You may have a higher risk of bleeding if you take warfarin sodium tablets and:

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1 MEDICATION GUIDE Warfarin (WAR-far-in) Sdium (SO-dee-um) Tablets USP The 7.5 mg tablets cntain FD&C Yellw N. 5 (tartrazine), which may cause allergic-type reactins (including brnchial asthma) in certain susceptible individuals. Althugh the verall incidence f FD&C Yellw N. 5 (tartrazine) sensitivity in the general ppulatin is lw, it is frequently seen in patients wh als have aspirin hypersensitivity. Read this Medicatin Guide befre yu start taking warfarin sdium tablets and each time yu get a refill. There may be new infrmatin. This Medicatin Guide des nt take the place f talking t yur healthcare prvider abut yur medical cnditin r treatment. Yu and yur healthcare prvider shuld talk abut warfarin sdium when yu start taking it and at regular checkups. What is the mst imprtant infrmatin I shuld knw abut warfarin sdium tablets? Warfarin sdium tablets can cause bleeding which can be serius and smetimes lead t death. This is because warfarin sdium tablets are a bld thinner medicine that lwers the chance f bld clts frming in yur bdy. Yu may have a higher risk f bleeding if yu take warfarin sdium tablets and: are 65 years f age r lder have a histry f stmach r intestinal bleeding have high bld pressure (hypertensin) have a histry f strke, r mini-strke (transient ischemic attack r TIA) have serius heart disease have a lw bld cunt r cancer have had trauma, such as an accident r surgery have kidney prblems take ther medicines that increase yur risk f bleeding, including: a medicine that cntains heparin ther medicines t prevent r treat bld clts nn-steridal anti-inflammatry drugs (NSAIDs) take warfarin sdium fr a lng time. Warfarin sdium is the active ingredient in warfarin sdium tablets. Tell yur healthcare prvider if yu take any f these medicines. Ask yur healthcare prvider if yu are nt sure if yur medicine is ne listed abve. Many ther medicines can interact with warfarin sdium tablets and affect the dse yu need r increase warfarin sdium tablets side effects. D nt change r stp any f yur medicines r start any new medicines befre yu talk t yur healthcare prvider. D nt take ther medicines that cntain warfarin sdium while taking warfarin sdium tablets. Get yur regular bld test t check fr yur respnse t warfarin sdium tablets. This bld test is called an INR test. The INR test checks t see hw fast yur bld clts. Yur healthcare prvider

2 will decide what INR numbers are best fr yu. Yur dse f warfarin sdium tablets will be adjusted t keep yur INR in a target range fr yu. Call yur healthcare prvider right away if yu get any f the fllwing signs r symptms f bleeding prblems: pain, swelling, r discmfrt headaches, dizziness, r weakness unusual bruising (bruises that develp withut knwn cause r grw in size) nsebleeds bleeding gums bleeding frm cuts takes a lng time t stp menstrual bleeding r vaginal bleeding that is heavier than nrmal pink r brwn urine red r black stls cughing up bld vmiting bld r material that lks like cffee grunds Sme fds and beverages can interact with warfarin sdium tablets and affect yur treatment and dse. Eat a nrmal, balanced diet. Talk t yur healthcare prvider befre yu make any diet changes. D nt eat large amunts f leafy, green vegetables. Leafy, green vegetables cntain vitamin K. Certain vegetable ils als cntain large amunts f vitamin K. T much vitamin K can lwer the effect f warfarin sdium tablets. Always tell all f yur healthcare prviders that yu take warfarin sdium tablets. Wear r carry infrmatin that yu take warfarin sdium tablets. See What are the pssible side effects f warfarin sdium tablets? fr mre infrmatin abut side effects. What are warfarin sdium tablets? Warfarin sdium tablets are prescriptin medicine used t treat bld clts and t lwer the chance f bld clts frming in yur bdy. Bld clts can cause a strke, heart attack, r ther serius cnditins if they frm in the legs r lungs. Wh shuld nt take warfarin sdium tablets? D nt take warfarin sdium tablets if: yur chance f having bleeding prblems is higher than the pssible benefit f treatment. Yur healthcare prvider will decide if warfarin sdium tablets are right fr yu. Talk t yur healthcare prvider abut all f yur health cnditins. yu are pregnant unless yu have a mechanical heart valve. Warfarin sdium tablets may cause birth defects, miscarriage, r death f yur unbrn baby. yu are allergic t warfarin r any f the ther ingredients in warfarin sdium tablets. See the end f this leaflet fr a cmplete list f ingredients in warfarin sdium tablets. What shuld I tell my healthcare prvider befre taking warfarin sdium tablets? Befre yu take warfarin sdium tablets, tell yur healthcare prvider if yu:

3 have bleeding prblems fall ften have liver r kidney prblems have high bld pressure have a heart prblem called cngestive heart failure have diabetes plan t have any surgery r a dental prcedure have any ther medical cnditins are pregnant r plan t becme pregnant. See Wh shuld nt take warfarin sdium tablets? Yur healthcare prvider will d a pregnancy test befre yu start treatment with warfarin sdium tablets. Females wh can becme pregnant shuld use effective birth cntrl during treatment, and fr at least 1 mnth after the last dse f warfarin sdium tablets. are breastfeeding. Yu and yur healthcare prvider shuld decide if yu will take warfarin sdium tablets and breastfeed. Check yur baby fr bruising r bleeding if yu take warfarin sdium tablets and breastfeed. Tell all f yur healthcare prviders and dentists that yu are taking warfarin sdium tablets. They shuld talk t the healthcare prvider wh prescribed warfarin sdium tablets fr yu befre yu have any surgery r dental prcedure. Yur warfarin sdium tablets may need t be stpped fr a shrt time r yu may need yur dse adjusted. Tell yur healthcare prvider abut all the medicines yu take, including prescriptin and ver-thecunter medicines, vitamins, and herbal supplements. Sme f yur ther medicines may affect the way warfarin sdium tablets wrk. Certain medicines may increase yur risk f bleeding. See What is the mst imprtant infrmatin I shuld knw abut warfarin sdium tablets? Knw the medicines yu take. Keep a list f them t shw yur healthcare prvider and pharmacist when yu get a new medicine. Hw shuld I take warfarin sdium tablets? Take warfarin sdium tablets exactly as prescribed. Yur healthcare prvider will adjust yur dse frm time t time depending n yur respnse t warfarin sdium tablets. Yu must have regular bld tests and visits with yur healthcare prvider t mnitr yur cnditin. If yu miss a dse f warfarin sdium tablets, call yur healthcare prvider. Take the dse as sn as pssible n the same day. D nt take a duble dse f warfarin sdium tablets the next day t make up fr a missed dse. Call yur healthcare prvider right away if yu: take t much warfarin sdium tablets are sick with diarrhea, an infectin, r have a fever fall r injure yurself, especially if yu hit yur head. Yur healthcare prvider may need t check yu. What shuld I avid while taking warfarin sdium tablets?

4 D nt d any activity r sprt that may cause a serius injury. What are the pssible side effects f warfarin sdium tablets? Warfarin sdium tablets may cause serius side effects including: Tell yur healthcare prvider if yu have any side effect that bthers yu r des nt g away. These are nt all f the side effects f warfarin sdium tablets. Fr mre infrmatin, ask yur healthcare prvider r pharmacist. Call yur dctr fr medical advice abut side effects. Yu may reprt side effects t FDA at FDA Hw shuld I stre warfarin sdium tablets? See What is the mst imprtant infrmatin I shuld knw abut warfarin sdium tablets? Death f skin tissue (skin necrsis r gangrene). This can happen sn after starting warfarin sdium tablets. It happens because bld clts frm and blck bld flw t an area f yur bdy. Call yur healthcare prvider right away if yu have pain, clr, r temperature change t any area f yur bdy. Yu may need medical care right away t prevent death r lss (amputatin) f yur affected bdy part. Purple tes syndrme. Call yur healthcare prvider right away if yu have pain in yur tes and they lk purple in clr r dark in clr. Stre warfarin sdium tablets at 20 t 25 C (68 t 77 F). Keep warfarin sdium tablets in a tightly clsed cntainer, and keep warfarin sdium tablets ut f the light. Fllw yur healthcare prvider r pharmacist instructins abut the right way t thrw away utdated r unused warfarin sdium tablets. Females wh are pregnant shuld nt handle crushed r brken warfarin sdium tablets. Keep warfarin sdium tablets and all medicines ut f the reach f children. General infrmatin abut warfarin sdium tablets. Medicines are smetimes prescribed fr purpses ther than thse listed in a Medicatin Guide. D nt use warfarin sdium tablets fr a cnditin fr which they were nt prescribed. D nt give warfarin sdium tablets t ther peple, even if they have the same symptms that yu have. They may harm them. This Medicatin Guide summarizes the mst imprtant infrmatin abut warfarin sdium tablets. If yu wuld like mre infrmatin, talk with yur healthcare prvider. Yu can ask yur healthcare prvider r pharmacist fr infrmatin abut warfarin sdium tablets that is written fr health prfessinals. If yu wuld like mre infrmatin, call Teva Pharmaceuticals USA at , and als speak with yur healthcare prvider. What are the ingredients in warfarin sdium tablets? Active ingredient: warfarin sdium Inactive ingredients: cllidal silicn dixide, crscarmellse sdium, lactse mnhydrate, magnesium stearate, and micrcrystalline cellulse. The 1 mg als cntains FD&C red n. 40. The 2 mg als cntains FD&C blue n. 2 aluminum lake and FD&C red n. 40 aluminum lake. The 2.5 mg als cntains D&C yellw n. 10 aluminum lake and FD&C blue n. 1 aluminum lake. The 3 mg als cntains FD&C yellw n. 6 aluminum lake, FD&C blue n. 2 aluminum lake, FD&C red n. 40 aluminum lake, and D&C yellw n. 10 aluminum lake. The 4 mg als cntains FD&C blue n. 1 aluminum lake and FD&C blue n. 2 aluminum lake. The 5 mg als cntains FD&C yellw n. 6 aluminum lake, FD&C red n. 40 aluminum lake and D&C yellw n. 10 aluminum lake. The 6 mg als cntains D&C yellw n. 10 aluminum lake and

5 FD&C blue n. 1 aluminum lake. The 7.5 mg als cntains FD&C yellw n. 5 (tartrazine) aluminum lake and FD&C red n. 40 aluminum lake. Manufactured In Cratia By: PLIVA HRVATSKA d... Zagreb, Cratia Manufactured Fr: TEVA PHARMACEUTICALS USA, INC. Nrth Wales, PA This Medicatin Guide has been apprved by the U.S. Fd and Drug Administratin. Rev. A 11/2015

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