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OXELTRA 30MG PROLONGED-RELEASE TABLETS

Active substance(s): OXYCODONE HYDROCHLORIDE

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Transcript
Package leaflet: Information for the user
Oxeltra 5 mg, 10 mg, 15 mg, 20 mg, 30 mg, 40 mg,
60 mg and 80 mg
Prolonged-Release Tablets
Oxycodone hydrochloride
Read all of this leaflet carefully before you start taking this
medicine because it contains important information for you.
t ,FFQUIJTMFBøFU:PVNBZOFFEUPSFBEJUBHBJO
t *GZPVIBWFBOZGVSUIFSRVFTUJPOT BTLZPVSEPDUPSPSQIBSNBDJTU
t 5IJTNFEJDJOFIBTCFFOQSFTDSJCFEGPSZPVPOMZ%POPUQBTT
JUPOUPPUIFST*UNBZIBSNUIFN FWFOJGUIFJSTJHOTPGJMMOFTT
BSFUIFTBNFBTZPVST
t *GZPVHFUBOZTJEFFòFDUT UBMLUPZPVSEPDUPSPSQIBSNBDJTU
5IJTJODMVEFTBOZQPTTJCMFTJEFFòFDUTOPUMJTUFEJOUIJTMFBøFU
What is in this leaflet:
 8IBU0YFMUSBUBCMFUTBSFBOEXIBUUIFZBSFVTFEGPS
 8IBUZPVOFFEUPLOPXCFGPSFZPVUBLF0YFMUSBUBCMFUT
 )PXUPUBLF0YFMUSBUBCMFUT
 1PTTJCMFTJEFFòFDUT
 )PXUPTUPSF0YFMUSBUBCMFUT
 $POUFOUTPGUIFQBDLBOEPUIFSJOGPSNBUJPO

XXX

1. What Oxeltra tablets are and what they are used for
5IFTFUBCMFUTIBWFCFFOQSFTDSJCFEGPSZPVCZZPVSEPDUPSUP
SFMJFWFNPEFSBUFUPTFWFSFQBJOPWFSBQFSJPEPGIPVST
5IFZDPOUBJOUIFBDUJWFJOHSFEJFOUPYZDPEPOFXIJDICFMPOHT
UPBHSPVQPGNFEJDJOFTDBMMFETUSPOHBOBMHFTJDTPSAQBJOLJMMFST

5IFTFUBCMFUTNVTUOPUCFVTFEUPHFUIFSXJUIBNPOPBNJOF
PYJEBTFJOIJCJUPS PSJGZPVIBWFUBLFOUIJTUZQFPGNFEJDJOFJO
UIFMBTUUXPXFFLT TFFTFDUJPOi%POPUUBLFyw

5FMMZPVSEPDUPSPSQIBSNBDJTUJGZPVBSFUBLJOH
t NFEJDJOFTUPIFMQZPVTMFFQ GPSFYBNQMFUSBORVJMMJTFST 
IZQOPUJDTPSTFEBUJWFT

t NFEJDJOFTUPUSFBUEFQSFTTJPO TVDIBTQBSPYFUJOFBOE
øVPYFUJOF

t NFEJDJOFTUPUSFBUQTZDIJBUSJDPSNFOUBMEJTPSEFST TVDIBT
QIFOPUIJB[JOFTPSOFVSPMFQUJDESVHT

t PUIFSTUSPOHBOBMHFTJDTPSQBJOLJMMFST
t NFEJDJOFTUPUSFBUBMMFSHJFT USBWFMTJDLOFTTPSOBVTFB
BOUJIJTUBNJOFTPSBOUJFNFUJDT

t NVTDMFSFMBYBOUT
t NFEJDJOFTUPUSFBUIJHICMPPEQSFTTVSF
t NFEJDJOFTVTFEUPUSFBU1BSLJOTPOTEJTFBTF
t RVJOJEJOF BNFEJDJOFUPUSFBUBGBTUIFBSUCFBU

