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TEMAZEPAM 10 MG TABLETS

Active substance(s): TEMAZEPAM

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231-30-60838-Z LBL TEMAZEPAM 10mg TAB 500 TUK
1

21 November 2014

TEVA UK Ref:

For proofreading of Braille

10
mg

New advice for drivers - see leaflet inside

500

Braille placement only

10
temazepam
#10 mg mg
tablets
Tablets

UK Reg'd T.M.

Oral Use

500

30 mm

TEVA UK Ref:

231-30-60838-Z LBL TEMAZEPAM 10mg TAB 500 TUK
UK Reg'd T.M.

124 mm
Page 6

134 mm
Page 7

4HETABLETSSHOULDBESWALLOWEDPREFERABLYWITHAGLASSOFWater.
YOURDOCTORWILLDECIDETHECOrRECTDOSAGETHEUSUALDOSEIS
Insomnia
s Adults1 MGSHOULDBETAKENWHENGOINGTOBEDORUPTOMINUTESBEFOREGOINGTO
BED6ERYOCCASIONALLy THEDOSEMAYBEINCREASEDTO MGDAILy.
s Elderly patientsTHEDOSEIS1MGDAILy.6ERYOCCASIONALLy THISMAYBEINCREASEDTOMG
DAILy.
s Children:TEMAzepaMiS.O4ReCOMMENDEDFORUSEiNcHILDrenUNDERTHeAGEOF18YEars.
FORPATIENTSWHOHAVECErTAINPROBLEMSWITHBLOODVESSELSORTHEIRLiVERTHEDOSAGEMAYBELOWEr.
Do NOT change the dose yourself.
Premedication
s Adults MGSHOULDBETAKEN MINUTESBEFORESURGERy.
s ElderlyLOWERDOSESMAYBEREQUIREDBYELDERLYPATIENTS UPTOHALFTHENORMALADULTDOSE
MAYBEADEQUATE
s Children:TEMAzepaMISNOTReCOMMEnDEDFORUSeiNcHILDrenUNDERTHEageOF18YEars.
If you take more Temazepam than you should
)FYOUORSOMEONEELSE SWALLOWALOTOFTHETABLETSALLTOGETHEr ORIFYOUTHINKAcHILDHAS
sWALLOWEDAnYOFTHETABLETS CONTACTYOURNEARESTHOSPITALCASUALTYDEPArTMENTORYOURDOCTOR
IMMEDIATELy.!NOVERDOSEISLIKELYTOCAUSEDROWSINESS DIFFICULTYINCONTROLLINGMOVEMENTS
SLUrREDSPEEcHANDInvOLUNTARYEYEMOVEMENTSCOMA LOWBLOODPRESSUREANDBREATHING
PROBLEMSCANALSOOCCUr.
0LEASETAKETHISLEAFLET AnYREMAININGTABLETS ANDTHECONTAINERWITHYOUTOTHEHOSPITALOR
DOCTORSOTHATTHEYKNOWWHIcHTABLETSWERECONSUMED
If you forget to take Temazepam
)FYOUFALLASLEEPWITHOUTHAVINGTAKENADOSEANDWaKEUPSOMEHOUrSLATEr DONOTTAKETHE
MISSEDDOSE)FNECESSARy RETURNTOYOURNORMALDOSEScHEDULETHEFOLLOWINGNIGHT$ONOTTAKE
ADOUBLEDOSETOMAKEUPFORAFORGOtTENDOSE

