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PATIENT INFORMATION
ACIPHEX (a-se-feks)
(rabeprazole sodium)
Delayed-Release Tablets
Read
the
Patient
Information that comes with
ACIPHEX
before you
start
taking
it
and
each
time
you
get
a
refill.
There
may
be
new
information. This leaflet does not take the place
of talking to your healthcare provider about your
medical condition or treatment.
What is ACIPHEX?
ACIPHEX
is
a
medicine called
a
proton
pump
inhibitor or an “acid pump inhibitor". This means
it reduces the
amount of acid that is made by
your stomach. ACIPHEX is used in adults:
•
for the short-term (4 to 8 weeks) treatment
in
the
healing
and
symptom
relief
of
damaging
(erosive)
Gastroesophageal
Reflux Disease (GERD).
•
to maintain healing of damage (erosions) and
relief
of
heartburn
symptoms
with
GERD.
ACIPHEX has not been studied for treatment
lasting longer than 12 months (1 year).
•
for the treatment of daytime and
nighttime
heartburn and other symptoms that happen
with GERD.
•
for short-term treatment (up to 4 weeks) in
the
healing
and
relief
of
stomach-area
(duodenal) ulcers. The duodenal area is the
area where food passes when it leaves the
stomach. The main symptom of a duodenal
ulcer is a steady pain in the stomach area.
•
with
certain
antibiotic
medicines
for
the
treatment of an infection caused by bacteria
called
H.
pylori.
Sometimes
H.
pylori
bacteria
can
cause
duodenal
ulcers.
The
infection needs to be treated to prevent the
ulcers from coming back.
•
for the
long-term
treatment of conditions
where your stomach makes too much acid.
This includes a condition called
Zollinger-
Ellison syndrome.
ACIPHEX is used in adolescents 12 years otage
and above:
•
for the short-term (up to 8 weeks) treatment
of GERD.
•
The
safety
and
effectiveness
of
AC!PHEX
has not been established for children under
the age of 12.
Who should rot take ACIPHEX?
Do not take ACIPHEX if you:
•
are
allergic
to
any
of
the
ingredients
in
ACIPHEX.
See the end of this leaflet for a
complete list of ingredients in ACIPHEX.
•
are
allergic
to
any
other
Proton
Pump
inhibitor (PPI) medicine.
What
should
l
tell
my
doctor
before
I
take
ACIPHEX?
Tell
your
doctor
about
all
of
your
medical
conditions, including if you:
•
have any liver problems.
•
have any allergies.
•
are
pregnant
or
planning
to
become
pregnant.
It is
not
known
if ACIPHEX can
harm your unborn baby.
•
are
breastfeeding.
It
is
not
known
if
ACIPHEX passes into your breast milk or if
it can harm your baby. You should choose
to
breastfeed
or
take
ACIPHEX,
but
not
both. Talk to your doctor about other ways
to feed your baby while taking ACIPHEX.
Tell
your doctor about all the
medicines you
take,
including
prescription
and
non-
prescription
medicines,
vitamins
and
herbal
supplements. ACIPHEX and certain medicines
can
affect each
other.
This can cause serious
side effects. Know the medicines that you take.
Keep a list of them with you and show it to your
doctor when you get a new medicine. Be sure to
tell your doctor if you are taking:
•
atazanavir (Reyataz)
•
cyclosporine (Sandimmune, Neoral}
•
digoxin (Lanoxin)
•
ketoconazole (Nizoral)
•
warfarin (Coumadin)
•
antibiotics
How should I take ACIPHEX?
•
Take ACIPHEX exactly as
prescribed. Your
doctor will prescribe the dose that is right
for you and your medical condition. Do not
change your dose or stop taking ACfPHEX
unless
you
talk
to
your
doctor.
Take
ACIPHEX for as long as it is prescribed even
if you feel better.
•
ACIPHEX is usually taken once a day. Your
doctor will tell you the time of day to take
ACIPHEX, based on your medical condition.
•
ACIPHEX can be taken with or without food.
Your healthcare provider will tell you whether
to take this
medicine with or without food
based on your medical condition.
•
Swallow
each ACIPHEX tablet whole with
water.
Do
not
chew,
crush,
or
split
ACIPHEX tablets because this will damage
the tablet and the medicine will
not work.
Tell
your
doctor
if
you
cannot
swallow
tablets
whole.
