SYMBICORT for Asthma
For patients 12 years and older whose asthma is not well controlled on a long-term asthma medicine or whose
disease severity warrants
Important Information
About SYMBICORT

Asthma Treatments and Corticosteroids

There is a difference between corticosteroids and anabolic steroids.

Corticosteroids can be used to treat asthma symptoms. Anabolic steroids can be used to treat anemia and are sometimes abused by athletes to enhance performance.

CORTICOSTEROIDS

Corticosteroids are used to help control asthma by treating inflammation in the airways. Corticosteroids can be inhaled, taken orally, or injected.

Inhaled Corticosteroids

  • Inhaled corticosteroids (ICS) are breathed in through the mouth, not swallowed. As a result, most of the medicine goes straight to the lungs, where it is needed most. Very little of the medicine is absorbed into the body.
  • Inhaled corticosteroids treat the lining of the airways in your lungs by reducing inflammation. When the airways are less inflamed, the lungs are less sensitive to asthma triggers, such as pollen, dust, or smoke resulting in fewer asthma symptoms and asthma attacks. Inhaled corticosteroids help to control and reduce asthma symptoms.

Oral and Injected Corticosteroids

  • Oral corticosteroids (like prednisone) and corticosteroid injections are taken in much higher doses than inhaled corticosteroids and go through your entire system (not just your lungs) and may have side effects, such as weight gain and worsening of diabetes. These kinds of corticosteroids are typically prescribed only for a short time and/or for those with severe asthma. They are used to help control severe asthma attacks and swelling in the airways.

Switching from an oral corticosteroid to an inhaled corticosteroid

One of the 2 medicines in SYMBICORT, budesonide, is an inhaled corticosteroid. If you are switching to SYMBICORT from oral corticosteroids, follow your doctor's instructions to avoid health risks when you stop using oral corticosteroids.

ANABOLIC STEROIDS

  • Anabolic steroids are synthetic hormones that are sometimes abused by athletes in order to increase performance.
  • There are times anabolic steroids have a medical use, such as in the treatment of certain types of anemia.
  • Anabolic steroids are not used in the asthma treatment.

Take steps to help control your asthma symptoms.
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Important Safety Information About SYMBICORT for Asthma

SYMBICORT contains formoterol, a long-acting beta2-adrenergic agonist (LABA). LABA medicines such as formoterol increase the 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.

SYMBICORT should be used only if your health care provider decides that your asthma is not well controlled with a long-term asthma control medicine, such as an inhaled corticosteroid, or that your asthma is severe enough to begin treatment with SYMBICORT.

If you are taking SYMBICORT, see your health care provider if your asthma does not improve or gets worse. It is important that your health care provider assess your asthma control on a regular basis. Your doctor will decide if it is possible for you to stop taking SYMBICORT and start taking a long-term asthma control medicine without loss of asthma control.

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

SYMBICORT does not replace rescue inhalers for sudden asthma symptoms.

Be sure to tell your health care provider about all your health conditions, including heart conditions or high blood pressure, and all medicines you may be taking. Some patients taking SYMBICORT may experience increased blood pressure, heart rate, or change in heart rhythm.

Do not use SYMBICORT more often than prescribed. While taking SYMBICORT, never use another medicine containing a LABA for any reason. Ask your health care provider or pharmacist if any of your other medicines are LABA medicines, as using too much LABA may cause chest pain, increase in blood pressure, fast and irregular heartbeat, headache, tremor, and nervousness.

Patients taking SYMBICORT should call their health care provider or get emergency medical care:

  • if you experience serious allergic reactions including rash, hives, swelling of the face, mouth and tongue, and breathing problems.
  • if you think you are exposed to infections such as chicken pox or measles, or if you have any signs of infection. You may have a higher chance of infection.
  • if you experience an increase in wheezing right after taking SYMBICORT, eye problems including glaucoma and cataracts, decreases in bone mineral density, swelling of blood vessels (signs include a feeling of pins and needles or numbness of arms or legs, flu like symptoms, rash, pain and swelling of the sinuses), decrease in blood potassium and increase in blood sugar levels.

If you are switching to SYMBICORT from an oral corticosteroid, follow your health care provider’s instructions to avoid serious health risks when you stop using oral corticosteroids.

Common side effects include nose and throat irritation, headache, upper respiratory tract infection, sore throat, sinusitis, stomach discomfort, flu, back pain, nasal congestion, vomiting, and thrush in the mouth and throat.

Approved Uses for SYMBICORT for Asthma

SYMBICORT is a medicine for the treatment of asthma for people 12 years and older whose doctor has determined that their asthma is not well controlled with a long term asthma control medicine such as an inhaled corticosteroid or whose asthma is severe enough to begin treatment with SYMBICORT. SYMBICORT is not a treatment for sudden asthma symptoms.

Talk to your doctor about prescription SYMBICORT.

Please read Prescribing Information, including Boxed WARNING, with Medication Guide and discuss with your doctor.Adobe PDF (PDF — 551 KB)

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

The information on this Web site should not take the place of talking with your doctor or health care provider about how to manage and treat your asthma. If you have any questions about your condition, or if you would like more information about SYMBICORT or asthma, talk to your doctor or pharmacist. Only you and your doctor can decide if SYMBICORT is right for you.

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SYMBICORT is a registered trademark of the AstraZeneca group of companies.