Fluticasone Furoate/Umeclidinium/Vilanterol Dry Powder Inhaler 0.2 mg/0.0625 mg/0.025 mg per inhalation (30 actuations)

Instructions

This medicine will work best if you take it at about the same time every day.

Keep this medicine at room temperature. Protect from moisture and high humidity.

Do not use a spacer with this inhaler.

Ask your doctor, nurse or pharmacist to show you how to use this medicine correctly.

Keep the medicine in the foil pouch until you are ready to use it.

The medicine is a very fine powder. Some patients may not feel or taste the medicine. Do not take an extra dose of medicine if you do not taste or feel the medicine being delivered.

Do not wash the inhaler in water or take the inhaler apart.

Rinse mouth and throat with water after each use and spit the water out. Do not swallow the water.

Do not suddenly stop using this medicine. Stopping suddenly could cause your breathing to become worse.

It is important that you keep taking each dose of this medicine on time even if you are feeling well.

If you forget to take a dose on time, take it as soon as you remember. If it is almost time for the next dose, do not take the missed dose. Return to your normal dosing schedule. Do not take 2 doses of this medicine at one time.

Throw away 6 weeks after removing from the tray, or when the dose counter says zero, whichever comes first.

This medicine may affect your blood sugar levels. If you have diabetes, talk to your doctor before changing the dose of your diabetes medicine.

Drug interactions can change how medicines work or increase risk for side effects. Tell your health care providers about all medicines taken. Include prescription and over-the-counter medicines, vitamins, and herbal medicines. Speak with your doctor or pharmacist before starting or stopping any medicine.

Do not share this medicine with anyone who has not been prescribed this medicine.

Keep all appointments for medical exams and tests while on this medicine.

Cautions

This is a steroid medication used to prevent inflammation. Inflammation is our body's response to a disease that can sometimes worsen our symptoms.

If you are switching from an oral steroid medication to this medicine, it is important that your body adapts properly to this change. Please speak with your doctor or nurse for more information.

Tell your doctor and pharmacist if you ever had an allergic reaction to a medicine.

Some patients taking this medicine have experienced serious side effects. Please speak with your doctor to understand the risks and benefits associated with this medicine.

Do not use the medication any more than instructed.

This medicine may reduce your body's ability to fight infections. Avoid contact with people with colds, flu or other infections. Contact your doctor if you develop fever, cough, sore throat, or chills.

During pregnancy, this medicine should be used only when clearly needed. Talk to your doctor about the risks and benefits.

It is unknown if this medicine passes into breast milk. Ask your doctor before breastfeeding.

If this medicine causes more wheezing or makes it harder to breathe, stop the medicine. Get medical help right away.

Do not use this medicine during an asthma attack. It will not stop an attack once it has started.

Tell your doctor if you have severe or persistent sweating, diarrhea or vomiting. These can increase your risk of a serious side effect.

Side Effects

The following is a list of some common side effects from this medicine. Please speak with your doctor about what you should do if you experience these or other side effects.

• coughing
• dry mouth
• hoarseness or throat irritation

Call your doctor or get medical help right away if you notice any of these more serious side effects:

• agitated feeling or trouble sleeping
• bone pain
• chest pain
• dizziness
• eye pain or redness
• fainting
• fast or irregular heart beats
• high blood pressure
• mood changes
• muscle cramps
• shakiness
• excessive thirst
• unusual or unexplained tiredness or weakness
• difficulty or discomfort urinating
• increased urinary frequency
• blurring or changes of vision
• seeing halos or colors around lights
• sudden or unexplained weight gain
• worsening breathing symptoms
• slow wound healing
• yeast infection in the mouth or throat

A few people may have an allergic reaction to this medicine. Symptoms can include difficulty breathing, skin rash, itching, swelling, or severe dizziness. If you notice any of these symptoms, seek medical help quickly.