Medication Guide PLAVIX® (clopidogrel bisulfate)
(clopidogrel bisulfate) Do not stop taking Plavix without talking
tablets to the doctor who prescribes it for you.
People who are treated with a stent, and
stop taking Plavix too soon, have a higher
Read this Medication Guide before you
risk of getting a blood clot on the stent,
start taking Plavix and each time you get
having a heart attack, or dying. If you
a refill. There may be new information.
must stop Plavix because of bleeding,
This Medication Guide does not take the
your risk of a heart attack may be higher.
place of talking with your doctor about
your medical condition or your treatment. What is Plavix?
What is the most important Plavix is a prescription medicine used
information I should know about to treat people who have any of the
Plavix (clopidogrel bisulfate)? following:
• chest pain due to heart problems
1. Plavix may not work as well in p
• oor circulation in their legs
people who: (peripheral arterial disease)
• ave certain genetic factors that • a heart attack
affect how the body breaks down • a stroke
Plavix. Your doctor may do genetic
tests to make sure Plavix is right for Plavix is used alone or with aspirin to
you. lower your chance of having another
• ake certain medicines, especially
t serious problem with your heart or blood
omeprazole (Prilosec ®). Your vessels such as heart attack, stroke, or
doctor may change the medicine you blood clot that can lead to death.
take for stomach acid problems while Platelets are blood cells that help your
you take Plavix. blood clot normally. Plavix helps to
2. Plavix can cause bleeding which prevent platelets from sticking together
can be serious and can sometimes and forming a clot that can block an
lead to death. Plavix is a blood thinner artery.
medicine that lowers the chance of It is not known if Plavix is safe and
blood clots forming in your body. While effective in children.
you take Plavix:
• ou may bruise and bleed more
y Who should not take Plavix?
easily Do not take Plavix if you:
• ou are more likely to have nose
• urrently have a condition that causes
bleeds bleeding, such as a stomach ulcer
• t will take longer for any bleeding to
• re allergic to clopidogrel or other
stop ingredients in Plavix. See the end
of this leaflet for a complete list of
Call your doctor right away if you have any ingredients in Plavix.
of these signs or symptoms of bleeding:
• nexpected bleeding or bleeding that
u What should I tell my doctor before
lasts a long time taking Plavix?
• lood in your urine (pink, red or
b Before you take Plavix, tell your doctor if
brown urine) you:
• red or black stools (looks like tar) h
• ave a history of bowel (gastro-
• ruises that happen without a known
b intestinal) or stomach ulcers
cause or get larger • have a history of bleeding problems
• cough up blood or blood clots p
• lan to have surgery or a dental
• omit blood or your vomit looks like
v procedure. See “How should I take
coffee grounds Plavix?”
PLAVIX® (clopidogrel bisulfate) PLAVIX® (clopidogrel bisulfate)
• re pregnant or plan to become T
• ake Plavix with aspirin as instructed
pregnant. It is not known if Plavix will by your doctor.
harm your unborn baby Y
• ou can take Plavix with or without
• re breastfeeding or plan to food.
breastfeed. It is not known if Plavix I
• f you miss a dose, take Plavix
passes into your breast milk. You and as soon as you remember. If it is
your doctor should decide if you will almost time for your next dose,
take Plavix or breastfeed. You should skip the missed dose. Take the
not do both without talking to your next dose at your regular time. Do
doctor. not take 2 doses of Plavix at the
Tell all of your doctors and your dentist same time unless your doctor tells
that you are taking Plavix. They should you to.
talk to the doctor who prescribed Plavix I
• f you take too much Plavix, call
for you before you have any surgery or your doctor or go to the nearest
invasive procedure. emergency room right away.
