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.

You should not use this medicine if you are allergic to fluticasone, umeclidinium, vilanterol, or milk proteins.

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.

This medicine is not approved for use by anyone younger than 18 years old.

Use Trelegy Ellipta (Fluticasone, Umeclidinium, And Vilanterol) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• 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.

Do not use a second inhaled bronchodilator that contains vilanterol or a similar medicine (such as formoterol, arformoterol, indacaterol, olodaterol, or salmeterol).

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).