t DJNFUJEJOF BNFEJDJOFGPSTUPNBDIVMDFST JOEJHFTUJPOPS
IFBSUCVSO

t SJGBNQJDJO VTFEUPUSFBUUVCFSDVMPTJT

t DBSCBNB[FQJOF VTFEUPUSFBUTFJ[VSFT öUTPSDPOWVMTJPOT
BOEDFSUBJOQBJODPOEJUJPOT

t QIFOZUPJO VTFEUPUSFBUTFJ[VSFT öUTPSDPOWVMTJPOT

t 4U+PIOT8PSU BIFSCBMNFEJDJOF

t BOUJGVOHBMNFEJDJOFT TVDIBTLFUPDPOB[PMF WPSJDPOB[PMF 
JUSBDPOJ[PMFBOEQPTBDPOB[PMF

t BOUJCJPUJDT TVDIBTFSZUISPNZDJO DMBSJUISPNZDJOBOE
UFMJUISPNZDJO

"MTPUFMMZPVSEPDUPSJGZPVIBWFSFDFOUMZCFFOHJWFOBO
BOBFTUIFUJD

2. What you need to know before you take Oxeltra tablets
Taking Oxeltra tablets with food, drink and alcohol
%SJOLJOHBMDPIPMXIJMTUUBLJOH0YFMUSBUBCMFUTNBZNBLFZPV
GFFMNPSFTMFFQZPSJODSFBTFUIFSJTLPGTFSJPVTTJEFFòFDUT
TVDIBTTIBMMPXCSFBUIJOHXJUIBSJTLPGTUPQQJOHCSFBUIJOH 
BOEMPTTPGDPOTDJPVTOFTT*UJTSFDPNNFOEFEOPUUPESJOL
BMDPIPMXIJMFZPVSFUBLJOH0YFMUSBUBCMFUT

Do not take Oxeltra tablets if you:
t BSFBMMFSHJD IZQFSTFOTJUJWF
UPPYZDPEPOF PSBOZPGUIF
PUIFSJOHSFEJFOUTPGUIFUBCMFUT TFFTFDUJPOA'VSUIFS
*OGPSNBUJPO

t IBWFCSFBUIJOHQSPCMFNT TVDIBTDISPOJDPCTUSVDUJWF
BJSXBZTEJTFBTF TFWFSFCSPODIJBMBTUINBPSTFWFSF
SFTQJSBUPSZEFQSFTTJPOXJUIMPXMFWFMTPGPYZHFOJOZPVS
CMPPE IZQPYJB
PSUPPNVDIDBSCPOEJPYJEFJOZPVSCMPPE
:PVSEPDUPSXJMMIBWFUPMEZPVJGZPVIBWFBOZPGUIFTF
DPOEJUJPOT4ZNQUPNTNBZJODMVEFCSFBUIMFTTOFTT 
DPVHIJOHPSCSFBUIJOHNPSFTMPXMZPSXFBLMZUIBOFYQFDUFE
t IBWFBIFBEJOKVSZUIBUDBVTFTBTFWFSFIFBEBDIFPSNBLFT
ZPVGFFMTJDL5IJTJTCFDBVTFUIFUBCMFUTNBZNBLFUIFTF
TZNQUPNTXPSTFPSIJEFUIFFYUFOUPGUIFIFBEJOKVSZ
t IBWFBDPOEJUJPOXIFSFUIFTNBMMCPXFMEPFTOPUXPSL
QSPQFSMZ QBSBMZUJDJMFVT
ZPVSTUPNBDIFNQUJFTNPSFTMPXMZ
UIBOJUTIPVME EFMBZFEHBTUSJDFNQUZJOH
PSZPVIBWFTFWFSF
QBJOJOZPVSBCEPNFO
t IBWFBIFBSUQSPCMFNBGUFSMPOHUFSNMVOHEJTFBTF DPS
QVMNPOBMF

