Skip to Content

SUMATRIPTAN 50 MG TABLETS

Active substance(s): SUMATRIPTAN SUCCINATE / SUMATRIPTAN SUCCINATE / SUMATRIPTAN SUCCINATE

View full screen / Print PDF » Download PDF ⇩

PDF Transcript

3$&.$*(/($)/(7,1)250$7,21)257+(86(5

6XPDWULSWDQPJ7DEOHWV
6XPDWULSWDQPJ7DEOHWV
 6XPDWULSWDQVXFFLQDWH 



5HDGDOORIWKLVOHDIOHWFDUHIXOO\EHIRUH\RXVWDUWWDNLQJWKLVPHGLFLQHEHFDXVHLWFRQWDLQV
LPSRUWDQWLQIRUPDWLRQIRU\RX
x .HHSWKLVOHDIOHW x ,I\RXKDYHDQ\IXUWKHUTXHVWLRQVDVN\RXUGRFWRURUSKDUPDFLVW
x 7KLVPHGLFLQHKDVEHHQSUHVFULEHGIRU\RXRQO\'RQRWSDVVLWRQWRRWKHUV,WPD\KDUPWKHP
HYHQLIWKHLUVLJQVRILOOQHVVDUHWKHVDPHDV\RXUV
x ,I\RXJHWDQ\VLGHHIIHFWVWDONWR\RXUGRFWRURUSKDUPDFLVW7KLVLQFOXGHVDQ\SRVVLEOHVLGH
HIIHFWVQRWOLVWHGLQWKLVOHDIOHW

:KDWLVLQWKLVOHDIOHW
 :KDW6XPDWULSWDQ7DEOHWVDUHDQGZKDWWKH\DUHXVHGIRU
 :KDW\RXQHHGWRNQRZEHIRUH\RXWDNH6XPDWULSWDQ7DEOHWV
 +RZWRWDNH6XPDWULSWDQ7DEOHWV
 3RVVLEOHVLGHHIIHFWV
 +RZWRVWRUH6XPDWULSWDQ7DEOHWV
 &RQWHQWVRIWKHSDFNDQGRWKHULQIRUPDWLRQ



 :KDW6XPDWULSWDQWDEOHWVDUHDQGZKDWWKH\DUHXVHGIRU

6XPDWULSWDQ7DEOHWVKDYHEHHQGHYHORSHGIRUWKHWUHDWPHQWRIPLJUDLQH7KHV\PSWRPVRIPLJUDLQH
ZKLFKDUHWKRXJKWWREHGXHWRWHPSRUDU\VZHOOLQJRIEORRGYHVVHOVLQWKHKHDGPD\LQFOXGHDXUD
ZDUQLQJVHQVDWLRQVRIYLVXDOGLVWRUWLRQVXFKDVIODVKHVRIOLJKWDQG]LJ]DJOLQHVRUZDYHV 0HGLFLQHV
OLNH6XPDWULSWDQ7DEOHWVDUHEHOLHYHGWRZRUNE\UHGXFLQJWKHVL]HRIWKHVHEORRGYHVVHOV7KHVH
PHGLFLQHVDUHFDOOHG+7UHFHSWRUDJRQLVWV



