respiratory tract infection
  • throat pain
  • inflammation of mucous membranes of the sinuses (sinusitis)
  • flu
  • back pain
  • nasal congestion
  • stomach discomfort
  • vomiting
  • thrush in the mouth and throat

Patients with COPD:

  • throat irritation
  • thrush in the mouth and throat
  • lower respiratory tract infections, mostly infections and/or inflammation of the mucous membranes of the bronchial tubes (bronchitis)
  • inflammation of mucous membranes in the sinuses (sinusitis)
  • upper respiratory tract infection

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 (budesonide and formoterol fumarate dihydrate) . 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-FDA-1088 and/or ASTRAZENECA at 1-800-236-9933.

How do I store SYMBICORT (budesonide and formoterol fumarate dihydrate) ?

  • Store SYMBICORT (budesonide and formoterol fumarate dihydrate) at room temperature between 68°F to 77°F (20°C to 25°C).
  • Store with the mouthpiece down.
  • The contents of your SYMBICORT (budesonide and formoterol fumarate dihydrate) canister are under pressure. Do not puncture or throw the canister into a fire or incinerator. Do not use or store it near heat or open flame. Storage above 120F may cause the canister to burst.
  • Throw away SYMBICORT (budesonide and formoterol fumarate dihydrate) when the counter reaches zero (“0”) or 3 months after you take SYMBICORT (budesonide and formoterol fumarate dihydrate) out of its foil pouch, whichever comes first.
  • Keep SYMBICORT (budesonide and formoterol fumarate dihydrate) and all medicines out of the reach of children.

General Information about SYMBICORT (budesonide and formoterol fumarate dihydrate)

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SYMBICORT (budesonide and formoterol fumarate dihydrate) for a condition for which it was not prescribed. Do not give your SYMBICORT (budesonide and formoterol fumarate dihydrate) to other people, even if they have the same condition. It may harm them.

This Medication Guide summarizes the most important information about SYMBICORT (budesonide and formoterol fumarate dihydrate) . 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 (budesonide and formoterol fumarate dihydrate) that was written for healthcare professionals. For more information, call 1-800-236-9933 or go to www.MySymbicort (budesonide and formoterol fumarate dihydrate) .com.

What are the ingredients in SYMBICORT (budesonide and formoterol fumarate dihydrate) ?

Active ingredient: micronized budesonide and micronized formoterol fumarate dihydrate

Inactive ingredients: hydrofluroalkane (HFA 227), povidone K25 USP, and polyethylene glycol 1000 NF

Upright Position

Upright Position - Illustration

How to Use SYMBICORT (budesonide and formoterol fumarate dihydrate)

Follow the instructions below for using SYMBICORT (budesonide and formoterol fumarate dihydrate) . You will breathe-in (inhale) the medicine. If you have any questions, ask your doctor or pharmacist.

Preparing your inhaler for use

  1. Take your SYMBICORT (budesonide and formoterol fumarate dihydrate) out of the moisture-protective foil pouch before you use it for the first time and throw the foil away. Write the date that you open the foil pouch on the box.
  2. A counter is attached to the top of the metal canister. The counter will count down each time you release a puff of SYMBICORT (budesonide and formoterol fumarate dihydrate) . The arrow points to the number of inhalations (puffs) left in the canister. The counter will stop counting at zero (“0”).
  3. Use the SYMBICORT (budesonide and formoterol fumarate dihydrate) canister only with the red SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler supplied with the product. Parts of the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler should not be used with parts from any other inhalation product.
  4. Shake your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler well for 5 seconds right before each use. Remove the mouthpiece cover. Check the mouthpiece for foreign objects before use.
  5. Priming Before you use SYMBICORT (budesonide and formoterol fumarate dihydrate) for the first time, you will need to prime it. To prime SYMBICORT (budesonide and formoterol fumarate dihydrate) , hold it in the upright position. See figure 1 above. Shake the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler well for 5 seconds. Hold your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler facing away from you and then release a test spray. Then shake it again for 5 seconds and release a second test spray. Your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler is now primed and ready for use. After you have primed the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler for the first time, the counter will read either 120 or 60, depending on which size was provided to you.

If you do not use your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler for more than 7 days or if you drop it, you will need to prime again.

Ways to hold the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler for use

Ways to hold the SYMBICORT inhaler - Illustration

or

Ways to hold the SYMBICORT inhaler - Illustration

Using your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler

6. Shake your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler well for 5 seconds. Remove the mouthpiece cover. Check the mouthpiece for foreign objects.

7. Breathe out fully (exhale). Hold the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler up to your mouth. Place the white mouthpiece fully into your mouth and close your lips around it. Make sure that the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler is upright and that the opening of the mouthpiece is pointing towards the back of your throat (see Figure 4).

SYMBICORT® (budesonide/formoterol fumarate dihydrate) Figure 4 Illustration

8. Breathe in (inhale) deeply and slowly through your mouth. Press down firmly and fully on the top of the counter on the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler to release the medicine (see Figures 2 and 3).

9. Continue to breathe in (inhale) and hold your breath for about 10 seconds, or for as long as is comfortable. Before you breathe out (exhale), release your finger from the top of the counter. Keep the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler upright and remove from your mouth.

10. Shake the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler again for 5 seconds and repeat steps 7 to 9.

After using your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler

11. Replace the mouthpiece cover after use.

12. After you finish taking SYMBICORT (budesonide and formoterol fumarate dihydrate) (two puffs), rinse your mouth with water. Spit out the water. Do not swallow it.

Reading the counter

  • The arrow on the counter on the top of the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler points to the number of inhalations (puffs) left in your inhaler.

COUNTER

Counter - Illustration

  • The counter will count down each time you release a puff of medicine (either when preparing your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler for use or when taking the medicine).
  • When the arrow on the counter approaches 20, you will notice the beginning of a yellow area letting you know that it is time to call your healthcare provider for a refill.

COUNTER

Counter - Illustration

  • It is important that you pay attention to the number of inhalations (puffs) left in your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler by reading the counter. Throw away SYMBICORT (budesonide and formoterol fumarate dihydrate) when the counter shows zero (“0”). Your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler may not feel empty and it may continue to operate, but you will not get the right amount of medicine if you keep using it. Use a new SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler and follow the instructions for priming (instruction 5 above).

How to clean your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler

Clean the white mouthpiece of your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler every 7 days. To clean the mouthpiece:

  • Remove the grey mouthpiece cover
  • Wipe the inside and outside of the white mouthpiece opening with a clean, dry cloth
  • Replace the mouthpiece cover
  • Do not put the SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler into water
  • Do not try to take apart your SYMBICORT (budesonide and formoterol fumarate dihydrate) inhaler

Last reviewed on RxList: 6/2/2009
This monograph has been modified to include the generic and brand name in many instances.

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