Fluticasone Furoate Inhalation powder, Vilanterol Inhalation powder

What is this medicine?

FLUTICASONE; VILANTEROL (floo TIK a sone; vye LAN ter ol) inhalation is a combination of two medicines that decrease inflammation and help to open up the airways of your lungs. It is for chronic obstructive pulmonary disease (COPD), including chronic bronchitis or emphysema. It is also used for asthma in adults to help control symptoms. Do NOT use for an acute asthma attack or COPD 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:

• bone problems

• immune system problems

• diabetes

• heart disease or irregular heartbeat

• high blood pressure

• infection

• pheochromocytoma

• seizures

• thyroid disease

• an unusual or allergic reaction to fluticasone, vilanterol, milk proteins, 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. It is used once per day. 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 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. This medicine is not approved for use in children under 18 years of age.

Overdosage: If you think you've 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 can. If it is almost time for your next dose, use only that dose and continue with your regular schedule. Do not use double or extra doses.

What may interact with this medicine?

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

• cisapride

• dofetilide

• dronedarone

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

• pimozide

• thioridazine

• ziprasidone

This medicine may also interact with the following medications:

• antiviral medicines for HIV or AIDS

• beta-blockers like metoprolol and propranolol

• certain medicines for depression, anxiety, or psychotic disturbances

• diuretics

• medicines for colds

• medicines for fungal infections like ketoconazole and itraconazole

• other medicines for breathing problems

• other medicines that prolong the QT interval (cause an abnormal heart rhythm)

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?

Visit your doctor or health care professional for regular checkups. Tell your doctor or health care professional if your symptoms do not get better.

If your symptoms get worse or if you need your short-acting inhalers more often, call your doctor right away. Do not use this medicine more than every 24 hours.

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

• breathing problems right after inhaling your medicine

• changes in vision

• chest pain

• fast, irregular heartbeat

• feeling faint or lightheaded, falls

• fever or chills

• nausea, vomiting

• tiredness

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

• cough

• headache

• nervousness

• sore throat

• 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 15 and 30 degrees C (59 and 86 degrees F). Store in a dry place away from direct heat or sunlight. Throw away 6 weeks after you remove the inhaler from the foil tray, or after the dose indicator reads 0, whichever comes first. Throw away any 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.