F
lo
V
e
n
t D
i s
k
u
s
5 0
meg,
w o
meg,
2 5 0
meg
( f l u t i c a s o n e p r o p i o n a t e i n h a l a t i o n p o w d e r ,
5 0 m e g , JOO m e g , 2 5 0 m e g )
BRIEF 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.
W h a t i s F L O V E N T D I S K U S ?
FLOVENT
DISKUS
is
an
inhaled
prescription
corticosteroid
medicine
for
the
long-term
treatment of asthma in people aged 4 and older.
• FLOVENT DISKUS helps to prevent symptoms
of asthma.
• FLOVENT DISKUS does not treat the sudden
symptoms
of
an
asthma
attack,
such
as
wheezing,
cough,
shortness of breath,
and
chest pain or tightness. Always have a fast-
acting
bronchodilator
medicine
(rescue
inhaler) with you to treat sudden symptoms.
It is not known if FLOVENT DISKUS is safe and
effective in children younger than 4 years of age.
W h o s h o u l d n o t u s e F L O V E N T D I S K U S ?
Do not use FLOVENT DISKUS:
• to treat sudden symptoms of asthma. FLOVENT
DISKUS is not a rescue inhaler and should
not be used to give you fast relief from
your asthm a attack. Always use a rescue
inhaler,
such
as
albuterol,
during
a
sudden
asthma attack.
• if you have severe allergy to milk proteins or
fluticasone propionate. Ask your doctor if you
are not sure.
W h a t s h o u l d I t e l l m y d o c t o r b e f o r e t a k i n g
F L O V E N T D I S K U S ?
Before you use FLOVENT DISKUS, tell your doctor
if you:
• have liver problems.
• have been exposed to chickenpox or measles.
• have any other medical conditions.
• are pregnant or planning to become pregnant.
It is not known if FLOVENT DISKUS will harm
your unborn baby. Talk to your doctor if you are
pregnant or plan to become pregnant.
• are breastfeeding or plan to breastfeed. It is not
known if FLOVENT DISKUS passes into your
breast milk. You and your doctor should decide
if you should use FLOVENT DISKUS while you
breastfeed.
Tell your doctor about all the medicines you take
including
prescription
and
non-prescription
medicines,
vitamins,
and
herbal
supplements.
FLOVENT
DISKUS
may
affect the
way
other
medicines work, and other medicines may affect
how FLOVENT DISKUS works. Especially, tell your
doctor if you take:
• anti-viral medicines, including medicines that
contain ritonavir (commonly used to treat HIV
infection or AIDS).
• any other corticosteroid medicines.
• ketoconazole
(NIZORAL®),
an
antifungal
medicine.
This is not a complete list of medicines that can
affect FLOVENT DISKUS. Ask your doctor if you
are not sure if any of your medicines are the
kinds listed above.
Know the medicines you take. Keep a list of them
and show it to your doctor and pharmacist when
you get a new medicine.
H o w s h o u l d I u s e F L O V E N T D I S K U S ?
•
Read
the
detailed
Instructions
for
Use
that
comes with FLOVENT DISKUS.
•An
adult
should
always
watch
a
child
use
FLOVENT DISKUS to make sure that it is used
correctly, as instructed by your doctor.
• FLOVENT
DISKUS
comes
in
3
strengths.
Your doctor has prescribed the one that is best
for your condition.
• Use FLOVENT DISKUS exactly as your doctor
tells you to
use
it.
Do
not change the dose
yourself. Your doctor will tell you how many times
to inhale your FLOVENT DISKUS and when to
use your FLOVENT DISKUS. Do not inhale more
doses or use your FLOVENT DISKUS more often
than your doctor has prescribed.
• FLOVENT
DISKUS
delivers
your
dose
of
medicine as a very fine powder th at m ost
people,
but
not
all,
can
taste
or
feel.
