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SALMETEROL/FLUTICASONE INHALATION-ORAL (cont.)

PRECAUTIONS: This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: irregular/fast heartbeat (cardiac tachyarrhythmias), untreated lung infection (bacterial, fungal, or TB), certain lung diseases (bronchiectasis). Before using this medication, tell your doctor or pharmacist your medical history, especially of: bone loss (osteoporosis), heart disease (angina, arrhythmias), liver problems, diabetes, high blood pressure, low potassium levels (hypokalemia), eye problems (e.g., cataracts, glaucoma), depression, recent infection, seizures, thyroid problems (hyperthyroid or hypothyroid), any allergies. This drug may make you dizzy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. If you have switched from an oral corticosteroid (e.g., prednisone tablets) to this inhaler within the past 12 months, or if you have been using this product in higher-than-usual doses and suddenly stop using it, your body may not produce enough natural steroids. You may need to start taking additional corticosteroids, especially if your body is stressed due to a major infection, surgery or injury. Deaths have sometimes occurred during such stresses, due to low steroid levels. Tell your doctor immediately if any of the following side effects occur: unusual weakness, sudden weight loss, dizziness. Consult your doctor or pharmacist for more details, and inform them that you use (or have used) any type of corticosteroid. Carry a warning card or medical ID bracelet that identifies your need for oral corticosteroids during times of stress as noted. Consult your doctor or pharmacist now for specific advice regarding stress situations; you may need to carry a supply of corticosteroid tablets as a precaution. Caution is advised when using this drug in the elderly because they may be more sensitive to the effects of the drug, especially the effects on the heart (cardiovascular). Caution is advised when using this drug in children. Though it is unlikely to occur with inhaled steroids (fluticasone), this medication may temporarily slow down a child's rate of growth, but it will probably not affect final adult height. Monitor your child's height periodically. Though it is very unlikely with inhaled steroid use, children might be prone to serious cases of common infections, such as chickenpox or measles. Avoid exposing the child to such diseases. Consult the doctor or pharmacist for more details. This medication should be used only when clearly needed during pregnancy. Discuss the risks and benefits with your doctor. One of the medications in this product (salmeterol) passes into breast milk; it is unknown if the other product (fluticasone) passes into breast milk. Because of the potential risk to the infant, breast-feeding is not recommended. Consult your doctor before breast feeding.



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