 :KDW\RXQHHGWRNQRZEHIRUH\RXWDNH6XPDWULSWDQWDEOHWV

'RQRWWDNH6XPDWULSWDQWDEOHWVDQGWHOO\RXUGRFWRULI\RX
x DUHDOOHUJLFWRVXPDWULSWDQRUDQ\RIWKHRWKHULQJUHGLHQWVLQ6XPDWULSWDQ7DEOHWV DOOHUJLFLIDIWHUWDNLQJVXPDWULSWDQ\RXVXGGHQO\H[SHULHQFHIHHOLQJVRIWLJKWQHVVLQWKHWKURDWRU
FKHVWVZHOOLQJRIWKHWRQJXHOLSVRUH\HOLGVGLIILFXOW\LQEUHDWKLQJRUVZDOORZLQJDZLGHVSUHDG
IHHOLQJRIZDUPWKIOXVKLQJRULWFKLQJRIWKHVNLQDQGRUDUDVKOLNHµKLYHV¶SURJUHVVLQJWRIHHOLQJ
IDLQWRUORVVRIFRQVFLRXVQHVV6KRXOGDQ\RIWKHVHRFFXUVWRSWDNLQJWKHVXPDWULSWDQWDEOHWVDQG
JHWPHGLFDODVVLVWDQFHLPPHGLDWHO\
x KDYHKDGDKHDUWDWWDFNRUVXIIHUIURPDQ\KHDUWGLVHDVH
x KDYHV\PSWRPVWKDWPLJKWLQGLFDWHKHDUWGLVHDVHVXFKDVFKHVWSDLQRUDVHQVDWLRQRISUHVVXUHRU
WLJKWQHVVLQ\RXUFKHVW
x KDYHKLJKEORRGSUHVVXUHRULI\RXUEORRGSUHVVXUHLVKLJKGHVSLWHPHGLFDWLRQ
x KDYHSRRUEORRGFLUFXODWLRQLQ\RXUOHJVWKDWFDXVHVFUDPSOLNHSDLQZKHQ\RXZDONWRRIDU
SHULSKHUDOYDVFXODUGLVHDVH 
x KDYHDKLVWRU\RIVWURNHRUWUDQVLHQWLVFKDHPLFDWWDFN 7,$DPLQRUIRUPRIVWURNHWKDWODVWVOHVV
WKDQKUV 
x KDYHVHYHUHOLYHUSUREOHPV
x DUHWDNLQJDQ\PHGLFLQHVIRU\RXUPLJUDLQHZKLFKFRQWDLQHUJRWDPLQHRUHUJRWDPLQHGHULYDWLYHV
VXFKDVHUJRWDPLQHWDUWUDWHRUDQ\RWKHUWULSWDQ+7UHFHSWRUDJRQLVWRUPHWK\VHUJLGHPDOHDWH

DOVRZDLWDWOHDVWKRXUVDIWHUWDNLQJ6XPDWULSWDQ7DEOHWVEHIRUHWDNLQJDQHUJRWDPLQHFRQWDLQLQJ
SURGXFWRUDWOHDVWKRXUVEHIRUHWDNLQJDWULSWDQB+7UHFHSWRUDJRQLVW
x DUHWDNLQJDQ\PHGLFLQHVRQDGRFWRU¶VSUHVFULSWLRQIRUWKHWUHDWPHQWRIGHSUHVVLRQVXFKDV
OLWKLXPPRQRDPLQHR[LGDVHLQKLELWRUV 0$2,V VHOHFWLYHVHURWRQLQUHXSWDNHLQKLELWRUV 665,V 
RUVHURWRQLQQRUHSLQHSKULQHUHXSWDNHLQKLELWRUV 615,V  LQFOXGLQJFLWDORSUDPIOXR[HWLQH
IOXYR[DPLQHSDUR[HWLQHDQGVHUWUDOLQH RULI\RXKDYHWDNHQDQ0$2,LQWKHODVWZHHNV


