ZYLORIC Written by witri ardini Thursday, 12 June 2008 09:

Nama Obat Komposisi/Nama Generik Kategori Golongan/Kelas terapi Indikasi

ZYLORIC
alopurinol Obat keras Antipirai Keadaan yang berhubungan dengan kelebihan garam urat termasuk artritis gout. Pencegahan & pengobatan batu ginjal Ca pada penderita yang kadar asam urat dalam serum atau urinnya meningkat. Intoleransi saluran cerna Serangan akut artritis gout pada awal terapi. eaksi kulit. !arang" hepatitis granulomatosa. Kadang" trombositopenia" agranulositosis" anemia aplastik pada pasien dengan gangguan #ungsi ginjal. Dewasa $%&' mg(kg())(hari. Kasus ringan &''%$'' mg(hari. Kasus berat maksimal * +'' mg(hari. nak !"# ta$%n &'%$' mg(kg())(hari atau &''% ,'' mg(hari. -ablet &'' mg" .'' mg

Kontraindikasi Efek samping

Dosis/Cara pemakaian

&ediaan

Zy!"ri# Tab!ets 100$%, 00$% Tab!e "& C"ntents

1' ()*+ O, T-+ *+.ICI()L /RO.0CT 2' 10)LIT)TI2+ )(. 10)(TIT)TI2+ CO*/O3ITIO( ' /-)R*)C+0TIC)L ,OR* 4' CLI(IC)L /)RTIC0L)R3 4'1 Thera5euti# indi#ati"ns 4'2 /"s"!"%y and $eth"d "& ad$inistrati"n 4' C"ntraindi#ati"ns 4'4 35e#ia! warnin%s and 5re#auti"ns &"r use 4'6 Intera#ti"n with "ther $edi#ina! 5r"du#ts and "ther &"r$s "& intera#ti"n 4'7 /re%nan#y and !a#tati"n 4'8 +&&e#ts "n abi!ity t" dri9e and use $a#hines 4'8 0ndesirab!e e&&e#ts 4'9 O9erd"se 6' /-)R*)COLO:IC)L /RO/+RTI+3 6'1 /har$a#"dyna$i# 5r"5erties 6'2 /har$a#";ineti# 5r"5erties

6' /re#!ini#a! sa&ety data 7' /-)R*)C+0TIC)L /)RTIC0L)R3 7'1 List "& e<#i5ients 7'2 In#"$5atibi!ities 7' 3he!& !i&e 7'4 35e#ia! 5re#auti"ns &"r st"ra%e 7'6 (ature and #"ntents "& #"ntainer 7'7 35e#ia! 5re#auti"ns &"r dis5"sa! and "ther hand!in% )d$inistrati9e .ata 8' *)R=+TI(: )0T-ORI3)TIO( -OL.+R 8' *)R=+TI(: )0T-ORI3)TIO( (0*>+R?3@ 9' .)T+ O, ,IR3T )0T-ORI3)TIO(AR+(+W)L O, T-+ )0T-ORI3)TIO( 10' .)T+ O, R+2I3IO( O, T-+ T+BT 11' Le%a! 3tatus

:" t" t"5 "& the 5a%e 1' ()*+ O, T-+ *+.ICI()L /RO.0CT Zy!"ri# 100 $% Tab!ets Zy!"ri# 00 $% Tab!ets :" t" t"5 "& the 5a%e 2' 10)LIT)TI2+ )(. 10)(TIT)TI2+ CO*/O3ITIO( )!!"5urin"! 100 $% ?Zy!"ri# Tab!ets@ )!!"5urin"! 00 $% ?Zy!"ri#C 00 Tab!ets@ :" t" t"5 "& the 5a%e ' /-)R*)C+0TIC)L ,OR* Tab!et :" t" t"5 "& the 5a%e 4' CLI(IC)L /)RTIC0L)R3 :" t" t"5 "& the 5a%e 4'1 Thera5euti# indi#ati"ns Zy!"ri# is indi#ated &"r redu#in% urateAuri# a#id &"r$ati"n in #"nditi"ns where urateAuri# a#id de5"siti"n has a!ready "##urred ?e'%' %"uty arthritis, s;in t"5hi, ne5hr"!ithiasis@ "r is a 5redi#tab!e #!ini#a! ris; ?e'%' treat$ent "& $a!i%nan#y

5"tentia!!y !eadin% t" a#ute uri# a#id ne5hr"5athy@' The $ain #!ini#a! #"nditi"ns where urateAuri# a#id de5"siti"n $ay "##ur are: idi"5athi# %"utD uri# a#id !ithiasisD a#ute uri# a#id ne5hr"5athyD ne"5!asti# disease and $ye!"5r"!i&erati9e disease with hi%h #e!! turn"9er rates, in whi#h hi%h urate !e9e!s "##ur either s5"ntane"us!y, "r a&ter #yt"t"<i# thera5yD #ertain enEy$e dis"rders whi#h !ead t" "9er5r"du#ti"n "& urate, &"r e<a$5!e: hy5"<anthineC%uanine 5h"s5h"rib"sy!trans&erase, in#!udin% Les#hC(yhan syndr"$eD %!u#"seC7C5h"s5hatase in#!udin% %!y#"%en st"ra%e diseaseD 5h"s5h"rib"sy!5yr"5h"s5hate synthetase, 5h"s5h"rib"sy!5yr"5h"s5hate a$id"trans&eraseD adenine 5h"s5h"rib"sy!trans&erase' Zy!"ri# is indi#ated &"r $ana%e$ent "& 2,8Cdihydr"<yadenine ?2,8C.-)@ rena! st"nes re!ated t" de&i#ient a#ti9ity "& adenine 5h"s5h"rib"sy!trans&erase' Zy!"ri# is indi#ated &"r the $ana%e$ent "& re#urrent $i<ed #a!#iu$ "<a!ate rena! st"nes in the 5resen#e "& hy5eruri#"suria, when &!uid, dietary and si$i!ar $easures ha9e &ai!ed' :" t" t"5 "& the 5a%e 4'2 /"s"!"%y and $eth"d "& ad$inistrati"n Dosage in Adults: Zy!"ri# sh"u!d be intr"du#ed at !"w d"sa%e e'%' 100$%Aday t" redu#e the ris; "& ad9erse rea#ti"ns and in#reased "n!y i& the seru$ urate res5"nse is unsatis&a#t"ry' +<tra #auti"n sh"u!d be e<er#ised i& rena! &un#ti"n is 5""r ?see Dosage in renal impairment@' The &"!!"win% d"sa%e s#hedu!es are su%%ested: 100 t" 200 $% dai!y in $i!d #"nditi"ns, 00 t" 700 $% dai!y in $"derate!y se9ere #"nditi"ns, 800 t" 900 $% dai!y in se9ere #"nditi"ns' I& d"sa%e "n a $%A;% b"dywei%ht basis is reFuired, 2 t" 10 $%A;% b"dywei%htAday sh"u!d be used' Dosage in children: Chi!dren under 16 years: 10 t" 20 $%A;% b"dywei%htAday u5 t" a $a<i$u$ "& 400 $% dai!y' 0se in #hi!dren is rare!y indi#ated, e<#e5t in $a!i%nant #"nditi"ns ?es5e#ia!!y !eu;ae$ia@ and #ertain enEy$e dis"rders su#h as Les#hC(yhan syndr"$e' Dosage in the elderly: In the absen#e "& s5e#i&i# data, the !"west d"sa%e whi#h 5r"du#es satis&a#t"ry urate redu#ti"n sh"u!d be used' /arti#u!ar attenti"n sh"u!d be 5aid t" ad9i#e in Dosage in renal impairment and Precautions and Warnings. Dosage in renal impairment: 3in#e a!!"5urin"! and its $etab"!ites are e<#reted by the ;idney, i$5aired rena! &un#ti"n $ay !ead t" retenti"n "& the dru% andA"r its $etab"!ites with #"nseFuent 5r"!"n%ati"n "& 5!as$a ha!&C!i9es' In se9ere rena! insu&&i#ien#y, it $ay be ad9isab!e t" use !ess than 100 $% 5er day "r t" use sin%!e

