Mannitol

Bronchitol is used together with other medicines to improve breathing in adults with cystic fibrosis. Bronchitol is given only after you have passed a tolerance test to make sure you can safely use this medicine.

Aridol is used as a part of medical testing for asthma in children at least 6 years old.

Mannitol inhalation may also be used for purposes not listed in this medication guide.

You should not use this medicine if you've ever had an allergic reaction or bronchospasm (wheezing, chest tightness, trouble breathing) after using mannitol.

You also should not use this medicine if you are allergic to anything used to make the capsules (such as gelatin, shellac, isopropyl alcohol, propylene glycol, ammonia solution, titanium dioxide, or iron oxides).

You should not be treated with Aridol if you have:

• an aneurysm;
• untreated or uncontrolled high blood pressure; or
• a recent heart attack or stroke.

Tell your doctor if you have ever had:

• a severe cough, or a cough with bloody mucus;
• a collapsed lung or punctured lung;
• angina (chest pain);
• surgery on your stomach or chest, or your eyes;
• if you have ever coughed up blood; or
• if you have active symptoms of an infection that could affect your lungs (such as stuffy nose, sore throat, fever, chills, cough, chest pain, or trouble breathing).

Tell your doctor if you are pregnant or breastfeeding.

Aridol is given only in a medical setting as part of testing for asthma or other lung disorders. You will be quickly treated if the test causes you to have severe breathing problems.

You will receive your first Bronchitol dose (a tolerance test dose) in a clinic setting. Your doctor will monitor your breathing to make sure this medicine is safe for you to use.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Use the medicine exactly as directed.

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

The usual schedule for Bronchitol is one dose in the morning and one dose about 2 to 3 hours before bedtime.

Your doctor will prescribe another inhaled medicine that you should use 5 to 15 minutes before each dose of Bronchitol. Do not use any other medicines not recommended by your doctor.

Do not swallow a mannitol inhalation capsule. It is for use only in the inhaler device provided with this medicine.

Each Bronchitol inhaler device should be used for no more than 7 days. Replace it with a new inhaler each week.

Do not change your dose or stop using Bronchitol without your doctor's advice.

Store at room temperature away from moisture and high heat. Do not freeze or refrigerate.

Throw away any Bronchitol capsules that have been kept at temperatures higher than 86 degrees F (30 degrees C). Throw away the Bronchitol inhaler device after 7 days of use.

Call your doctor for instructions if you miss a dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include cough, wheezing, or severe shortness of breath.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• wheezing, choking, or other breathing problems after using this medicine; or
• if you cough up large amounts of blood.

Common side effects of Bronchitol may include:

• pain or irritation in your mouth or throat;
• trouble swallowing;
• fever; or
• vomiting.

Common side effects of Aridol may include:

• wheezing, trouble breathing, chest discomfort;
• cough, throat pain or irritation;
• runny nose;
• headache, dizziness; or
• nausea, vomiting.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect mannitol inhalation, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.

Your doctor or pharmacist can provide more information about mannitol.