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

Drug Manufacturer: GLAXO SMITH KLINE

Common Uses: This product is a combination "controller" medicine for long-term treatment of asthma and chronic lung diseases (such as emphysema, chronic bronchitis, or 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.

Before Using This Medicine: WARNING: LONG-ACTING BETA-AGONISTS SUCH AS SALMETEROL, AN INGREDIENT IN THIS MEDICINE, HAVE BEEN RARELY ASSOCIATED WITH AN INCREASED RISK OF ASTHMA-RELATED DEATH. This medicine should only be used by certain patients with severe asthma or by patients who cannot get adequate control of asthma symptoms by using other asthma-controller medicines (eg, inhaled corticosteroids). If you experience signs of worsening asthma and find that your fast-acting inhaler is not working as well or if you need to use it more often than usual (such as using 4 or more puffs daily or using more than 1 inhaler every 8 weeks), seek immediate medical attention. This may be a sign of worsening asthma which is a very serious condition. DO NOT SUDDENLY STOP using this medicine. Doing so may cause your breathing condition to get worse. Discuss with your doctor the benefits and risks of using this medicine. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. DO NOT TAKE THIS MEDICINE if you are taking azole antifungals (such as ketoconazole), certain HIV protease inhibitors (such as ritonavir), macrolide antibiotics (such as clarithromycin), nefazodone, telithromycin, or if you are using another type of long-acting inhaled bronchodilator (such as salmeterol inhalation powder, formoterol inhalation powder). ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are also taking diuretics (such as hydrochlorothiazide, furosemide), long-acting beta-agonist bronchodilators (such as formoterol inhalation powder), beta-blockers (such as propranolol), catechol-O-methyltransferase (COMT) inhibitors (such as entacapone), delavirdine, HIV protease inhibitors (such as lopinavir), MAOIs (such as phenelzine), short-acting beta-agonist bronchodilators (such as albuterol), or tricyclic antidepressants (such as amitriptyline) Use of this inhaler within 2 weeks after stopping MAO inhibitors or tricyclic antidepressants is not recommended, since these medicines may increase the serious side effects of salmeterol. DO NOT USE THIS MEDICINE DURING AN ASTHMA ATTACK. DO NOT START OR STOP any medicine without doctor or pharmacist approval. Inform your doctor of any other medical conditions including heart problems (such as angina, heart blood vessel problems, fast or irregular heartbeat), immune system problems, nervous system problems, liver problems, diabetes, high blood pressure, low potassium levels (hypokalemia), eye problems (such as cataracts or glaucoma), an adrenal gland tumor, depression, recent infection, recent vaccination, seizures, thyroid problems (hyperthyroid or hypothyroid), any allergies, pregnancy, or breast-feeding. Tell your doctor if you are having a COPD flare-up, have recently been to an emergency room for asthma, have a history of frequent hospitalizations for asthma, or if you have ever had a life-threatening asthma attack. Tell your doctor if you have weak bones (osteoporosis) or risk factors for osteoporosis (such as a family history of osteoporosis, tobacco use, long-term use of corticosteroids or certain seizure medicines, limited physical exercise, poor nutrition), untreated lung infections (such as bacterial, fungal, or tuberculosis), status asthmaticus, or certain lung diseases (such as bronchiectasis). Contact your doctor or pharmacist if you have any questions or concerns about taking this medicine. Use of this medicine in children under 4 years old is not recommended. Discuss with your doctor the risks and benefits of giving this medicine to your child.

How to Use This Medicine: Follow the directions for using this medicine provided by your doctor. This medicine comes with a MEDICATION GUIDE approved by the U.S. Food and Drug Administration. Read it carefully each time you refill this medicine. Ask your doctor, nurse, or pharmacist any questions that you may have about this medicine. Refer to the illustrated directions provided for instruction on the correct use of this device. YOUR DOSE OF MEDICINE IS A VERY FINE POWDER. MOST, BUT NOT ALL, PATIENTS CAN TASTE OR FEEL THE DOSE. DO NOT USE ANOTHER DOSE IF YOU DO NOT TASTE OR FEEL THE MEDICINE. If you are not sure if you are receiving your dose, contact your doctor or pharmacist. Rinse your mouth with water after using this medicine. Do NOT swallow the rinse solution. Spit the rinse water out. If you are using other inhaled medicines, wait a few minutes between using this medicine and other inhalers, unless directed otherwise by your doctor. You may breathe more easily after you use the first dose of this medicine. However, it may take 1 week or longer before you get the most benefit. USE THIS MEDICINE ON A REGULAR SCHEDULE to get the most benefit from it, unless your doctor tells you otherwise. Using this medicine at the same times each day will help you remember to use it. IF YOU HAVE BEEN REGULARLY USING A SHORT-ACTING BRONCHODILATOR INHALER (such as albuterol), talk with your doctor about how to use it with this medicine. Short-acting bronchodilators are normally only used with this medicine to treat breathing problems that may occur between doses. Talk with your doctor or pharmacist about all of your asthma medicines and how to use them with this medicine. STORE THIS MEDICINE at room temperature between 68 and 77 degrees F (20 and 25 degrees C) away from heat, moisture, or light. Keep the inhaler dry at all times. Throw this medicine away 1 month after you remove it from the foil pouch, or after the dose indicator reads "0", whichever comes first. CONTINUE TO USE THIS MEDICINE even if you feel well. Do not miss any doses. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do NOT use 2 doses at once.