,I\RXWKLQN\RXPD\KDYHDQ\RIWKHVHSUREOHPVFRQWDFW\RXUGRFWRUEHIRUHWDNLQJVXPDWULSWDQ

%HIRUHSUHVFULELQJVXPDWULSWDQ\RXUGRFWRUZLOOHVWDEOLVKZKHWKHU\RXUKHDGDFKHLVFDXVHGE\
PLJUDLQHDQGQRWE\DQ\RWKHUFRQGLWLRQ

:DUQLQJVDQGSUHFDXWLRQV
x LI\RXNQRZWKDW\RXKDYHSUREOHPVZLWK\RXUOLYHURUNLGQH\V
x LI\RXKDYHEHHQGLDJQRVHGZLWKHSLOHSV\RUDQ\RWKHUGLVHDVHWKDWUHGXFHVWKHWKUHVKROGIRU
HSLOHSWLFILWV
x LI\RXNQRZWKDW\RXDUHDOOHUJLFWRDQWLEDFWHULDOPHGLFLQHVWKDWEHORQJWRWKHJURXSRI
VXOSKRQDPLGHV
x LI\RXDUHEHLQJWUHDWHGIRUKLJKEORRGSUHVVXUHDVLQDVPDOOQXPEHURIFDVHVVXPDWULSWDQKDV
EHHQVHHQWRLQFUHDVHEORRGSUHVVXUH
x LI\RXH[SHULHQFHSDLQDQGRUWLJKWQHVVLQWKHFKHVWRUWKURDW7KHVHHIIHFWVDUHXVXDOO\VKRUW
ODVWLQJ,IWKH\KRZHYHUSHUVLVWDQG\RXDUHFRQFHUQHGRUWKH\EHFRPHVHYHUHFRQWDFW\RXU
GRFWRULPPHGLDWHO\IRUDGYLFH
x LI\RXH[SHULHQFHFKURQLFGDLO\KHDGDFKHV7DNLQJVXPDWULSWDQWRRRIWHQPD\UHVXOWLQGHYHORSLQJ
DFKURQLFKHDGDFKH,QVXFKFDVHV\RXVKRXOGFRQWDFW\RXUGRFWRUDV\RXPD\KDYHWRVWRSWDNLQJ
VXPDWULSWDQ
x LI\RXDUHFRQVLGHUHGWREHDWULVNRIGHYHORSLQJKHDUWGLVHDVH HJGLDEHWLFRUDKHDY\VPRNHU 
DQGSDUWLFXODUO\LI\RXDUHDSRVWPHQRSDXVDOZRPDQRUDPDQRYHU\HDUVZLWKWKHVHULVN
IDFWRUV\RXUGRFWRUVKRXOGFKHFN\RXUKHDUWIXQFWLRQEHIRUHSUHVFULELQJVXPDWULSWDQ,QYHU\UDUH
FDVHVVHULRXVKHDUWFRQGLWLRQVKDYHRFFXUUHGDIWHUWDNLQJVXPDWULSWDQHYHQLIQRVLJQVRIDQ\
KHDUWGLVHDVHZHUHIRXQG&RQWDFW\RXUGRFWRUIRUDGYLFHLI\RXKDYHDQ\FRQFHUQV

&KLOGUHQDQGDGROHVFHQWV
6XPDWULSWDQ7DEOHWVVKRXOGQRWEHXVHGLQFKLOGUHQXQGHU\HDUVRIDJHDVWKHVDIHW\DQG
HIIHFWLYHQHVVRIWKLVPHGLFLQHLQFKLOGUHQKDVQRWEHHQHVWDEOLVKHG

2WKHUPHGLFLQHVDQG6XPDWULSWDQWDEOHWV
3OHDVHWHOO\RXUGRFWRURUSKDUPDFLVWLI\RXDUHWDNLQJRUKDYHUHFHQWO\WDNHQRUPLJKWWDNHDQ\RWKHU
PHGLFLQHV

&HUWDLQPHGLFLQHVPD\LQIOXHQFHWKHHIIHFWLYHQHVVRIVXPDWULSWDQDQGVXPDWULSWDQPD\LQIOXHQFHWKH
HIIHFWLYHQHVVRIRWKHUPHGLFLQHV&RQWDFW\RXUGRFWRULI\RXWDNH
x RWKHUPHGLFLQHVIRUPLJUDLQHVXFKDVHUJRWDPLQHRUVLPLODUPHGLFLQHVVXFKDVRWKHUWULSWDQ
+7UHFHSWRUDJRQLVWV
x PHGLFLQHVWRWUHDWGHSUHVVLRQ 0$2LQKLELWRUVRUVHURWRQLQUHXSWDNHLQKLELWRUVVHURWRQLQ
QRUDGUHQDOLQHUHXSWDNHLQKLELWRUV 
x PHGLFLQHVWRWUHDWPDQLFGHSUHVVLYH ELSRODU GLVRUGHUVVXFKDVOLWKLXP