Whether or not you can taste or feel your dose
of medicine, you should not take more than the
prescribed dose. If you are not sure you are
getting your dose of FLOVENT DISKUS, contact
your doctor or pharmacist.
• It
may
take
1
to
2
weeks
or
longer
after
you start FLOVENT DISKUS for your asthma
symptoms to get better. You must use FLOVENT
DISKUS regularly. Do not stop using FLOVENT
DISKUS, even
If you
are
feeling
better,
unless your doctor tells you to.
• If you miss a dose, just take your next dose at
your regular time. Do not take 2 doses at the
sam e time unless your doctor tells you to.
If you are not sure about your dosing, call
your doctor.
• Your doctor may prescribe a rescue inhaler for
emergency relief of sudden asthma attacks.
Contact your doctor right away if:
- an asthma attack does not respond to your
rescue inhaler or
- you need more of your rescue inhaler than
usual.
• If you also use another medicine by inhalation,
you should ask your doctor for instructions on
when
to
use
it
while
you
are
also
using
FLOVENT DISKUS.
• Do not use FLOVENT DISKUS with a spacer
device.
W h a t s h o u l d I a v o i d w h i l e t a k i n g F L O V E N T
D I S K U S ?
•
If you have not had or have not been vaccinated
against
chickenpox,
measles,
or
active
tuberculosis, you should stay away from people
who are infected.
W h a t a r e t h e p o s s i b l e s i d e e f f e c t s o f
F L O V E N T D I S K U S ?
FLOVENT
DISKUS
can
cause
serious
side
effects, including:
• fungal infection (thrush) in your mouth and
throat. Tell your doctor if you have any redness
or white-colored coating in your mouth.
• decreased
ability
to
fight
infections.
Symptoms of infection may include: fever, pain,
aches, chills, feeling tired, nausea and vomiting.
Tell your doctor about any signs of infection
while you use FLOVENT DISKUS.
• decreased
adrenal
function
(adrenal
insufficiency).
Symptoms
of
decreased
adrenal function include tiredness, weakness,
nausea and vomiting, and low blood pressure.
Decreased adrenal function can lead to death.
• allergic
reaction
(anaphylaxis). Call your
doctor and stop FLOVENT DISKUS right away if
you have any symptoms of an allergic reaction:
- swelling of the face, throat, and tongue
- hives
-ra sh
- breathing problems
• lower bone mineral density. This may be a
problem for people who already have a higher
chance of low bone density (osteoporosis).
• slow
growth
in
children.
The
growth
of
children
using
FLOVENT
DISKUS
should
be
checked regularly.
• eye problem s including
glaucom a
and
cataracts. Tell your doctor about any vision
changes while using FLOVENT DISKUS. Your
doctor
may
tell
you
to
have
your
eyes
checked.
• increased
wheezing
(bronchospasm).
Increased
wheezing
can
happen
right
away
after using FLOVENT DISKUS. Always have a
rescue inhaler with you to treat sudden wheezing.
Call your doctor right away if you have any of the
serious side effects listed above or if you have
worsening lung symptoms.
T h e m o s t c o m m o n s i d e e f f e c t s o f
F L O V E N T D I S K U S i n c l u d e :
•
a cold or upper respiratory tract infection
• throat irritation
• nausea and vomiting
• fever
• headache
Tell your doctor if you have any side effects that
bother you or that do not go away. These are not all
the possible side effects of FLOVENT DISKUS. For
more information ask your doctor or pharmacist.
Call your doctor for medical advice about side
effects. You may report side effects to FDA at
1-800-FDA-1088 or 1 -800-332-1088.
GlaxoSmithKline
Research Triangle Park, NC 27709
FLD:4BRS
May 2010
FLOVENT
DISKUS
and
DISKUS
are
registered
©2011 The GlaxoSmithKline Group of Companies
trademarks
of
GlaxoSmithKline.
NIZORAL
is
a
All rights reserved. Printed in USA.
registered trademark of Johnson and Johnson.
FLO969R0
January 2011
