Fluticasone Propionate, Salmeterol Xinafoate Inhalation powder

What is this medicine?

FLUTICASONE; SALMETEROL (floo TIK a sone; sal ME te role) inhalation is a combination of two medicines that decrease inflammation and help to open up the airways in your lungs. It is used to prevent the symptoms of COPD with chronic bronchitis and the symptoms of asthma. Do NOT use in an acute asthma attack.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

What should I tell my health care provider before I take this medicine?

They need to know if you have any of these conditions:

• diabetes
• heart disease or irregular heartbeat
• high blood pressure
• infection
• osteoporosis or other bone disease
• an unusual or allergic reaction to fluticasone; salmeterol, other corticosteroids, other medicines, foods, dyes, or preservatives
• pregnant or trying to get pregnant
• breast-feeding

How should I use this medicine?

This medicine is inhaled through the mouth. Follow the directions on the prescription label. Do not use a spacer device with this inhaler. Take your medicine at regular intervals. Do not take your medicine more often than directed. Do not stop taking except on your doctor's advice. Make sure that you are using your inhaler correctly. Ask you doctor or health care provider if you have any questions.

A patient information sheet for the product will be given with each prescription and refill. Read this sheet carefully each time. The sheet may change frequently.

A special MedGuide will be given to you by the pharmacist with each prescription and refill. Be sure to read this information carefully each time.

Talk to your pediatrician regarding the use of this medicine in children. Special care may be needed.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, use it as soon as you remember. If it is almost time for your next dose, use only that dose and continue with your regular schedule, spacing doses evenly. Do not use double or extra doses.

What may interact with this medicine?

Do not take this medicine with any of the following medications:

• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate

This medicine may also interact with the following medications:

• aminophylline or theophylline
• antiviral medicines for HIV or AIDS
• diuretics
• medicines for colds
• medicines for depression or emotional conditions
• medicines for fungal infections like ketoconazole and itraconazole
• medicines for the heart like metoprolol, propanolol
• medicines for weight loss including some herbal products
• other medicine for breathing problems
• pimozide
• some antibiotics like clarithromycin, erythromycin, levofloxacin, linezolid, and telithromycin
• vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medicine?

Tell your doctor or health care professional if your symptoms do not improve or get worse. If you need to use your short-acting inhalers more often, call your doctor right away. Do not use more than every 12 hours. Do not stop your medicine unless your doctor tells you to.

Never use this medicine for an acute asthma attack.

If you are going to have surgery tell your doctor or health care professional that you are using this medicine. Try not to come in contact with people with the chicken pox or measles. If you do, call your doctor.

What side effects may I notice from receiving this medicine?

Side effects that you should report to your doctor or health care professional as soon as possible:

• allergic reactions like skin rash or hives, swelling of the face, lips, or tongue
• chest pain
• dizziness or lightheaded
• fever or chills
• irregular heartbeat
• vision problems

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• coughing, hoarseness, throat irritation
• headache
• nervousness
• stomach problems
• stuffy nose
• tremor

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medicine?

Keep out of the reach of children.

Store at room temperature between 68 and 77 degrees F (20 and 25 degrees C). Do not leave your medicine in the heat or sun. Throw away 1 month after you open the package or whenever the dose indicator reads 0, whichever comes first. Throw away unopened packages after the expiration date.

NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.