d"ses "& 100$% at !"n%er inter9a!s than "ne day' I& &a#i!ities are a9ai!ab!e t" $"nit"r 5!as$a "<i5urin"! #"n#entrati"ns, the d"se sh"u!d be adGusted t" $aintain 5!as$a "<i5urin"! !e9e!s be!"w 100 $i#r"$"!A!itre ?16'2 $%A!itre@' )!!"5urin"! and its $etab"!ites are re$"9ed by rena! dia!ysis' I& dia!ysis is reFuired tw" t" three ti$es a wee; #"nsiderati"n sh"u!d be %i9en t" an a!ternati9e d"sa%e s#hedu!e "& 00C400 $% Zy!"ri# i$$ediate!y a&ter ea#h dia!ysis with n"ne in the interi$' Dosage in hepatic impairment: Redu#ed d"ses sh"u!d be used in 5atients with he5ati# i$5air$ent' /eri"di# !i9er &un#ti"n tests are re#"$$ended durin% the ear!y sta%es "& thera5y' Treatment of high urate turnover conditions, e.g. neoplasia, Lesch-Nyhan syndrome: It is ad9isab!e t" #"rre#t e<istin% hy5eruri#ae$ia andA"r hy5eruri#"suria with Zy!"ri# be&"re startin% #yt"t"<i# thera5y' It is i$5"rtant t" ensure adeFuate hydrati"n t" $aintain "5ti$u$ diuresis and t" atte$5t a!;a!inisati"n "& urine t" in#rease s"!ubi!ity "& urinary urateAuri# a#id' ."sa%e "& Zy!"ri# sh"u!d be at the !"wer end "& the re#"$$ended d"sa%e s#hedu!e' I& urate ne5hr"5athy "r "ther 5ath"!"%y has #"$5r"$ised rena! &un#ti"n, the ad9i#e %i9en in Dosage in renal impairment sh"u!d be &"!!"wed' These ste5s $ay redu#e the ris; "& <anthine andA"r "<i5urin"! de5"siti"n #"$5!i#atin% the #!ini#a! situati"n' 3ee a!s" Drug nteractions )nd Adverse !eactions. "onitoring Advice: The d"sa%e sh"u!d be adGusted by $"nit"rin% seru$ urate #"n#entrati"ns and urinary urateAuri# a#id !e9e!s at a55r"5riate inter9a!s' nstructions for #se: Zy!"ri# $ay be ta;en "ra!!y "n#e a day a&ter a $ea!' It is we!! t"!erated, es5e#ia!!y a&ter &""d' 3h"u!d the dai!y d"sa%e e<#eed 00 $% and %astr"intestina! int"!eran#e be $ani&ested, a di9ided d"ses re%i$en $ay be a55r"5riate' :" t" t"5 "& the 5a%e 4' C"ntraindi#ati"ns Zy!"ri# sh"u!d n"t be ad$inistered t" indi9idua!s ;n"wn t" be hy5ersensiti9e t" a!!"5urin"! "r t" any "& the #"$5"nents "& the &"r$u!ati"n' :" t" t"5 "& the 5a%e 4'4 35e#ia! warnin%s and 5re#auti"ns &"r use

Zy!"ri# sh"u!d be withdrawn immediately when a s;in rash "r "ther e9iden#e "& sensiti9ity "##urs' Redu#ed d"ses sh"u!d be used in 5atients with he5ati# "r rena! i$5air$ent' /atients under treat$ent &"r hy5ertensi"n "r #ardia# insu&&i#ien#y, &"r e<a$5!e with diureti#s "r )C+ inhibit"rs, $ay ha9e s"$e #"n#"$itant i$5air$ent "& rena! &un#ti"n and a!!"5urin"! sh"u!d be used with #are in this %r"u5' )sy$5t"$ati# hy5eruri#ae$ia 5er se is %enera!!y n"t #"nsidered an indi#ati"n &"r use "& Zy!"ri#' ,!uid and dietary $"di&i#ati"n with $ana%e$ent "& the under!yin% #ause $ay #"rre#t the #"nditi"n' Acute gouty attac$s: )!!"5urin"! treat$ent sh"u!d n"t be started unti! an a#ute atta#; "& %"ut has #"$5!ete!y subsided, as &urther atta#;s $ay be 5re#i5itated' In the ear!y sta%es "& treat$ent with Zy!"ri#, as with uri#"suri# a%ents, an a#ute atta#; "& %"uty arthritis $ay be 5re#i5itated' There&"re it is ad9isab!e t" %i9e 5r"5hy!a<is with a suitab!e antiCin&!a$$at"ry a%ent "r #"!#hi#ine &"r at !east "ne $"nth' The !iterature sh"u!d be #"nsu!ted &"r detai!s "& a55r"5riate d"sa%e and 5re#auti"ns and warnin%s' I& a#ute atta#;s de9e!"5 in 5atients re#ei9in% a!!"5urin"!, treat$ent sh"u!d #"ntinue at the sa$e d"sa%e whi!e the a#ute atta#; is treated with a suitab!e antiCin&!a$$at"ry a%ent' %anthine deposition: In #"nditi"ns where the rate "& urate &"r$ati"n is %reat!y in#reased ?e'%' $a!i%nant disease and its treat$ent, Les#hC(yhan syndr"$e@ the abs"!ute #"n#entrati"n "& <anthine in urine #"u!d, in rare #ases, rise su&&i#ient!y t" a!!"w de5"siti"n in the urinary tra#t' This ris; $ay be $ini$ised by adeFuate hydrati"n t" a#hie9e "5ti$a! urine di!uti"n' mpaction of uric acid renal stones: )deFuate thera5y with Zy!"ri# wi!! !ead t" diss"!uti"n "& !ar%e uri# a#id rena! 5e!9i# st"nes, with the re$"te 5"ssibi!ity "& i$5a#ti"n in the ureter' :" t" t"5 "& the 5a%e 4'6 Intera#ti"n with "ther $edi#ina! 5r"du#ts and "ther &"r$s "& intera#ti"n & -mercaptopurine and a'athioprine: )Eathi"5rine is $etab"!ised t" 7C$er#a5t"5urine whi#h is ina#ti9ated by the a#ti"n "& <anthine "<idase' When 7C$er#a5t"5urine "r aEathi"5rine is %i9en #"n#urrent!y with Zy!"ri#, "n!y "neCFuarter "& the usua! d"se "& 7C$er#a5t"5urine "r aEathi"5rine sh"u!d be %i9en be#ause inhibiti"n "& <anthine "<idase wi!! 5r"!"n% their a#ti9ity' (idara)ine *Adenine Ara)inoside+: +9iden#e su%%ests that the 5!as$a ha!&C!i&e "& 9idarabine is in#reased in the 5resen#e "& a!!"5urin"!' When the tw" 5r"du#ts are used #"n#"$itant!y e<tra 9i%i!an#e is ne#essary, t" re#"%nise enhan#ed t"<i# e&&e#ts'

