• Calcium
and vitamin
D
may
be taken
at the same tim e as
EVISTA.
It
is
im portant to take
calcium
and
vitam in
D,
as directed by your physician, to prevent or treat osteoporosis.
• If you miss a dose, take it as soon as you remember. However,
if it is alm ost time for your next dose, skip the missed dose
and take only your
next
regularly scheduled
dose.
Do
not
take two doses at the same time.
What should I avoid while taking EVISTA?
•B eing
still
fo r a
long
tim e
(such
as
during
long
trips
or
being
in
bed
after surgery)
can
increase the
risk of
blood
clots. EVISTA may add to this risk. If you will need to be still
for a long time, talk with your doctor about ways to reduce
the
risk
o f
blood
c lo ts .
On
long
trip s ,
m ove
around
periodically.
Stop taking
EVISTA at
least 3
days
before
a
planned surgery or before you plan on being still for a long
time. You should start taking EVISTA again when you return
to your normal activities.
•S o m e
m edicines
should
not
be taken
w ith
EVISTA
(see
“What should I tell my doctor before taking EVISTA?”).
What are the possible side effects of EVISTA?
Serious and
life-threatening
side
effects
can
occur w hile
taking EVISTA. These include blood clots and dying from stroke:
• Increased risk of blood clots in the legs (deep vein thrombosis)
and
lungs
(pulmonary em bolism)
have
been
reported with
EVISTA.
Women
who
have
or have
had
blood
clots
in the
legs, lungs, or eyes should not take EVISTA.
• Women
who
have
had
a
heart attack
or are at
risk fo r a
heart attack
may
have
an
increased
risk
of
dying
from
stroke when taking EVISTA.
See
“What is the most important information I should know
about EVISTA?”
The most com mon side effects of EVISTA are hot flashes, leg
cramps,
swelling
of the feet,
ankles,
and
legs,
flu
syndrome,
joint pain, and sweating.
Hot flashes are more com mon during
the first 6 months after starting treatment.
These are not all the side effects of EVISTA. Tell your doctor
about any side effect that bothers you or that does not go away.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-800-FDA-1088.
What else should I know about EVISTA?
• Do not use EVISTA to prevent heart disease, heart attack, or
strokes.
•T o
get the
calcium
and
vitam in
D
you
need,
your doctor
m ay
a d vise
you
to
cha n g e
y o u r
d ie t
a n d /o r
take
supplem ental
calcium
and
vitam in
D.
Your doctor
may
suggest other ways to help treat or prevent osteoporosis, in
addition
to taking
EVISTA and
getting the
calcium
and
vitam in
D
you
need.
These
may
include
regular exercise,
stopping smoking, and drinking less alcohol.
•W om en
who
have
hot flashes
can
take
EVISTA.
EVISTA
does not treat hot flashes, and
it may cause hot flashes in
some women.
(See
“What are the possible side effects
of EVISTA?”)
• EVISTA has
not been found to cause breast tenderness or
enlargement. If you notice any changes in your breasts, call
EVISTA® (raloxifene hydrochloride tablets)
PV 3125 AMP
your doctor to find out the cause. Before starting and while
ta k in g
EVISTA
you
s h o u ld
have
b re a s t
exam s
and
mammograms, as directed by your doctor. Because EVISTA
does not eliminate the chance of developing breast cancers,
you
need these examinations to find any breast cancers as
early as possible.
•E V IS TA
should
not
cause
s p o ttin g
o r
m e n stru a l-typ e
bleeding.
If you have any vaginal bleeding, call your doctor
to
fin d
out the
cause.
EVISTA
has
not
been
found
to
increase the risk for cancer of the lining of the uterus.
•W o m e n
in
clin ica l
tria ls
have
taken
EVISTA fo r
up
to
eight years.
How should I store EVISTA?
• Store EVISTA at 68°F to 77°F (20°C-25°C).
•Keep
EVISTA
and
all
m edicines
out
of the
reach
of children.
General Information about
the safe and effective use of EVISTA
Medicines are sometimes prescribed for purposes other than
the ones listed.
Do not use EVISTA for a condition for which
it
was
not prescribed.
Do
not give your EVISTA to other people,
even if they have the same symptoms you have. It may harm them.
This is a sum m ary of the most im portant information about
EVISTA.
If you would
like more information about EVISTA, talk
w ith your doctor.
You
can
ask your doctor or
pharm acist for
information about EVISTA that is written for health professionals.
For more
information,
call
1-800-545-5979
(toll-free)
or go to
the following website: www.evista.com .
*The brands listed are trademarks of their respective owners
and are not trademarks of Eli Lilly and Company. The makers of
these brands are not affiliated with and do not endorse Eli Lilly
and Company or its products.
Literature issued October 30,2008
Eli Lilly and Company,
Indianapolis, IN 46285, USA
Copyright © 1997, 2008, Eli Lilly and Company.
All rights reserved.
Based on Medication Guide PV 3125 AMP
PRINTED IN USA
EVISTA® (raloxifene hydrochloride tablets)
PV 3125 AMP
