What is Breo Ellipta? Uses, warnings & side effects

The prescriber will tell you how much medicine to use. Do not use more than directed. 

Use this medicine at the same time each day.

Please read the Patient Information sheet and Instructions for Use that come with this medicine. 

Each inhaler comes with 30 doses. When first opened, the inhaler’s dose counter should read “30.”

To take a dose, open the cover of the inhaler. When completely opened, it will click to signal that a dose is ready to be taken. Do not close the cover until you have taken a dose. If you do, the dose will be lost.

Looking away from the inhaler, breathe out fully to get as much air out of the lungs as possible. 

Put the mouthpiece between your lips and close your lips firmly around it.

Do not cover the air vents with your fingers or hands. 

Take one long, steady, deep breath in through your mouth. 

Take your mouth off the mouthpiece, hold your breath for about three to four seconds, and then breathe out slowly.

Do not take another dose.

Close the inhaler. If needed, clean the mouthpiece using dry tissue before closing the cover.

When you have finished, rinse your mouth and spit out the water.

Throw the empty inhaler away when the dose count reaches “0.”

Store the inhaler in a closed container at room temperature in a dry place protected from heat and light.

Take a dose as soon as you remember. 

If it is almost time for your next dose, wait until then and take a regular dose. 

Do not take extra medicine to make up for a missed dose. 

Do not take more than one inhalation per day.

This medicine is not right for everyone. 

Do not use it if you have had an allergic reaction to fluticasone or vilanterol.

People with severe allergies to milk proteins should not use Breo Ellipta.

Do not use Breo Ellipta to treat asthma attacks or sudden worsening of COPD symptoms.

Tell any doctor or other healthcare provider who treats you that you are using this medicine. You may need to stop using this medicine several days before major surgery or certain medical tests.

The prescriber will need regular office visits and lab tests to monitor the effects of this medicine and make dose adjustments. Keep all appointments.

Tell your doctor if you are pregnant or breastfeeding.

Tell your doctor if you have:

• Liver problems

• Heart problems

• Abnormal heart rhythms

• High blood pressure

• Bone density problems (osteoporosis)

• Thyroid problems

• Immune system problems

• Diabetes

• A history of seizures

• Eye problems, including cataracts, high eye pressure, glaucoma, or vision changes

• Any active infection

• Exposure to measles or chickenpox

• Milk protein allergies

Breo Ellipta can cause serious problems, including:

• Increased risk of infection, including fungus infection in the mouth (thrush)

• Increased risk of pneumonia in people who have COPD

• Adrenal gland problems

• Sudden difficulty breathing immediately after taking a dose

• Heart rhythm problems

• Increased blood pressure

• Chest pain

• Low bone mineral density, which may lead to osteoporosis

• Glaucoma or cataracts

• Increased blood sugar levels

• Low potassium

• Slowed growth in children

• Increased risk of asthma-related hospital stays, intubations, and death

Do not use this medicine to treat acute attacks. You should have another medicine to use for an acute asthma attack or COPD flare-up. 

Call the doctor if your symptoms do not improve or if they get worse.

Do not use Breo Ellipta with other inhaled medicines containing long-acting beta agonists such as formoterol, indacaterol, or salmeterol. 

To avoid potentially hazardous drug interactions, tell the prescribing healthcare provider about all prescription drugs, over-the-counter medications, and supplements you use, particularly:

• Monoamine oxidase inhibitors (MAOIs)

• Tricyclic antidepressants

• Beta blockers

• Drugs that make you pee (diuretics)

• Drugs that treat fungal infections

• Drugs that treat HIV/AIDS

• Atazanavir, clarithromycin, nefazodone

Doctors use inhaled corticosteroids cautiously in people currently taking oral corticosteroids for their disease. Switching from oral corticosteroids to Breo Ellipta may cause withdrawal symptoms. To prevent severe side effects, people who have switched to Breo Ellipta from oral corticosteroids may need to start taking them again in times of stress, severe asthma, or COPD problems.

Tell other healthcare providers you are using this medicine before they prescribe new medications.