,alicylates and uricosuric agents: "<i5urin"!, the $aG"r $etab"!ite "& a!!"5urin"! and itse!& thera5euti#a!!y a#ti9e, is e<#reted by the ;idney in a si$i!ar way t" urate' -en#e, dru%s with uri#"suri# a#ti9ity su#h as 5r"bene#id "r !ar%e d"ses "& sa!i#y!ate $ay a##e!erate the e<#reti"n "& "<i5urin"!' This $ay de#rease the thera5euti# a#ti9ity "& Zy!"ri#, but the si%ni&i#an#e needs t" be assessed in ea#h #ase' -hlorpropamide: I& Zy!"ri# is %i9en #"n#"$itant!y with #h!"r5r"5a$ide when rena! &un#ti"n is 5""r, there $ay be an in#reased ris; "& 5r"!"n%ed hy5"%!y#ae$i# a#ti9ity be#ause a!!"5urin"! and #h!"r5r"5a$ide $ay #"$5ete &"r e<#reti"n in the rena! tubu!e' -oumarin anticoagulants There ha9e been rare re5"rts "& in#reased e&&e#t "& war&arin and "ther #"u$arin anti#"a%u!ants when #"Cad$inistered with a!!"5urin"!, there&"re, a!! 5atients re#ei9in% anti#"a%u!ants $ust be #are&u!!y $"nit"red' Phenytoin: )!!"5urin"! $ay inhibit he5ati# "<idati"n "& 5henyt"in but the #!ini#a! si%ni&i#an#e has n"t been de$"nstrated' Theophylline: Inhibiti"n "& the $etab"!is$ "& the"5hy!!ine has been re5"rted' The $e#hanis$ "& the intera#ti"n $ay be e<5!ained by <anthine "<idase bein% in9"!9ed in the bi"trans&"r$ati"n "& the"5hy!!ine in $an' The"5hy!!ine !e9e!s sh"u!d be $"nit"red in 5atients startin% "r in#reasin% a!!"5urin"! thera5y' Ampicillin.Amo/icillin: )n in#rease in &reFuen#y "& s;in rash has been re5"rted a$"n% 5atients re#ei9in% a$5i#i!!in "r a$"<i#i!!in #"n#urrent!y with a!!"5urin"! #"$5ared t" 5atients wh" are n"t re#ei9in% b"th dru%s' The #ause "& the re5"rted ass"#iati"n has n"t been estab!ished' -"we9er, it is re#"$$ended that in 5atients re#ei9in% a!!"5urin"! an a!ternati9e t" a$5i#i!!in "r a$"<i#i!!in is used where a9ai!ab!e' -yclophosphamide, do/oru)icin, )leomycin, procar)a'ine, mechloroethamine: +nhan#ed b"ne $arr"w su55ressi"n by #y#!"5h"s5ha$ide and "ther #yt"t"<i# a%ents has been re5"rted a$"n% 5atients with ne"5!asti# disease ?"ther than !eu;ae$ia@, in the 5resen#e "& a!!"5urin"!' -"we9er, in a we!!C#"ntr"!!ed study "& 5atients treated with #y#!"5h"s5ha$ide, d"<"rubi#in, b!e"$y#in, 5r"#arbaEine andA"r $e#h!"r"etha$ine ?#h!"r$ethine hydr"#h!"ride@ a!!"5urin"! did n"t a55ear t" in#rease the t"<i# rea#ti"n "& these #yt"t"<i# a%ents' -iclosporin: Re5"rts su%%est that the 5!as$a #"n#entrati"n "& #i#!"s5"rin $ay be in#reased durin% #"n#"$itant treat$ent with a!!"5urin"!' The 5"ssibi!ity "& enhan#ed #i#!"s5"rin t"<i#ity sh"u!d be #"nsidered i& the dru%s are #"Cad$inistered' Didanosine: In hea!thy 9"!unteers and -I2 5atients re#ei9in% didan"sine, 5!as$a

didan"sine C$a< and )0C 9a!ues were a55r"<i$ate!y d"ub!ed with #"n#"$itant a!!"5urin"! treat$ent ? 00 $% dai!y@ with"ut a&&e#tin% ter$ina! ha!& !i&e' C"C ad$inistrati"n "& these 2 dru%s is %enera!!y n"t re#"$$ended' I& #"n#"$itant use is una9"idab!e, a d"se redu#ti"n "& didan"sine $ay be reFuired, and 5atients sh"u!d be #!"se!y $"nit"red' :" t" t"5 "& the 5a%e 4'7 /re%nan#y and !a#tati"n There is inadeFuate e9iden#e "& sa&ety "& Zy!"ri# in hu$an 5re%nan#y, a!th"u%h it has been in wide use &"r $any years with"ut a55arent i!! #"nseFuen#e' 0se in 5re%nan#y "n!y when there is n" sa&er a!ternati9e and when the disease itse!& #arries ris; &"r the $"ther "r unb"rn #hi!d' Re5"rts indi#ate that a!!"5urin"! and "<i5urin"! are e<#reted in hu$an breast $i!;' C"n#entrati"ns "& 1'4$%A!itre a!!"5urin"! and 6 '8 $%A!itre "<i5urin"! ha9e been de$"nstrated in breast $i!; &r"$ w"$an ta;in% Zy!"ri# 00 $%Aday' -"we9er, there are n" data #"n#ernin% the e&&e#ts "& a!!"5urin"! "r its $etab"!ites "n the breastC&ed baby' :" t" t"5 "& the 5a%e 4'8 +&&e#ts "n abi!ity t" dri9e and use $a#hines 3in#e ad9erse rea#ti"ns su#h as s"$n"!en#e, 9erti%" and ata<ia ha9e been re5"rted in 5atients re#ei9in% a!!"5urin"!, 5atients sh"u!d e<er#ise #auti"n be&"re dri9in%, usin% $a#hinery "r 5arti#i5atin% in dan%er"us a#ti9ities unti! they are reas"nab!y #ertain that a!!"5urin"! d"es n"t ad9erse!y a&&e#t 5er&"r$an#e' :" t" t"5 "& the 5a%e 4'8 0ndesirab!e e&&e#ts ,"r this 5r"du#t there is n" $"dern #!ini#a! d"#u$entati"n whi#h #an be used as su55"rt &"r deter$inin% the &reFuen#y "& undesirab!e e&&e#ts' 0ndesirab!e e&&e#ts $ay 9ary in their in#iden#e de5endin% "n the d"se re#ei9ed and a!s" when %i9en in #"$binati"n with "ther thera5euti# a%ents' The &reFuen#y #ate%"ries assi%ned t" the ad9erse dru% rea#ti"ns be!"w are esti$ates: &"r $"st rea#ti"ns, suitab!e data &"r #a!#u!atin% in#iden#e are n"t a9ai!ab!e' )d9erse dru% rea#ti"ns identi&ied thr"u%h 5"stC$ar;etin% sur9ei!!an#e were #"nsidered t" be rare "r 9ery rare' The &"!!"win% #"n9enti"n has been used &"r the #!assi&i#ati"n "& &reFuen#y: 2ery #"$$"n C"$$"n 1A10 ? 10H@