'XULQJFRQFRPLWDQWXVHRIVXPDWULSWDQDQGKHUEDOSUHSDUDWLRQVFRQWDLQLQJ6W-RKQ¶V:RUW
+\SHULFXPSHUIRUDWXP VLGHHIIHFWVPD\EHFRPHPRUHFRPPRQ

3UHJQDQF\DQGEUHDVWIHHGLQJ
,I\RXDUHSUHJQDQWRUEUHDVWIHHGLQJWKLQN\RXPD\EHSUHJQDQWRUDUHSODQQLQJWRKDYHDEDE\DVN
\RXUGRFWRURUSKDUPDFLVWIRUDGYLFHEHIRUHWDNLQJDQ\PHGLFLQH

6XPDWULSWDQ7DEOHWVVKRXOGQRWEHWDNHQLI\RXDUHSUHJQDQWOLNHO\WREHFRPHSUHJQDQWRULI\RXDUH
EUHDVWIHHGLQJXQOHVVDGYLVHGWRGRVRE\\RXUGRFWRU%UHDVWIHHGLQJVKRXOGEHDYRLGHGIRUKRXUV
DIWHUDGRVHDQGGXULQJWKLVWLPHDQ\EUHDVWPLONH[SUHVVHGVKRXOGEHGLVFDUGHG

'ULYLQJDQGXVLQJPDFKLQHV
6XPDWULSWDQ7DEOHWVPD\FDXVHGURZVLQHVV,I\RXDUHDIIHFWHGGRQRWGULYHRURSHUDWHPDFKLQHU\

6XPDWULSWDQWDEOHWVFRQWDLQODFWRVH DW\SHRIVXJDU 
,I\RXKDYHEHHQWROGE\\RXUGRFWRUWKDW\RXKDYHLQWROHUDQFHWRVRPHVXJDUVFRQWDFW\RXUGRFWRU
EHIRUHWDNLQJWKLVPHGLFLQDOSURGXFW


 +RZWRWDNH6XPDWULSWDQWDEOHWV

$OZD\VWDNHWKLVPHGLFLQHH[DFWO\DV\RXUGRFWRUKDVWROG\RX,I\RXDUHQRWVXUHFKHFNZLWK\RXU
GRFWRURUSKDUPDFLVW
21(WDEOHWVKRXOGEHWDNHQDWWKHILUVWVLJQRIDPLJUDLQHDWWDFNDOWKRXJKLWZLOOVWLOOEHHIIHFWLYHLI
WDNHQDWDODWHUVWDJH,IWKLVWDEOHWGRHVQRWPDNH\RXUPLJUDLQHEHWWHUGRQRWWDNHDQ\PRUHWDEOHWVIRU
WKLVDWWDFNEHFDXVHLWLVXQOLNHO\WKDWDVHFRQGGRVHZLOOZRUN6XPDWULSWDQ7DEOHWVFDQEHXVHGIRU
\RXUQH[WDWWDFN
,IDIWHU\RXUILUVWGRVH\RXUPLJUDLQHJRHVDZD\EXWWKHQUHWXUQV\RXPD\WDNHDQRWKHUWDEOHW
SURYLGHGLWLVDWOHDVWWZRKRXUVVLQFH\RXWRRNWKHILUVWWDEOHW
'21277$.(025(7+$1PJRI6XPDWULSWDQLQDQ\KRXUSHULRG6ZDOORZHDFKWDEOHW
ZKROHZLWKZDWHU'RQRWFKHZRUFUXVKWKHP

8VHLQFKLOGUHQDQGDGROHVFHQWV
6XPDWULSWDQ7DEOHWVVKRXOGQRWEHXVHGLQFKLOGUHQXQGHU\HDUVRIDJHDVWKHVDIHW\DQG
HIIHFWLYHQHVVRIWKLVPHGLFLQHLQFKLOGUHQKDVQRWEHHQHVWDEOLVKHG

8VHLQROGHUSHRSOH
7KHUHLVOLWWOHH[SHULHQFHRI6XPDWULSWDQ7DEOHWVLQWKRVHRYHU\HDUVRIDJHVRLWLVQRWXVXDOO\
SUHVFULEHGIRUWKLVDJHJURXS

