• Bronchitol is a prescription medicine that is used along with other therapies to improve lung function in people 18 years of age and older with cystic fibrosis (CF).
• Bronchitol is only for adults who have passed the Bronchitol Tolerance Test (BTT). Your first dose is given during the BTT by your healthcare provider and tests if Bronchitol is right for you. Your healthcare provider will use equipment to monitor you and have medicine ready if you have bronchospasms during the test. If you have bronchospasms during your BTT, then you should not be prescribed Bronchitol.

Bronchitol should not be used in children and adolescents. It is not known if this medicine is safe and effective in children under 18 years of age.

See the step-by-step Patient Instructions for Use leaflet that comes with your prescription.

•  Bronchitol is for oral inhalation only.
• Do not use Bronchitol until your healthcare provider has given you the BTT and approved you for treatment. Ask your healthcare provider or pharmacist if you have any questions.
• Use Bronchitol exactly as your healthcare provider tells you to use it.
• Do not swallow Bronchitol capsules. Bronchitol capsules should be used only with the provided inhaler device.
• An inhaled short-acting bronchodilator should be used 5 to15 minutes before every dose.
• Use Bronchitol 2 times each day. Breathe in (inhale) through your mouth (oral inhalation) the capsule contents in 10 single Bronchitol capsules using the Bronchitol inhaler:
  • 1 time in the morning
  • 1 time at least 2 to 3 hours before bedtime
• If you use too much Bronchitol, call your healthcare provider or go to the nearest emergency room right away if you have any unusual symptoms, such as feelings that you cannot breathe, have wheezing, or cough a lot.
• Do not stop using Bronchitol or any other medicines unless told to do so by your healthcare provider because your symptoms might get worse.
• Your healthcare provider may change your medicines as needed.

Call your healthcare provider or get emergency medical care right away if your breathing problems get worse while taking Bronchitol.

Do not take Bronchitol if you:

• have had an allergic reaction to mannitol or any parts of the Bronchitol capsule. See the end of this page for a complete list of ingredients.
• do not pass the BTT.

Before using Bronchitol

Before you use Bronchitol, tell your healthcare provider about all your medical conditions, including if you:

• have ever coughed up blood or had blood in your mucus (sputum).
• are pregnant or planning on becoming pregnant. It is not known if Bronchitol will harm your unborn baby. Tell your healthcare provider right away if you become pregnant during treatment.
• are breastfeeding or plan to breastfeed. It is not known if Bronchitol passes into your breast milk or if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby during treatment.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
Know the medicines you take. Keep a list of the medicines you take and show it to your healthcare provider and pharmacist when you get a new medicine.

Bronchitol may cause serious side effects, including:

• sudden breathing problems immediately after inhaling your medicine. Use your short-acting bronchodilator or rescue medicine if you have sudden breathing problems. Get emergency medical care right away if your bronchodilator or rescue medicine does not relieve the symptoms.
• coughing up of blood (hemoptysis). This is a serious but common side effect. Coughing up blood in your mucus can happen while you are using Bronchitol. Call your healthcare provider or get emergency medical care right away if you cough up a large amount of blood.

The most common side effects include:

• cough
• coughing up of blood
• pain or irritation in the back of your mouth and throat and discomfort when swallowing
• vomiting
• fever
• joint pain
• bacteria in your sputum

Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects. You can ask your healthcare provider or pharmacist for more information. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA1088. You may also report side effects to Chiesi USA, Inc. at 1-888-661-9260.