1A100 and I1A10 ? 1H and I10H@

0n#"$$"n Rare

1A1000 and I1A100 ? 0'1H and I1H@

1A10,000 and I1A1000 ? 0'01H and I0'1H@

2ery rare I1A10,000 ?I0'01H@ )d9erse rea#ti"ns in ass"#iati"n with Zy!"ri# are rare in the "9era!! treated 5"5u!ati"n and $"st!y "& a $in"r nature' The in#iden#e is hi%her in the 5resen#e "& rena! andA"r he5ati# dis"rder' Infections and infestations 2ery rare ,urun#u!"sis Blood and lymphatic system disorders 2ery rare )%ranu!"#yt"sis, a5!asti# anae$ia, thr"$b"#yt"5enia 2ery rare re5"rts ha9e been re#ei9ed "& thr"$b"#yt"5enia, a%ranu!"#yt"sis and a5!asti# anae$ia, 5arti#u!ar!y in indi9idua!s with i$5aired rena! andA"r he5ati# &un#ti"n, rein&"r#in% the need &"r 5arti#u!ar #are in this %r"u5 "& 5atients' Immune system disorders 0n#"$$"n -y5ersensiti9ity rea#ti"ns 2ery rare )n%i"i$$un"b!asti# !y$5haden"5athy 3eri"us hy5ersensiti9ity rea#ti"ns, in#!udin% s;in rea#ti"ns ass"#iated with e<&"!iati"n, &e9er, !y$5haden"5athy, arthra!%ia andA"r e"sin"5hi!ia in#!udin% 3te9ensCJ"hns"n 3yndr"$e and T"<i# +5ider$a! (e#r"!ysis "##ur rare!y ?see 3;in and sub#utane"us tissue dis"rders@' )ss"#iated 9as#u!itis and tissue res5"nse $ay be $ani&ested in 9ari"us ways in#!udin% he5atitis, rena! i$5air$ent and 9ery rare!y, seiEures' 2ery rare!y a#ute ana5hy!a#ti# sh"#; has been re5"rted' I& su#h rea#ti"ns d" "##ur, it $ay be at any ti$e durin% treat$ent, Zy!"ri# sh"u!d be withdrawn immediately and permanently. C"rti#"ster"ids $ay be bene&i#ia! in "9er#"$in% hy5ersensiti9ity s;in rea#ti"ns' When %enera!ised hy5ersensiti9ity rea#ti"ns ha9e "##urred, rena! andA"r he5ati# dis"rder has usua!!y been 5resent 5arti#u!ar!y when the "ut#"$e has been &ata!' )n%i"i$$un"b!asti# !y$5haden"5athy has been des#ribed 9ery rare!y &"!!"win% bi"5sy "& a %enera!ised !y$5haden"5athy' It a55ears t" be re9ersib!e "n withdrawa! "& Zy!"ri#'

Metabolism and nutrition disorders 2ery rare .iabetes $e!!itus, hy5er!i5idae$ia Psychiatric disorders 2ery rare .e5ressi"n Nervous system disorders 2ery rare C"$a, 5ara!ysis, ata<ia, neur"5athy, 5araesthesiae, s"$n"!en#e, heada#he, taste 5er9ersi"n Eye disorders 2ery rare Catara#t, 9isua! dis"rder, $a#u!ar #han%es Ear and labyrinth disorders 2ery rare 2erti%" Cardiac disorders 2ery rare )n%ina, brady#ardia Vascular disorders 2ery rare -y5ertensi"n Gastrointestinal disorders 0n#"$$"n 2"$itin%, nausea 2ery rare Re#urrent hae$ate$esis, steat"rrh"ea, st"$atitis, #han%ed b"we! habit In ear!y #!ini#a! studies, nausea and 9"$itin% were re5"rted' ,urther re5"rts su%%est that this rea#ti"n is n"t a si%ni&i#ant 5r"b!e$ and #an be a9"ided by ta;in% Zy!"ri# a&ter $ea!s' Hepatobiliary disorders 0n#"$$"n )sy$5t"$ati# in#reases in !i9er &un#ti"n tests Rare -e5atitis ?in#!udin% he5ati# ne#r"sis and %ranu!"$at"us he5atitis@

-e5ati# dys&un#ti"n has been re5"rted with"ut "9ert e9iden#e "& $"re %enera!ised hy5ersensiti9ity' S in and subcutaneous tissue disorders C"$$"n Rash 2ery rare )n%i"ede$a, &i<ed dru% eru5ti"n, a!"5e#ia, dis#"!"ured hair 3;in rea#ti"ns are the $"st #"$$"n rea#ti"ns and $ay "##ur at any ti$e durin% treat$ent' They $ay be 5ruriti#, $a#u!"5a5u!ar, s"$eti$es s#a!y, s"$eti$es 5ur5uri# and rare!y e<&"!iati9e' Zy!"ri# sh"u!d be withdrawn immediately sh"u!d su#h rea#ti"ns "##ur' )&ter re#"9ery &r"$ $i!d rea#ti"ns, Zy!"ri# $ay, i& desired, be reC intr"du#ed at a s$a!! d"se ?e'%' 60$%Aday@ and %radua!!y in#reased' I& the rash re#urs, Zy!"ri# sh"u!d be permanently withdrawn as $"re se9ere hy5ersensiti9ity $ay "##ur ?see I$$une syste$ dis"rders@' )n%i"ede$a has been re5"rted t" "##ur with and with"ut si%ns and sy$5t"$s "& a $"re %enera!ised hy5ersensiti9ity rea#ti"n' !enal and urinary disorders 2ery rare -ae$aturia, urae$ia !eproductive system and breast disorders 2ery rare *a!e in&erti!ity, ere#ti!e dys&un#ti"n, %ynae#"$astia General disorders and administration site conditions 2ery rare Oede$a, %enera! $a!aise, asthenia, &e9er ,e9er has been re5"rted t" "##ur with and with"ut si%ns and sy$5t"$s "& a $"re %enera!ised Zy!"ri# hy5ersensiti9ity rea#ti"n ?see I$$une syste$ dis"rders@' :" t" t"5 "& the 5a%e 4'9 O9erd"se In%esti"n "& u5 t" 22'6 % a!!"5urin"! with"ut ad9erse e&&e#t has been re5"rted' 3y$5t"$s and si%ns in#!udin% nausea, 9"$itin%, diarrh"ea and diEEiness ha9e been re5"rted in a 5atient wh" in%ested 20 % a!!"5urin"!' Re#"9ery &"!!"wed %enera! su55"rti9e $easures' *assi9e abs"r5ti"n "& Zy!"ri# $ay !ead t" #"nsiderab!e inhibiti"n "& <anthine "<idase a#ti9ity, whi#h sh"u!d ha9e n" unt"ward e&&e#ts un!ess a&&e#tin% #"n#"$itant $edi#ati"n, es5e#ia!!y with 7C$er#a5t"5urine andA"r aEathi"5rine' )deFuate hydrati"n t" $aintain "5ti$u$ diuresis &a#i!itates e<#reti"n

