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|Fluticasone/Salmeterol

Fluticasone/Salmeterol

Fluticasone/Salmeterol is used for:

Long-term prevention and treatment of asthma and chronic lung diseases. It should not be used to treat a sudden symptom of shortness of breath (eg, sudden severe onset or worsening of wheezing, cough, chest tightness) because it does not work right away. It may also be used to treat other breathing conditions as determined by your doctor.

Fluticasone/Salmeterol is a combination "controller" medicine. It improves lung function and makes breathing easier by reducing airway swelling and irritation and by causing muscle relaxation.

Do NOT use Fluticasone/Salmeterol if:

• you are allergic to any ingredient in Fluticasone/Salmeterol
• you are having sudden symptoms of shortness of breath (eg, sudden severe onset or worsening of wheezing, cough, chest tightness)

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

Before using Fluticasone/Salmeterol :

Some medical conditions may interact with Fluticasone/Salmeterol . 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 or have taken a monoamine oxidase inhibitor (MAOI) or tricyclic antidepressant (eg, amitriptyline) within the last 14 days
• if you have heart disease, liver problems, diabetes, high blood pressure, low potassium levels, depression, recent infection, seizures, thyroid problems, an irregular or fast heartbeat, tumors on your adrenal gland, tuberculosis (TB) or a positive TB skin test, diarrhea, measles, or chickenpox, shingles
• if you have a fungal, bacterial, viral, or parasitic infections; an untreated lung infection; or eye problems or a herpes eye infection
• if you have had a recent vaccination

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

• Beta-blockers (eg, propranolol) because the effectiveness of Fluticasone/Salmeterol may be decreased
• HIV protease inhibitors (eg, ritonavir) because side effects of Fluticasone/Salmeterol may be increased
• Catechol-O-methyltransferase (COMT) inhibitors (eg, entacapone), cocaine, MAOIs (eg, phenelzine), or tricyclic antidepressants (eg, amitriptyline) because the actions and side effects of these medicines may be increased

This may not be a complete list of all interactions that may occur. Ask your health care provider if Fluticasone/Salmeterol 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 :

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

• Fluticasone/Salmeterol comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Fluticasone/Salmeterol refilled.
• Always activate and use this device in a level, horizontal position. Do not breathe into the inhaler. Do not use a spacer. Gargle and rinse your mouth with water after using Fluticasone/Salmeterol to prevent dryness and mouth infections and relieve throat irritation. Do NOT swallow the rinse solution.
• If you are using other inhalers, wait a few minutes between using Fluticasone/Salmeterol and other inhalers, unless directed otherwise by your doctor.
• Fluticasone/Salmeterol delivers your dose as a very fine powder that most, but not all, patients can taste or feel. Whether you are able to taste or feel your dose of medicine, you should not take more than the recommended dose of 1 inhalation each morning and evening (approximately 12 hours apart). If you are not sure if you are receiving your dose, contact your doctor or pharmacist.
• You may breathe more easily after the first dose of Fluticasone/Salmeterol . It may take 1 week or longer to achieve the most benefit. It is important that you use Fluticasone/Salmeterol regularly. Do not stop treatment even if you are feeling better unless your doctor tells you to do so.
• Never wash the mouthpiece or any other part of the inhaler. Keep it dry and always keep it in a dry place.
• If you miss a dose of Fluticasone/Salmeterol , 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 .

Important safety information:

• Fluticasone/Salmeterol may cause dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Fluticasone/Salmeterol with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
• Fluticasone/Salmeterol will not stop an asthma attack once one has started. If you are also using another inhaler for asthma attacks, be sure to carry it with you at all times for use during an asthma attack. If you have any questions about which medicines stop asthma attacks, check with your doctor or pharmacist.
• Try to avoid irritants that may trigger an asthma attack, such as smoke, pollen, pet dander, dust, or molds.
• Learn to use a peak flow meter, use it daily, and promptly report worsening of asthma (such as readings in the yellow or red range).
• Tell your doctor at once if your condition is getting worse, indicated by these situations: your inhaled, short-acting bronchodilator becomes less effective; you need more inhalation than usual of your inhaled, short-acting bronchodilator; you have asthma and you have a serious decrease in your peak flow measurement as previously defined by your doctor.
• Rarely, your wheezing may increase right after using Fluticasone/Salmeterol . If this occurs, use your "quick-relief" inhaler. Seek immediate medical attention if your breathing does not improve at that time.
• If you have been taking oral steroids (eg, prednisone) on a regular basis (eg, 4 times a day or more than 20 mg/day of prednisone), you may need to stop taking the oral medicines before staring this one. Joint and muscle pain, lack of energy, and depression may occur when you stop taking oral steroids.
• Additional oral steroids may be needed during periods of high stress (eg, trauma, surgery, infection) or during a severe asthma attack. Carry a warning card indicating this potential need.
• You should have regular eye exams while on Fluticasone/Salmeterol .
• Avoid exposure to measles or chickenpox. If you are exposed, contact your doctor immediately.
• Diabetes patients - Fluticasone/Salmeterol may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
• Lab tests may be performed while you use this medicine. 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 with caution in the ELDERLY; they may be more sensitive to its effects, especially effects on the heart.
• Caution is advised when using Fluticasone/Salmeterol in CHILDREN. Though it is very unlikely to occur with inhaled steroids, Fluticasone/Salmeterol may decrease a child"s growth rate, but not necessarily their final adult height. Your doctor will prescribe the lowest possible dose of Fluticasone/Salmeterol to control asthma. It is important that children taking Fluticasone/Salmeterol see their doctors regularly for growth monitoring. Children who are taking Fluticasone/Salmeterol may be more likely to get infections. Take care to avoid exposure to chickenpox or measles. If the child is exposed or the disease develops, contact your doctor at once.
• Fluticasone/Salmeterol should not be used in CHILDREN younger than 4 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluticasone/Salmeterol while you are pregnant. Fluticasone/Salmeterol is found in breast milk.] Do not breast-feed while taking Fluticasone/Salmeterol .

Possible side effects of Fluticasone/Salmeterol :

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:

Cough; diarrhea; dizziness; dry mouth or throat; headache; hoarseness; nausea; nervousness; stomach pain; upper respiratory tract or viral infection; vomiting.

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); chest pain; choking; fast or irregular heartbeat; lack of energy; numbness or tingling in hands or feet; pounding in the chest; seizures; severe muscle weakness or cramping; swollen or painful mouth/tongue; throat spasms, irritation, and swelling; tremor; trouble sleeping; vision changes; weakness; weight gain; wheezing; white patches on the tongue or mouth; worsening of asthma symptoms (increased wheezing, coughing, or difficulty breathing).

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 at room temperature, between 68 and 77 degrees F (20 and 25 degrees C), in a dry place. Store away from direct heat and sunlight, moisture, and light. The inhalation device is not reusable and should be discarded 1 month after removal from the moisture-protective foil overwrap pouch or after all blisters have been used (when the dose indicator reads "0"), whichever comes first. Do not attempt to take the device apart. Do not store Fluticasone/Salmeterol in the bathroom. Keep Fluticasone/Salmeterol out of the reach of children and away from pets.

General information:

• If you have any questions about Fluticasone/Salmeterol , please talk with your doctor, pharmacist, or other health care provider.
• Fluticasone/Salmeterol 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 . 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.