Medication Guide Plavix PLAV iks clopidogrel bisulfate

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					            Medication Guide                                PLAVIX® (clopidogrel bisulfate)
           Plavix® (PLAV-iks)
         (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)	
      h
	 •	 	 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	
     y                                                   c
                                                    	 •	 	 urrently	have	a	condition	that	causes	
     bleeds                                              bleeding,	such	as	a	stomach	ulcer	
	 •	 	t	will	take	longer	for	any	bleeding	to	
     i                                                   a
                                                    	 •	 	 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)

     a
	 •	 	 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	
     a
	 •	 	 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.
                                                         T
                                                    	 •	 	 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	
     a                                                   A
                                                    	 •	 	 	 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
                                                            the skin
     D
	 •	 	 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?
       f
	 	 •	 	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	
       l
	 	 •	 	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
                                                    Administration.
	 	 •	 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	
     S
	 •	 	 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.

				
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posted:8/9/2011
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