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|Fluticasone/Salmeterol Inhaler

Fluticasone/Salmeterol Inhaler

Fluticasone/Salmeterol Inhaler is used for:

Long-term treatment of asthma in certain patients. It may also be used to treat other breathing conditions as determined by your doctor.

Fluticasone/Salmeterol Inhaler is a long-acting corticosteroid and bronchodilator combination. It works by reducing inflammation and widening the airways in the lungs, which helps you breathe more easily.

Do NOT use Fluticasone/Salmeterol Inhaler if:

• you are allergic to any ingredient in Fluticasone/Salmeterol Inhaler
• you are having an asthma attack (eg, sudden, severe onset or worsening of asthma symptoms, such as wheezing, cough, chest tightness, shortness of breath)
• you are using another type of long-acting inhaled bronchodilator (eg, salmeterol inhalation powder, formoterol inhalation powder)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluticasone/Salmeterol Inhaler:

Some medical conditions may interact with Fluticasone/Salmeterol Inhaler. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

• if you are pregnant, planning to become pregnant, or are breast-feeding
• if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
• if you have allergies to medicines, foods, or other substances
• if you are taking a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) or tricyclic antidepressant (eg, amitriptyline), or if you have taken any of these medicines within the last 14 days
• if you have a history of diabetes, glaucoma or increased pressure in the eye, heart problems (eg, fast or irregular heartbeat, heart blood vessel problems), high blood pressure, liver problems, low blood potassium levels, seizures, thyroid problems, or tumors on your adrenal gland
• if you 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
• if you have a fungal, bacterial, or parasitic infection; a viral infection (eg, measles, chickenpox, shingles); herpes virus infection of the eye; tuberculosis (TB); a history of a positive TB skin test; or immune system problems; or if you have had a recent vaccination
• if you have weak bones (osteoporosis) or have risk factors for osteoporosis (eg, a family history of osteoporosis, tobacco use, long-term use of corticosteroids or certain seizure medicines, limited physical exercise, poor nutrition)

Some MEDICINES MAY INTERACT with Fluticasone/Salmeterol Inhaler. Tell your health care provider if you are taking any other medicines, especially any of the following:

• Diuretics (eg, hydrochlorothiazide, furosemide) or long-acting beta-agonist bronchodilators (eg, salmeterol inhalation powder, formoterol inhalation powder) because the risk of low blood potassium or irregular heartbeat may be increased
• Beta-blockers (eg, propranolol) because they may decrease Fluticasone/Salmeterol Inhaler"s effectiveness
• Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), delavirdine, HIV protease inhibitors (eg, ritonavir), ketoconazole, MAOIs (eg, phenelzine), short-acting beta-agonist bronchodilators (eg, albuterol), or tricyclic antidepressants (eg, amitriptyline) because they may increase the risk of Fluticasone/Salmeterol Inhaler"s side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluticasone/Salmeterol Inhaler may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluticasone/Salmeterol Inhaler:

Use Fluticasone/Salmeterol Inhaler as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• Fluticasone/Salmeterol Inhaler comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fluticasone/Salmeterol Inhaler refilled.
• You must prime the inhaler before you use it for the first time. To prime the inhaler, shake it well for 5 seconds, then pump 1 test spray into the air away from your face. Repeat this 3 more times to be sure the inhaler is fully primed.
• You will need to reprime the inhaler if you drop it or if you have not used it in more than 4 weeks. To reprime the inhaler, shake it well for 5 seconds, then pump 1 test spray into the air away from your face. Repeat this step 1 more time to be sure the inhaler is fully primed.
• Before using Fluticasone/Salmeterol Inhaler, be sure that the canister is properly placed in the inhaler unit. Be sure the medicine is at room temperature and that there are no foreign objects inside the inhaler unit. Shake well for 5 seconds before each use. Breathe out slowly and completely. Place the mouthpiece between your lips and try to rest your tongue flat, unless your doctor has told you otherwise. Your doctor may have told you to hold the inhaler 1 or 2 inches (2 or 3 centimeters) away from your open mouth or to use a special spacing device. As you start to take a slow deep breath, press the canister and mouthpiece together at exactly the same time. This will release a dose of Fluticasone/Salmeterol Inhaler. Continue breathing in slowly and deeply and hold for as long as comfortable, then breathe out slowly through pursed lips or your nose. If you are using more than 1 inhalation, wait about 30 seconds. Shake the inhaler again and repeat the above steps. Keep the spray away from your eyes.
• Place the cap over the mouthpiece of the inhaler after use.
• Rinse your mouth with water after using Fluticasone/Salmeterol Inhaler. Do NOT swallow the rinse solution. Spit the rinse water out.
• Clean the inhaler once a week according to the directions in the Medication Guide.
• Do NOT put Fluticasone/Salmeterol Inhaler in water to estimate how much medicine is left in the canister. Fluticasone/Salmeterol Inhaler is made to deliver 120 sprays. Keep track of how many times you use Fluticasone/Salmeterol Inhaler. Throw Fluticasone/Salmeterol Inhaler away after you have used 120 sprays, even if the canister is not empty. You may not get the right amount of medicine in each spray after you have used 120 sprays.
• You may breathe more easily after you use the first dose of Fluticasone/Salmeterol Inhaler. However, it may take 1 week or longer before you get the most benefit.
• Use Fluticasone/Salmeterol Inhaler on a regular schedule to get the most benefit from it. Using Fluticasone/Salmeterol Inhaler at the same time each day will help you remember to use it. Do not stop using Fluticasone/Salmeterol Inhaler even if you feel better unless your doctor tells you to.
• If you miss a dose of Fluticasone/Salmeterol Inhaler, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Fluticasone/Salmeterol Inhaler.

