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Indication

BRONCHITOL (mannitol) inhalation powder is a sugar alcohol indicated as add-on maintenance therapy to improve pulmonary function in adult patients 18 years of age and older with cystic fibrosis. Use BRONCHITOL only in adults who have passed the BRONCHITOL Tolerance Test.

Important Safety Information

BRONCHITOL is contraindicated in patients with hypersensitivity to mannitol or to any of the capsule components. BRONCHITOL is contraindicated in patients who fail to pass the BRONCHITOL Tolerance Test (BTT).

BRONCHITOL can cause bronchospasm, which can be severe in susceptible patients. Because of the risk of bronchospasm, prior to prescribing BRONCHITOL, patients must pass the BRONCHITOL Tolerance Test (BTT). The BTT must be administered under the supervision of a healthcare practitioner who can treat severe bronchospasm.

Patients who pass the BRONCHITOL tolerance test (BTT) may experience bronchospasm with add-on maintenance therapy with BRONCHITOL. Patients should premedicate with an inhaled short-acting bronchodilator prior to each administration of BRONCHITOL. If bronchospasm occurs, immediately discontinue BRONCHITOL and treat bronchospasm with an inhaled short-acting bronchodilator.

Hemoptysis can occur with BRONCHITOL use. Monitor patients with history of episodes of hemoptysis. If hemoptysis occurs, discontinue use of BRONCHITOL.

Most common adverse reactions (≥3%) include cough, hemoptysis, oropharyngeal pain, vomiting, bacteria sputum identified, pyrexia, and arthralgia.

Please see Full Prescribing Information.

About BRONCHITOL® (mannitol) inhalation powder

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 of BRONCHITOL 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 bronchospasm during the test. If you have bronchospasm during your BTT, then you should not be prescribed BRONCHITOL.

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

Important Safety Information

Do not take BRONCHITOL if you have had an allergic reaction to mannitol or any parts of the BRONCHITOL capsule or if you do not pass the BRONCHITOL Tolerance Test (BTT).

Before you take BRONCHTOL, 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 while using BRONCHITOL; 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 while using BRONCHITOL.

Tell your healthcare provider about all medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

BRONCHITOL may cause serious side effects, including sudden breathing problems immediately after inhaling your medicine; coughing up of blood (hemoptysis). 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 of BRONCHITOL 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 of BRONCHITOL. You can ask your healthcare provider or pharmacist for more information.

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 Patient Information within the accompanying Full Prescribing Information.

Bronchitol® is a registered trademark of Chiesi Farmaceutici, S.p.A.