fluticasone/salmeterol inhalation disk - oral, Advair Diskus (cont.)
SIDE EFFECTS: See also Precautions.Hoarseness, throat irritation, headache, rapid heartbeat, nervousness, cough, dry mouth/throat, or upset stomach may occur.To relieve dry mouth, suck on (sugarless) hard candy or ice chips, chew (sugarless) gum, drink water, or use a saliva substitute.If any of these effects persist or worsen, notify your doctor or pharmacist promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: white patches on tongue/in mouth, increased thirst/urination, persistent weight gain, vision problems (e.g., blurred vision), shaking, severe muscle cramping.Seek immediate medical attention if any of these rare but very serious side effects occur: chest pain, fast/slow/irregular heartbeat, severe dizziness, fainting, seizures.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 (especially of the face/tongue/throat), severe dizziness, trouble breathing.Rarely, this medication has caused severe (rarely fatal), sudden worsening of breathing problems/asthma (paradoxical bronchospasm). If you have trouble breathing or experience sudden wheezing, use your quick-relief inhaler and seek immediate medical attention.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.
PRECAUTIONS: Before using this medication, tell your doctor or pharmacist if you are allergic to it; or if you have a severe allergy (anaphylaxis) to lactose or milk proteins (not lactose intolerance); or if you have any other allergies.Before using this medication, tell your doctor or pharmacist your medical history, especially of: high blood pressure, bone loss (osteoporosis), depression, diabetes, eye problems (e.g., cataracts, glaucoma), heart problems (e.g., angina, irregular heartbeat), any recent infection, liver problems, seizures, smoking, thyroid problems (e.g., overactive thyroid).Fluticasone/salmeterol may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that require immediate medical attention. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm (see also Drug Interactions section). Before using fluticasone/salmeterol, tell your doctor or pharmacist if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using fluticasone/salmeterol safely.This product may make you dizzy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Limit alcoholic beverages.Avoid contact with people who have chickenpox or measles unless you have previously had these diseases (e.g., in childhood). If you are exposed to one of these infections and you have not previously had it, seek immediate medical attention.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 for an extended time 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. Consult your doctor or pharmacist now for advice regarding future stress situations. You may need to carry a supply of corticosteroid tablets as a precaution. Carry a warning card or medical ID bracelet that identifies your need for oral corticosteroids during times of stress as noted. (See also Medical Alert section.)This medication may make it harder to notice the signs of an infection or put you at greater risk of developing an infection. If you have COPD, your risk of developing pneumonia is higher. Tell your doctor immediately if you have any signs of pneumonia or other infection (such as persistent sore throat, fever, chills, increased cough, an increase in the amount of mucus/sputum or a change in its color, increased trouble breathing).Older adults may be more sensitive to the effects of this drug, especially dizziness, increased risk of pneumonia, and effects on the heart.Caution is advised when using this drug in children. Though it is unlikely to occur with inhaled steroids, 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.During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.It is not known if salmeterol or fluticasone pass into breast milk. Based on information for similar drugs, fluticasone may pass into breast milk. 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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