Important safety information:

• Fluticasone/Salmeterol Inhaler may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fluticasone/Salmeterol Inhaler with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Fluticasone/Salmeterol Inhaler will not stop an asthma attack once it has already started. Be sure to carry a short-acting bronchodilator with you at all times to treat any breathing problems that may occur between doses of Fluticasone/Salmeterol Inhaler (eg, severe or sudden onset of wheezing or shortness of breath). If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
• If you have been regularly using a short-acting bronchodilator inhaler (eg, albuterol), talk with your doctor about how to use it with Fluticasone/Salmeterol Inhaler. Short-acting bronchodilators are normally only used with Fluticasone/Salmeterol Inhaler 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. Do not start, stop, or change the dose of any asthma medicine unless your doctor tells you to.
• If your symptoms do not get better within 1 week or if they get worse after you start using Fluticasone/Salmeterol Inhaler, check with your doctor.
• Tell your doctor at once if you notice that your short-acting bronchodilator inhaler does not work as well, if you need to use it often (eg, more than 4 times a day for more than 2 days in a row), or if you have a decrease in your peak flow meter results.
• The risk of serious heart problems (eg, irregular heartbeat) may be greater if you use Fluticasone/Salmeterol Inhaler in high doses. Do NOT use more than the recommended dose or use for longer than prescribed without checking with your doctor.
• Fluticasone/Salmeterol Inhaler may sometimes cause severe breathing problems right after you use a dose. When this occurs, it is often after the first use of a new canister. If this happens, use your short-acting bronchodilator inhaler. Seek medical care at once if your breathing does not improve after you use the short-acting bronchodilator. Tell you doctor about this reaction.
• Use caution if you switch from an oral steroid (eg, prednisone) to Fluticasone/Salmeterol Inhaler. It may take several months for your body to make enough natural steroids to handle events that cause physical stress. Such events may include injury, surgery, infection, loss of blood electrolytes, or a sudden asthma attack. These may be severe and sometimes fatal. Contact your doctor right away if any of these events occur. You may need to take an oral steroid (eg, prednisone) again. Carry a card at all times that says you may need an oral steroid (eg, prednisone) if any of these events occur.
• 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.
• Diabetes patients - Fluticasone/Salmeterol Inhaler may affect your blood sugar. Check blood sugar levels closely and ask your doctor before adjusting the dose of your diabetes medicine.
• Lab tests, including lung function tests and eye exams, may be performed while you use Fluticasone/Salmeterol Inhaler. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
• Use Fluticasone/Salmeterol Inhaler with caution in the ELDERLY; they may be more sensitive to its effects, especially the effects on the heart.
• Corticosteroids may affect growth rate in CHILDREN and teenagers in some cases. They may need regular growth checks while they use Fluticasone/Salmeterol Inhaler.
• Fluticasone/Salmeterol Inhaler should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you think you may be pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluticasone/Salmeterol Inhaler while you are pregnant. It is not known if Fluticasone/Salmeterol Inhaler is found in breast milk. If you are or will be breast-feeding while you use Fluticasone/Salmeterol Inhaler, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluticasone/Salmeterol Inhaler:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Dizziness; headache; menstrual changes; nausea; nervousness; throat irritation; tremor; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); behavior changes; blurred vision or other vision changes; bone pain; 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; signs of infection (eg, fever, chills, persistent headache/sore throat, ear pain); swelling or tightness in the throat; trouble sleeping; vaginal odor or discharge; weight gain; white patches or sores on the tongue or mouth; worsening of asthma symptoms (eg, increased wheezing, coughing, chest tightness, shortness of breath).

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center ( http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest pain; fainting; muscle cramping; seizures; severe muscle weakness; unusually fast/irregular heartbeat.

Store Fluticasone/Salmeterol Inhaler at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store the inhaler with the mouthpiece down. Store away from heat, direct sunlight, and open flame. Do not puncture, break, or burn the canister even if it appears to be empty. Do not store in the bathroom. Keep Fluticasone/Salmeterol Inhaler out of the reach of children and away from pets.

General information:

• If you have any questions about Fluticasone/Salmeterol Inhaler, please talk with your doctor, pharmacist, or other health care provider.
• Fluticasone/Salmeterol Inhaler is to be used only by the patient for whom it is prescribed. Do not share it with other people.
• If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluticasone/Salmeterol Inhaler. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.