fluticasone, umeclidinium, and vilanterol

What is the most important information I should know about this medicine?

What is fluticasone, umeclidinium, and vilanterol?

Fluticasone, umeclidinium, and vilanterol is a combination medicine used to prevent airflow obstruction and reduce flare-ups in adults with COPD (chronic obstructive pulmonary disease), including bronchitis and emphysema.

Fluticasone, umeclidinium, and vilanterol is also used to prevent and control symptoms of asthma in adults.

This medicine is not for use in treating an asthma or bronchospasm attack.

Vilanterol when used alone may increase the risk of death in people with asthma. However, this risk is not increased when vilanterol is used in a combination product with fluticasone and umeclidinium.

Fluticasone, umeclidinium, and vilanterol may also be used for purposes not listed in this medication guide.

What should I discuss with my healthcare provider before using this medicine?

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a seizure;
• a weak immune system;
• any type of bacterial, fungal, or viral infection, or an infection caused by parasites;
• liver disease;
• glaucoma, cataracts, or other vision problems;
• diabetes (or ketoacidosis);
• osteoporosis;
• a thyroid disorder; or
• an enlarged prostate, bladder obstruction, or urination problems.

If you have been using an oral steroid medication, you should not stop using it suddenly. Follow your doctor's instructions about tapering your dose.

Tell your doctor if you are pregnant or breastfeeding.

How should I use this medicine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed. Using this medicine improperly can cause death or serious side effects on the heart.

Use the medicine at the same time each day, and not more than once in a 24-hour period.

Read and follow all patient instructions provided with the inhaler device. Ask your doctor or pharmacist if you do not understand these instructions.

To prevent yeast infection in your mouth, rinse with water (but do not swallow) after using this medicine.

Your dose needs may change due to surgery, illness, stress, or worsened COPD. Do not change your dose or dosing schedule without your doctor's advice.

You may need frequent medical tests. Your vision and your bone mineral density may also need to be checked.

Throw the inhaler device away 6 weeks after you have taken it out of the foil pouch, or if the dose indicator shows a zero, whichever comes first.

What happens if I miss a dose?

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Do not use more than 1 inhalation in a single day.

What happens if I overdose?

Overdose symptoms may include chest pain, fast heart rate, and feeling shaky or short of breath.

What should I avoid while using this medicine?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chickenpox or measles. These conditions can be serious or even fatal in people who are using a medicine that contains fluticasone (a steroid).

What are the possible side effects of fluticasone, umeclidinium, and vilanterol?

• tremors, nervousness, chest pain, fast or pounding heartbeats;
• sores or white patches in your mouth and throat, pain when swallowing;
• wheezing, choking, or other breathing problems after using this medicine;
• painful or difficult urination;
• blurred vision, tunnel vision, eye pain or redness, or seeing halos around lights;
• a lung infection --fever, chills, cough with mucus, feeling short of breath;
• high blood sugar --increased thirst, increased urination, dry mouth, fruity breath odor;
• low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling; or
• signs of a hormonal disorder --tiredness or weakness, feeling light-headed, nausea, vomiting.

Common side effects may include:

• cold or flu symptoms such as runny or stuffy nose, sinus pain, sore throat, cough, chest tightness;
• a lung infection;
• nausea, vomiting, constipation, diarrhea;
• urination problems;
• joint pain;
• mouth sores, hoarse voice;
• headache, back pain; or
• mouth pain, changes in your sense of taste.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What other drugs will affect fluticasone, umeclidinium, and vilanterol?

Tell your doctor about all your other medicines, especially:

• atropine;
• antifungal or antiviral medicine;
• medicine to treat depression, anxiety, mood disorders, or mental illness;
• cold or allergy medicine (Benadryl and others);
• medicine to treat Parkinson's disease;
• medicine to treat stomach problems, motion sickness, or irritable bowel syndrome;
• medicine to treat overactive bladder; or
• other bronchodilator medication.

This list is not complete. Other drugs may affect fluticasone, umeclidinium, and vilanterol, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.

Where can I get more information?

Your pharmacist can provide more information about fluticasone, umeclidinium, and vilanterol.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2023 Cerner Multum, Inc. Version: 5.02. Revision date: 11/3/2020.