•
Calcium and vitamin D may be taken at the same time
as EVISTA. It is important to take calcium and vitamin D, as
directed by your physician, to prevent or treat osteoporosis.
•
If you m iss a dose, take it as soon as you remember.
However, if it is almost 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?
•
Being still for a long time (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 of blood clots. On long trips, move 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.
•
Some medicines should not be taken with EVISTA (see
“W hat should I tell my doctor before taking EVISTA?” ).
W hat are the possible side effects of EVISTA?
Serious and life-threatening side effects can occur while
taking EVISTA. These include blood clots and dying from stroke:
•
Increased risk of blood clots in the legs (deep vein
thrombosis) and lungs (pulmonary embolism) 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 for a
heart attack may have an increased risk of dying from
stroke when taking EVISTA.
See
“W hat is the most important information I should know
about EVISTA?”
The most common 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 common 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. If you have any problems or questions that concern you
while taking EVISTA, ask your doctor or pharm acist for
more information.
•
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch.
or call 1-800-FDA-1088.
What else should I know about EVISTA?
•
Do not use EVISTA to prevent heart disease, heart attack,
or strokes.
•
To get the calcium and vitamin D you need, your doctor
may
advise you
to
change
your
diet
and/or take
supplemental calcium and vitamin
D.
Your doctor may
suggest other ways to help treat or prevent osteoporosis,
in addition to taking EVISTA and getting the calcium and
vitamin D you need. These may include regular exercise,
stopping smoking, and drinking less alcohol.
•
Women who have hot flashes can take EVISTA. EVISTA
does not treat hot flashes, and it may cause hot flashes in
some women. (See
“W hat are the possible side effects
Of
EVISTA?” )
EVISTA® (raloxifene hydrochloride)
PV 3124 AMP
•
EVISTA has not been found to cause breast tenderness or
enlargement. If you notice any changes in your breasts,
call your doctor to find out the cause. Before starting and
while taking EVISTA you should have breast exams
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.
•
EVISTA should not cause spotting or menstrual-type
bleeding. If you have any vaginal bleeding, call your doctor
to find out the cause. EVISTA has not been found to
increase the risk for cancer of the lining of the uterus.
•
Women in clinical trials have taken EVISTA for 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 summary of the most important information about
EVISTA. If you would like more information about EVISTA, talk
with your doctor. You can ask your doctor or pharmacist 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 September 13, 2007
S & e e y
Eli Lilly and Company,
Indianapolis, IN 46285, USA
Copyright © 1997,2007, Eli Lilly and Company. All rights reserved.
Based on Medication Guide PV 3124 AMP
PRINTED IN USA
EVISTA® (raloxifene hydrochloride)
PV 3124 AMP
