MEDICATION GUIDE XARELTO (zah-rel-te) (rivarxaban) tablets Read this Medicatin Guide befre yu start taking XARELTO and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking with yur dctr abut yur medical cnditin r yur treatment. What is the mst imprtant infrmatin I shuld knw abut XARELTO? Fr peple taking XARELTO fr atrial fibrillatin: Peple with atrial fibrillatin (an irregular heart beat) are at an increased risk f frming a bld clt in the heart, which can travel t the brain, causing a strke, r t ther parts f the bdy. XARELTO lwers yur chance f having a strke by helping t prevent clts frm frming. If yu stp taking XARELTO, yu may have increased risk f frming a clt in yur bld. D nt stp taking XARELTO withut talking t the dctr wh prescribes it fr yu. Stpping XARELTO increases yur risk f having a strke. If yu have t stp taking XARELTO, yur dctr may prescribe anther bld thinner medicine t prevent a bld clt frm frming. XARELTO can cause bleeding which can be serius, and rarely may lead t death. This is because XARELTO is a bld thinner medicine that reduces bld cltting. While yu take XARELTO yu are likely t bruise mre easily and it may take lnger fr bleeding t stp. Yu may have a higher risk f bleeding if yu take XARELTO and take ther medicines that increase yur risk f bleeding, including: aspirin r aspirin cntaining prducts nn-steridal anti-inflammatry drugs (NSAIDs) warfarin sdium (Cumadin, Jantven ) any medicine that cntains heparin clpidgrel (Plavix ) ther medicines t prevent r treat bld clts Tell yur dctr if yu take any f these medicines. Ask yur dctr r pharmacist if yu are nt sure if yur medicine is ne listed abve. Call yur dctr r get medical help right away if yu develp any f these signs r symptms f bleeding: unexpected bleeding r bleeding that lasts a lng time, such as: nse bleeds that happen ften unusual bleeding frm the gums menstrual bleeding that is heavier than nrmal r vaginal bleeding 41
bleeding that is severe r yu cannt cntrl red, pink r brwn urine bright red r black stls (lks like tar) cugh up bld r bld clts vmit bld r yur vmit lks like cffee grunds headaches, feeling dizzy r weak pain, swelling, r new drainage at wund sites Spinal r epidural bld clts (hematma). Peple wh take a bld thinner medicine (anticagulant) like XARELTO, and have medicine injected int their spinal and epidural area, r have a spinal puncture have a risk f frming a bld clt that can cause lng-term r permanent lss f the ability t mve (paralysis). Yur risk f develping a spinal r epidural bld clt is higher if: a thin tube called an epidural catheter is placed in yur back t give yu certain medicine yu take NSAIDs r a medicine t prevent bld frm cltting yu have a histry f difficult r repeated epidural r spinal punctures yu have a histry f prblems with yur spine r have had surgery n yur spine If yu take XARELTO and receive spinal anesthesia r have a spinal puncture, yur dctr shuld watch yu clsely fr symptms f spinal r epidural bld clts. Tell yur dctr right away if yu have back pain, tingling, numbness, muscle weakness (especially in yur legs and feet), lss f cntrl f the bwels r bladder (incntinence). XARELTO is nt fr patients with artificial heart valves. See What are the pssible side effects f XARELTO? fr mre infrmatin abut side effects. What is XARELTO? XARELTO is a prescriptin medicine used t: reduce the risk f strke and bld clts in peple wh have a medical cnditin called atrial fibrillatin. With atrial fibrillatin, part f the heart des nt beat the way it shuld. This can lead t the frmatin f bld clts, which can travel t the brain, causing a strke, r t ther parts f the bdy. treat bld clts in the veins f yur legs (deep vein thrmbsis) r lungs (pulmnary emblism) and reduce the risk f them ccurring again reduce the risk f frming a bld clt in the legs and lungs f peple wh have just had hip r knee replacement surgery It is nt knwn if XARELTO is safe and effective in children. 42
Wh shuld nt take XARELTO? D nt take XARELTO if yu: currently have certain types f abnrmal bleeding. Talk t yur dctr befre taking XARELTO if yu currently have unusual bleeding. are allergic t rivarxaban r any f the ingredients in XARELTO. See the end f this leaflet fr a cmplete list f ingredients in XARELTO. What shuld I tell my dctr befre taking XARELTO? Befre yu take XARELTO, tell yur dctr if yu: have ever had bleeding prblems have liver r kidney prblems have any ther medical cnditin are pregnant r plan t becme pregnant. It is nt knwn if XARELTO will harm yur unbrn baby. Tell yur dctr right away if yu becme pregnant while taking XARELTO. If yu take XARELTO during pregnancy tell yur dctr right away if yu have any bleeding r symptms f bld lss. are breastfeeding r plan t breastfeed. It is nt knwn if XARELTO passes int yur breast milk. Yu and yur dctr shuld decide if yu will take XARELTO r breastfeed. Tell all f yur dctrs and dentists