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 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 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.
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.