"& a!!"5urin"! and its $etab"!ites' I& #"nsidered ne#essary hae$"dia!ysis $ay be used' :" t" t"5 "& the 5a%e 6' /-)R*)COLO:IC)L /RO/+RTI+3 :" t" t"5 "& the 5a%e 6'1 /har$a#"dyna$i# 5r"5erties )!!"5urin"! is a <anthineC"<idase inhibit"r' )!!"5urin"! and its $ain $etab"!ite "<i5urin"! !"wer the !e9e! "& uri# a#id in 5!as$a and urine by inhibiti"n "& <anthine "<idase, the enEy$e #ata!yEin% the "<idati"n "& hy5"<anthine t" <anthine and <anthine t" uri# a#id' In additi"n t" the inhibiti"n "& 5urine #atab"!is$ in s"$e but n"t a!! hy5eruri#ae$i# 5atients, de n"9" 5urine bi"synthesis is de5ressed 9ia &eedba#; inhibiti"n "& hy5"<anthineC%uanine 5h"s5h"rib"sy!trans&erase' Other $etab"!ites "& a!!"5urin"! in#!ude a!!"5urin"!Crib"side and "<i5urin"!C8 rib"side' :" t" t"5 "& the 5a%e 6'2 /har$a#";ineti# 5r"5erties )!!"5urin"! is a#ti9e when %i9en "ra!!y and is ra5id!y abs"rbed &r"$ the u55er %astr"intestina! tra#t' 3tudies ha9e dete#ted a!!"5urin"! in the b!""d 0C70 $inutes a&ter d"sin%' +sti$ates "& bi"a9ai!abi!ity 9ary &r"$ 78H t" 90H' /ea; 5!as$a !e9e!s "& a!!"5urin"! %enera!!y "##ur a55r"<i$ate!y 1'6 h"urs a&ter "ra! ad$inistrati"n "& Zy!"ri#, but &a!! ra5id!y and are bare!y dete#tab!e a&ter 7 h"urs' /ea; !e9e!s "& "<i5urin"! %enera!!y "##ur a&ter C6 h"urs a&ter "ra! ad$inistrati"n "& Zy!"ri# and are $u#h $"re sustained' )!!"5urin"! is ne%!i%ib!y b"und by 5!as$a 5r"teins and there&"re 9ariati"ns in 5r"tein bindin% are n"t th"u%ht t" si%ni&i#ant!y a!ter #!earan#e' The a55arent 9"!u$e "& distributi"n "& a!!"5urin"! is a55r"<i$ate!y 1'7 !itreA;% whi#h su%%ests re!ati9e!y e<tensi9e u5ta;e by tissues' Tissue #"n#entrati"ns "& a!!"5urin"! ha9e n"t been re5"rted in hu$ans, but it is !i;e!y that a!!"5urin"! and "<i5urin"! wi!! be 5resent in the hi%hest #"n#entrati"ns in the !i9er and intestina! $u#"sa where <anthine "<idase a#ti9ity is hi%h' )55r"<i$ate!y 20H "& the in%ested a!!"5urin"! is e<#reted in the &ae#es' +!i$inati"n "& a!!"5urin"! is $ain!y by $etab"!i# #"n9ersi"n t" "<i5urin"! by <anthine "<idase and a!dehyde "<idase, with !ess than 10H "& the un#han%ed dru% e<#reted in the urine' )!!"5urin"! has a 5!as$a ha!&C!i&e "& ab"ut 1 t" 2 h"urs' O<i5urin"! is a !ess 5"tent inhibit"r "& <anthine "<idase than a!!"5urin"!, but the 5!as$a ha!&C!i&e "& "<i5urin"! is &ar $"re 5r"!"n%ed' +sti$ates ran%e &r"$ 1 t" 0 h"urs in $an' There&"re e&&e#ti9e inhibiti"n "& <anthine "<idase is $aintained "9er a 24 h"ur 5eri"d with a sin%!e dai!y d"se "& Zy!"ri#' /atients with n"r$a! rena!

&un#ti"n wi!! %radua!!y a##u$u!ate "<i5urin"! unti! a steadyCstate 5!as$a "<i5urin"! #"n#entrati"n is rea#hed' 3u#h 5atients, ta;in% 00 $% "& a!!"5urin"! 5er day wi!! %enera!!y ha9e 5!as$a "<i5urin"! #"n#entrati"ns "& 6C10 $%A!itre' O<i5urin"! is e!i$inated un#han%ed in the urine but has a !"n% e!i$inati"n ha!&C!i&e be#ause it under%"es tubu!ar reabs"r5ti"n' Re5"rted 9a!ues &"r the e!i$inati"n ha!&C !i&e ran%e &r"$ 1 '7 h"urs t" 29 h"urs' The !ar%e dis#re5an#ies in these 9a!ues $ay be a##"unted &"r by 9ariati"ns in study desi%n andA"r #reatinine #!earan#e in the 5atients' Pharmaco inetics in patients "ith renal impairment# )!!"5urin"! and "<i5urin"! #!earan#e is %reat!y redu#ed in 5atients with 5""r rena! &un#ti"n resu!tin% in hi%her 5!as$a !e9e!s in #hr"ni# thera5y' /atients with rena! i$5air$ent, where #reatinine #!earan#e 9a!ues were between 10 and 20$!A$in, sh"wed 5!as$a "<i5urin"! #"n#entrati"ns "& a55r"<i$ate!y 0$%A!itre a&ter 5r"!"n%ed treat$ent with 00 $% a!!"5urin"! 5er day' This is a55r"<i$ate!y the #"n#entrati"n whi#h w"u!d be a#hie9ed by d"ses "& 700 $%Aday in th"se with n"r$a! rena! &un#ti"n' ) redu#ti"n in the d"se "& Zy!"ri# is there&"re reFuired in 5atients with rena! i$5air$ent' Pharmaco inetics in elderly patients# The ;ineti#s "& the dru% are n"t !i;e!y t" be a!tered "ther than due t" deteri"rati"n in rena! &un#ti"n ?see /har$"#";ineti#s in 5atients with rena! i$5air$ent@' :" t" t"5 "& the 5a%e 6' /re#!ini#a! sa&ety data )' *uta%eni#ity Cyt"%eneti# studies sh"w that a!!"5urin"! d"es n"t indu#e #hr"$"s"$e aberrati"ns in hu$an b!""d #e!!s in vitro at #"n#entrati"ns u5 t" 100 $i#r"%ra$sA$! and in vivo at d"ses u5 t" 700 $%Aday &"r $ean 5eri"d "& 40 $"nths' )!!"5urin"! d"es n"t 5r"du#e nitras" #"$5"unds in vitro "r a&&e#t !y$5h"#yte trans&"r$ati"n in vitro. +9iden#e &r"$ bi"#he$i#a! and "ther #yt"!"%i#a! in9esti%ati"ns str"n%!y su%%ests that a!!"5urin"! has n" de!eteri"us e&&e#ts "n .() at any sta%e "& the #e!! #y#!e and is n"t $uta%eni#' >' Car#in"%eni#ity (" e9iden#e "& #ar#in"%eni#ity has been &"und in $i#e and rats treated with

a!!"5urin"! &"r u5 t" 2 years' C' Terat"%eni#ity One study in $i#e re#ei9in% intra5erit"nea! d"ses "& 60 "r 100 $%A;% "n days 10 "r 1 "& %estati"n resu!ted in &"eta! abn"r$a!ities, h"we9er in a si$i!ar study in rats at 120 $%A;% "n day 12 "& %estati"n n" abn"r$a!ities were "bser9ed' +<tensi9e studies "& hi%h "ra! d"ses "& a!!"5urin"! in $i#e u5 t" 100 $%A;%Aday, rats u5 t" 200 $%A;%Aday and rabbits u5 t" 160 $%A;%Aday durin% days 8 t" 17 "& %estati"n 5r"du#ed n" terat"%eni# e&&e#ts' )n in vitro study usin% &"eta! $"use sa!i9ary %!ands in #u!ture t" dete#t e$bry"t"<i#ity indi#ated that a!!"5urin"! w"u!d n"t be e<5e#ted t" #ause e$bry"t"<i#ity with"ut a!s" #ausin% $aterna! t"<i#ity' :" t" t"5 "& the 5a%e 7' /-)R*)C+0TIC)L /)RTIC0L)R3 :" t" t"5 "& the 5a%e 7'1 List "& e<#i5ients La#t"se *aiEe 3tar#h /"9id"ne *a%nesiu$ 3tearate /uri&ied Water :" t" t"5 "& the 5a%e 7'2 In#"$5atibi!ities ("ne ;n"wn' :" t" t"5 "& the 5a%e 7' 3he!& !i&e 6 years' :" t" t"5 "& the 5a%e 7'4 35e#ia! 5re#auti"ns &"r st"ra%e ." n"t st"re ab"9e 26JC' 3t"re in the "ri%ina! 5a#;a%e