If you stop taking Temazepam
YOUWILLBETOLDBYYOURDOCTORTOSTOPTAKINGTHETABLETSASSOONASISPOSSIBLEANDTHEDOSEWILLBE
REDUCEDGRADUALLy.YOUSHOULDNOTSTOPTAKINGTHETABLETSSUDDENLYORWITHOUTMEDICALADVICE)FTHE
TABLETSARESTOPPEDABRUPTLYORTHEDOSEREDUCEDTOORAPIDLYYOUMAYGETUNPLEASANTEFFECTS
4HESEWITHDRAWALEFFECTSCANINCLUDEHEADAcHE MUSCLEPAIN TENSION SEVEREANXIETy CONFUSION
DEPRESSION RESTLESSNESS IrRITABILITYANDSWEATING)NSEVERECASESOFWITHDRAWALYOUMAYEXPERIENCEA
FEELINGOFTHINGSBEINGUNREAL AFEELINGOFDETAcHMENTFROMYOURSUrROUNDINGS NUMBNESSANDTINGLING
INTHEHANDSANDFEET SOUNDSSEEMINGTOBELOUDERTHANUSUALANDWHIcHCANSOMETIMESBEPAINFULIF
THESOUNDISLOUD SENSITiVITYTOLIGHTORTOUcH HALLUCINATIONS InvOLUNTARYMOVEMENTS BEINGSIcK
vOMITING ANDFITS)NADDITION PROBLEMSWITHSLEEPING FEELINGRESTLESSANDANXIOUSANDMOODcHANGES
MAYRETURN
)FYOUEXPERIENCETHESEORAnYOTHERUNUSUALEFFECTSWHENYOUSTOPTAKINGTEMAzEPAM SPEAKTOYOUR
DOCTOr.





)FYOUHAVEAnYFUrTHERQUESTIONSONTHEUSEOFTHISPRODUCT ASKYOURDOCTORORPHARMACIST

134 mm
Page 1

TEMAZEPAM 10 mg TABLETS

10 mg Tablets

New advice for drivers - see leaflet inside

10 mm
Glue

P!CK!'%,%!&,%4).&/2-!4)/.&/24(%53%2
Read all of this leaflet carefully before you start taking this medicine.
s KEEPTHISLEAFLETYOUMAYNEEDTOREADITAgain.
s )FYOUHAVEAnYFUrTHERQUESTIONS ASKYOURDOCTORORPHARMACIST
s 4HISMEDicineHASBEeNpreSCRIBEDFORyOU$ONOTpaSSITOnTOOTHers.)TMAYHARMThEM EVEnIFTHEIR
SYMPTOMSARETHESAMEASYOUrs.
s )FYOUGETAnYSIDEEFFECTS TALKTOYOURDOCTOr PHARMACISTORNUrse.4HISINCLUDESAnYPOSSIBLESIDE
eFFECTSNOTLISTEDINTHISLEAFLET3EESECTION

).4()3L%!&LET:
1. What Temazepam is and what it is used for
2. Before you take Temazepam
3. How to take Temazepam
4. Possible side effects
5. How to store Temazepam
6. Further information

1
PL 00289/0148
60838-Z

Tablets

124 mm

MA Holder:
TEVA UK Limited,
Eastbourne, BN22 9AG.

500

11 mm
Tab/Glue

Each tablet contains 10 mg of temazepam. Also contains lactose.
DOSAGE: Use as directed by the doctor. Read the package leaflet
before use. This medicine can make you feel sleepy. Do not
drive while taking this medicine until you know how it makes you
feel. See the leaflet inside for more information.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in a dry place. Protect from light.

New advice for drivers - see leaflet inside

20 mm

21 November 2014

1

21 November 2014

4

134 mm
Page 8

POSSIBLE SIDE EFFECTS

LiKEALLMEDICINES TEMAzEPAMCANCAUSESIDEEFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
)FTHEFOLLOWINGHAPPENS STOPTAKINGTHETABLETSANDTELLYOURDOCTORIMMEDIATELYORGOTOTHECASUALTY
DEPArTMENTATYOURNEARESTHOSPITAL
s ANALLERGICREACTIONSWELLINGOFTHELIPS FACEORNEcKLEADINGTOSEVEREDIFFICULTYINBREATHINGSKIN
RASHORHives).
ThiSISAvERYSERIOUSBUTRARESIDEEFFect.YOUMaYnEEDUrgenTMeDiCALattentiONORHOspitaLISATION.
TELLYOURDOCTORIMMEDIATELYIFYOUSUFFERFROM
s BEHAVIOURALcHANGESSUcHASRESTLESSNESS AGITATION IrRITABILITy AGGRESSiVENESS DELUSIONS EXCiteMent
rages nIGHTMaRES HALLUCINAtiOns COnFUSION PSYcHIATRICDISOrDerSaNDINAPpROPRIATeBEHAVIOUr AS
YOURTREATMENTMAYBESTOPPEDYOUAREMORELIKELYTOSUFFERTHESEEFFECTSIFYOUAREELDERLy.