You
may
need
a
different
medicine.
•
If you miss a dose of ACfPHEX, take it as
soon as possible. If it is almost time for
your next dose, skip the missed dose and
go back to your normal schedule. Do
not
take 2 doses at the same time.
•
If you take
too
much
ACIPHEX,
call
your
doctor or Poison Control Center right away,
or go to the emergency department.
•
Your
doctor
may
prescribe
antibiotic
medicines
with
ACIPHEX
to
help
treat
a
stomach
infection
and
heal
stomach-area
(duodenal)
ulcers
that
are
caused
by
bacteria
called
H.
pylori.
Make
sure
you
read
the
patient
information
that
comes
with an antibiotic before you start taking it.
What
are
the
possible
side
effects
ot
ACIPHEX?
ACIPHEX,
like
other proton pump
inhibitors,
may cause serious allergic reactions. See the
end
of
this
leaflet
for
a
complete
list
of
ingredients in ACIPHEX.
The
most common side effects with
ACIPHEX
may include:
•
headache
• flatulence
•
pain
* infection
•
pharyngitis
• constipation
These are
not all
the side
effects of ACIPHEX.
For
more
information,
ask
your
doctor
or
pharmacist.
Call your healthcare provider for medical advice
about side effects. You may report side effects
to FDA at 1-800-FDA-1088.
How should I store ACIPHEX?
*
Store
ACIPHEX
in
a
dry
place
at
room
temperature, 59°F to 86®F (15°C to 30°C).
*
Keep
ACIPHEX and all
medicines out of
the reach of children.
General Information about ACIPHEX
Medicines
are
sometimes
prescribed
for
conditions other than those described in patient
information
leaflets.
Do
not
use ACIPHEX
for
any condition for which it was not prescribed by
your
doctor.
Do
not
give
ACIPHEX
to
other
people, even if they have the same symptoms as
you. It may harm them.
This
leaflet
summarizes
the
most
important
information
about ACIPHEX.
If you
would
like
more
information,
talk
to
your
doctor.
You
can
also
ask
your
doctor
or
pharmacist
for
information
about
ACIPHEX
that
is
written
for
healthcare
professionals.
For
full
product
information,
visit
the
website
at
attp://www.aciphex.com/
or
call
the
toll-free
numbers 1 -888-4-ACIPHEX or 1 -800 JANSSEN.
Wbat are the ingredients in ACIPHEX?
Active Ingredient: rabeprazole sodium
Inactive
ingredients
of
the
20
mg
tablet
are
carnauba
wax,
crospovidone,
diacetyiated
monoglycerides,
ethylcellulose,
hydroxypropyl
cellulose,
hyprotmeliose
phthalate,
magnesium
stearate,
mannitol,
propylene
glycol,
sodium
hydroxide,
sodium
stearyl
fumarate,
talc,
and
titanium
dioxide.
Iron
oxide
yellow
is
the
coloring agent for the tablet coating. Iron oxide
red is the ink pigment.
The following are registered trademarks of their
respective
manufacturers:
Reyataz
(Bristol-
Myers
Squibb
Company).
Sandimmune
and
Neoral (Novartis Pharmaceuticals Corporation),
Lanoxin
(GlaxoSmithKline),
Nizoral
(Janssen
Pharmaceutica
Products,
LP),
and
Coumadin
(Bristol-Myers Squibb Company).
What is GERD?
Your
stomach
needs
acid
to
help
your
body
digest food. Stomach acid is made by tiny acid
pumps
in
the
cells that line your stomach.
If
your
body
makes
too
much
acid
or
cannot
protect itself against a normal amount of acid,
medical problems such as GERD can happen.
GERD happens
when
acid
in
your
stomach
backs
up
into
the
tube
(esophagus)
that
connects
your
mouth
to
your
stomach.
Stomach acid can damage (erode) the lining of
your esophagus. Some symptoms of GERD are
heartburn, sour taste in the back of your throat
and burping.
For prescription only
Revised January 2009
ACIPHEX is a registered trademark of
Eisai Co., Ltd., Tokyo, Japan.
Manufactured and Marketed by Eisai Inc.,
Woodcliff Lake, NJ 07677
Marketed by PRICARA,
Division of Ortho-McNeil-Janssen
Pharmaceuticals, Inc.,
Raritan, NJ 08869
AC0109P