t IBWFTFWFSFLJEOFZQSPCMFNTPSNPEFSBUFUPTFWFSFMJWFS
QSPCMFNT*GZPVIBWFPUIFSMPOHUFSNLJEOFZPSMJWFS
QSPCMFNTZPVTIPVMEPOMZUBLFUIFTFUBCMFUTJG
SFDPNNFOEFECZZPVSEPDUPS
t IBWFPOHPJOHQSPCMFNTXJUIDPOTUJQBUJPO
t BSFUBLJOHBUZQFPGNFEJDJOFLOPXOBTBNPOPBNJOF
PYJEBTFJOIJCJUPS FYBNQMFTJODMVEFUSBOZMDZQSPNJOF 
QIFOFM[JOF JTPDBSCPYB[JE NPDMPCFNJEFBOEMJOF[PMJE
PS
ZPVIBWFUBLFOUIJTUZQFPGNFEJDJOFJOUIFMBTUUXPXFFLT
t BSFVOEFSZFBSTPGBHF

Driving and using machines
5IFNFEJDJOFDBOBòFDUZPVSBCJMJUZUPESJWFBTJUNBZNBLF
ZPVTMFFQZPSEJ[[Z
t %POPUESJWFXIJMFUBLJOHUIJTNFEJDJOFVOUJMZPVLOPXIPX
JUBòFDUTZPV
t *UJTBOPòFODFUPESJWFJGUIJTNFEJDJOFBòFDUTZPVSBCJMJUZUP
ESJWF
t )PXFWFS ZPVXPVMEOPUCFDPNNJUUJOHBOPòFODFJG
o 5IFNFEJDJOFIBTCFFOQSFTDSJCFEUPUSFBUBNFEJDBMPS
EFOUBMQSPCMFNBOE
o :PVIBWFUBLFOJUBDDPSEJOHUPUIFJOTUSVDUJPOTHJWFOCZ
UIFQSFTDSJCFSPSJOUIFJOGPSNBUJPOQSPWJEFEXJUIUIF
NFEJDJOFBOE
o *UXBTOPUBòFDUJOHZPVSBCJMJUZUPESJWFTBGFMZ
5BMLUPZPVSEPDUPSPSQIBSNBDJTUJGZPVBSFOPUTVSFXIFUIFSJU
JTTBGFGPSZPVUPESJWFXIJMFUBLJOHUIJTNFEJDJOF

*GZPVBSFHPJOHUPIBWFBOPQFSBUJPO QMFBTFUFMMUIFEPDUPSBU
UIFIPTQJUBMUIBUZPVBSFUBLJOHUIFTFUBCMFUT

5IFTFUBCMFUTNBZBòFDUZPVSBCJMJUZUPPQFSBUFNBDIJOFT
%JTDVTTXJUIZPVEPDUPSXIFUIFSZPVNBZPQFSBUFNBDIJOFT

Warnings and precautions
5BMLUPZPVSEPDUPSPSQIBSNBDJTUCFGPSFUBLJOH0YFMUSBUBCMFUT
JGZPV
t BSFPMEFSBOEEFCJMJUBUFE XFBL

t IBWFBOVOEFSBDUJWFUIZSPJEHMBOE IZQPUIZSPJEJTN
BTZPV
NBZOFFEBMPXFSEPTF
t IBWFBUIZSPJEEJTPSEFSXJUIESZOFTT DPMEOFTTBOETXFMMJOH
AQVóOFTT
PGUIFTLJO BòFDUJOHUIFGBDFBOEMJNCT
NZYPFEFNB

t IBWFBTFWFSFIFBEBDIFPSGFFMTJDLBTUIJTNBZJOEJDBUFUIBU
UIFQSFTTVSFJOZPVSTLVMMJTJODSFBTFE
t IBWFMPXCMPPEQSFTTVSF IZQPUFOTJPO
PSSFEVDFECMPPE
WPMVNF
t IBWFBNFOUBMEJTPSEFSBTBSFTVMUPGBOJOGFDUJPO UPYJD
QTZDIPTJT