,I\RXKDYHWKHLPSUHVVLRQWKDWWKHHIIHFWRI6XPDWULSWDQ7DEOHWVLVWRRVWURQJRUWRRZHDNWDONWR\RXU
GRFWRURUSKDUPDFLVW

+RZTXLFNO\ZLOOWKHWUHDWPHQWVWDUWWRZRUN"
,WWDNHV6XPDWULSWDQ7DEOHWVDERXWPLQXWHVWRVWDUWZRUNLQJ,IWKHWDEOHWVGRQRWHDVH\RXU
PLJUDLQHWKHQ\RXPD\WDNH\RXUXVXDOµSDLQNLOOHUV¶SURYLGHGWKH\GRQRWFRQWDLQHUJRWDPLQHRULWV
GHULYDWLYHV:DLWDWOHDVWVL[KRXUVDIWHUWDNLQJD6XPDWULSWDQWDEOHWEHIRUHWDNLQJDQ\PHGLFLQHV
FRQWDLQLQJHUJRWDPLQHRULWVGHULYDWLYHV

,I\RXWDNHPRUH6XPDWULSWDQ7DEOHWVWKDQ\RXVKRXOG
,WLVLPSRUWDQWWRNHHSWRWKHGRVHRQWKHODEHORUIROORZWKHLQVWUXFWLRQVDERYH7DNLQJPRUHWKDQWKLV
FRXOGPDNH\RXLOO,IDQRYHUGRVHLVWDNHQ'2127'(/$<DVN\RXUGRFWRUZKDWWRGRRUFRQWDFW
\RXUQHDUHVWDFFLGHQWDQGHPHUJHQF\GHSDUWPHQW

,I\RXKDYHDQ\IXUWKHUTXHVWLRQVRQWKHXVHRIWKLVPHGLFLQHDVN\RXUGRFWRURUSKDUPDFLVW


 3RVVLEOHVLGHHIIHFWV
/LNHDOOPHGLFLQHVWKLVPHGLFLQHFDQFDXVHVLGHHIIHFWVDOWKRXJKQRWHYHU\ERG\JHWVWKHP

6WRSWDNLQJ6XPDWULSWDQ7DEOHWVDQGVHHNPHGLFDODGYLFHLPPHGLDWHO\LI\RXQRWLFHDQ\RIWKH
IROORZLQJVHULRXVVLGHHIIHFWV



x 6XGGHQZKHH]LQHVVIOXWWHULQJRUWLJKWQHVVLQWKHFKHVWVZHOOLQJRIH\HOLGVIDFHRUOLSVVNLQ
UDVKUHGVSRWVRUKLYHV VNLQOXPSV ZKLFKPD\EHVLJQVRIDQDOOHUJLFUHDFWLRQ
x +HDUWDWWDFN P\RFDUGLDOLQIDUFWLRQ 
x 6HYHUHVXIIRFDWLQJSDLQUDGLDWLQJIURPWKHFKHVWGRZQWKHOHIWDUP DQJLQD 
x 3DLQLQWKHFHQWUHRIWKHFKHVWFDXVHGE\DQDUURZLQJRIWKHEORRGYHVVHOVWKDWVXSSO\WKHKHDUW
FRURQDU\DUWHU\VSDVP 
x 7KHUHKDYHUDUHUHSRUWVGHVFULELQJSDWLHQWVZLWKVHURWRQLQV\QGURPH6\PSWRPVLQFOXGH
IHHOLQJFRQIXVHGIHHOLQJUHVWOHVVVZHDWLQJVKDNLQJVKLYHULQJKDOOXFLQDWLRQV VWUDQJHYLVLRQV
RUVRXQGV VXGGHQMHUNVRIWKHPXVFOHVRUDIDVWKHDUWEHDW


