IMPORTANT SAFETY INFORMATION

IMPORTANT SAFETY INFORMATION

Severe breathing problems (bronchospasm). Tell your doctor right away if you get shortness of breath with wheezing or coughing and chest tightness while using TOBI PODHALER.

Hearing loss or ringing in the ears (ototoxicity). Tell your doctor right away if you have hearing loss, noises in your ears such as ringing or hissing, vertigo, difficulty with balance, or dizziness.

Worsening kidney problems (nephrotoxicity). TOBI PODHALER is in a class of medicines that may cause worsening kidney problems, especially in people with known or suspected kidney problems. Your healthcare provider may do a blood test to check how your kidneys are working while you are using TOBI PODHALER.

Worsening muscle weakness. TOBI PODHALER is in a class of medicines that can cause worsening muscle weakness in people who already have problems with muscle weakness (myasthenia gravis or Parkinson's disease).

TOBI PODHALER is in a class of medicines which may cause harm to an unborn baby.

The most common side effects of TOBI PODHALER include cough, worsening of lung problems or cystic fibrosis, productive cough, shortness of breath, fever, sore throat, changes in your voice (hoarseness), coughing up blood, and headache.

Let your doctor know if your symptoms worsen or if you have a side effect that bothers you enough to stop treatment or that does not go away.

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 Product Information.