t IBWFJOøBNNBUJPOPGUIFQBODSFBT XIJDIDBVTFTTFWFSFQBJO
JOUIFBCEPNFOBOECBDL
PSQSPCMFNTXJUIZPVSHBMMCMBEEFS
t IBWFJOøBNNBUPSZCPXFMEJTPSEFST
t IBWFSFDFOUMZIBEBCEPNJOBMTVSHFSZ
t IBWFQSPTUBUFQSPCMFNT
t IBWFQPPSBESFOBMHMBOEGVODUJPO ZPVSBESFOBMHMBOEJTOPU
XPSLJOHQSPQFSMZXIJDINBZDBVTFTZNQUPNTJODMVEJOH
XFBLOFTT XFJHIUMPTT EJ[[JOFTT GFFMJOHPSCFJOHTJDL

t IBWFTFWFSFMVOHQSPCMFNT
t IBWFMJWFSPSLJEOFZQSPCMFNT
t IBWFQSFWJPVTMZTVòFSFEGSPNXJUIESBXBMTZNQUPNTTVDIBT
BHJUBUJPO BOYJFUZ TIBLJOHPSTXFBUJOH VQPOTUPQQJOH
UBLJOHBMDPIPMPSESVHT
t TVòFSGSPNBMDPIPMJTNPSBSFVOEFSHPJOHBMDPIPMXJUIESBXBM
t IBWFBIJTUPSZPGBMDPIPMPSESVHBCVTF

Important information about some of the ingredients of
Oxeltra tablets
5IFTFUBCMFUTDPOUBJOMBDUPTFXIJDIJTBGPSNPGTVHBS*GZPV
IBWFCFFOUPMECZZPVSEPDUPSUIBUZPVIBWFBOJOUPMFSBODFUP
TPNFTVHBST DPOUBDUZPVSEPDUPSCFGPSFUBLJOHUIFTFUBCMFUT

Pregnancy and breastfeeding
%POPUUBLFUIFTFUBCMFUTJGZPVBSFQSFHOBOUPSCSFBTUGFFEJOH
"TLZPVSEPDUPSPSQIBSNBDJTUGPSBEWJDFCFGPSFUBLJOHBOZ
NFEJDJOF

3. How to take Oxeltra tablets
"MXBZTUBLFUIFTFUBCMFUTFYBDUMZBTZPVSEPDUPSIBTUPMEZPV
5IFMBCFMPOZPVSNFEJDJOFXJMMUFMMZPVIPXNBOZUBCMFUTUP
UBLFBOEIPXPGUFO
Adults (over 18 years of age)
5IFVTVBMTUBSUJOHEPTFJTPOFNHUBCMFUFWFSZIPVST
)PXFWFS ZPVSEPDUPSXJMMQSFTDSJCFUIFEPTFSFRVJSFEUPUSFBU
ZPVSQBJO*GZPVöOEUIBUZPVBSFTUJMMJOQBJOXIJMTUUBLJOH
UIFTFUBCMFUT EJTDVTTUIJTXJUIZPVSEPDUPS
%POPUFYDFFEUIFEPTFSFDPNNFOEFECZZPVSEPDUPS:PV
TIPVMEDIFDLXJUIZPVSEPDUPSPSQIBSNBDJTUJGZPVBSFOPU
TVSF
4XBMMPXZPVSUBCMFUTXIPMFXJUIXBUFSDo not crush,
dissolve or chew them.
Oxeltra tablets are designed to work properly over
12 hours when swallowed whole. If a tablet is broken,
crushed, dissolved or chewed, the entire 12-hour dose
may be absorbed rapidly into your body. This can be
dangerous, causing serious problems such as an overdose,
which may be fatal.
:PVTIPVMEUBLFZPVSUBCMFUTFWFSZIPVST'PSJOTUBODF JG
ZPVUBLFBUBCMFUBUPDMPDLJOUIFNPSOJOH ZPVTIPVMEUBLF
ZPVSOFYUUBCMFUBUPDMPDLJOUIFFWFOJOH


