Complete Prescribing Information and Medication Guide for ADVAIR DISKUS

Important Safety Information About ADVAIR DISKUS 250/50 for COPD

Do not use ADVAIR to treat sudden, severe symptoms of asthma or COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms. CONTINUED BELOW

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ADVAIR DISKUS 250/50 for COPD

ABOUT ADVAIR DISKUS

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ABOUT COPD

What Is COPD?
Living With COPD

Talking to Your Doctor About COPD

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Your healthcare provider can be a tremendous resource in treating COPD, including chronic bronchitis, emphysema, or both. Chronic bronchitis is increased coughing and mucus production caused by inflammation of the airways. Bronchitis is considered chronic (or long-term) if a person coughs and produces excess mucus most days during three months in a year, for two years in a row.

Emphysema is a type of chronic obstructive pulmonary disease (COPD) associated with damage of the air sacs and/or the smallest breathing tubes in the lungs.

The six simple questions below are designed to help you and your healthcare provider evaluate your condition.

Select the answers that best describe your symptoms. Then print out this page and list all the medications you are taking in the space provided. Share this information with your healthcare provider at your next appointment.

How often do you become short of breath?

Never
Only during strenuous activity
When walking up stairs or short distances
While sitting/at rest

How often do you have trouble breathing or experience wheezing?

Never
Once a day
Several times a day
Frequently

How often do you cough even when you don't have a cold?

Never
Sometimes
Most days
Every day

When you cough, how often do you cough up mucus/phlegm?

Never
Sometimes
Most days
Every day

Have you ever suffered from a marked worsening of these COPD symptoms that lasted for a few days and required your healthcare provider's attention?

Yes
No

List all the medicines you take, including prescription and nonprescription medicines, vitamins, and herbal supplements.

Ask your doctor if ADVAIR DISKUS is right for you.

Approved Uses for ADVAIR DISKUS 250/50

ADVAIR DISKUS 250/50 is approved for adults with COPD, including chronic bronchitis, emphysema, or both. ADVAIR DISKUS is not for, and should not be used to treat, sudden, severe symptoms of COPD. ADVAIR won’t replace a rescue inhaler. You should only take 1 inhalation of ADVAIR twice a day. Higher doses will not provide additional benefits.

Important Safety Information About ADVAIR DISKUS^® 250/50 (fluticasone propionate 250 mcg and salmeterol 50 mcg inhalation powder)

Do not use ADVAIR to treat sudden, severe symptoms of asthma or COPD. Always have a rescue inhaler medicine with you to treat sudden symptoms.
Do not use ADVAIR DISKUS if you have severe allergy to milk proteins. Ask your doctor if you are not sure.
Do not use ADVAIR more often than prescribed. Do not take ADVAIR with other medicines that contain long-acting beta₂-agonists for any reason. Tell your doctor about medicines you take and about all of your medical conditions.
ADVAIR DISKUS can cause serious side effects, including:
- serious allergic reactions. Call your healthcare provider or get emergency medical care if you get any of the following symptoms of a serious allergic reaction:
  - rash
  - hives
  - swelling of the face, mouth, and tongue
  - breathing problems
- sudden breathing problems immediately after inhaling your medicine
- effects on heart
  - increased blood pressure
  - a fast and irregular heartbeat
  - chest pain
- effects on nervous system
  - tremor
  - nervousness
- reduced adrenal function (may result in loss of energy)
- changes in blood (sugar, potassium, certain types of white blood cells)
- weakened immune system and a higher chance of infections. You should avoid exposure to chickenpox and measles, and, if exposed, consult your healthcare provider without delay. Worsening of existing tuberculosis, fungal, bacterial, viral, or parasitic infections, or ocular herpes simplex may occur.
- lower bone mineral density. This may be a problem for people who already have a higher chance of low bone density (osteoporosis).
- eye problems including glaucoma and cataracts. You should have regular eye exams while using ADVAIR.
- pneumonia. People with COPD have a higher chance of getting pneumonia. ADVAIR may increase the chance of getting pneumonia. Call your doctor if you notice any of the following symptoms:
  - increase in mucus (sputum) production
  - change in mucus color
  - fever
  - chills
  - increased cough
  - increased breathing problems
Common side effects of ADVAIR DISKUS 250/50 for COPD include:
- thrush in the mouth and throat
- throat irritation
- hoarseness and voice changes
- viral respiratory infections
- headache
- muscle and bone pain

Complete Prescribing Information and Medication Guide for ADVAIR DISKUS

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