Umeclidinium Bromide (ue-mek-li-DIN-ee-um BROE-mide), Vilanterol Trifenatate (vye-LAN-ter-ol trye-FEN-a-tate)

Treats breathing problems caused by chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema. This medicine contains a bronchodilator.

Brand Name(s):

Anoro Ellipta

When This Medicine Should Not Be Used:

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.
• 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 block the air vent with your fingers. 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.
• Read and follow the patient instructions that come with this medicine. Talk to your doctor or pharmacist if you have any questions.
• 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, budesonide/formoterol, formoterol, indacaterol, salmeterol, or salmeterol/fluticasone.
• 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, tiotropium
  • Beta-blocker medicine
  • Diuretic (water pill)
  • Medicine to treat an infection (including clarithromycin, itraconazole, ketoconazole, telithromycin, troleandomycin, voriconazole)
  • Medicine to treat HIV/AIDS (including indinavir, lopinavir, nelfinavir, ritonavir, saquinavir)
  • Medicine to treat depression (including an MAO inhibitor, TCAs)

Warnings While Using This Medicine:

• Tell your doctor if you are pregnant or breastfeeding, or if you have kidney disease, liver disease, heart or blood vessel disease, heart rhythm problems, high blood pressure, diabetes, glaucoma, thyroid problems, electrolyte imbalance, seizures, enlarged prostate, or trouble urinating.
• This medicine may cause the following problems:
  • Increased risk of worsening asthma, which may lead to hospitalization, intubation, and death in patients with asthma who take this medicine without an inhaled steroid
  • Paradoxical bronchospasm (trouble breathing right after use), which can be life-threatening
  • High blood pressure
  • Heart rhythm problems
  • Eye or vision problems
  • High blood sugar levels
• Tell your doctor if you are also using any other medicine for your COPD. Your doctor may want you to use your other medicine only during a severe COPD attack.
• Do not use this medicine if you are having a severe COPD attack, or if symptoms of a COPD attack has already started. Your doctor may prescribe another medicine for you to use in case of an acute COPD attack. If the other medicine does not work as well, tell your doctor right away.
• Call your doctor if your symptoms do not improve or if they get worse.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. 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
• Dizziness, lightheadedness, or fainting
• Increased hunger, thirst, or urination, weight loss
• Increased troubled breathing
• Eye pain, vision loss or changes
• Fast, pounding, or uneven heartbeat, chest pain
• Seizures or tremors, nervousness

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