XXX

Other medicines and Oxeltra tablets
1MFBTFUFMMZPVSEPDUPSPSQIBSNBDJTUJGZPVBSFUBLJOHPSIBWF
SFDFOUMZUBLFOBOZPUIFSNFEJDJOFT JODMVEJOHNFEJDJOFT
PCUBJOFEXJUIPVUBQSFTDSJQUJPO*GZPVUBLFUIFTFUBCMFUTXJUI
TPNFPUIFSNFEJDJOFT UIFFòFDUPGUIFTFUBCMFUTPSUIFPUIFS
NFEJDJOFNBZCFDIBOHFE

:PVTIPVMEBWPJEESJOLJOHHSBQFGSVJUKVJDFXIJMFZPVBSF
UBLJOHUIFTFUBCMFUT

:PVNVTUPOMZUBLFUIFUBCMFUTCZNPVUI5IFUBCMFUTTIPVME
OFWFSCFDSVTIFEPSJOKFDUFEBTUIJTNBZMFBEUPTFSJPVTTJEF
FòFDUT XIJDINBZCFGBUBM
Children
$IJMESFOBOEBEPMFTDFOUTVOEFSZFBSTPGBHFTIPVMEOPU
UBLFUIFUBCMFUT
If you take more Oxeltra tablets than you should or if
someone accidentally swallows your tablets
$BMMZPVSEPDUPSPSIPTQJUBMTUSBJHIUBXBZ1FPQMFXIPIBWF
UBLFOBOPWFSEPTFNBZGFFMWFSZTMFFQZ TJDLPSEJ[[Z PSIBWF
IBMMVDJOBUJPOT5IFZNBZBMTPIBWFCSFBUIJOHEJóDVMUJFT
MFBEJOHUPVODPOTDJPVTOFTTPSFWFOEFBUIBOENBZOFFE
FNFSHFODZUSFBUNFOUJOIPTQJUBM8IFOTFFLJOHNFEJDBM
BUUFOUJPONBLFTVSFUIBUZPVUBLFUIJTMFBøFUBOEBOZ
SFNBJOJOHUBCMFUTXJUIZPVUPTIPXUPUIFEPDUPS

XXX

If you forget to take your Oxeltra tablets
*GZPVSFNFNCFSXJUIJOIPVSTPGUIFUJNFZPVSUBCMFUXBT
EVF UBLFZPVSUBCMFUTUSBJHIUBXBZ5BLFZPVSOFYUUBCMFUBU
ZPVSOPSNBMUJNF*GZPVBSFNPSFUIBOIPVSTMBUF QMFBTFDBMM
ZPVSEPDUPSPSQIBSNBDJTUGPSBEWJDF%POPUUBLFBEPVCMF
EPTFUPNBLFVQGPSBGPSHPUUFOUBCMFU
If you stop taking Oxeltra tablets
:PVTIPVMEOPUTVEEFOMZTUPQUBLJOHUIFTFUBCMFUTVOMFTTZPVS
EPDUPSUFMMTZPVUP*GZPVXBOUUPTUPQUBLJOHZPVSUBCMFUT 
EJTDVTTUIJTXJUIZPVSEPDUPSöSTU5IFZXJMMUFMMZPVIPXUPEP
UIJT VTVBMMZCZSFEVDJOHUIFEPTFHSBEVBMMZTPZPVEPOPU
FYQFSJFODFVOQMFBTBOUFòFDUT8JUIESBXBMTZNQUPNTTVDIBT
BHJUBUJPO BOYJFUZ QBMQJUBUJPOT TIBLJOHPSTXFBUJOHNBZPDDVS
JGZPVTVEEFOMZTUPQUBLJOHUIFTFUBCMFUT
*GZPVIBWFBOZGVSUIFSRVFTUJPOTPOUIFVTFPGUIJTNFEJDJOF 
BTLZPVSEPDUPSPSQIBSNBDJTU
4. Possible side effects
-JLFBMMNFEJDJOFT UIFTFUBCMFUTDBODBVTFTJEFFòFDUT 
BMUIPVHIOPUFWFSZCPEZHFUTUIFN
"MMNFEJDJOFTDBODBVTFBMMFSHJDSFBDUJPOT BMUIPVHITFSJPVT
BMMFSHJDSFBDUJPOTBSFSBSF5FMMZPVSEPDUPSJNNFEJBUFMZJGZPV
HFUBOZTVEEFOXIFF[JOFTT EJóDVMUJFTJOCSFBUIJOH TXFMMJOH
PGUIFFZFMJET GBDFPSMJQT SBTIPSJUDIJOHFTQFDJBMMZUIPTF
DPWFSJOHZPVSXIPMFCPEZ
5IFNPTUTFSJPVTTJEFFòFDUJTBDPOEJUJPOXIFSFZPVCSFBUIF
NPSFTMPXMZPSXFBLMZUIBOFYQFDUFE SFTQJSBUPSZEFQSFTTJPO