:" t" t"5 "& the 5a%e 7'6 (ature and #"ntents "& #"ntainer Zy!"ri# 100$% Tab!ets /2CAa!u$iniu$ &"i! b!ister 5a#; Zy!"ri#C 00 Tab!ets /2CAa!u$iniu$ &"i! b!ister 5a#; :" t" t"5 "& the 5a%e 7'7 35e#ia! 5re#auti"ns &"r dis5"sa! and "ther hand!in% (" s5e#ia! instru#ti"ns' :" t" t"5 "& the 5a%e )d$inistrati9e .ata :" t" t"5 "& the 5a%e 8' *)R=+TI(: )0T-ORI3)TIO( -OL.+R The We!!#"$e ,"undati"n Ltd :!a<" We!!#"$e -"use >er;e!ey )9enue :reen&"rd *idd!ese< Tradin% as :!a<"3$ith=!ine 0= 3t"#;!ey /ar; West 0<brid%e *idd!ese< 0>11 1>T :" t" t"5 "& the 5a%e 8' *)R=+TI(: )0T-ORI3)TIO( (0*>+R?3@ /L 0000 A6208R K Zy!"ri# 100$% Tab!ets

/L 0000 A0092R K Zy!"ri#C 00 Tab!ets :" t" t"5 "& the 5a%e 9' .)T+ O, ,IR3T )0T-ORI3)TIO(AR+(+W)L O, T-+ )0T-ORI3)TIO( Zy!"ri# 100$% Tab!etsZy!"ri#C 00 Tab!ets *)): 20'0 '80 14'08'80 Renewa!: 07'07'90 18'02'91 Renewa!: 14'11'96 26'11'98 :" t" t"5 "& the 5a%e 10' .)T+ O, R+2I3IO( O, T-+ T+BT 18 3e5te$ber 2007 :" t" t"5 "& the 5a%e 11' Le%a! 3tatus /O*

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/atient In&"r$ati"n Lea&!ets ?/ILs@: Zy!"ri# Tab!ets 100$%, 00$%

*edi#ine :uides: Zy!"ri#

Zy!"ri# Zy!"ri#

*ain 0se :una;an uta$a /re9enti"n "& %"ut /en#e%ahan en#";

)#ti9e In%redient In%redient a;ti& )!!"5urin"!' )!!"5urin"!'

*anu&a#turer /abri;an :!a<"3$ith=!ine :!a<"3$ith=!ine

-"w d"es it w"r;L >a%ai$ana #ara ;erGanyaL Zy!"ri# tab!ets #"ntain the a#ti9e in%redient a!!"5urin"!, whi#h is a ty5e

"& $edi#ine #a!!ed a <anthine "<idase inhibit"r' Zy!"ri# tab!et $en%andun% bahan a;ti& a!!"5urin"!, yan% $eru5a;an Genis "bat yan% disebut Eat y% $en#e%ah <anthine "<idase' ?(>' )!!"5urin"! tab!ets are a!s" a9ai!ab!e with"ut a brand na$e, ie as the %eneri# $edi#ine a!!"5urin"!'@ )!!"5urin"! is used t" !"wer uri# a#id !e9e!s in the b"dy' ?(>' )!!"5urin"! tab!et Gu%a tersedia tan5a $ere;, ya;ni seba%ai "bat %eneri; a!!"5urin"!'@ )!!"5urin"! di%una;an untu; $enurun;an tin%;at asa$ uri# di da!a$ tubuh' 0ri# a#id is 5r"du#ed by an enEy$e in the b"dy #a!!ed <anthine "<idase' 0ri# asa$ dihasi!;an "!eh sebuah enEi$ di da!a$ tubuh disebut <anthine "<idase' )!!"5urin"! inhibits the a#ti"n "& this enEy$e and as a resu!t !"wers uri# a#id !e9e!s' )!!"5urin"! inhibits tinda;an ini enEi$ dan a;ibatnya $enurun;an tin%;at asa$ uri#' The $ain use "& a!!"5urin"! is in 5re9entin% %"ut, whi#h is #aused by a bui!dCu5 "& uri# a#id #rysta!s in the G"ints' 0ta$a 5en%%unaan a!!"5urin"! da!a$ $en#e%ah en#"; yan% disebab;an "!eh bai;Cbai; dari uri# a#id ;rista! di sendi' It is these #ysta!s that #ause the #hara#teristi# 5ain and in&!a$$ati"n "& %"ut' It is #ysta!s ini yan% $enyebab;an rasa sa;it dan 5eradan%an ;ara;teristi; dari sen%a!' >y !"werin% the 5r"du#ti"n "& uri# a#id, &!areCu5s "& %"ut #an be 5re9ented' O!eh 5enurunan 5r"du;si uri# a#id, suarCu5 dari en#"; da5at di#e%ah' )!!"5urin"! is used &"r the !"n% ter$ 5re9enti"n "& %"ut and n"t &"r i$$ediate treat$ent "& %"ut &!areCu5s' )!!"5urin"! di%una;an untu; Gan%;a 5anGan% 5en#e%ahan en#"; dan tida; !an%sun% untu; 5erawatan en#"; suarCu5' Other $edi#ines are used &"r the ra5id re!ie& "& %"ut sy$5t"$s' ObatC"batan !ainnya yan% di%una;an untu; bantuan #e5at dari %eGa!a sen%a!' ) bui!d u5 "& uri# a#id is a!s" res5"nsib!e &"r #ertain ty5es "& ;idney disease and s"$e ty5es "& ;idney st"ne' J $e$ban%un dari uri# a#id Gu%a bertan%%un% Gawab untu; bebera5a Genis 5enya;it %inGa! dan bebera5a Genis batu %inGa!' In the sa$e way that a!!"5urin"! 5re9ents %"ut, it #an a!s" 5re9ent the &"r$ati"n "& new ;idney st"nes' .en%an #ara yan% sa$a yan% a!!"5urin"! $en#e%ah en#";, ia Gu%a da5at $en#e%ah 5e$bentu;an batu %inGa! baru' (>' (>' There are 9ari"us di&&erent ty5es "& ;idney st"nes, and a!!"5urin"! is "n!y e&&e#ti9e a%ainst #ertain ty5es' )da berba%ai Genis batu %inGa!, dan a!!"5urin"! hanya e&e;ti& terhada5 Genis tertentu' Certain ty5es "& #an#er and treat$ents &"r #an#er #an raise uri# a#id !e9e!s' >ebera5a Genis ;an;er dan 5en%"batan untu; ;an;er da5at $enin%;at;an tin%;at asa$ uri#' )s this #"u!d 5"tentia!!y #ause ;idney 5r"b!e$s, a!!"5urin"! is s"$eti$es used t" 5re9ent this' =arena ha! ini da5at ber5"tensi $eni$bu!;an $asa!ah %inGa!, a!!"5urin"! ;adan%C ;adan% di%una;an untu; $en#e%ah ha! ini'

