Patient information: uses, side effects, how to take - Umeclidinium and Vilanterol

What is Umeclidinium and Vilanterol ELLIPTA?

Umeclidinium and Vilanterol ELLIPTA combines 2 medicines in 1 inhaler, an anticholinergic medicine (umeclidinium) and a long‑acting beta₂-adrenergic agonist (LABA) medicine (vilanterol).
- Anticholinergic medicines such as umeclidinium and LABA medicines such as vilanterol help the muscles around the airways in your lungs stay relaxed to prevent symptoms such as wheezing, cough, chest tightness, and shortness of breath. These symptoms can happen when the muscles around the airways tighten. This makes it hard to breathe.
Umeclidinium and Vilanterol ELLIPTA is not used to relieve sudden breathing problems and will not replace a rescue inhaler.
Umeclidinium and Vilanterol ELLIPTA is a prescription medicine used long term (chronic) to treat people with chronic obstructive pulmonary disease (COPD). COPD is a chronic lung disease that includes chronic bronchitis, emphysema, or both.
Umeclidinium and Vilanterol ELLIPTA is used as 1 inhalation 1 time each day to improve symptoms of COPD for better breathing and to reduce the number of flare-ups (the worsening of your COPD symptoms for several days).
Umeclidinium and Vilanterol ELLIPTA is not for the treatment of asthma. It is not known if Umeclidinium and Vilanterol ELLIPTA is safe and effective in people with asthma.

Umeclidinium and Vilanterol ELLIPTA should not be used in children.

It is not known if Umeclidinium and Vilanterol ELLIPTA is safe and effective in children.

Do not use Umeclidinium and Vilanterol ELLIPTA if you:

have a severe allergy to milk proteins. Ask your healthcare provider if you are not sure.
are allergic to umeclidinium, vilanterol, or any of the ingredients in Umeclidinium and Vilanterol ELLIPTA. See the end of this Patient Information for a complete list of ingredients in Umeclidinium and Vilanterol ELLIPTA.
have asthma.

Before using Umeclidinium and Vilanterol ELLIPTA, tell your healthcare provider about all of your medical conditions, including if you:

have heart problems.
have high blood pressure.
have seizures.
have thyroid problems.
have diabetes.
have liver problems.
have eye problems such as glaucoma. Umeclidinium and Vilanterol ELLIPTA may make your glaucoma worse.
are allergic to milk proteins.
have prostate or bladder problems, or problems passing urine. Umeclidinium and Vilanterol ELLIPTA may make these problems worse.
are pregnant or plan to become pregnant. It is not known if Umeclidinium and Vilanterol ELLIPTA may harm your unborn baby.
are breastfeeding or plan to breastfeed. It is not known if the medicines in Umeclidinium and Vilanterol ELLIPTA pass into your breast milk and if they can harm your baby.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Umeclidinium and Vilanterol ELLIPTA and certain other medicines may interact with each other. This may cause serious side effects.

Especially tell your healthcare provider if you take:

anticholinergics (including tiotropium, ipratropium, aclidinium)
atropine
other LABAs (including salmeterol, formoterol, arformoterol, olodaterol, and indacaterol)
antifungal or anti-HIV medicines

Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

How should I use Umeclidinium and Vilanterol ELLIPTA?

Read the step-by-step instructions for using Umeclidinium and Vilanterol ELLIPTA at the end of this Patient Information.

Do not use Umeclidinium and Vilanterol ELLIPTA unless your healthcare provider has taught you how to use the inhaler and you understand how to use it correctly.
Use Umeclidinium and Vilanterol ELLIPTA exactly as your healthcare provider tells you to use it. Do not use Umeclidinium and Vilanterol ELLIPTA more often than prescribed.
Use 1 inhalation of Umeclidinium and Vilanterol ELLIPTA 1 time each day. Use Umeclidinium and Vilanterol ELLIPTA at the same time each day.
If you miss a dose of Umeclidinium and Vilanterol ELLIPTA, take it as soon as you remember. Do not take more than 1 inhalation per day. Take your next dose at your usual time. Do not take 2 doses at 1 time.
If you take too much Umeclidinium and Vilanterol ELLIPTA, call your healthcare provider or go to the nearest hospital emergency room right away if you have any unusual symptoms, such as worsening shortness of breath, chest pain, increased heart rate, or shakiness.
Do not use other medicines that contain a LABA or an anticholinergic for any reason. Ask your healthcare provider or pharmacist if any of your other medicines are LABA or anticholinergic medicines.
Do not stop using Umeclidinium and Vilanterol ELLIPTA unless told to do so by your healthcare provider because your symptoms might get worse. Your healthcare provider will change your medicines as needed.
Umeclidinium and Vilanterol ELLIPTA does not relieve sudden symptoms of COPD and you should not take extra doses of Umeclidinium and Vilanterol ELLIPTA to relieve these sudden symptoms. Always have a rescue inhaler with you to treat sudden symptoms. If you do not have a rescue inhaler, call your healthcare provider to have one prescribed for you.
Call your healthcare provider or get medical care right away if:
- your breathing problems get worse.
- you need to use your rescue inhaler more often than usual.
- your rescue inhaler does not work as well to relieve your symptoms.