"TXJUIBMMTUSPOHQBJOLJMMFST UIFSFJTBSJTLUIBUZPVNBZ
CFDPNFBEEJDUFEPSSFMJBOUPOUIFTFUBCMFUT
Other possible side effects
Very common (may affect more than 1 in 10 people):
t IFBEBDIF
t GFFMJOHTJDL OBVTFB

t CFJOHTJDL WPNJUJOH

t DPOTUJQBUJPO
t ESPXTJOFTT
t EJ[[JOFTT
t JUDIZTLJO

5IJTTIPVMEOPUBòFDUIPXUIFUBCMFUTXPSL
Reporting of side effects
*GZPVHFUBOZTJEFFòFDUT UBMLUPZPVSEPDUPSPSQIBSNBDJTU
5IJTJODMVEFTBOZQPTTJCMFTJEFFòFDUTOPUMJTUFEJOUIJTMFBøFU
:PVDBOBMTPSFQPSUTJEFFòFDUTEJSFDUMZWJBUIF:FMMPX$BSE
4DIFNFBUIUUQXXXNISBHPWVLZFMMPXDBSE
#ZSFQPSUJOHTJEFFòFDUTZPVDBOIFMQQSPWJEFNPSF
JOGPSNBUJPOPOUIFTBGFUZPGUIJTNFEJDJOF
5. How to store Oxeltra tablets
,FFQPVUPGUIFTJHIUBOESFBDIPGDIJMESFO"DDJEFOUBM
PWFSEPTFCZBDIJMEJTEBOHFSPVTBOENBZCFGBUBM
%POPUVTFBOZUBCMFUTBGUFSUIFFYQJSZEBUFXIJDIJTTUBUFEPO
UIFCMJTUFSBOEDBSUPOPSCPUUMFMBCFM5IFFYQJSZEBUFSFGFSTUP
UIFMBTUEBZPGUIBUNPOUI
%POPUTUPSFBCPWF¡$
%POPUUBLFZPVSUBCMFUTJGUIFZBSFCSPLFOPSDSVTIFEBTUIJTDBO
CFEBOHFSPVTBOEDBODBVTFTFSJPVTQSPCMFNTTVDIBTPWFSEPTF
.FEJDJOFTTIPVMEOPUCFEJTQPTFEPGWJBXBTUFXBUFSPS
IPVTFIPMEXBTUF"TLZPVSQIBSNBDJTUIPXUPEJTQPTFPG
NFEJDJOFTOPMPOHFSSFRVJSFE5IFTFNFBTVSFTXJMMIFMQUP
QSPUFDUUIFFOWJSPONFOU
6. Contents of the pack and other information
What Oxeltra tablets contain
5IFBDUJWFJOHSFEJFOUJTPYZDPEPOFIZESPDIMPSJEF&BDIUBCMFU
DPOUBJOTNH NH NH NH NH NH NHPS
NHPGPYZDPEPOFIZESPDIMPSJEF
5IFPUIFSJOHSFEJFOUTBSFMBDUPTFNPOPIZESBUF IZQSPNFMMPTF
&
QPWJEPOF TUFBSJDBDJE NBHOFTJVNTUFBSBUFBOE
BOIZESPVTTJMJDBDPMMPJEBM
*OBEEJUJPO UIFUBCMFUDPBUJOHTDPOUBJOUIFGPMMPXJOH
NHoQPMZWJOZMBMDPIPM &
UJUBOJVNEJPYJEF &