WHAT TEMAZEPAM IS AND WHAT IT IS USED FOR

TEMAzEPAMISANANTI ANXIETYDRUGWHIcHISUSEDINTHESHOrT TERMTOHELPPEOPLESLEEP)TBELONGSTOA
GROUPOFDRUGSCALLEDBENzODIAzepines.
TEMAzEPAMISUSEDFOR
s SHOrT TERMTREATMENTOFINSOMNIADIFFICULTYINSLEEPING WHIcHISSEVERE DISABLINGORCAUSING

EXTREMEDISTRESS
s PRE MEDICATIONBEFOREMINORSURGERYOROTHERPROCEDURES

134 mm
Page 2

2

BEFORE YOU TAKE TEMAZEPAM

Do NOT take Temazepam if you:
s AREALLERGIChypersensitivE TOTEMAzEPAMOrOTHERBenzODIazepinESe.gDiazepaM)ORAnyOFtheOTHER
INGREDIENTSOFTHISMEDICINESEESECTION
s HAVEDIFFICULTYINBREATHINGORLUNGPROBLEMS
s HAVEACONDITIONCALLEDSLEEPAPNOEASYNDROMEWHEREBREATHINGSTOPSDURINGSLEEP
s HAVEMYASTHENIAGRAVISACONDITIONWHERETHEMUSCLESBECOMEWEAKANDTIREEASILY
s HAVESEVERELiVERPROBLEMS
s HAVEAHISTORYOFMENTALILLNESS SUcHASOBSESSIONSORPHOBIASIrRATIONALFEArs)
s SUFFERFROMANXIETYORPSYcHOTICILLNESSTEMAzEPAMTABLETSMAYUNMASKORWOrSENSYMPTOMS
s AREBREAST FEEDING
s AREAcHILDUNDERTHEAGEOF1YEArs.
Take special care with Temazepam
Talk to your doctor before you start to take this medicine if you:
s AREELDERLYORFRAIL)FYOUGETUPATNIGHT TAKECAREASTHEREISANINCREASEDRISKOFFALLINGAND
CONSEQUENTLYOFHIPFRACTURESDUETOMUSCLERELAXANTEFFECTOFTHETABLETS
s HAVELONG TERMLUNG KIDNEYORLiVERPROBLEMS
s HAVEHISTORYOFBREATHINGPROBLEMS7HILSTTAKINGTEMAzEPAMTABLETSYOURBREATHINGMAYBECOME
LESSFORCEFUL
s HAVEAHISTORYOFPROBLEMSWITHALCOHOLORDRUGABUSEYOURRISKOFDEPENDENCEISHIGHER
s SUFFERFROMMENTALILLNESS DEPRESSIONORDEPRESSIONWITHANXIETY
s HAVERECENTLYSUFFEREDABEREAVEMENTIFTEMAzEPAMISTAKENTOHELPSLEEPDURINGPERIODSOF
BEREAVEMENTITMAYSTOPYOUCOMINGTOTERMSWITHTHELOSS
s AREORSUSPECTTHATYOUAREPREGNANT
Taking other medicines
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKINGORHAVERECENTLYTAKENANYOTHERMEDICINEINCLUDing
MEDicinesOBTAIneDWIThOUTaprescripTIOnTEMazepaMTaBLETSMaYInFLUenceThEEFFECtANDORSIDE

