SYMBICORT 160/4.5 for COPD

SYMBICORT 160/4.5 for COPD

SYMBICORT can help improve lung function and make a significant difference in breathing.*

*Your results may vary

Important Safety Information About SYMBICORT including Boxed WARNING

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.

  • Call your health care provider if breathing problems worsen over time while using SYMBICORT. You may need different treatment
  • Get emergency medical care if:
    • Breathing problems worsen quickly, and
    • You use your rescue inhaler medicine, but it does not relieve your breathing 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.

SYMBICORT can cause serious side effects, including:

  • Pneumonia and other lower respiratory tract infections. People with COPD may have a higher chance of pneumonia. Call your doctor if you notice any of the following symptoms: change in amount or color of mucus, fever, chills, increased cough, or increased breathing problems
  • Serious allergic reactions including rash, hives, swelling of the face, mouth and tongue, and breathing problems
  • Immune system effect and a higher chance of infection. Tell your health care provider if you think you are exposed to infections such as chicken pox or measles, or if you have any signs of infection such as fever, pain, body aches, chills, feeling tired, nausea, or vomiting
  • Adrenal insufficiency. This can happen when you stop taking oral corticosteroid medicines and start inhaled corticosteroid medicine
  • Using too much of a LABA medicine may cause chest pain, increase in blood pressure, fast and irregular heartbeat, headache, tremor, or nervousness
  • Increased wheezing right after taking SYMBICORT. Always have a rescue inhaler with you to treat sudden wheezing
  • Eye problems including glaucoma and cataracts. You should have regular eye exams while using SYMBICORT
  • Lower bone mineral density can happen in people who have a high chance for low bone mineral density (osteoporosis)
  • Swelling of blood vessels (signs include a feeling of pins and needles or numbness of arms or legs, flu like symptoms, rash, pain or swelling of the sinuses), decrease in blood potassium and increase in blood sugar levels

Common side effects in patients with COPD include inflammation of the nasal passages and throat, thrush in the mouth and throat, bronchitis, sinusitis, and upper respiratory tract infection.

Approved Uses for SYMBICORT

SYMBICORT 160/4.5 is for adults with COPD, including chronic bronchitis and emphysema. You should only take 2 inhalations of SYMBICORT twice a day. Higher doses will not provide additional benefits.

Please see full Prescribing Information and Medication Guide and discuss with your doctor.

Talk to your doctor about prescription SYMBICORT.

Read Prescribing Information, including Boxed WARNING, with Medication GuideAdobe 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.

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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 or COPD. If you have any questions about your condition, or if you would like more information about SYMBICORT, asthma, or COPD, talk to your doctor or pharmacist. Only you and your doctor can decide if SYMBICORT is right for you.

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