Generic Name: E: FLUTICASONE (flew-TICK-uh-sone) and SALMETEROL (sal-MET-er-all)

Drug Manufacturer: GLAXOSMITHKLINE

Common Uses: This product is a combination "controller" medicine for long-term (maintenance) treatment to prevent or decrease the symptoms of asthma (e.g., wheezing, trouble breathing), and also chronic lung disease (e.g., emphysema, bronchitis, - COPD). It works to open the airways of the lungs in two ways (decreasing bronchiolar swelling and causing muscle relaxation). It may also be used to treat other breathing conditions as determined by your doctor. This medicine does not work immediately and should not be used for acute asthma attacks. Use other "quick-relief" medicines/inhalers for sudden shortness of breath or asthma attacks.

How to use this Medicine: Follow the directions for using this medicine provided by your doctor. This medicine comes with a patient information leaflet. Read it carefully. Refer to the illustrated directions provided for instruction on the correct use of this device. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Always activate and use this device in a level, horizontal position. Do not breathe into (exhale into) the inhaler. Do not use a spacer. Inhale this medicine usually twice daily, in the morning and in the evening (12 hours apart); or as directed by your doctor. Your dose is based on your condition and response to treatment. Gargle and rinse your mouth after using this medicine to help prevent dryness, relieve throat irritation, and to prevent mouth infections (e.g., thrush). Do not swallow the rinse solution. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. If you have been using a "quick-relief" beta agonist inhaler (such as salbutamol/albuterol) on a regular daily schedule (such as 4 times daily), you must discontinue this schedule and only use it "as needed" for acute asthma attacks. Consult your doctor. If you find that your "quick-relief" inhaler is not working as well or if you need to use it more often than usual, (i.e., using 4 or more puffs daily or using more than 1 inhaler every 8 weeks) tell your doctor or pharmacist promptly. This may be a sign of worsening asthma which is a serious condition. Do not take the inhaler apart, or wash the mouthpiece of the inhaler. STORE THIS MEDICINE at room temperature as directed on the package, away from heat, moisture, or light. Keep the inhaler dry at all times. IF YOU MISS A DOSE OF THIS MEDICINE, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do NOT use 2 doses at once.

Cautions: DO NOT STOP USING THIS MEDICINE without first checking with your doctor. Some conditions may become worse when the medicine is suddenly stopped. Your dose may need to be gradually decreased. DO NOT EXCEED THE RECOMMENDED DOSE or use this medicine more often than prescribed without checking with your doctor. Doing so would decrease the effectiveness of the medicine and increase the risk of side effects. THIS MEDICINE MAY CAUSE DIZZINESS. DO NOT DRIVE, OPERATE MACHINERY, OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Limit alcoholic beverages. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. Check the labels on all your medicines (e.g., cough-and-cold products, diet aids) because they may contain ingredients that could increase your heart rate and blood pressure. Ask your pharmacist about the safe use of those products. 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. 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 stating that you may need supplemental corticosteroids (e.g., prednisone) during stress periods (such as trauma or major surgery). Contact your doctor if you experience any symptoms of low steroid levels including unusual weakness, weight loss, fainting, or dizziness. 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 medicine in children. Though it is very unlikely to occur with inhaled steroids (fluticasone), this medicine may decrease a child's growth rate, but not necessarily their final adult height. 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. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. ONE OF THE MEDICINES IN THIS PRODUCT (SALMETEROL) IS EXCRETED in breast milk; it is unknown if the other medicine (fluticasone) passes into breast milk. DO NOT BREAST-FEED while using this medicine.

Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include hoarseness (dysphonia), throat irritation, headache, cough, dry mouth or throat. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR IMMEDIATELY if you experience white patches on tongue or mouth, or if your mouth/tongue becomes swollen and painful. CONTACT YOUR DOCTOR IMMEDIATELY if you experience any of the following unlikely but serious side effects weight gain, vision changes, trouble sleeping, tremors, seizures, severe muscle weakness or cramping, fast/irregular heartbeat, numbness or tingling in hands or feet, chest pain, or worsening of asthma symptoms (e.g., wheezing, coughing). AN ALLERGIC REACTION to this medicine is unlikely but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. Rarely, your wheezing might actually increase immediately after using this medicine (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, nurse, or pharmacist.