Fluticasone; Vilanterol Dry Powder Inhaler (DPI)

What is this medication?

FLUTICASONE; VILANTEROL (floo TIK a sone; vye LAN ter ol) treats asthma and chronic obstructive pulmonary disease (COPD). It works by opening the airways of the lungs, making it easier to breathe. It is a combination of an inhaled steroid and a bronchodilator. It is often called a controller inhaler. Do not use it to treat a sudden asthma attack or COPD flare-up.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): BREO ELLIPTA

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Diabetes
• Eye disease
• Immune system problems
• Heart disease
• High blood pressure
• Infection
• Irregular heartbeat or rhythm
• Osteoporosis, weak bones
• Pheochromocytoma
• Seizures
• Thyroid disease
• Vision problems
• An unusual or allergic reaction to fluticasone, vilanterol, milk proteins, corticosteroids, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is inhaled through the mouth. Rinse your mouth with water after use. Make sure not to swallow the water. Take it as directed on the prescription label at the same time every day. Do not use it more often than directed.

A patient package insert for the product will be given with each prescription and refill. Be sure to read this information carefully each time. The sheet may change often.

This medication comes with INSTRUCTIONS FOR USE. Ask your pharmacist for directions on how to use this medication. Read the information carefully. Talk to your pharmacist or care team if you have questions.

Talk to your care team about the use of this medication in children. It is not approved for use in children.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

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

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

Do not take this medication with any of the following:

• Cisapride
• Dofetilide
• Dronedarone
• MAOIs like Carbex, Eldepryl, Marplan, Nardil, and Parnate
• Pimozide
• Thioridazine
• Ziprasidone

This medication may also interact with the following:

• Antiviral medications for HIV or AIDS
• Beta-blockers like metoprolol and propranolol
• Certain medications for depression, anxiety, or psychotic disturbances
• Certain medications for fungal infections like ketoconazole, itraconazole, posaconazole, voriconazole
• Conivaptan
• Diuretics
• Medications for colds
• Nefazodone
• Other medications for breathing problems
• Other medications that prolong the QT interval (cause an abnormal heart rhythm)

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress. Tell your care team if your symptoms do not start to get better or if they get worse.

NEVER use this medication for an acute asthma attack. You should use your short-acting rescue inhaler for an acute attack. If your symptoms get worse or if you need your short-acting inhalers more often, call your care team right away.

This medication can worsen breathing or cause wheezing right after you use it. Be sure you have a short-acting inhaler for acute attacks (wheezing) nearby. If this happens, stop using this medication right away and call your care team.

This medication may increase your risk of serious asthma-related problems. Talk to your care team if you have questions.

Do not treat yourself for coughs, colds or allergies without asking your care team for advice. Some nonprescription medications can affect this one.

You and your care team should develop an Asthma Action Plan that is just for you. Be sure to know what to do if you are in the yellow (asthma is getting worse) or red (medical alert) zones.

If you are going to need surgery or other procedure, tell your care team that you are using this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication may increase blood sugar. The risk maybe higher in patients who already have diabetes. Ask your care team what you can do to lower your risk of diabetes while taking this medication.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Heart rhythm changes—fast or irregular heartbeat, dizziness, feeling faint or lightheaded, chest pain, trouble breathing
• Increase in blood pressure
• Low adrenal gland function—nausea, vomiting, loss of appetite, unusual weakness or fatigue, dizziness
• Muscle pain or cramps
• Thrush—white patches in the mouth
• Wheezing or trouble breathing that is worse after use

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

• Change in taste
• Cough
• Dry mouth
• Headache
• Hoarseness
• Sore throat
• Tremors or shaking
• Trouble sleeping

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 20 and 25 degrees C (68 and 77 degrees F). Keep inhaler away from extreme heat, cold or humidity. Get rid of it 6 weeks after removing it from the foil pouch, when the dose counter reads "0" or after the expiration date, whichever is first.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, ask your pharmacist or care team how to get rid of this medication safely.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.