7HOO\RXUGRFWRULI\RXQRWLFHDQ\RIWKHIROORZLQJVLGHHIIHFWVRUQRWLFHDQ\RWKHUHIIHFWVQRWOLVWHG

&RPPRQVLGHHIIHFWVPD\DIIHFWXSWRLQSHRSOH
x 7LQJOLQJGL]]LQHVVDQGGURZVLQHVV ,03257$17LI\RXDUHGULYLQJRUZRUNLQJDPDFKLQH 
x 6HQVRU\GLVWXUEDQFHVLQFOXGLQJSLQVDQGQHHGOHV¶WLQJOLQJ SDUDHVWKHVLD DQGUHGXFHGVHQVH
RIWRXFK K\SRDHVWKHVLD 
x 6KRUWODVWLQJLQFUHDVHVLQEORRGSUHVVXUHVRRQDIWHUWDNLQJWKHPHGLFLQH
x )OXVKLQJ UHGQHVVRIWKHIDFHODVWLQJDIHZPLQXWHV 
x '\VSQRHD GLIILFXOW\EUHDWKLQJ 
x )HHOLQJVLFN QDXVHD RUEHLQJVLFN YRPLWLQJ ZKHQQRWSDUWRIPLJUDLQHDWWDFN
x 6HQVDWLRQVRIKHDYLQHVV XVXDOO\VKRUWWHUPDQGPD\EHLQWHQVHDQGFDQDIIHFWDQ\SDUWRIWKH
ERG\LQFOXGLQJWKHFKHVWDQGWKURDW 
x 0XVFOHSDLQ P\DOJLD 
x 3DLQVHQVDWLRQVRIKHDWRUFROGSUHVVXUHRUWLJKWQHVV WKHVHHYHQWVDUHXVXDOO\VKRUWWHUPDQG
PD\EHLQWHQVHDQGFDQDIIHFWDQ\SDUWRIWKHERG\LQFOXGLQJWKHFKHVWDQGWKURDW 
x )HHOLQJVRIZHDNQHVVIDWLJXH ERWKHYHQWVDUHPRVWO\PLOGWRPRGHUDWHLQLQWHQVLW\DQGVKRUW
WHUP 

9HU\UDUHVLGHHIIHFWVPD\DIIHFWXSWRLQSHRSOH
x ,I\RXKDYHDEORRGWHVWWRFKHFNKRZ\RXUOLYHULVZRUNLQJDQGKDYHWDNHQ6XPDWULSWDQ
WDEOHWVWHOO\RXUGRFWRUDVLWPD\DIIHFWWKHUHVXOWV

1RWNQRZQIUHTXHQF\FDQQRWEHHVWLPDWHGIURPWKHDYDLODEOHGDWD
x )LWV XVXDOO\LQSHRSOHZLWKDKLVWRU\RIHSLOHSV\ 
x 6KDNLQJWUHPRUVRUXQFRQWUROOHGPRYHPHQWV
x 9LVXDOGLVWXUEDQFHVLQFOXGLQJXQFRQWUROOHGH\HPRYHPHQWV Q\VWDJPXV EOLQGVSRW VFRWRPD 
IOLFNHULQJGRXEOHYLVLRQDQGUHGXFHGYLVLRQ7KHUHKDYHEHHQFDVHVZKHUHSHUPDQHQWYLVLRQ
GHIHFWVKDYHRFFXUUHG
x 6ORZLQJRUTXLFNHQLQJLQWKHVSHHGRI\RXUKHDUWEHDWSDOSLWDWLRQV IHHOLQJRIIDVWKHDUWEHDW 
FKDQJHVLQKHDUWUK\WKP
x /RZHULQJRIEORRGSUHVVXUHWKDWFDQOHDGWRIHHOLQJRIIDLQWQHVVHVSHFLDOO\RQVWDQGLQJXS
x 5D\QDXG VSKHQRPHQRQ DSDLQIXOFRQGLWLRQFDXVLQJWKHILQJHUVRUWRHVWRWXUQZKLWHWKHQ
EOXHDQGUHG 
x ,QIODPPDWLRQRIWKHFRORQ SDUWRIWKHLQWHVWLQH ZKLFKPD\SUHVHQWDVORZHUOHIWVLGHG
DEGRPLQDOSDLQDQGRUEORRG\GLDUUKRHD
x 'LDUUKRHD
x 6WLIIQHVVLQWKHQHFN
x -RLQWSDLQ DUWKUDOJLD 
x *HQHUDOLVHGIHDUZRUU\ DQ[LHW\ 
x ([FHVVLYHVZHDWLQJ K\SHUKLGURVLV 