NBDSPHPM &
UBMD &C
JOEJHPDBSNJOFBMVNJOJVNMBLF
&
BOEJSPOPYJEFZFMMPX &

NHoIZQSPNFMMPTF &
UJUBOJVNEJPYJEF &

NBDSPHPM &
QPMZTPSCBUF &

NHoQPMZWJOZMBMDPIPM &
UJUBOJVNEJPYJEF &

NBDSPHPM &
UBMD &C
JSPOPYJEFCMBDL &
BOE
JSPOPYJEFZFMMPX &

NHQPMZWJOZMBMDPIPM &
UJUBOJVNEJPYJEF &

NBDSPHPM &
UBMD &C
BOEJSPOPYJEFSFE &

NHQPMZWJOZMBMDPIPM &
NBDSPHPM &
UBMD
&C
JSPOPYJEFSFE &
JSPOPYJEFCMBDL &
BOE
JOEJHPDBSNJOFBMVNJOJVNMBLF &

NHQPMZWJOZMBMDPIPM &
UJUBOJVNEJPYJEF &

NBDSPHPM &
UBMD &C
BOEJSPOPYJEFZFMMPX &

NHoQPMZWJOZMBMDPIPM &
NBDSPHPM &
UBMD &C

JSPOPYJEFSFE &
DBSNJOFBOEJSPOPYJEFCMBDL &

NHoQPMZWJOZMBMDPIPM &
UJUBOJVNEJPYJEF &

NBDSPHPM &
UBMD &C
JOEJHPDBSNJOFBMVNJOJVNMBLF
&
BOEJSPOPYJEFZFMMPX &


Common (may affect up to 1 in 10 people):
t ESZNPVUI MPTTPGBQQFUJUF JOEJHFTUJPO BCEPNJOBMQBJO 
EJBSSIPFB
t DPOGVTJPO BGFFMJOHPGVOVTVBMXFBLOFTT BOYJFUZ EFQSFTTJPO 
OFSWPVTOFTT EJóDVMUZJOTMFFQJOH BCOPSNBMUIPVHIUT
t EJóDVMUZJOCSFBUIJOHPSXIFF[JOH TIPSUOFTTPGCSFBUI
t SBTI
t TXFBUJOH
t TIBLJOH

What Oxeltra tablets look like and the contents of the pack
5IFUBCMFUTBSFNBSLFE09BMPOHXJUIUIFTUSFOHUI   FUD
PO
POFTJEF"MMTUSFOHUITBSFSPVOE CJDPOWFY öMNDPBUFEUBCMFUT

Uncommon (may affect up to 1 in 100 people):
t EJóDVMUZJOTXBMMPXJOH CFMDIJOH XJOE DIBOHFTJOUBTUF
t BGFFMJOHPGEJ[[JOFTTPSATQJOOJOH BGFFMJOHPGAGBJOUOFTT
FTQFDJBMMZPOTUBOEJOHVQ IBMMVDJOBUJPOT NPPEDIBOHFT B
GFFMJOHPGFYUSFNFIBQQJOFTT BHJUBUJPO HFOFSBMMZGFFMJOH
VOXFMM MPTTPGNFNPSZ UXJUDIJOH EJóDVMUJFTXJUITQFFDI 
SFEVDFETFOTJUJWJUZUPQBJOPSUPVDI UJOHMJOHPSOVNCOFTT 
TFJ[VSFT öUTPSDPOWVMTJPOT CMVSSFEWJTJPO
t EJóDVMUZJOQBTTJOHVSJOF JNQPUFODF EFDSFBTFETFYVBMESJWF
t øVTIJOHPGUIFTLJO
t EFIZESBUJPO UIJSTU DIJMMT TXFMMJOHPGUIFIBOET BOLMFTPSGFFU
t ESZTLJO
t SFEVDUJPOJOTJ[FPGUIFQVQJMTJOUIFFZF NVTDMFTQBTN
t BOFFEUPUBLFJODSFBTJOHMZIJHIFSEPTFTUPPCUBJOUIFTBNF
MFWFMPGQBJOSFMJFG UPMFSBODF


