Breo Ellipta inhalation powder contains a combination of fluticasone and vilanterol. Fluticasone is a steroid that prevents the release of substances in the body that cause inflammation. Vilanterol is a bronchodilator that works by relaxing muscles in the airways to improve breathing.

Breo Ellipta is a once-daily combination medicine used in adults with asthma or COPD (chronic obstructive pulmonary disease), to improve symptoms and prevent bronchospasm or asthma attacks.

In people with COPD, Breo Ellipta is for long-term treatment. In people with asthma, this medicine is for short-term treatment until symptoms are well-controlled with with other medicines.

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

Breo Ellipta is not a rescue medicine. It will not work fast enough to treat an asthma or bronchospasm attack.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Breo Ellipta may interact with other medicines and this may cause serious side effects. Tell your healthcare provider if you take antifungal or anti-HIV medicines.

Use Breo Ellipta inhalation powder exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Breo Ellipta is not a rescue medicine for asthma or 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 asthma medications are not working as well.

Breo Ellipta is a powder that comes with a special inhaler device preloaded with blister packs containing measured doses of the medicine. The device opens and loads a blister of Breo Ellipta each time you use the inhaler. Follow the patient instructions provided with the inhaler device.

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

Your dose needs may change due to surgery, illness, stress, or a recent asthma attack. Do not change your Breo Ellipta dose or dosage schedule without your doctor's advice.

Always rinse out your mouth with water after using the inhaler device, to help prevent thrush (a fungal infection in the mouth or throat).

While using Breo Ellipta, your doctor will need to check your lung function on a regular basis. Your vision and your bone mineral density may also need to be checked.

Once your asthma is under control, your doctor may want you to stop using Breo Ellipta. Keep all follow-up appointments and do not stop using the medicine unless your doctor tells you to.

Store Breo Ellipta 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.

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

Fluticasone can weaken your immune system, making it easier for you to get an infection or worsening an infection you already have or have recently had. Tell your doctor about any illness or infection you have had within the past several weeks.

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.

Long-term use of steroids may lead to bone loss (osteoporosis), especially if you smoke, if you do not exercise, if you do not get enough vitamin D or calcium in your diet, or if you have a family history of osteoporosis. Talk with your doctor about your risk.

Tell your doctor if you are pregnant. It is not known whether Breo Ellipta will harm an unborn baby. However, having untreated or uncontrolled asthma during pregnancy may cause complications such as low birth weight, premature birth, or eclampsia (dangerously high blood pressure that can lead to medical problems in both mother and baby). The benefit of treating asthma may outweigh any risks to the baby.

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

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

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

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.

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.

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. This includes formoterol (Perforomist, Symbicort, Bevespi, Dulera), arformoterol (Brovana), indacaterol (Arcapta), olodaterol (Striverdi, Stiolto Respimat), salmeterol (Serevent), or vilanterol (Anoro Ellipta).

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

Call your doctor at once if you have:

• 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.

Common Breo Ellipta side effects may include:

• 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. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Many drugs can interact with fluticasone and vilanterol. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.