What are the possible side effects of Umeclidinium and Vilanterol ELLIPTA?

Umeclidinium and Vilanterol ELLIPTA can cause serious side effects, including:

serious problems in people with asthma. People with asthma who take LABA medicines, such as vilanterol (one of the medicines in Umeclidinium and Vilanterol ELLIPTA), without also using a medicine called an inhaled corticosteroid, have an increased risk of serious problems from asthma, including death.
- Call your healthcare provider if breathing problems worsen over time while using Umeclidinium and Vilanterol ELLIPTA. You may need a different treatment.
- Get emergency medical care if:
  - your breathing problems worsen quickly.
  - you use your rescue inhaler medicine, but it does not relieve your breathing problems.
COPD symptoms that get worse over time. If your COPD symptoms worsen over time, do not increase your dose of Umeclidinium and Vilanterol ELLIPTA; instead call your healthcare provider.
symptoms of using too much of a LABA medicine, including:

○chest pain
○fast or irregular heartbeat
○tremor

○increased blood pressure
○headache
○nervousness

sudden breathing problems immediately after inhaling your medicine. If you have sudden breathing problems immediately after inhaling your medicine, stop using Umeclidinium and Vilanterol ELLIPTA and call your healthcare provider right away.
serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:

○rash
○hives

○swelling of your face, mouth, and tongue
○breathing problems

effects on heart.

○increased blood pressure
○a fast or irregular heartbeat, awareness of heartbeat

○chest pain

effects on nervous system.

○tremor

○nervousness

new or worsening eye problems including acute narrow-angle glaucoma. You should have regular eye exams while using Umeclidinium and Vilanterol ELLIPTA. Acute narrow-angle glaucoma can cause permanent loss of vision if not treated. Symptoms of acute narrow-angle glaucoma may include:

○eye pain or discomfort
○blurred vision
○red eyes

○nausea or vomiting
○seeing halos or bright colors around lights

If you have these symptoms, call your healthcare provider right away before taking another dose.
• urinary retention. People who take Umeclidinium and Vilanterol ELLIPTA may develop new or worse urinary retention. Symptoms of urinary retention may include:

○difficulty urinating
○urinating frequently

○painful urination
○urination in a weak stream or drips

If you have these symptoms of urinary retention, stop taking Umeclidinium and Vilanterol ELLIPTA and call your healthcare provider right away before taking another dose.
• changes in laboratory blood values, including high levels of blood sugar (hyperglycemia) and low levels of potassium (hypokalemia).

Common side effects of Umeclidinium and Vilanterol ELLIPTA include:

sore throat
common cold symptoms
pain in your arms or legs
chest pain

sinus infection
constipation
muscle spasms

lower respiratory infection
diarrhea
neck pain

These are not all the possible side effects of Umeclidinium and Vilanterol ELLIPTA.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store Umeclidinium and Vilanterol ELLIPTA?

Store Umeclidinium and Vilanterol ELLIPTA at room temperature between 68°F and 77°F (20°C and 25°C). Keep in a dry place away from heat and sunlight.
Store Umeclidinium and Vilanterol ELLIPTA in the unopened tray and only open when ready for use.
Safely throw away Umeclidinium and Vilanterol ELLIPTA in the trash 6 weeks after you open the tray or when the counter reads “0”, whichever comes first. Write the date you open the tray on the label on the inhaler.
Keep Umeclidinium and Vilanterol ELLIPTA and all medicines out of the reach of children.

General information about the safe and effective use of Umeclidinium and Vilanterol ELLIPTA.

Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. Do not use Umeclidinium and Vilanterol ELLIPTA for a condition for which it was not prescribed. Do not give Umeclidinium and Vilanterol ELLIPTA to other people, even if they have the same symptoms that you have. It may harm them.