134 mm
Page 3
EFFECTSOFOTHERMEDICINES)FYOUSEEANOTHERDOCTORORGOINTOHOSPITAL PARTICULARLYIFYOUAREHAVING
ANOPERATIONUNDERANAESTHESIATELLTHEDOCTORWHICHMEDICINESYOUUSE
4HEFOLLOWINGMEDICINESMAYINCREASETHESEDATINGEFFECTOF4EMAZEPAMTABLETS
s MEDICINESTOTREATMENTALILLNESSANTIPSYCHOTICS
s MEDICINESTOTREATDEPRESSION SUCHASPHENELZINEANDAMITRIPTYLINE
s OTHERSLEEPINGPILLS SUCHASZOPICLONE
s ANXIOLYTICORSEDATIVEDRUGS SUCHASDIAZEPAM
s NARCOTICSstrONGPAiNKiLLERS)SUChaSCODEINE MORPHINEFeeLingSOFEXciteMENTEUPHORIA)May
INCREASE WHICHINTURNINCREASETHECHANCEONPHYSICALORMENTALDEPENDENCE
s MEDICINESUSEDTOTREATEPILEPSY
s ANAESTHETICSUSEDDURINGSURGERY
s SEDATIVEANTIHISTAMINES SUCHASPROMETHAZINE
s MEDICINESUSEDTOTREATHIGHBLOODPRESSURE SUCHASDOXAZOSINANDLOFEXIDINE
s NABILONEUSEDTOTREATVOMITINGANDNAUSEA
s CISAPRIDEUSEDFORSTOMACHDISORDERS
s MUSCLERELAXANTS SUCHASBACLOFENANDTIZANIDINE
Zidovudine and ritonavirRETROANTIVIRALDRUGSUSEDTOTREAT()6INFECTIONAND!)$3 nMAYCAUSEAN
INCREASEINCONCENTRATIONOFTEMAZEPAMINTHEBLOOD
TheophyllineUSEDTOTREATASTHMA nMAYDECREASETHEEFFECTOFTEMAZEPAM
DisulfiramUSEDTOTREATALCOHOLDEPENDENCE nINHIBITSTHEMETABOLISMOFTEMAZEPAMANDINCREASES
THERISKOFTEMAZEPAMPOISONING
FluvoxamineUSEDTOTREATDEPRESSION nINCREASESTHECONCENTRATIONOFTEMAZEPAMINTHEBLOOD
CimetidineUSEDtOTREATSTOMAChULCERS)nDECREASeSTHEBLOODCOncentratIONOFTEMAZepaMINTHe
BLOOD
RifampicinANANTIBACTERIALDRUG nINCREASESTHEMETABOLISMOFTEMAZEPAMANDDECREASESTHE
TEMAZEPAMBLOODCONCENTRATION
ClozapineMEDICINESUSEDTOTREATPSYCHOSES

134 mm
Page 9

4HEFOLLOWINGSIDEEFFECTSARECOMMONATTHEBEGINNINGOFTHERAPy.4HESEEFFECTSAREOFTENMILDAND
USUALLYWEAROFFAFTERAFEWDAYSTREATMENT
s DAYTIMEDROWSINESSORDROWSINESSTHEFOLLOWINGDAY
sREDUCEDALErTNESS
s LOSSOFCO ORDINATION

sNUMBEDEMOTIONS
s CONFUSION


sTIREDNESS
s DIZZINESS


sMUSCLEWEAKNESS
s DOUBLEVISION


sLIGHT HEADEDNESS
4HEFOLLOWINGRAREEFFECTSMAYALSOOCCUR
s SKINREACTIONEGRASH

sHEADAche
s SPINNINGSENSATIONVErTIGO
ssTOMacHUPSEtINDIgESTION DiarrhOea CONSTIPATION)
s viVIDDREAMSORNIGHTMARES
sSLEEPDISTURBANCE
s cHANGESINSEXDRiVE