,I\RXJHWDQ\VLGHHIIHFWVWDONWR\RXUGRFWRURUSKDUPDFLVW7KLVLQFOXGHVDQ\SRVVLEOHVLGHHIIHFWV
QRWOLVWHGLQWKLVOHDIOHW



:HEVLWHZZZPKUDJRYXN\HOORZFDUG

%\UHSRUWLQJVLGHHIIHFWV\RXFDQKHOSSURYLGHPRUHLQIRUPDWLRQRQWKHVDIHW\RIWKLVPHGLFLQH


 +RZWRVWRUH6XPDWULSWDQWDEOHWV

.HHSWKLVPHGLFLQHRXWRIWKHVLJKWDQGUHDFKRIFKLOGUHQ
7KLVPHGLFLQDOSURGXFWGRHVQRWUHTXLUHDQ\VSHFLDOVWRUDJHFRQGLWLRQV
'RQRWXVHWKLVPHGLFLQHDIWHUWKHH[SLU\GDWHVWDWHGRQWKHFDUWRQEOLVWHUDQGODEHODIWHU(;37KH
H[SLU\GDWHUHIHUVWRWKHODVWGD\RIWKDWPRQWK
'RQRWWKURZDZD\PHGLFLQHVYLDZDVWHZDWHURUKRXVHKROGZDVWH$VN\RXUSKDUPDFLVWKRZWRWKURZ
DZD\PHGLFLQHV\RXQRORQJHUXVH7KHVHPHDVXUHVZLOOKHOSSURWHFWWKHHQYLURQPHQW



&RQWHQWVRIWKHSDFNDQGRWKHULQIRUPDWLRQ

:KDW6XPDWULSWDQWDEOHWVFRQWDLQ
x (DFKWDEOHWFRQWDLQVHLWKHUPJRUPJVXPDWULSWDQ DVWKHVXFFLQDWH 
x 7KHRWKHULQJUHGLHQWVDUHODFWRVHPRQRK\GUDWHFURVFDUPHOORVHVRGLXPDQK\GURXVODFWRVH
PLFURFU\VWDOOLQHFHOOXORVHPDJQHVLXPVWHDUDWHPDQQLWROWLWDQLXPGLR[LGH(WDOFWULDFHWLQ

:KDW6XPDWULSWDQWDEOHWVORRNOLNHDQGFRQWHQWVRIWKHSDFN
6XPDWULSWDQPJ7DEOHWVDUH:KLWHRYDOELFRQYH[[PPFRDWHGWDEOHWVZLWKVFRUHRQERWK
VLGHVDQGVLGHVFRUHHPERVVHGZLWK61RQRQHVLGHDQG³´RQWKHRWKHUVLGH
6XPDWULSWDQPJ7DEOHWVDUH:KLWHRYDOELFRQYH[[PPFRDWHGWDEOHWVHPERVVHGZLWKµ61¶
RQRQHVLGHDQG³´RQWKHRWKHUVLGH
7KHIROORZLQJSDFNVL]HVDUHDYDLODEOHRU
7DEOHWV
1RWDOOSDFNVL]HVPD\EHPDUNHWHG

0DUNHWLQJ$XWKRULVDWLRQ+ROGHU
$SWLO3KDUPD/LPLWHG
WK)ORRU&3+RXVH8[EULGJH5RDG(DOLQJ/RQGRQ:7/

0DQXIDFWXUHU
$FWDYLV*URXS37&HKI
5H\NMDYtNXUYHJXU+DIQDUIMRUGXU,FHODQG

7KLVOHDIOHWZDVODVWUHYLVHGLQ

Expand Transcript

Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

Hide