Important Safety Information

COMBIVENT Inhalation Aerosol is indicated for use in patients with chronic obstructive pulmonary disease (COPD) on a regular aerosol bronchodilator who continue to have evidence of bronchospasm and who require a second bronchodilator.

COMBIVENT Inhalation Aerosol should not be used in patients who:

• Are allergic to soya lecithin or related food products such as soybeans and peanuts
• Are allergic to any of the ingredients in COMBIVENT Inhalation Aerosol or to atropine or other similar drugs

COMBIVENT Inhalation Aerosol can cause the narrowing of the airways to get worse (paradoxical bronchospasm) in some patients, which may be life threatening. If this happens, stop taking COMBIVENT Inhalation Aerosol at once and call your doctor or get emergency help.

COMBIVENT Inhalation Aerosol can cause serious allergic reactions. Symptoms include itching, swelling of the face, lips, tongue, or throat (which may cause difficulty in breathing or swallowing), skin rash, hives, bronchospasm (airway narrowing), or anaphylaxis. If you experience any of these symptoms stop taking COMBIVENT Inhalation Aerosol at once and call your doctor or get emergency help.

COMBIVENT Inhalation Aerosol can cause serious heart-related side effects, such as an increase in pulse, blood pressure, and/or related symptoms.

Deaths have been reported with similar inhaled medicines in asthma patients who use the medicine too much. Do not use COMBIVENT Inhalation Aerosol more often than your healthcare provider has directed.

Certain medical conditions may increase your risk of side effects.

Tell your healthcare provider about all your conditions and medicines you take, including if you:

• Have narrow-angle glaucoma
• Have prostate or urinary problems
• Have a history of heart disease (e.g., reduced heart circulation, irregular heartbeat, and high blood pressure)
• Have seizures
• Have a thyroid disorder
• Have diabetes
• Have low potassium levels
• Have kidney disease
• Have liver disease
• Are pregnant or planning to become pregnant or are breast-feeding
• Are taking any heart medications or drugs to treat depression

Read the step-by-step Patient's Instructions for use before using this medicine.

Remember to vigorously shake your COMBIVENT Inhalation Aerosol for 10 seconds before each use or inhalation.

Do not get the spray into your eyes.

The most common side effects reported with use of COMBIVENT Inhalation Aerosol include bronchitis, infection of the ears, nose, and throat, headache, shortness of breath, and cough.

Please see accompanying full Prescribing Information including Patient Instructions for Use.

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.