A D V A I R Q M S
(fluticasone propionate and
BRIEF
salmeterol inhalation powder)
SUMMARY
This summary does not take the place of talking to your
healthcare provider about your medical condition or
treatment. See full Prescribing Information for complete
product information.
What is the most important information I should
know about ADVAIR DISKUS?
ADVAIR DISKUS can cause serious side effects, including:
1. People with asthma who take long-acting beta2-
adrenergic agonist (LABA) medicines, such as
salmeterol (one of the medicines in ADVAIR DISKUS),
have an increased risk of death from asthma
problems. It is not known whether fluticasone propionate,
the other medicine in ADVAIR DISKUS, reduces the risk of
death from asthma problems seen with salmeterol.
• Call your healthcare provider if breathing problems
worsen over time while using ADVAIR DISKUS. You
may need different treatment.
• Get emergency medical care if:
- breathing problems worsen quickly and
- you use your rescue inhaler medicine, but it does not
relieve your breathing problems.
2. ADVAIR DISKUS should be used only if your healthcare
provider decides that your asthma is not well controlled
with a long-term asthma control medicine, such as
inhaled corticosteroids.
3. When your asthma is well controlled, your healthcare
provider may tell you to stop taking ADVAIR DISKUS. Your
healthcare provider will decide if you can stop ADVAIR
DISKUS without loss of asthma control. Your healthcare
provider may prescribe a different asthma control
medicine for you, such as an inhaled corticosteroid.
4. Children and adolescents who take LABA medicines may
have an increased risk of being hospitalized for asthma
problems.
What is ADVAIR DISKUS?
• ADVAIR DISKUS combines an inhaled corticosteroid
medicine, fluticasone propionate (the same medicine
found in FLOVENT®), and a LABA medicine, salmeterol
(the same medicine found in SEREVENT®).
- Inhaled corticosteroids help to decrease inflammation in
the lungs. Inflammation in the lungs can lead to asthma
symptoms.
- LABA medicines are used in people with asthma and
chronic obstructive pulmonary disease (COPD). LABA
medicines help the muscles around the airways in your
lungs stay relaxed to prevent symptoms, such as wheezing
and shortness of breath. These symptoms can happen
when the muscles around the airways tighten. This makes
it hard to breathe. In severe cases, wheezing can stop your
breathing and cause death if not treated right away.
• ADVAIR DISKUS is used for asthma and COPD as follows:
Asthma
ADVAIR DISKUS is used to control symptoms of asthma
and to prevent symptoms such as wheezing in adults and
children aged 4 years and older.
ADVAIR DISKUS contains salmeterol (the same medicine
found in SEREVENT). LABA medicines, such as salmeterol,
increase the risk of death from asthma problems.
ADVAIR DISKUS is not for adults and children with asthma
who
are
well
controlled
with
an
asthma
control
medicine, such as a low to medium dose of an inhaled
corticosteroid medicine.
COPD
COPD is a chronic lung disease that includes chronic
bronchitis,emphysema,orboth.ADVAIRDISKUS250/50
is used long term,
2
times each day to help improve lung
function for better breathing in adults with COPD.
ADVAIR DISKUS 250/50 has been shown to decrease
the
number of flare-ups and
worsening
of
COPD
symptoms (exacerbations).
Who should not use ADVAIR DISKUS?
Do not use ADVAIR DISKUS:
• to treat sudden, severe symptoms of asthma or COPD.
• if you have a severe allergy to milk proteins. Ask your
doctor if you are not sure.
What should I tell my healthcare provider before
using ADVAIR DISKUS?
Tell your healthcare provider about all of your health
conditions, including if you:
• have heart problems
• have high blood pressure
• have seizures
• have thyroid problems
• have diabetes
• have liver problems
• have osteoporosis
• have an immune system problem
• are pregnant or planning to become pregnant. It is not
known if ADVAIR DISKUS may harm your unborn baby.
• are breastfeeding. It is not known if ADVAIR DISKUS
passes into your milk and if it can harm your baby.
• are allergic to any of the ingredients in ADVAIR
DISKUS, any other medicines, or food products
• are exposed to chickenpox or measles
Tell your healthcare provider about all the medicines you
take including prescription and non-prescription medicines,
vitamins, and herbal supplements. ADVAIR DISKUS and
certain other medicines may interact with each
other.
