• 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.
• Jf you miss 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 tor a Eong time (such as during long trips or
being in bed after surgery) car 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
“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 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
“What 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.
Call your doctor for medical advice about side effects. You may
report side effects to FDA at 1-8O0-FDA-1083.
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
“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
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).
•K eep
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 Ell 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.
Ail rights reserved.
Based on Medication Guide PV 3125 AMP PRINTED IN USA
EVISTA® (raloxifene hydrochloride tablets)
PV 3125 AMP
