IMPORTANT
INFORMATION
ABOUT
VIMOVO
P l e a s e r e a d t h i s s u m m a r y c a r e f u l l y . It d o e s n o t t a k e t h e p l a c e o f d i s c u s s i o n s w i t h y o u r d o c t o r
a b o u t t h e f u l l P r e s c r i b i n g I n f o r m a t i o n f o r V I M O V O a n d w h e t h e r t h i s d r u g i s r i g h t f o r y o u .
WHAT IS THE MOST
IMPORTANT INFORMATION
I SHOULD KNOW ABOUT
VIMOVO?
VIMOVO, which contains naproxen
[a nonsteroidal anti-inflammatory
drug (NSAID)] and esomeprazole
magnesium [a proton pump
inhibitor (PPI)], may increase the
chance of a heart attack or stroke
that can lead to death. This chance
increases
•
with longer use of NSAID
medicines
•
in people who have heart disease
NSAID medicines should never be
used right before or after a heart
surgery called a coronary artery
bypass graft (CABG).
NSAID medicines can cause ulcers
and bleeding in the stomach
and intestines at any time during
treatment. Ulcers and bleeding
•
can happen without warning
symptoms
•
may cause death
The chance of a person getting an
ulcer or bleeding increases with
•
taking medicines called steroid
hormones and blood thinners
•
longer use
•
smoking
•
drinking alcohol
•
older age
•
having poor health
NSAID medicines should only be
used
•
exactly as prescribed
•
at the lowest dose possible for
your treatment
•
for the shortest time needed
WHAT ARE THE POSSIBLE
SIDE EFFECTS OF NSAIDS?
Serious side effects include
heart attack
stroke
high blood pressure
heart failure from body swelling
(fluid retention)
kidney problems including kidney
failure
bleeding and ulcers in the stomach
and intestine
low red blood cells (anemia)
life-threatening skin reactions
life-threatening allergic reactions
liver problems including liver failure
asthma attacks in people who
have asthma
Other side effects include
stomach pain
constipation
diarrhea
gas
heartburn
nausea
vomiting
dizziness
Get emergency help right away
if you have any of the following
symptoms
•
shortness of breath or trouble
breathing
•
chest pain
•
weakness in one part or side of
your body
•
slurred speech
•
swelling of the face or throat
Stop your NSAID medicine and call
your health care provider right away
if you have any of the following
symptoms
•
nausea
•
more tired or weaker than usual
•
itching
•
your skin or eyes look yellow
•
stomach pain
•
flu-like symptoms
•
vomit blood
•
there is blood in your bowel
movement or it is black and sticky
like tar
•
skin rash or blisters with fever
•
unusual weight gain
•
swelling of the arms and legs,
hands and feet
These are not all the possible side
effects with NSAIDs.
WHAT IS VIMOVO?
VIMOVO is a prescription medicine
used to
•
relieve signs and symptoms of
osteoarthritis, rheumatoid arthritis,
and ankylosing spondylitis
•
decrease the risk of developing
stomach (gastric) ulcers in people
who are at risk of developing gastric
ulcers with NSAIDs
It is not known if VIMOVO is safe or
effective in children under the age of 18.
WHO SHOULD NOT TAKE
VIMOVO?
Do not take VIMOVO
•
If you had an asthma attack, hives,
or other allergic reaction after taking
aspirin or other NSAID medicine
•
If you are allergic to any of the
ingredients in VIMOVO
•
If you are allergic to any other PPI
medicine
•
For pain right before or after heart
bypass surgery
•
If you are in the third trimester
of pregnancy
WHAT SHOULD I TELL MY
HEALTH CARE PROVIDER
BEFORE TAKING VIMOVO?
Before you take VIMOVO, tell
your health care provider about
all your medical conditions and all
the medicines you take, including
prescription and non-prescription,
vitamins, and herbal supplements.
Talk to your health care provider before
taking any other NSAID-containing
products.
