fluticasone, umeclidinium, and vilanterol

Pronunciation: floo TIK a sone, ue ME kli DIN ee um, and vye LAN ter ol

Brand: Trelegy Ellipta

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

This medicine is for use only in people with chronic obstructive pulmonary disease (COPD) and should not be used to treat asthma.

Fluticasone, umeclidinium, and vilanterol is not a rescue medicine. It will not work fast enough to treat a bronchospasm attack.

Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

What is fluticasone, umeclidinium, and vilanterol?

Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation.

Umeclidinium is an anticholinergic. Vilanterol is a bronchodilator. These medications work by relaxing muscles in the airways to improve breathing.

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 may also be used for purposes not listed in this medication guide.

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

You should not use this medicine if you are allergic to fluticasone, umeclidinium, vilanterol, or milk proteins. This medicine is for use only in people with COPD and should not be used to treat asthma.

Tell your doctor if you have ever had:

  • heart disease, high blood pressure;
  • a seizure;
  • a weak immune system;
  • any type of infection, including tuberculosis, herpes infection of the eyes, or an infection caused by parasites;
  • liver disease;
  • glaucoma or cataracts;
  • diabetes (or ketoacidosis);
  • osteoporosis;
  • a thyroid disorder; or
  • an enlarge prostate, bladder obstruction, or urination problems.

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

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

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

How should I use this medicine?

Follow all directions on your prescription label and read all medication guides or instruction sheets. 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.

This medicine is not a rescue medicine for bronchospasm attacks. Use only fast-acting inhalation medicine for an attack. Seek medical attention if your breathing problems get worse quickly, or if you think your medications are not working as well.

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.

Store at room temperature away from moisture, heat, and light. Keep the inhaler device in the sealed foil tray until ready to start using it.

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?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

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

What should I avoid while using this medicine?

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

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 medicine that contains a steroid.

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

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;
  • fever, chills, cough with mucus, feeling short of breath;
  • nausea, vomiting, feeling weak or light-headed;
  • 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 seeing halos around lights;
  • increased thirst or increased urination; or
  • low potassium level --leg cramps, constipation, irregular heartbeats, fluttering in your chest, numbness or tingling, muscle weakness or limp feeling.

Common side effects may include:

  • cold or flu symptoms such as runny or stuffy nose, sore throat, cough;
  • nausea, vomiting, stomach pain;
  • constipation, diarrhea;
  • joint pain;
  • 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;
  • cold or allergy medicine that contains an antihistamine (Benadryl and others);
  • medicine to treat Parkinson's disease;
  • medicine to treat excess stomach acid, stomach ulcer, motion sickness, or irritable bowel syndrome;
  • bladder or urinary medicines --darifenacin, fesoterodine, oxybutynin, tolterodine, solifenacin; or
  • bronchodilators --aclidinium, ipratropium, tiotropium, umeclidinium.

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.

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