0YFMUSBNH NH NH NH NH NHBOENH
5BCMFUTBSFBWBJMBCMFJODBSUPOTDPOUBJOJOHPSUBCMFUT
/PUBMMQBDLTJ[FTNBZCFNBSLFUFE

Rare (may affect up to 1 in 1,000 people):
t MPXCMPPEQSFTTVSF
Not known (frequency cannot be estimated from the
available data):
t UPPUIEFDBZ
t BCMPDLBHFJOUIFøPXPGCJMFGSPNUIFMJWFS DIPMFTUBTJT
5IJT
DBODBVTFJUDIZTLJOZFMMPXTLJO WFSZEBSLVSJOFBOEWFSZ
QBMFTUPPMT
t BCTFODFPGNFOTUSVBMQFSJPET
t BHHSFTTJPO
t JODSFBTFETFOTJUJWJUZUPQBJO
:PVNBZTFFUIFSFNBJOTPGUIFUBCMFUTJOZPVSGBFDFT

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
8PDLIBSEU6,-UE "TI3PBE/PSUI 8SFYIBN --6' 6,
Manufacturer
$11IBSNBDFVUJDBMT-UE "TI3PBE/PSUI 8SFYIBN --6' 6,

XXX

6ODPNNPOMZ UIFTFUBCMFUTNBZBòFDUUIFSFTVMUTPGCMPPE
UFTUTUPDIFDLUIBUZPVSMJWFSJTXPSLJOHQSPQFSMZ

5IFUBCMFUTBSFBMMöMNDPBUFEJOUIFGPMMPXJOHDPMPVST
NHCMVF NHXIJUF NHoHSFZ NHQJOL 
NHoCSPXO NHZFMMPX NHoSFE NHoHSFFO
0YFMUSBNH5BCMFUTBSFBWBJMBCMFJODBSUPOTDPOUBJOJOH
PSUBCMFUT

Other formats:
5PMJTUFOUPPSSFRVFTUBDPQZPGUIJTMFBøFUJO#SBJMMF MBSHFQSJOU
PSBVEJPQMFBTFDBMM GSFFPGDIBSHF 6,POMZ

1MFBTFCFSFBEZUPHJWFUIFGPMMPXJOHJOGPSNBUJPO
Product name
Reference number
 0YFMUSBNH1SPMPOHFE3FMFBTF5BCMFUT
1-
0YFMUSBNH1SPMPOHFE3FMFBTF5BCMFUT 1-
0YFMUSBNH1SPMPOHFE3FMFBTF5BCMFUT 1-
0YFMUSBNH1SPMPOHFE3FMFBTF5BCMFUT 1-
0YFMUSBNH1SPMPOHFE3FMFBTF5BCMFUT 1-
0YFMUSBNH1SPMPOHFE3FMFBTF5BCMFUT 1-
0YFMUSBNH1SPMPOHFE3FMFBTF5BCMFUT 1-
0YFMUSBNH1SPMPOHFE3FMFBTF5BCMFUT 1-
5IJTJTBTFSWJDFQSPWJEFECZUIF3PZBM/BUJPOBM*OTUJUVUFPG
#MJOE1FPQMF
-FBøFU1SFQBSFE


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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.

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