•
Using VIMOVO with other medicines
can cause serious side effects
•
Talk to your health care provider if
you are pregnant or breast-feeding.
NSAID medicine should not be
used by pregnant women late in
their pregnancy
HOW SHOULD I TAKE VIMOVO?
•
Take VIMOVO at least 30 minutes
before a meal
•
Swallow VIMOVO tablets whole with
liquid. Do not split, chew, crush, or
dissolve the VIMOVO tablet
•
You may use antacids while taking
VIMOVO
•
Do not change your dose or stop
VIMOVO without first talking to your
health care provider
•
If you forget to take a dose of
VIMOVO, take it as soon as you
remember. If it is almost time for
your next dose, do not take the
missed dose. Take the next dose
on time. Do not take 2 doses at one
time to make up for a missed dose
•
If you take too much VIMOVO, tell
your health care provider, go to the
closest hospital emergency room
right away, or call your Poison
Control Center at 1-800-222-1222
WHAT ARE THE POSSIBLE
SIDE EFFECTS OF VIMOVO?
Serious side effects may include
•
High blood pressure
•
Heart problems
such as
congestive heart failure, heart
attack, or stroke
•
Active bleeding
•
Serious allergic reactions
•
Serious skin reactions
•
Liver problems
•
Bone fracture
Tell your health care provider or get
emergency help right away if you
have any of the following symptoms
•
chest pain, weakness, or slurred
speech
•
trouble breathing or wheezing
•
swelling of face, throat, or body
•
severe skin blisters or peeling
•
blood in your bowel movement or
it is black and sticky like tar
•
yellowing of skin or eyes
The most common side effects of
VIMOVO include
•
inflammation of the lining of the
stomach
•
indigestion
•
diarrhea
•
stomach ulcers
•
stomach pain
•
nausea
These are not all the possible side
effects of VIMOVO. Call your health
care provider for medical advice
about side effects.
You may report side effects to the
FDA at 1-800-FDA-1088.
OTHER INFORMATION ABOUT NONSTEROIDAL
ANTI-INFLAMMATORY DRUGS (NSAIDS)
• Aspirin is an NSAID medicine but it does not increase the chance of a heart
attack. Aspirin can cause bleeding in the brain, stomach, and intestines.
Aspirin can also cause ulcers in the stomach and intestines
• Some of these NSAID medicines are sold in lower doses without a
prescription (over-the-counter). Talk to your health care provider before
using over-the-counter NSAIDs for more than 10 days
NSAID medicines that need a prescription
Generic Name
Trade Name
Celecoxib
Celebrex
Diclofenac
Cataflam, Voltaren, Arthrotec (combined with
misoprostol)
Diflunisal
Dolobid
Etodolac
Lodine, Lodine XL
Fenoprofen
Nalfon, Nalfon 200
Flurbiprofen
Ansaid
Ibuprofen
Motrin, Tab-Profen, Vicoprofen* (combined with
hydrocodone), Combunox (combined with oxycodone)
Indomethacin
Indocin, Indocin SR, Indo-Lemmon, Indomethagan
Ketoprofen
Oruvail
Ketorolac
Toradol
Mefenamic Acid
Ponstel
Meloxicam
Mobic
Nabumetone
Relafen
Naproxen
Naprosyn, Anaprox, Anaprox DS, EC-Naproxyn,
Naprelan, VIMOVO
Oxaprozin
Daypro
Piroxicam
Feldene
Sulindac
Clinoril
Tolmetin
Tolectin, Tolectin DS, Tolectin 600
* Vicoprofen contains the same dose of ibuprofen as over-the-counter (OTC) NSAIDs, and is usually used for
less than 10 days to treat pain. The OTC NSAID label warns that long-term continuous use may increase the
risk of heart attack or stroke.
For more information, call 1-800-236-9933 or go to www.VIMOVO.com
VIMOVO is a trademark of the AstraZeneca group of companies.
Other trademarks are the property of their respective companies.
© 2011 AstraZeneca LP, Wilmington, DE 19850
1082704 2/11
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