When This Medicine Should Not Be Used:
This medicine is not right for everyone. Do not use it if you had an allergic reaction to fluticasone, vilanterol, or milk proteins.

How to Use This Medicine:
Powder

• Use this medicine at the same time every day exactly as directed. Never use it more often than your doctor told you to.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• This medicine is a powder that is used with its own inhaler device. Keep the medicine in the foil tray until you are ready to use the inhaler.
• Each time you open the cover of the inhaler and hear a click, the inhaler is ready to use. Do not close the cover again until you have taken your dose. You will lose the dose if you open and close the cover without inhaling the medicine.
• When you take a dose, inhale through your mouth. Do not breath in through your nose.
• When the counter on the medicine turns red, there are less than 10 doses left. Refill your prescription as soon as possible.
• When you have finished all your inhalations, rinse your mouth out with water.
• Missed dose: Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose. Do not take more than 1 puff per day.
• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Throw away this medicine 6 weeks after it was opened or when the counter reads "0."

Drugs and Foods to Avoid:
Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Do not use this medicine together with similar inhaled medicines, including arformoterol, budesonide/formoterol, formoterol, indacaterol, or salmeterol.
• Some medicines can affect how this medicine works. Tell your doctor if you are using any of the following:
  
  • Clarithromycin, conivaptan, indinavir, itraconazole, ketoconazole, lopinavir, nefazodone, nelfinavir, ritonavir, saquinavir, telithromycin, troleandomycin, voriconazole
  • Beta-blocker
  • Diuretic (water pill)
  • Tricyclic antidepressant or MAO inhibitor within the past 2 weeks

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have liver disease, diabetes, cataracts, glaucoma, heart or blood vessel disease, high blood pressure, heart rhythm problems, osteoporosis, thyroid problems, or a history of seizures.
• This medicine may cause the following problems:
  
  • Increased risk of pneumonia
  • Adrenal gland problems
  • Increased risk of paradoxical bronchospasm (trouble breathing right after use) and asthma-related death
  • Changes in heart rhythm
  • Osteoporosis (when used for a long time)
  • Glaucoma or cataracts
• Do not use this medicine to treat acute attacks. You should have another medicine to use for an acute asthma attack or COPD flare-up. Tell your doctor right away if your condition gets worse or you need to use your other medicine more often than usual.
• This medicine may weaken your immune system and increase your risk for infection. Tell your doctor about any immune system problems or infections you have, including herpes in your eye or tuberculosis. Tell your doctor right away if you have been exposed to chickenpox or measles.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Changes in skin color, dark freckles, weakness, tiredness, nausea, vomiting, weight loss
• Chest pain
• Eye pain, vision loss, seeing halos around lights
• Fast, pounding, or uneven heartbeat
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Lightheadedness, dizziness, fainting
• Worsening of breathing problems, shortness of breath, wheezing

If you notice these less serious side effects, talk with your doctor:

• Dry mouth
• White patches in your mouth or throat, pain when you eat or swallow

If you notice other side effects that you think are caused by this medicine, tell your doctor.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088