Important Safety Information About ADVAIR DISKUS
__________________________________________________
This brief summary does not take 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 patients w ith asthm a, long-acting beta2-agonist
(LABA) m edicines, such as salm eterol (one of the
m edicines in ADVAIR DISKUS), m ay increase the
chance of death from asthm a problems. In a large
asthma study, more patients who used salmeterol
died from asthma problems compared with patients
who did not use salmeterol. It is not known whether
fl uticasone propionate, the other medicine 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 with ADVAIR DISKUS.
• ADVAIR DISKUS does not relieve sudden sym ptom s.
Always have a fast-acting inhaler (short-acting beta2-
agonist medicine) w ith you to treat sudden symptoms.
If you do not have a fast-acting in haler, 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
sym ptom s m ight get worse.
• ADVAIR DISKUS should be used only if your
healthcare provider decides that another asthm a-
controller medicine alone does not control your asthma
or th at you need 2 asthm a-controller m edicines.
• Call your healthcare provider if breathing problems
worsen over time while using ADVAIR DISKUS. You
may need different treatment.
• Get em ergency m edical care if:
- breathing problem s 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 m edicines:
- fl uticasone propionate (the same medicine 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.
Asthm a
ADVAIR DISKUS is used long term, twice a day, to control
symptoms of asthma and to prevent symptoms such as
wheezing in adults and children ages 4 and older.
Chronic O bstructive Pulm onary Disease (COPD)
COPD is a chronic lung disease that includes chronic
bronchitis, emphysema, or both. ADVAIR DISKUS 250/50 is
used long term, twice a 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 he
a
lthcare 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 im m une 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 m edicines, or food products
• are exposed to chickenpox or measles
Tell your healthcare provider about all the medicines you
take, including prescription and nonprescription 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
will prescribe the one that is best for your condition.
• The usual dosage of ADVAIR DISKUS is 1 inhalation
twice a 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.
• W hile you are using ADVAIR DISKUS tw ice a day, do
not use other m edicines that contain a LABA fo r any
reason. Ask your healthcare provider or pharm acist
if any of your other medicines are LABA medicines.
• 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 pro
v
ider or get medical care
right away if:
• your breathing problems worsen with 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 fl ow 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 am the possible side effects with ADVAIR DISKUS?
• See
“What is the most impo
r
tant information I should
know about ADVAIR DISKUS?"
• Patients 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 follow ing symptoms:
- increase in mucus (sputum) production
- change in mucus color
- increased breathing problems
- fever
- increased cough
- chills
• serious a lle rg ic reactions. Call your healthcare
provider or get emergency medical care if you get
any of the following symptoms of a serious allergic
reaction, including:
- rash
- swelling of the face, mouth, and tongue
- hives
- breathing problems
• increased blood pressure
• chest pain
• a fa st and irregular heartbeat
• headache
• trem or
• nervousness
• weakened im mune system and a higher chance of
infections
• l ow er bone m ineral density. This may be a problem
for people who already have a higher chance of low
bone density (osteoporosis).
• eye problem s including glaucom a and cataracts.
You should have regular eye exams while using
ADVAIR DISKUS.
• slowed grow th in children. A child’s growth should
be checked often.
Other com m on 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 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.
ADVAIR DISKUS, DISKUS, FLOVENT, and SEREVENT are
registered trademarks of GlaxoSmithKline. Norvir and
Kaletra are registered trademarks of Abbott Laboratories.
GlaxoSm ithKline
Research Triangle Park, NC 27709
ADD:6PI
April 2009
© 2010 The GlaxoSmithKline Group of Companies
All rights reserved. Printed in USA.
AD5249R0
February 2010