You can ask your healthcare provider or pharmacist for information about Umeclidinium and Vilanterol ELLIPTA that is written for health professionals.

What are the ingredients in Umeclidinium and Vilanterol ELLIPTA?

Active ingredients: umeclidinium, vilanterol

Inactive ingredients: lactose monohydrate (contains milk proteins), magnesium stearate

For more information about Umeclidinium and Vilanterol ELLIPTA, call 1-866-525-0688.

ELLIPTA is a registered trademark of the GSK group of companies.

Manufactured for:

Prasco Laboratories

Mason, OH 45040 USA

Manufactured by:

GlaxoSmithKline

Durham, NC 27701

ANR-PS:1PIL

This Patient Information has been approved by the U.S. Food and Drug Administration Revised: November 2024

INSTRUCTIONS FOR USE Umeclidinium and Vilanterol ELLIPTA (ue-ME-kli-DIN-ee-um vye-lan’-ter-ol e-LIP-ta) inhalation powder, for oral inhalation use
Read this before you start: If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take a double dose or an extra dose in 1 inhalation. Your Umeclidinium and Vilanterol ELLIPTA inhaler How to use your inhaler Umeclidinium and Vilanterol ELLIPTA comes in a tray. Peel back the lid to open the tray. See Figure A. The tray contains a desiccant to reduce moisture. Do not eat or inhale. Throw it away in the household trash out of reach of children and pets. See Figure B.
Figure A	Figure B
Important Notes: Your inhaler contains 30 doses. Each time you fully open the cover of the inhaler (you will hear a clicking sound), a dose is ready to be inhaled. This is shown by a decrease in the number on the counter. If you open and close the cover without inhaling the medicine, you will lose the dose. The lost dose will be held in the inhaler, but it will no longer be available to be inhaled. It is not possible to accidentally take a double dose or an extra dose in 1 inhalation. Do not open the cover of the inhaler until you are ready to use it. To avoid wasting doses after the inhaler is ready, do not close the cover until after you have inhaled the medicine. Write the “Tray opened” and “Discard” dates on the inhaler label. The “Discard” date is 6 weeks from the date you open the tray. Check the counter. See Figure C.
Figure C	Before the inhaler is used for the first time, the counter should show the number 30. This is the number of doses in the inhaler. Each time you open the cover, you prepare 1 dose of medicine. The counter counts down by 1 each time you open the cover.
Prepare your dose: Wait to open the cover until you are ready to take your dose.
Figure D	Step 1. Open the cover of the inhaler. See Figure D. Slide the cover down to expose the mouthpiece. You should hear a “click.” The counter will count down by 1 number. You do not need to shake this kind of inhaler. Your inhaler is now ready to use. If the counter does not count down as you hear the click, the inhaler will not deliver the medicine. Call your healthcare provider or pharmacist if this happens.
Figure E	Step 2. Breathe out. See Figure E. While holding the inhaler away from your mouth, breathe out (exhale) fully. Do not breathe out into the mouthpiece.
Figure F	Step 3. Inhale your medicine. See Figure F. Put the mouthpiece between your lips, and close your lips firmly around it. Your lips should fit over the curved shape of the mouthpiece. Take 1 long, steady, deep breath in through your mouth. Do not breathe in through your nose.
Figure G	Do not block the air vent with your fingers. See Figure G.
Figure H	Remove the inhaler from your mouth and hold your breath for about 3 to 4 seconds (or as long as comfortable for you). See Figure H.
Figure I	Step 4. Breathe out slowly and gently. See Figure I. You may not taste or feel the medicine, even when you are using the inhaler correctly. Do not take another dose from the inhaler even if you do not feel or taste the medicine.
Figure J	Step 5. Close the inhaler. See Figure J. You can clean the mouthpiece if needed, using a dry tissue, before you close the cover. Routine cleaning is not required. Slide the cover up and over the mouthpiece as far as it will go.
Important Note: When should you get a refill?
Figure K	When you have fewer than 10 doses remaining in your inhaler, the left half of the counter shows red as a reminder to get a refill. See Figure K. After you have inhaled the last dose, the counter will show “0” and will be empty. Throw the empty inhaler away in your household trash out of reach of children and pets.
For more information about Umeclidinium and Vilanterol ELLIPTA, call 1-866-525-0688. ELLIPTA is a registered trademark of the GSK group of companies. Manufactured for: Prasco Laboratories Mason, OH 45040 USA Manufactured by: GlaxoSmithKline Durham, NC 27701 ANR-PS:1IFU