Cautions: DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it, to milk proteins, or if you are allergic to any ingredient in this product. THIS MEDICINE WILL NOT STOP AN ASTHMA ATTACK ONCE IT HAS ALREADY STARTED. Always carry a short-acting bronchodilator to treat breathing problems that may occur between doses of this medicine. DO NOT START, STOP, OR CHANGE THE DOSE OF ANY ASTHMA MEDICINE unless your doctor tells you to. DO NOT EXCEED THE RECOMMENDED DOSE or use this medicine more often than prescribed without checking with your doctor. The risk of serious heart problems (such as irregular heartbeat) maybe greater if you use this medicine in high doses. Laboratory and/or medical tests, including lung function and eye exams may be performed to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS. BEFORE YOU HAVE ANY MEDICAL OR DENTAL TREATMENTS, EMERGENCY CARE, VACCINATIONS, OR SURGERY, tell the doctor or dentist that you are using this medicine. IF YOU HAVE NOT HAD CHICKENPOX, SHINGLES, OR MEASLES, AVOID CONTACT WITH ANYONE WHO DOES. Contact your doctor at once if you have contact with anyone who has these infections. 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. USE CAUTION IF YOU SWITCH FROM AN ORAL STEROID (SUCH AS PREDNISONE) TO THIS MEDICINE. It may take several months for your body to make enough natural steroids to handle events that cause physical stress (such as injury, surgery, infection, or a sudden asthma attack). Contact your doctor right away if any of these events occur. You may need to take an oral steroid again. Caution is advised when using this medicine in children and the elderly; they may be more sensitive to the effects of the medicine. Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use this medicine. FOR WOMEN: IF YOU BECOME PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. IT IS UNKNOWN IF THIS MEDICINE IS EXCRETED in breast milk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby. IF YOU HAVE DIABETES, this medicine may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.

Possible Side Effects: SIDE EFFECTS that may occur while taking this medicine include diarrhea, dizziness, headache, mild muscle or bone pain, nausea, nervousness, throat irritation, tremor, or vomiting. If they continue or are bothersome, check with your doctor. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience trouble sleeping, unusual tiredness or weakness, or weight gain. CONTACT YOUR DOCTOR IMMEDIATELY if you experience behavior changes; blurred vision or other vision changes; chest pain; choking; fast or irregular heartbeat; hoarseness; numbness or tingling in hands or feet; seizures; severe muscle weakness, cramps, or spasms; severe or persistent dizziness or headache; severe or persistent bone pain; signs of infection (eg, fever, chills, persistent headache/sore throat, ear pain, increased mucus production or change in mucus color); swelling or tightness in the throat; vaginal odor or discharge; white patches or sores on the tongue or mouth; or worsening of asthma symptoms (such as increased wheezing, coughing, chest tightness, shortness of breath). 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. THIS MEDICINE MAY SOMETIMES CAUSE SEVERE BREATHING PROBLEMS RIGHT AFTER YOU USE A DOSE. If this happens, use your short-acting bronchodilator inhaler. Seek medical care at once if your breathing does not improve after you use it. Tell your doctor about this reaction. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Overdose: If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include chest pain; fainting; muscle cramping; seizures; severe or persistent dizziness, headache, or trouble sleeping; severe muscle weakness; or unusually fast or irregular heartbeat.

Additional Information: Carry an identification card at all times that states you are taking this medicine. If your symptoms do not improve within a week or if they become worse, check with your doctor. IT IS IMPORTANT that you keep all doctor and laboratory appointments while you are using this medicine. Laboratory and/or medical tests (e.g., IOP, children's rate of growth) should be performed periodically to monitor your progress or check for side effects. Consult your doctor for more information. Learn to use a peak flow meter, use it daily, and promptly report worsening asthma (such as readings in the yellow or red range or increased use of quick-relief inhalers). Try to avoid irritants that may trigger an asthma attack such as smoke, pollen, pet dander, dust, or molds. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

Copyright 2009 Wolters Kluwer Health, Inc.

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