IMPORTANT PRODUCT INFORMATION

SINGULAIR is indicated for prevention of exercise-induced bronchoconstriction (EIB) in patients aged 15 years and older.

For prevention of EIB, a single dose of SINGULAIR should be taken at least 2 hours before exercise. An additional dose of SINGULAIR should not be taken within 24 hours of a previous dose.

Patients already taking 1 tablet daily for another indication should not take an additional dose to prevent EIB.

SELECTED SAFETY INFORMATION

SINGULAIR should not be used as rescue medication to treat acute asthma episodes. Patients should be advised to have appropriate rescue medication available.

Neuropsychiatric events have been reported in patients taking SINGULAIR. These events included agitation, aggressive behavior or hostility, anxiousness, depression, dream abnormalities, hallucinations, insomnia, irritability, restlessness, somnambulism, suicidal thinking and behavior (including suicide), and tremor. The clinical details of some postmarketing reports appear consistent with a drug-induced effect. Patients should be advised to report any neuropsychiatric events.

Chronic daily administration of SINGULAIR for other indications has not been established to prevent acute episodes of EIB.

Patients with known aspirin sensitivity should continue avoidance of aspirin or nonsteroidal antiinflammatory agents while taking SINGULAIR.

Safety and effectiveness of SINGULAIR for EIB in patients younger than 15 years have not been established.

Before prescribing SINGULAIR, please read the Prescribing Information. The Patient Information also is available.