SALMETEROL/FLUTICASONE INHALATION DISK-ORAL (cont.)
SIDE EFFECTS: Hoarseness (dysphonia), throat irritation, headache, cough, dry mouth or throat may occur. If any of these effects persist or worsen, notify your doctor or pharmacist promptly. Tell your doctor immediately if any of these serious side effects occur: white patches on tongue or mouth, swollen/painful mouth or tongue. Tell your doctor immediately if any of these unlikely but serious side effects occur: weight gain, vision changes, trouble sleeping, tremors. Tell your doctor immediately if any of these highly unlikely but very serious side effects occur: seizures, severe muscle weakness or cramping, fast/irregular heartbeat, numbness/tingling of the hands or feet, chest pain, worsening of breathing symptoms (e.g., wheezing, coughing). An allergic reaction to this drug is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include: rash, itching, swelling, dizziness, trouble breathing. Rarely, your wheezing might actually increase immediately after using this medication (paradoxical bronchospasm). If this occurs, use your "quick relief" inhaler (such as albuterol). Seek immediate medical attention if your breathing does not improve at that time. If you notice other effects not listed above, contact your doctor or pharmacist.
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, tuberculosis), certain lung diseases (bronchiectasis). Before using this medication, tell your doctor your medical history, especially of: 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 (e.g., hyperthyroid), any allergies you may have. This product 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 while using this drug is not recommended. Consult your doctor before breast-feeding.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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