ADVAIR D
ISKUS
lOOAn.
25
D/
50
.
500/50
(Mcasoie propian
iti
110
,
250
,
510
into
m
il salneteral
51
ntg iilatim
piwder)
What is the most important information I should
know
about ADVAIR
DISKUS?
•
In patients w
ith asthma, long-acting beta2-agonist
(LABA) medicines, such as salmeterol (one of the
medicines in ADVAIR
DISKUS), may increase the
chance of death from
asthma problems. In
a large
asthma study, more patients who
used salmeterol
died
from
asthma problems compared w
ith
patients
who
d
id
not use salmeterol. It is not known
whether
fluticasone prop
ionate, the other medicine in
ADVAIR
DISKUS, changes your chance of death
from
asthma
prob
lems seen
w
ith
salmetero
l. Talk w
ith
your healthcare
provider about this risk and the benefits of treating
your asthma w
ith
ADVAIR
DISKUS.
•
ADVAIR DISKUS does not relieve sudden symptoms.
Always have a fast-acting inhaler (short-acting beta
2
-
agonist medicine) w
ith you to
treat sudden symptoms.
If you do not have a fast-acting inhaler, contact your
healthcare provider to have one prescribed for you.
•
Do
not stop using ADVAIR
DISKUS unless told to
do so by your healthcare provider because your
symptoms m
ight get worse.
•
ADVAIR
DISKUS should be used only if your
healthcare provider decides that another asthma-
controller medicine alone does not contro
l your asthma
or that you need 2 asthma-controller medicines.
•
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 fast-acting inhaler, but it does not
relieve your breathing problems.
What is ADVAIR
DISKUS?
•
ADVAIR
DISKUS contains
2
medicines:
- fluticasone propionate (the same medicine found in
FLOVENT®), an inhaled
corticostero
id
med
icine. Inhaled
corticostero
ids he
lp
to
decrease inflammation
in
the
lungs.
Inflammation
in
the
lungs can lead
to
asthma symptoms.
- salmeterol (the same medicine found
in SEREVENT®),
a LABA
. LABA
med
icines are
used
in
patients w
ith
asthma
or 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 breath
ing
and
cause death
if not treated
right away.
Asthma
ADVAIR
DISKUS is used long
term
, tw
ice a day, to
contro
l
symptoms of asthma and to
prevent symptoms such as
wheezing in
adults and children ages
4
and
o
lder.
Chronic Obstructive Pulmonary Disease (COPD)
COPD
is a chronic lung disease that includes chronic
bronchitis, emphysema, or both. ADVAIR
DISKUS
250/50
is
used long
term
, tw
ice a day, to
help
improve lung function
for better breathing in
adults w
ith
COPD. ADVAIR
DISKUS
250/50
has been
shown to
decrease the number of
flare-ups and
worsen
ing
of COPD
symptoms (exacerbations).
Who should not use ADVAIR
DISKUS?
Do
not use ADVAIR
DISKUS:
•
to
treat sudden, severe symptoms of asthma or COPD
•
i f you have a severe allergy to
m
ilk proteins. Ask your
doctor if you are not sure.
Important Information
This brief summary does not take the
place of talking
to
your healthcare provider about your medical cond
ition
or treatment.
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 m
ilk 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, includ
ing
prescription
and
nonprescription
med
icines,
vitam
ins, and
herbal supplements. ADVAIR
DISKUS and
certain other medicines may interact w
ith
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
everyth
ing. Ask your
healthcare provider or pharmacist if you
have any questions.
•
Ch
ildren
should
use ADVAIR
DISKUS w
ith
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
w
ill prescribe the one that is best for your condition.
•
The usual dosage of ADVAIR
DISKUS is
1
inhalation
tw
ice a day (morn
ing
and
evening). The
2
doses should
be
about
12
hours apart. R
inse your mouth
w
ith
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 m
iss 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 w
ith
ADVAIR
DISKUS.
•
Do
not breathe into
ADVAIR
DISKUS.
•
While you are using ADVAIR
DISKUS tw
ice a 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 change or stop
any of your medicines used to
contro
l or treat your breath
ing
prob
lems. Your healthcare
provider w
ill adjust your medicines as needed.
•
Make sure you always have a fast-acting inhaler w
ith
you. Use your fast-acting inhaler if you have breathing
problems between
doses of ADVA
i
R
DISKUS.
Call your healthcare provider or get medical care
right away if:
•
your breathing problems worsen w
ith
ADVAIR
DISKUS
•
you
need
to
use your fast-acting inhaler more often
than
usual
•
your fast-acting inhaler does not work as well for you
at relieving symptoms
•
you
need
to
use
4
or more
inhalations of your fast-acting
inhaler for 2 or more days in
a row
•
you
use 1 whole canister of your fast-acting inhaler in
8 weeks’ time
•
your peak flow
meter results decrease. Your healthcare
provider w
ill 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 w
ith ADVAIR
DISKUS?
•
See
“What is the most important information I should
know
about ADVAiR DISKUS?”
•
Patients w
ith
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 follow
ing symptoms:
- increase in
mucus (sputum) production
- change in
mucus color
- increased breathing problems
- fever
- increased cough
- chills
•
serious allergic reactions. Call your healthcare
provider or get emergency medical care if you
get
any of the follow
ing symptoms of a serious allergic
reaction, including:
- rash
- swelling of the face, mouth, and
tongue
- hives
- breathing problems
•
increased blood pressure
•
chest pain
•
a fast and irregular heartbeat
•
headache
•
tremor
•
nervousness
•
weakened immune system
and a higher chance of
infections
•
lower bone m
ineral density. This may be a prob
lem
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.
Other common side effects include:
•
hoarseness and
voice changes
•
throat irritation
•
thrush in
the mouth
and
throat
•
respiratory tract infections
Tell your healthcare provider about any side effect that
bothers you or that does not go
away.
These are not all the
side effects w
ith
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 (to
ll free)
at
1
-
888
-
825-5249
or at www
.advair.com
.
ADVAIR
DISKUS, DISKUS, FLOVENT, and
SEREVENT are
registered trademarks of G
laxoSm
ithKline. Norvir and
Kaletra are registered trademarks of Abbott Laboratories.
GlaxoSm
ithKline
Research Triangle Park, NC
27709
ADD:
3
PI
June
2008
©2008
The G
laxoSm
ithKline Group
of Companies
A
ll rights reserved. Printed
in
USA
.
AD
4576
R
0
August
2008
