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 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 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)
• Slowed growth in children. A child's growth should be checked regularly while using SYMBICORT
• 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 asthma 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.

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 80/4.5 and 160/4.5 are medicines 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.

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.