This may cause serious side effects. Especially, tell your
healthcare provider if you take ritonavir. The anti-HIV
medicines NORVIR® (ritonavir capsules) Soft Gelatin,
NORVIR (ritonavir oral solution), and KALETRA® (lopinavir/
ritonavir) Tablets contain ritonavir.
Know the medicines you take. Keep a list and show it
to your healthcare provider and pharmacist each time you
get a new medicine.
How do I use ADVAIR DISKUS?
Do not
use ADVAIR
DISKUS
unless your healthcare
provider has taught you and you understand everything.
Ask your healthcare provider or pharmacist if you have
any questions.
• Children should use ADVAIR DISKUS with an adult's help,
as instructed by the child’s healthcare provider.
• Use ADVAIR DISKUS exactly as prescribed. Do not use
ADVAIR DISKUS more often than prescribed. ADVAIR
DISKUS comes in 3 strengths. Your healthcare provider
has prescribed the one that is best for your condition.
• The usual dosage of ADVAIR DISKUS is 1
inhalation
2 times each day (morning and evening). The 2 doses
should be about 12 hours apart. Rinse your mouth with
water after using ADVAIR DISKUS.
• If you take more ADVAIR DISKUS than your doctor has
prescribed, get medical help right away if you have any
unusual
symptoms,
such
as worsening
shortness of
breath, chest pain, increased heart rate, or shakiness.
• If you miss a dose of ADVAIR DISKUS, just skip that dose.
Take your next dose at your usual time. Do not take 2
doses at one time.
• Do not use a spacer device with ADVAIR DISKUS.
• Do not breathe into ADVAIR DISKUS.
• While you are using ADVAIR DISKUS 2 times each day,
do not use other medicines that contain a LABA for
any reason. Ask your healthcare provider or pharmacist if
any of your other medicines are LABA medicines.
• Do not stop using ADVAIR DISKUS or other asthma
medicines unless told to do so by your healthcare provider
because your symptoms might get worse. Your healthcare
provider will change your medicines as needed.
• ADVAIR DISKUS does not relieve sudden symptoms.
Always have a rescue inhaler medicine with you to treat
sudden symptoms. If you do not have an inhaled, short-
acting bronchodilator, call your healthcare provider to
have one prescribed for you.
Call your healthcare provider or get medical care
right away if:
• your breathing problems worsen with ADVAIR DISKUS
• you need to use your rescue inhaler medicine more often
than usual
• your rescue inhaler medicine does not work as well for you
at relieving symptoms
• you need to use 4 or more inhalations of your rescue
inhaler medicine for
2
or more days in a row
• you use 1 whole canister of your rescue inhaler medicine
in 8 weeks’ time
• your peak flow meter results decrease. Your healthcare
provider will tell you the numbers that are right for you.
• you have asthma and your symptoms do not improve after
using ADVAIR DISKUS regularly for 1 week
What are the possible side effects with ADVAIR DISKUS?
• ADVAIR DISKUS can cause serious side effects,
including:
• See “What is the most important information I should
know about ADVAIR DISKUS?”
• 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
• 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 DISKUS.
• slowed growth in children. A child’s growth should be
checked often.
• pneumonia. People with COPD have a higher chance
of getting pneumonia. ADVAIR DISKUS may increase
the chance of getting pneumonia. Call your healthcare
provider 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 include:
Asthma:
• upper respiratory tract
infection
• throat irritation
•hoarseness and voice
changes
• thrush in the mouth and
throat
• bronchitis
• cough
• headache
• nausea and vomiting
COPD:
• thrush in the mouth and
throat
• throat irritation
• hoarseness and voice
changes
• viral respiratory infections
• headache
• muscle and bone pain
In children with asthma, infections in the ear, nose, and
throat are common.
Tell your healthcare provider about any side effect that
bothers you or that does not go away.
These are not all the side effects with ADVAIR DISKUS. Ask
your healthcare provider or pharmacist for more information.
Call your doctor for medical advice about side effects. You
may report side effects to the FDA at 1-800-FDA-1088.
Ask your healthcare provider or pharmacist for additional
information about ADVAIR DISKUS. You can also contact
the company that makes ADVAIR DISKUS (toll free)
at 1-888-825-5249 or at www.advair.com.
GlaxoSmithKline
ADVAIR DISKUS, DISKUS, FLOVENT, and SEREVENT are
©2011 The GlaxoSmithKline Group of Companies
Research Triangle Park, NC 27709
registered trademarks of GlaxoSmithKline. Norvir and
All rights reserved. Printed in USA.
