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APPROVED USE

  • AirDuo Digihaler is a prescription medicine used to control symptoms of asthma and to prevent symptoms such as wheezing in people 12 years of age and older.
  • AirDuo Digihaler is not used to relieve sudden breathing problems from asthma and won't replace a rescue inhaler.

AirDuo Digihaler contains a built-in electronic module that records and stores information about inhaler events. AirDuo Digihaler may be used with, and transmits information to, a mobile App. AirDuo Digihaler does not need to be connected to the app in order for you to take your medicine.

IMPORTANT SAFETY INFORMATION

  • AirDuo Digihaler contains salmeterol. Long-acting beta2-agonist (LABA) medicines such as salmeterol when used alone increase the risk of hospitalizations and death from asthma problems. AirDuo Digihaler contains an inhaled corticosteroid (ICS) and a LABA. When an ICS and a LABA are used together, there is not a significant increased risk in hospitalizations and death from asthma problems.
  • Do not use AirDuo Digihaler to treat sudden breathing problems from asthma. Always have a rescue inhaler with you to treat sudden symptoms.
  • Do not use AirDuo Digihaler if you have a severe allergy to milk proteins or if you are allergic to any of the ingredients in the product. Ask your healthcare provider if you are not sure.
  • Do not use AirDuo Digihaler more often than prescribed.
  • Do not take AirDuo Digihaler with other medicines that contain a LABA for any reason.
  • Tell your healthcare provider about all the medicines you take and about all of your health conditions.
  • AirDuo Digihaler can cause serious side effects, including:
    • Fungal infection in your mouth or throat (thrush). Rinse your mouth with water without swallowing after using AirDuo Digihaler to help reduce your chance of getting thrush.
    • Weakened immune system and increased chance of getting infections (immunosuppression). You should avoid exposure to chickenpox and measles, and, if exposed, tell your healthcare provider right away. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or herpes infection of the eye (ocular herpes simplex) may occur.
    • Reduced adrenal function. This can happen when you stop taking an oral corticosteroid (such as prednisone) and start taking a medicine containing an inhaled corticosteroid (such as AirDuo Digihaler). During this transition period, when your body is under stress such as from fever, trauma (such as a car accident), infection, or surgery, adrenal insufficiency can get worse and may cause death. Symptoms of adrenal insufficiency include:
      • feeling tired
      • lack of energy
      • weakness
      • nausea and vomiting
      • low blood pressure
    • Sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using AirDuo Digihaler and call your healthcare provider right away.
    • Serious allergic reactions. Stop using AirDuo Digihaler and call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
      • rash
      • hives
      • swelling of your face, mouth, and tongue
      • breathing problems
    • Effects on heart
      • increased blood pressure
      • a fast or irregular heartbeat
      • chest pain
    • Effects on nervous system
      • tremor
      • nervousness
    • Bone thinning or weakness (osteoporosis)
    • Slowed growth in children. A child's growth should be checked often.
    • Eye problems including glaucoma and cataracts. You should have regular eye exams while using AirDuo Digihaler.
    • Changes in laboratory blood values (sugar, potassium, certain types of white blood cells)
  • Common side effects of AirDuo Digihaler include:
    • Infection of nose and throat (nasopharyngitis)
    • thrush in your mouth or throat. Rinse your mouth with water without swallowing after use to help prevent this.
    • back pain
    • headache
    • cough
  • These are not all the possible side effects of AirDuo Digihaler. Call your healthcare provider for medical advice about side effects.
  • 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.

Please see full Prescribing Information and Patient Information for AirDuo Digihaler.

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by Teva could void the user’s authority to operate the equipment.