that yu are taking XARELTO. They shuld talk t the dctr wh prescribed XARELTO fr yu befre yu have any surgery, medical r dental prcedure. Tell yur dctr abut all the medicines yu take, including prescriptin and nnprescriptin medicines, vitamins, and herbal supplements. Sme f yur ther medicines may affect the way XARELTO wrks. Certain medicines may increase yur risk f bleeding. See What is the mst imprtant infrmatin I shuld knw abut XARELTO? Especially tell yur dctr if yu take: ketcnazle (Nizral ) itracnazle (Onmel, Spranx ) ritnavir (Nrvir ) lpinavir/ritnavir (Kaletra ) indinavir (Crixivan ) carbamazepine (Carbatrl, Equetr, Tegretl, Tegretl -XR, Teril, Epitl ) phenytin (Dilantin-125, Dilantin ) phenbarbital (Slftn ) rifampin (Rifater, Rifamate, Rimactane, Rifadin ) St. Jhn s wrt (Hypericum perfratum) Ask yur dctr if yu are nt sure if yur medicine is ne listed abve. 43
Knw the medicines yu take. Keep a list f them t shw yur dctr and pharmacist when yu get a new medicine. Hw shuld I take XARELTO? Take XARELTO exactly as prescribed by yur dctr. D nt change yur dse r stp taking XARELTO unless yur dctr tells yu t. Yur dctr will tell yu hw much XARELTO t take and when t take it. Yur dctr may change yur dse if needed. If yu take XARELTO fr: atrial fibrillatin: Take XARELTO 1 time a day with yur evening meal. If yu miss a dse f XARELTO, take it as sn as yu remember n the same day. Take yur next dse at yur regularly scheduled time. bld clts in the veins f yur legs r lungs: Take XARELTO nce r twice a day as prescribed by yur dctr. Take XARELTO with fd at the same time each day. If yu miss a dse f XARELTO: and take XARELTO 2 times a day: Take XARELTO as sn as yu remember n the same day. Yu may take 2 dses at the same time t make up fr the missed dse. Take yur next dse at yur regularly scheduled time. and take XARELTO 1 time a day: Take XARELTO as sn as yu remember n the same day. Take yur next dse at yur regularly scheduled time. hip r knee replacement surgery: Take XARELTO 1 time a day with r withut fd. If yu miss a dse f XARELTO, take it as sn as yu remember n the same day. Take yur next dse at yur regularly scheduled time. If yu have difficulty swallwing the tablet whle, talk t yur dctr abut ther ways t take XARELTO. Yur dctr will decide hw lng yu shuld take XARELTO. D nt stp taking XARELTO withut talking with yur dctr first. Yur dctr may stp XARELTO fr a shrt time befre any surgery, medical r dental prcedure. Yur dctr will tell yu when t start taking XARELTO again after yur surgery r prcedure. 44
D nt run ut f XARELTO. Refill yur prescriptin f XARELTO befre yu run ut. When leaving the hspital fllwing a hip r knee replacement, be sure that yu will have XARELTO available t avid missing any dses. If yu take t much XARELTO, g t the nearest hspital emergency rm r call yur dctr right away. What are the pssible side effects f XARELTO? See What is the mst imprtant infrmatin I shuld knw abut XARELTO? Tell yur dctr if yu have any side effect that bthers yu r that des nt g away. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at 1-800-FDA-1088. Hw shuld I stre XARELTO? Stre XARELTO at rm temperature between 68F t 77F (20 t 25C). Keep XARELTO and all medicines ut f the reach f children. General infrmatin abut XARELTO. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use XARELTO fr a cnditin fr which it was nt prescribed. D nt give XARELTO t ther peple, even if they have the same cnditin. It may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut XARELTO. If yu wuld like mre infrmatin, talk with yur dctr. Yu can ask yur pharmacist r dctr fr infrmatin abut XARELTO that is written fr health prfessinals. Fr mre infrmatin call 1-800-526-7736 r g t www.xarelto-us.cm. What are the ingredients in XARELTO? Active ingredient: rivarxaban Inactive ingredients: crscarmellse sdium, hyprmellse, lactse mnhydrate, magnesium stearate, micrcrystalline cellulse, and sdium lauryl sulfate. The prprietary film cating mixture fr XARELTO 10 mg tablets is Opadry Pink and cntains: ferric xide red, hyprmellse, plyethylene glycl 3350, and titanium dixide. The prprietary film cating mixture fr XARELTO 15 mg tablets is Opadry Red and cntains: ferric xide red, hyprmellse, plyethylene glycl 3350, and titanium dixide. 45
The prprietary film cating mixture fr XARELTO 20 mg tablets is Opadry II Dark Red and cntains: ferric xide red, plyethylene glycl 3350, plyvinyl alchl (partially hydrlyzed), talc, and titanium dixide. This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Finished Prduct Manufactured by: Janssen Orth, LLC Gurab, PR 00778 r Bayer Pharma AG 51368 Leverkusen, Germany Manufactured fr: Janssen Pharmaceuticals, Inc. Titusville, NJ 08560 Licensed frm: Bayer HealthCare AG 51368 Leverkusen, Germany Revised: December 2014 Janssen Pharmaceuticals, Inc. 2011 Trademarks are prperty f their respective wners. 46