• alk with your doctor about stopping
Tell your doctor about all the your Plavix before you have surgery.
medicines you take, including Your doctor may tell you to stop
prescription, non-prescription medicines, taking Plavix at least 5 days before
vitamins and herbal supplements. you have surgery to avoid excessive
Plavix may affect the way other medicines bleeding during surgery.
work, and other medicines may affect how What are the possible side effects of
Plavix works. See “What is the most Plavix?
important information I should know Plavix can cause serious side effects
about Plavix?” including:
Taking Plavix with certain other medicines S
• ee “What is the most important
may increase your risk of bleeding. information I should know about
Especially tell your doctor if you take: Plavix?”
• spirin, especially if you have had
• blood clotting problem called
a stroke. Always talk to your doctor Thrombotic Thrombocytopenic
about whether you should take Purpura (TTP). TTP can happen
aspirin along with Plavix to treat your with Plavix, sometimes after a short
condition. time (less than 2 weeks). TTP is a
• on-steroidal anti-inflammatory
N blood clotting problem where blood
drugs (NSAIDs). Ask your doctor clots form in blood vessels; and can
or pharmacist for a list of NSAID happen anywhere in the body. TTP
medicines if you are not sure. needs to be treated in a hospital right
• warfarin (Coumadin®, Jantoven®) away, because it may cause death.
Get medical help right away if you
Know the medicines you take. Keep a list have any of these symptoms and
of them to show your doctor or pharmacist they can not be explained by another
when you get a new medicine. medical condition:
How should I take Plavix? p
• urplish spots (called purpura) on
• ake Plavix exactly as your doctor
T the skin or in the mouth (mucous
tells you. membranes) due to bleeding under
• o not change your dose or stop
taking Plavix without talking to your y
• our skin or the whites of your
doctor first. Stopping Plavix may eyes are yellow (jaundice)
increase your risk of heart attack or • you feel tired or weak
stroke. • your skin looks very pale
PLAVIX® (clopidogrel bisulfate) PLAVIX® (clopidogrel bisulfate)
• fever What are the ingredients in Plavix?
• ast heart rate or feeling short of Active ingredient: clopidogrel bisulfate
breath Inactive ingredients:
• headache Tablet: hydrogenated castor oil,
• speech changes hydroxypropylcellulose, mannitol,
• confusion microcrystalline cellulose, polyethylene
• coma glycol 6000
• stroke Film coating: ferric oxide, hypromellose
• seizure 2910, lactose monohydrate, titanium
• ow amount of urine, or urine that dioxide, triacetin, Carnauba wax
is pink or has blood in it
• stomach area (abdominal) pain This Medication Guide has been
approved by the U.S. Food and Drug
• nausea, vomiting, or diarrhea
• vision changes
Issued February 2011
Tell your doctor if you have any side effect
that bothers you or that does not go away.
These are not all the possible side effects Distributed by:
of Plavix. For more information, ask your Bristol-Myers Squibb/Sanofi Pharmaceuticals Partnership
doctor or pharmacist. Bridgewater, NJ 08807
Call your doctor for medical advice about
side effects. You may report side effects to
FDA at 1-800-FDA-1088.
Plavix® is a registered trademark of sanofi-aventis.
How should I store Plavix? Coumadin® is a registered trademark of Bristol-Myers
• tore Plavix at 59°F to 86°F Squibb Pharma Company.
(15°C to 30°C). Prilosec® is a registered trademark of AstraZeneca.
Keep Plavix and all medicines out of Jantoven® is a registered trademark of USL Pharma.
the reach of children.
General information about Plavix
Medicines are sometimes used for purposes
other than those listed in a Medication
Guide. Do not take Plavix for a condition B1-B0001C-05-11 May 2011
for which it was not prescribed. Do not
give Plavix to other people, even if they
have the same symptoms that you have.
It may harm them.
This Medication Guide summarizes the
most important information about Plavix.
If you would like more information, talk to
your doctor. Ask your doctor or pharmacist
for information about Plavix that was
written for healthcare professionals.
For more information, go to
www.sanofi-aventis.us or www.bms.com
or call 1-800-321-1335.