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IMPORTANT INFORMATION ABOUT PULMICORT FLEXHALER

Important Safety Information

PULMICORT FLEXHALER is not a bronchodilator and should NOT be used to treat an acute asthma attack. If you are switching to PULMICORT FLEXHALER from an oral corticosteroid, follow your doctor's instructions to avoid serious health risks when you stop using oral corticosteroids.

Avoid exposure to infections such as chicken pox and measles. Tell your doctor immediately if exposed. Inhaled corticosteroids may cause a reduction in growth rate. The long-term effect on final adult height is unknown.

Rare instances of glaucoma, increased intraocular pressure, cataracts have been reported following the inhaled administration of corticosteroids.

PULMICORT FLEXHALER contains small amounts of lactose, which contains trace levels of milk proteins. In patients who have severe milk protein allergy (not those who are lactose intolerant) cough, wheezing, or bronchospasm may occur.

Be sure to tell your healthcare provider about all your health conditions, and all medicines you may be taking.

As with other inhaled asthma medications, bronchospasm, with an immediate increase in wheezing, may occur after dosing. If bronchospasm occurs following dosing with PULMICORT FLEXHALER, it should be treated immediately with a fast-acting inhaled bronchodilator. Treatment with PULMICORT FLEXHALER should be discontinued and alternate therapy instituted.

The most commonly reported side effects in clinical trials include inflammation of the nose and throat, nasal congestion, sore throat, nasal allergies, viral upper respiratory tract infection, and thrush in the mouth and throat.

Approved Use

PULMICORT FLEXHALER (budesonide inhalation powder, 90 mcg & 180 mcg), an inhaled corticosteroid, is used for the maintenance treatment of asthma in adults and children 6 years or older.

Please click here for full Prescribing Information for PULMICORT FLEXHALERPDF.


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.

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The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about PULMICORT FLEXHALER, talk to your doctor or pharmacist. Only you and your health care professional can decide if PULMICORT FLEXHALER is right for you.