What is it used &"rL What is it used &"rL

L"n%Cter$ 5re9enti"n "& %"ut Jan%;a 5anGan% 5en#e%ahan en#"; =idney st"nes >atu %inGa! Les#hC(yhan syndr"$e ?a hereditary enEy$e dis"rder resu!tin% in "9er5r"du#ti"n "& uri# a#id@ Les#hC(yhan syndr"$e ?a hereditary dis"rder enEi$ sehin%%a ber!ebihan dari uri# a#id@ Redu#in% the &"r$ati"n "& uri# a#id when this is a 5redi#tab!e #!ini#a! ris;, &"r e<a$5!e when treatin% #ertain ty5es "& #an#er *en%uran%i 5e$bentu;an asa$ uri# saat ini ada!ah 5redi#tab!e ;!inis risi;", $isa!nya ;eti;a $erawat bebera5a Genis ;an;er

Warnin%M /erin%atanM

Treat$ent with a!!"5urin"! sh"u!d n"t be started durin% an a#ute atta#; "& %"ut, as it #"u!d initia!!y w"rsen the atta#;' /en%"batan den%an a!!"5urin"! tida; b"!eh di$u!ai saat seran%an en#"; a;ut, ;arena 5ada awa!nya da5at $e$buru; seran%an' )!!"5urin"! sh"u!d n"t be started unti! the atta#; has #"$5!ete!y subsided' )!!"5urin"! tida; b"!eh di$u!ai sa$5ai seran%an te!ah se5enuhnya subsided' When y"u start treat$ent y"ur d"#t"r sh"u!d n"r$a!!y 5res#ribe y"u a suitab!e antiCin&!a$$at"ry $edi#ine, "r #"!#hi#ine, &"r at !east the &irst $"nth, as a!!"5urin"! $ay #ause an atta#; "& %"ut in the ear!y sta%es "& treat$ent' I& y"u %et an atta#; "& %"ut a&ter y"u ha9e started treat$ent with a!!"5urin"! y"u sh"u!d ;ee5 ta;in% it whi!e the atta#; is treated with a suitab!e antiCin&!a$$at"ry $edi#ine' =eti;a )nda $e$u!ai 5erawatan d";ter biasanya harus sesuai rese5 )nda "bat antiC;"baran, atau #"!#hi#ine, setida;nya untu; bu!an 5erta$a, seba%ai a!!"5urin"! yan% da5at $enyebab;an seran%an en#"; 5ada awa! taha5an 5erawatan' Ji;a )nda tida; $enda5at;an seran%an sete!ah sen%a! )nda sudah $u!ai 5en%"batan den%an a!!"5urin"! )nda harus teta5 $en%a$bi! saat seran%an dian%%a5 #"#"; den%an "bat antiC;"baran' It is i$5"rtant t" drin; 5!enty "& &!uids whi!st bein% treated with this $edi#ine' /entin% untu; $inu$ banya; #airan ;eti;a sedan% dirawat den%an "bat ini' I& y"u %et a s;in rash "r "ther si%ns "& a!!er%i# rea#ti"n t" this $edi#ine y"u sh"u!d st"5 ta;in% it and #"nsu!t y"ur d"#t"r i$$ediate!y' Ji;a )nda $enda5at;an rua$ ;u!it atau tandaCtanda rea;si a!er%i "bat ini )nda harus berhenti dan ber;"nsu!tasi den%an d";ter )nda den%an se%era'

0se with #auti"n in :una;an den%an hatiChati da!a$

+!der!y 5e"5!e Oran% tua =idney disease /enya;it %inGa! Li9er disease /enya;it hati

("t t" be used in Tida; b"!eh di%una;an da!a$

)!!er%y t" any in%redient )!er%i ;e bahan

This $edi#ine sh"u!d n"t be used i& y"u are a!!er%i# t" "ne "r any "& its in%redients' Obat ini tida; b"!eh di%una;an Gi;a )nda a!er%i den%an sa!ah satu atau sa!ah satu dari bahanCnya' /!ease in&"r$ y"ur d"#t"r "r 5har$a#ist i& y"u ha9e 5re9i"us!y e<5erien#ed su#h an a!!er%y' -ara5 beritahu d";ter atau a5"te;er Gi;a )nda 5ernah $en%a!a$i a!er%i yan% se5erti itu' I& y"u &ee! y"u ha9e e<5erien#ed an a!!er%i# rea#ti"n, st"5 usin% this $edi#ine and in&"r$ y"ur d"#t"r "r 5har$a#ist i$$ediate!y' Ji;a )nda $erasa )nda te!ah $en%a!a$i rea;si a!er%i, berhenti $en%%una;an "bat ini dan $e$beritahu d";ter atau a5"te;er se%era' /re%nan#y and >reast&eedin% =eha$i!an dan >reast&eedin% Certain $edi#ines sh"u!d n"t be used durin% 5re%nan#y "r breast&eedin%' >ebera5a "batC"batan tida; b"!eh di%una;an se!a$a ;eha$i!an $au5un $enyusui' -"we9er, "ther $edi#ines $ay be sa&e!y used in 5re%nan#y "r breast&eedin% 5r"9idin% the bene&its t" the $"ther "utwei%h the ris;s t" the unb"rn baby' (a$un, "batC"batan !ainnya $un%;in a$an di%una;an da!a$ ;eha$i!an atau $enyusui yan% $e$beri;an $an&aat ba%i ibu !ebih 5entin% dr risi;" ;e bayi y% be!u$ !ahir' )!ways in&"r$ y"ur d"#t"r i& y"u are 5re%nant "r 5!annin% a 5re%nan#y, be&"re usin% any $edi#ine' 3e!a!u $e$beritahu;an d";ter Gi;a anda ha$i! atau $eren#ana;an ;eha$i!an, sebe!u$ $en%%una;an "bat'

This $edi#ine sh"u!d be used with #auti"n durin% 5re%nan#y' Obat ini harus di%una;an den%an hatiChati se!a$a ;eha$i!an' 3ee; $edi#a! ad9i#e &r"$ y"ur d"#t"r' *en#ari saran $edis dari d";ter' This $edi#ine 5asses int" breast $i!;, h"we9er the e&&e#ts "n the nursin% in&ant are un;n"wn' Obat ini !"!"s ;e da!a$ air susu ibu, na$un e&e; 5ada 5erawatan bayi yan% di;etahui' 3ee; $edi#a! ad9i#e &r"$ y"ur d"#t"r be&"re usin% this $edi#ine durin% breast&eedin%' *en#ari saran $edis dari d";ter sebe!u$ $en%%una;an "bat ini se!a$a $enyusui'

Labe! warnin%s Labe! 5erin%atan

." n"t st"5 ta;in% this $edi#ati"n e<#e5t "n y"ur d"#t"rNs ad9i#e' Jan%an berhenti $en%a$bi! "bat ini ;e#ua!i 5ada saran d";ter' Ta;e this $edi#ati"n with "r a&ter &""d' )$bi! "bat ini den%an atau sete!ah $a;anan' This $edi#ati"n is t" be ta;en with 5!enty "& water' Obat ini harus dia$bi! den%an banya; air'

3ide e&&e#ts +&e; sa$5in% *edi#ines and their 5"ssib!e side e&&e#ts #an a&&e#t indi9idua! 5e"5!e in di&&erent ways' ObatC"batan dan e&e; sa$5in% yan% $un%;in da5at $e$5en%aruhi setia5 "ran% da!a$ berba%ai #ara' The &"!!"win% are s"$e "& the side e&&e#ts that are ;n"wn t" be ass"#iated with this $edi#ine' >eri;ut ada!ah bebera5a e&e; sa$5in% yan% di;ena! ter;ait den%an "bat ini' >e#ause a side e&&e#t is stated here, it d"es n"t $ean that a!! 5e"5!e usin% this $edi#ine wi!! e<5erien#e that "r any side e&&e#t' =arena e&e; sa$5in% yan% dinyata;an disini, tida; berarti bahwa se$ua "ran% a;an $en%%una;an "bat ini atau yan% $en%a!a$i e&e; sa$5in%'

