Im p o rtan t S a fe ty Info rm atio n A b ou t A D V A IR D IS K U S
_____________________________________
This brief summary does not fake the place of talking to your healthcare provider about your medical condition or treatment.
What is the most important information I should
know about ADVAIR DISKUS?
• In p a tie n ts w ith asthm a, lo n g -a ctin g beta2-a g o n ist
(LABA) m edicines, such as s a lm e te ro l (one o f the
m e dicin e s in ADVAIR DISKUS), m ay increase the
chance o f death fro m a sth m a problem s. In a large
asthm a study, more patients who used salmeterol
died from asthm a problems compared w ith patients
who did not use salmeterol. It is not known whether
fl uticasone propionate, the other m edicine in ADVAIR
DISKUS, changes your chance of death from asthma
problems seen with salmeterol. Talk with your healthcare
provider about this risk and the benefits of treating
your asthma w ith ADVAIR DISKUS.
• ADVAIR DISKUS does not relieve sudden sym ptom s.
Alw ays have a fast-acting inhaler (short-acting beta2-
agonist medicine) w ith you to treat sudden sym ptom s.
If you do not have a fa s t-a c tin g inhaler, c o n ta c t yo ur
healthcare provider to have one prescribed fo r you.
• Do not stop using ADVAIR DISKUS unless to ld to
do so by yo u r h ealthcare p ro vider because yo ur
sym ptom s m ig h t g e t w orse.
• ADVAIR DISKUS should be used only if yo ur
h ealthcare p ro vid er d ecide s th a t a no the r a sth m a -
controller medicine alone does not control your asthma
or th a t you need 2 a s th m a -c o n tro lle r m edicines.
• Call your healthcare provider if breathing problem s
w orsen over tim e w hile using ADVAIR DISKUS. You
m ay need different treatm ent.
• Get em erge n cy m e dical care if:
- b reathing p roblem s w orsen quickly, and
- you use yo u r fa s t-a c tin g inhaler, b ut it does not
relieve yo ur b reathing problem s.
What is ADVAIR DISKUS?
• ADVAIR DISKUS co ntain s 2 m edicines:
- fl uticasone propionate (the sam e m edicine found in
FLOVENT"), an inhaled corticosteroid medicine. Inhaled
corticosteroids help 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 medicines are used in patients with 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 breathing and cause death if not treated right away.
A sthm a
ADVAIR DISKUS is used long term , tw ice a day, to control
sym ptoms of asthm a and to prevent sym ptoms such as
wheezing in adults and children ages 4 and older.
C hronic O bstructive P ulm onary 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
2 50/50 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 sym ptoms of asthm a or COPD
• if you have a severe allergy to m ilk proteins. Ask your
doctor if you are not sure.
What should I tell my healthcare provider before
using ADVAIR DISKUS?
Tell yo u r h ealthcare p ro vid er a bo u t all o f yo u r health
c o nd itio n s, in clu d in g if you:
• have heart problem s
• have high blood pressure
• have seizures
• have th yro id p roblem s
• have dia b etes
• have live r problem s
• have osteoporosis
• have an im m u n e system problem
• are pregnant or planning to becom e pregnant. It is not
known if ADVAIR DISKUS may harm your unborn baby
• are bre astfe ed in g . It is not known if ADVAIR DISKUS
passes into your m ilk and if it can harm your baby
• are a lle rg ic to a ny o f th e in g re d ie nts in ADVAIR
DISKUS, any o th e r m edicines, or food p roducts
• are exposed to ch icken p o x o r m easles
Tell your healthcare provider about all the medicines you
take, including prescription and nonprescription medicines,
vitamins, and herbal supplements. ADVAIR DISKUS and
certain other m edicines may interact w ith each other.
This may cause serious side effects. Especially, tell
your healthcare provider if you take ritonavir. The
anti-H IV m edicines N orvir* (ritonavir capsules) Soft
Gelatin, N orvir* (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 pharm acist each tim e
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 n ot use
ADVAIR DISKUS m ore often than prescribed. ADVAIR
DISKUS comes in 3 strengths. Your healthcare provider
will prescribe the one that is best for your condition.
• The usual dosage of ADVAIR DISKUS is 1 inhalation
tw ice a day (morning and evening). The 2 doses should
be about 12 hours apart. Rinse 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 miss a dose of ADVAIR DISKUS, just skip that
dose. Take your next dose at your usual tim e. Do not
take 2 doses at one time.
• Do not use a spacer device w ith ADVAIR DISKUS.
• Do not breathe into ADVAIR DISKUS.
• W hile you are using ADVAIR DISKUS tw ic e a day, do
not use o ther m edicines th a t contain a LABA fo r any
reason. A sk yo ur healthcare provider or pharm acist
if any of your other m edicines are LABA m edicines.
• Do not change or stop any of your medicines used to
control or treat your breathing problems. Your healthcare
provider will adjust your medicines as needed.
• Make sure you always have a fast-acting inhaler with
you. Use your fast-acting inhaler if you have breathing
problems between doses of ADVAIR 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 w ork 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 w eeks’ tim e
• your peak fl ow meter results decrease. Your healthcare
provider will tell you the numbers that are right for you.
• you have asthm a and your sym ptoms do not improve
after using ADVAIR DISKUS regularly for 1 week
What are the possible side effects with ADVAIR DISKUS?
• See
“ W hat is the m o st im po rtan t inform ation I should
know about ADV
A
IR D
I
SKUS?"
• Patients w ith COPD have a higher chance of getting
pneumonia. ADVAIR DISKUS may increase the chance
of getting pneumonia. Call yo u r hea lth care p ro vid er
if you notice any o f th e fo llo w in g sym ptom s:
- increase in mucus (sputum) production
- change in mucus color
- increased breathing problems
- fever
- increased cough
- chills
• s e rio u s a lle rg ic re a c tio n s . Call your healthcare
provider or get em ergency medical care if you get
any of the following sym ptoms of a serious allergic
reaction, including:
- rash
- swelling of the face, mouth, and tongue
- hives
- breathing problems
• increased blood pressure
• ch est pain
• a fa s t and irre g u la r hea rtbe a t
• headache
• tre m o r
• nervousness
• w e akened im m une system and a h ig h er chance of
in fectio ns
• lo w e r bone m ineral density. This may be a problem
for people who already have a higher chance of low
bone density (osteoporosis).
• eye p roblem s in clu d in g g la u co m a and cata racts.
You should have regular eye exams while using
ADVAIR DISKUS.
• slo w e d g ro w th in ch ild re n . A child’s growth should
be checked often.
O ther com m on side e ffe cts 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 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 pharm acist for additional
information about ADVAIR DISKUS. You can also contact
the company that makes ADVAIR DISKUS (toll free)
at 1 -8 88 -8 2 5-52 4 9 or at www.advair.com .
ADVAIR DISKUS, DISKUS, FLOVENT, and SEREVENT are
registered tradem arks of GlaxoSmithKline. Norvir and
Kaletra are registered tradem arks of Abbott Laboratories.
G laxoS m ithK line
R esearch T riangle Park, NC 2 77 0 9
ADD:6PI
April 2009
© 2 0 1 0 The GlaxoSmithKline Group of Companies
All rights reserved. Printed in USA.
AD 5249R0
February 2010
