Class Name(s):

• 12:08.08 Antimuscarinics/Antispasmodics

Pronunciation:

• (ue me'' kli din' ee um)

Brand Name(s):

• Incruse Ellipta^®

WHY is this medicine prescribed?

Umeclidinium oral inhalation is used in adults to control wheezing, shortness of breath, coughing, and chest tightness caused by chronic obstructive pulmonary disease (COPD; a group of diseases that affect the lungs and airways, that includes chronic bronchitis and emphysema). Umeclidinium inhalation is in a class of medications called anticholinergics. It works by relaxing and opening air passages in the lungs, making it easier to breathe.

HOW should this medicine be used?

Umeclidinium comes as a powder to inhale by mouth using a special inhaler. It is usually inhaled once a day. Inhale umeclidinium at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use umeclidinium exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

Do not use umeclidinium inhalation during a sudden COPD attack. Your doctor will prescribe a short-acting (rescue) inhaler to use during COPD attacks.

Umeclidinium inhalation should not be used to treat COPD that is quickly getting worse. Call your doctor or get emergency medical help if your breathing problems worsen, if you have to use your short-acting inhaler to treat attacks of COPD more often, or if your short-acting inhaler does not relieve your symptoms.

Umeclidinium inhalation controls COPD but does not cure it. Continue to use umeclidinium even if you feel well. Do not stop using umeclidinium without talking to your doctor. If you stop using umeclidinium inhalation, your symptoms may get worse.

Before you use umeclidinium inhalation for the first time, ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Practice using your inhaler while he or she watches.

To use the inhaler, follow these steps:

1. If you will be using a new inhaler for the first time, remove it from the box and the foil tray. Fill in the "Tray opened" and "Discard" blanks on the inhaler label with the date that you opened the tray and the date 6 weeks later when you must replace the inhaler.
2. When you are ready to inhale your dose, slide the cover down to expose the mouthpiece until it clicks. If you open and close the inhaler without using your dose, you will waste the medication.
3. The counter will count down by 1 each time you open the cover. If the counter does not count down, your inhaler will not provide the medicine. If your inhaler does not count down, call your pharmacist or doctor.
4. Hold the inhaler away from your mouth and breathe out as far as you comfortably can. Do not breathe out into the mouthpiece.
5. Put the mouthpiece between your lips, and close your lips firmly around it. Take a long, steady, deep breath in through your mouth. Do not breathe in through your nose. Be careful not to block the air vent with your fingers.
6. Remove the inhaler from your mouth, and hold your breath for about 3 to 4 seconds or as long as you comfortably can. Breathe out slowly.
7. You may or may not taste or feel the medicine released by the inhaler. Even if you do not, do not inhale another dose. If you are not sure you are getting your dose of umeclidinium, call your doctor or pharmacist.
8. You may clean the mouthpiece with a dry tissue, if needed. Slide the cover up over the mouthpiece as far as it will go to close the inhaler.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medication?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before using umeclidinium,

• tell your doctor and pharmacist if you are allergic to umeclidinium, any other medications, milk protein, or any of the ingredients in umeclidinium inhalation. Ask your pharmacist or check the Patient Information for a list of the ingredients.
• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while using umeclidinium. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had glaucoma (an eye disease), prostate or bladder problems, or heart disease.
• tell your doctor if you are pregnant, plan to become pregnant, or are breastfeeding. If you become pregnant while using umeclidinium, call your doctor.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are using umeclidinium.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Inhale the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not use more than one dose in a day and do not inhale a double dose to make up for a missed one.

What SIDE EFFECTS can this medicine cause?

Umeclidinium may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• joint or muscle pain
• runny nose, sore throat
• cough

Some side effects can be serious. If you experience any of these symptoms, stop using umeclidinium and call your doctor immediately or get emergency medical treatment:

• rash
• hives
• itching
• swelling of the face, mouth, or tongue
• coughing, wheezing, or chest tightness that begins after you inhale umeclidinium
• eye pain, redness, or discomfort, blurred vision, seeing halos or bright colors around lights, sometimes along with nausea and vomiting
• difficulty urinating or urinating in a weak stream or drips
• frequent or painful urination
• fast or irregular heartbeat

Umeclidinium may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I do in case of OVERDOSE?

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at http://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include the following:

• chest pain
• shortness of breath
• fast heartbeat
• shaking of a part of your body that you cannot control
• dry mouth
• hot, dry, flushed skin
• blurred vision
• dilated pupils
• seeing things or hearing voices that do not exist (hallucinating)

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the foil tray it came in, tightly closed, and out of reach of children. Store it at room temperature and away from sunlight, excess heat and moisture (not in the bathroom). Dispose of the inhaler 6 weeks after you remove it from the foil tray or after every blister has been used (when the dose counter reads 0), whichever comes first.

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website http://goo.gl/c4Rm4p for more information.

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location - one that is up and away and out of their sight and reach. http://www.upandaway.org

What OTHER INFORMATION should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

AHFS^® Patient Medication Information™ Copyright, 2025. The American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland. All Rights Reserved. Duplication for commercial use must be authorized by ASHP.

Selected Revisions: February 15, 2017.