)!!er%i# s;in rea#ti"ns su#h as rash "r it#h Rea;si a!er%i ;u!it se5erti rua$ atau %ata! 3!ee5iness 3!ee5iness >a!an#e 5r"b!e$s in9"!9in% the inner ear ?9erti%"@ 3a!d" $asa!ah $e!ibat;an !abirin ?9erti%"@ .isturban#es "& the %ut su#h as diarrh"ea, #"nsti5ati"n, nausea, 9"$itin% "r abd"$ina! 5ain :an%%uan 5ada usus se5erti diare, se$be!it, $ua!, $untah atau sa;it abd"$ina! ,e9er ?5yre<ia@ .e$a$ ?5yre<ia@ ) %enera! &ee!in% "& bein% unwe!! ?$a!aise@ J u$u$ rasa sa;it yan% ?rasa tida; ena;@ -eada#he =e5a!a Wea;ness, nu$bness "r 5ins and need!es =e!e$ahan, atau rasa %e!isah 2isua! disturban#es :an%%uan 9isua! )!terati"n in taste /erubahan da!a$ rasa Chest 5ain ?an%ina@ 3a;it dada ?an%ina@ L"ss "r dis#"!"urati"n "& hair =ehi!an%an atau 5erubahan warna ra$but -i%h b!""d 5ressure ?hy5ertensi"n@ Te;anan darah tin%%i ?hi5ertensi@ +n!ar%e$ent "& the breasts /e$besaran di 5ayudara I$5"ten#e "r in&erti!ity I$5"ten atau in&erti!ity

Li9er dis"rders Li9er dis"rders >!""d dis"rders >!""d dis"rders

The side e&&e#ts !isted ab"9e $ay n"t in#!ude a!! "& the side e&&e#ts re5"rted by the dru%Ns $anu&a#turer' +&e; sa$5in% yan% terda&tar di atas tida; b"!eh $en#a;u5 se$ua e&e; sa$5in% yan% di!a5"r;an "!eh "bat dari 5r"dusen' ,"r $"re in&"r$ati"n ab"ut any "ther 5"ssib!e ris;s ass"#iated with this $edi#ine, 5!ease read the in&"r$ati"n 5r"9ided with the $edi#ine "r #"nsu!t y"ur d"#t"r "r 5har$a#ist' 0ntu; in&"r$asi !ebih !anGut tentan% !ain ;e$un%;inan risi;" yan% ter;ait den%an "batC"batan ini, si!a;an $e$ba#a in&"r$asi yan% diberi;an den%an "bat atau ;"nsu!tasi;an d";ter atau a5"te;er' -"w #an this $edi#ine a&&e#t "ther $edi#inesL >a%ai$ana "bat ini da5at $e$5en%aruhi "batC"batan !ainnyaL It is i$5"rtant t" te!! y"ur d"#t"r "r 5har$a#ist what $edi#ines y"u are a!ready ta;in%, in#!udin% th"se b"u%ht with"ut a 5res#ri5ti"n and herba! $edi#ines, be&"re y"u start treat$ent with this $edi#ine' /entin% ;iri$ ;e d";ter atau a5"te;er "bat a5a yan% sudah $en%a$bi!, ter$asu; yan% dibe!i tan5a rese5 d";ter dan "batC"batan herba!, sebe!u$ anda $u!ai 5erawatan den%an "bat ini' 3i$i!ar!y, #he#; with y"ur d"#t"r "r 5har$a#ist be&"re ta;in% any new $edi#ines whi!e ta;in% this "ne, t" ensure that the #"$binati"n is sa&e ' .e$i;ian Gu%a, 5eri;sa den%an d";ter atau a5"te;er sebe!u$ $en%a$bi! "batC"batan baru saat $en%a$bi! satu ini, untu; $e$asti;an bahwa ;"$binasi a$an' )!!"5urin"! in#reases the e&&e#ts "& aEathi"5rine and $er#a5t"5urine' )!!"5urin"! $enin%;at;an e&e; dari aEathi"5rine dan $er#a5t"5urine' ) !"wer than n"r$a! d"se "& these $edi#ines is ne#essary i& they are ta;en with a!!"5urin"!' Yan% !ebih rendah dari biasanya d"sis "batC"batan ini di5er!u;an Gi;a $ere;a dia$bi! den%an a!!"5urin"!' )!!"5urin"! $ay s!"w d"wn the re$"9a! "& the #he$"thera5y $edi#ine 9idarabine &r"$ the b"dy and s" $ay in#rease the ris; "& itNs side e&&e#ts' )!!"5urin"! da5at $e$5er!a$bat 5en%ha5usan dari "bat ;e$"tera5i 9idarabine dari tubuh dan ha! ini da5at $enin%;at;an risi;" dari e&e; sa$5in%' )!!"5urin"! $ay enhan#e the e&&e#ts "& antiCb!""dC#!"ttin% $edi#ines ?anti#"a%u!ants@ su#h as war&arin in s"$e 5e"5!e' *ei )!!"5urin"! $enin%;at;an e&e; antiC#!"ttin% darahC"batan ?anti#"a%u!ants@ se5erti war&arin da!a$ bebera5a "ran%' ,"r this reas"n a!! 5e"5!e ta;in% anti#"a%u!ants su#h as war&arin sh"u!d ha9e their b!""d #!"ttin% ti$e $"nit"red when startin% treat$ent with a!!"5urin"!' 0ntu; a!asan ini se$ua "ran% $en%a$bi! anti#"a%u!ants se5erti war&arin harus $e$i!i;i

darah $ere;a di$"nit"r wa;tu ;eti;a $u!ai 5en%"batan den%an a!!"5urin"!' )!!"5urin"! $ay in#rease the b!""d !e9e! "& the"5hy!!ine' )!!"5urin"! da5at $enin%;at;an tin%;at the"5hy!!ine darah' I& y"u are ta;in% the"5hy!!ine y"ur d"#t"r $ay want t" $"nit"r y"ur the"5hy!!ine b!""d !e9e! i& y"u start treat$ent with a!!"5urin"! "r y"ur d"se is in#reased' Ji;a )nda $en%a$bi! the"5hy!!ine d";ter )nda $un%;in in%in $e$"nit"r the"5hy!!ine darah tin%%i Gi;a )nda $u!ai 5en%"batan den%an d"sis a!!"5urin"! atau $enin%;at' )!!"5urin"! $ay in#rease the b!""d !e9e! "& #i#!"s5"rin' )!!"5urin"! da5at $enin%;at;an tin%;at #i#!"s5"rin darah' There is an in#reased #han#e "& a s;in rash i& the antibi"ti#s a$"<i#i!!in "r a$5i#i!!in are ta;en by 5e"5!e ta;in% a!!"5urin"!' )da ;ese$5atan $enin%;at dari rua$ ;u!it Gi;a antibi"ti; a$"<i#i!!in atau a$5i#i!!in dia$bi! "!eh "ran%C"ran% $en%a$bi! a!!"5urin"!' Other $edi#ines #"ntainin% the sa$e a#ti9e in%redient ObatC"batan !ainnya yan% $en%andun% bahan a;ti& yan% sa$a )!!"5urin"! tab!ets are a!s" a9ai!ab!e as the %eneri# $edi#ine, ie with"ut a brand na$e' )!!"5urin"! tab!et Gu%a tersedia seba%ai %eneri; "bat, ya;ni tan5a na$a $ere;'