Breo Ellipta (Fluticasone/Vilanterol) belongs to a class of medications called long-acting beta-agonists (LABAs). Breo Ellipta (Fluticasone/Vilanterol) is a combination of fluticasone and vilanterol that helps controlling symptoms of lung disease such as wheezing, shortness of breath, coughing, and chest tightness in patients with chronic obstructive pulmonary disease (COPD). COPD also includes chronic bronchitis (swelling of the tubes leading to the lungs) and emphysema (damage to the air sacs in the lungs). This medication works by relaxing and opening the air passages to the lungs to make breathing easier. It may also be used to control symptoms of asthma in adults.

Doctor's prescription is required to use this medicine.

Always use Breo Ellipta (Fluticasone/Vilanterol) as directed by your physician.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Ask your doctor if you have any questions.

Breo Ellipta (Fluticasone/Vilanterol) comes as a powder to inhale by mouth using a special inhaler. It is usually inhaled once a day. Use Breo Ellipta (Fluticasone/Vilanterol) at around the same time every day. Do not stop taking this medication without talking to your doctor. Make sure that you are using your inhaler correctly, ask your doctor, pharmacist, or respiratory therapist to show you how to use the inhaler. Rinse your mouth with water and spit it out after using the inhaler device, to help prevent thrush (a fungal infection in the mouth or throat).

Do not take more or less of it or take it more often than prescribed by your doctor.

Always use Breo Ellipta (Fluticasone/Vilanterol) exactly as directed by your doctor.

Before using Breo Ellipta, tell your doctor or pharmacist if you are allergic to it or any other medications. Tell your doctor or pharmacist about your medical history. Tell your doctor about all the other prescription and nonprescription medications you are taking.

You should not use Breo Ellipta if you are allergic to fluticasone, vilanterol, or milk proteins.

NEVER use this medicine for an acute asthma or COPD attack. Your doctor will prescribe a short acting (rescue) inhaler to use during asthma and COPD attacks.

To make sure Breo Ellipta is safe for you, tell your doctor if you have:

• glaucoma or cataracts;

• a weak immune system;

• heart disease, high blood pressure;

• liver disease;

• a thyroid disorder;

• a seizure;

• diabetes;

• any type of infection (bacterial, fungal, viral, or parasitic);or

• osteoporosis.

Tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using fluticasone and vilanterol, call your doctor.

If you are going to have surgery tell your doctor or health care professional that you are using this medicine. Try not to come in contact with people with the chicken pox or measles. If you do, call your doctor.

Breo Ellipta is not approved for use by anyone younger than 18 years old.

NOTE: This medicine is only for you. Do not share this medicine with others.

Side effects that you should report to your doctor or health care professional as soon as possible:

• Wheezing, choking, or other breathing problems after using this medicine;
• Chest pain, fast or pounding heartbeats, pounding in your neck or ears;
• Sores or white patches in your mouth and throat, pain when swallowing;
• Fever, chills, cough with yellow or green mucus;
• Blurred vision, tunnel vision, eye pain, or seeing halos around lights.
• High blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor;
• Low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or
• Signs of a hormonal disorder - worsening tiredness or muscle weakness, feeling light-headed, nausea, vomiting.

Side effects that usually do not require medical attention (report to your doctor or health care professional if they continue or are bothersome):

• Headache, back pain, joint pain;
• Fever, flu symptoms;
• Increased blood pressure;
• Runny or stuffy nose, sore throat, cough; or
• A hoarse voice.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

What happens if I miss a dose?

Take 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 take a double dose to make up for a missed one.

What happens if I overdose?

In case of an overdose, seek emergency medical attention or call the Poison Help line.

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

Long term use of an inhaled steroid can lead to glaucoma, cataracts, thinning skin, changes in body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

Where should I keep my medicine?

Keep out of reach of children.

Store the medicine at room temperature. Store in a dry place away from direct heat or sunlight.

Throw away any unused medicine after the expiration date.

What should I avoid while taking this medication?

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using a steroid such as fluticasone.

Do not use a second inhaled bronchodilator unless your doctor tells you to.