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

How to Use This Medicine:
Powder

• Your doctor will tell you how much medicine to use. Do not use more than directed. Use this medicine at the same time every day.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• To use:
  
  • Open the cover of the inhaler until you hear a click. The inhaler is now ready to use. Do not close the cover until you have taken your dose. If you open and close the cover without inhaling the dose, you will lose the medicine. Do not take more than 1 puff per day.
  • Before you inhale your dose, breathe out fully. Try to empty your lungs as much as possible.
  • Place the mouthpiece of the inhaler in your mouth and breathe in a steady, deep breath. Do not breathe in through your nose.
  • Remove the inhaler from your mouth. Hold your breath for about 3 to 4 seconds, then breathe out slowly.
  • The inhaler has a window that shows the number of doses that are left. The counter will turn red when the inhaler has fewer than 10 doses left. This will remind you to refill your prescription.
• 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. Keep the medicine in the foil tray. Do not open it until you are ready to use the inhaler for the first time. Throw away this medicine 6 weeks after opening 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.

• This medicine should not be used together with a similar inhaled medicine, such as arformoterol, formoterol, indacaterol, or salmeterol.
• Some foods and medicines can affect how umeclidinium/vilanterol works. Tell your doctor if you are using any of the following:
  
  • Aclidinium, atropine, conivaptan, ipratropium, nefazodone, or tiotropium
  • An MAO inhibitor, a diuretic (water pill), medicine to treat depression, a beta-blocker blood pressure medicine, medicine to treat an infection (such as clarithromycin, itraconazole, ketoconazole, telithromycin, troleandomycin, voriconazole), or medicine to treat HIV/AIDS (such as indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, diabetes, glaucoma, heart or blood vessel disease, heart rhythm problems, high blood pressure, an overactive thyroid, seizures, enlarged prostate, or trouble urinating.
• This medicine may cause the following problems:
  
  • Increased trouble breathing (may be life-threatening)
  • Changes to heart rhythm, pulse, or blood pressure
• Do not use this medicine to treat a COPD attack. Your doctor may prescribe another medicine that you should use when you have a COPD flare-up.
• Do not use this medicine to treat asthma. This medicine may increase the risk of a life-threatening asthma attack.
• 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
• Decrease in how much or how often you urinate, difficult or painful urination
• Eye pain, vision loss or changes
• Fast, pounding, or uneven heartbeat, chest pain
• Tremors or nervousness
• Worse breathing problems

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