sDEPRESSION
s IMPAIREDMUSCULARFUNCTION
sDRYMOUTH
s MEMORYLOSS


sYELLOWINgOFyOURSKINOrTHEWhiteSOFYOUREYEsjaUnDice)
s DIFFICULTYPASSINGURINELEADINGTOPAINANDDISCOMFOrt
s LOWBLOODPRESSURE

sAVERYFAST UNEVENORFORCEFULHEArTBEATPALPITATIONS
s SALiVATIONchanges

sVISUALDISTURBANCES
s SLUrREDSPEEcHDYSArthria)
sSHAKING
s INCONTINENCE


sBLOODDISORDErs

s ABNORMALRESULTSINLiVERFUNCTIONTESTS
5SEEVENATTHERAPEUTICDOSAGES MAYLEADTOPhYSICALDEPENDENCESUDDENDISCONTINUATIONOF
TREATMENTMAYRESULTINWITHDRAWALEFFECTSANDRECUrRENCEOFPROBLEMS
Reporting of side effects
)FYOUGETAnYSIDEEFFECTS TALKTOYOURDOCTOr PHARMACISTORNUrse.4HISINCLUDESAnYPOSSIBLESIDE
eFFECTSNOTLISTEDINTHISLEAFLETYOUCANALSOREPOrTSIDEEFFECTSDIRECTLYVIATHEYELLOW#ARD3cHEMEAT
WWWMHRAGOvUKYELLOWCARD
"YREPOrTINGSIDEEFFECTSYOUCANHELPPROVIDEMOREINFORMATIONONTHESAFETYOFTHISMEDICINE

5

HOW TO STORE TEMAZEPAM

Keep out of the sight and reach of children.
4HESETABLETSSHOULDBESTOREDINADRYPLACE PROTECTEDFROMLIGHTINTHEPAcKAGEORCONTAINERSUPPLIED
$ONOTTRANSFERTHEMTOANOTHERCONTAINEr.
$ONOTUSETEMAzEPAMAFTERTHEEXPIRYDATETHATISSTATEDONTHEOUTERPAcKaging.4HEEXPIRYDATEREFErS
TOTHELASTDAYOFTHATMONTH
-EDICINESSHOULDNOTBEDISPOSEDOFVIAWasteWATERORHOUSEHOLDWASTE
!SKYOURPHARMACISTHOWTODISPOSEOFMEDICINESNOLONGERREQUIRED4HESEMEASURESWILLHELPTO
PROTECTTHEEnVIRONMENT

6

FURTHER INFORMATION

What Temazepam Tablets contain:
s 4HEACTiVEINGREDIENTISTEMAzEPAM
s 4HEOTHERINGREDIENTSAREMICROCRYSTALLINECELLULOSE LACTOSEanhYDROUS CROSCARMELLOSESODIUM
MAGNESIUMSTEARATEANDTHECOLOUr TITANIUMDIOXIDE%171).
What Temazepam Tablets look like and contents of the pack:
s TEMAzEPAMTABLETS1MGAREWHITETOPALEYELLOW FLAT BEVELEDGEDTABLETSWITHABREAKLINEONONE
SIDEANDh+vONTHEREVErse.
s 4HEPRODUCTISAVAILABLEINPAcKSIzESOF7 1 1        10 11 11 1 1 1
1  0AND100TABLETS.OTALLPAcKSIzESMAYBEMARKETED
Marketing Authorisation Holder and Manufacturer
MarKeting!UTHORISATIONHOLDERANDCOMPAnYRESPONSIBLEFORMANUFACTURETE6!5+,IMITED
%ASTBOURNE ".!G.
This leaflet was last revised: December 2014.
0,00148
 :

134 mm
Page 4

134 mm
Page 5 (Front page inside)

4EMAZEPAM
s INCREASESORDECREASESTHELEVELOFPHENYTOIN
s increaseSTHEeFFECTSOFSODIUMOXYBAtEUSeDtOTReatnarcOLEpSYWITHcatapLEXYnSLEePDISORDersWITH
SUDDENANDTRANSIENTLOSSOFMUSCLETONE
s POSSIBLYREDUCESTHEEFFECTSOFLEVODOPAUSEDTOTREAT0ARKINSONSDISEASE
s ENHANCEStheBLOODPRESsURELOWERInGEFFeCTOFANTI hypersensitIVEMEDicinesEGMOXONIDine
BETA BLOCKERS 
Important information about some of the ingredients of Temazepam
s PATIENTSWHOAREIntOLeranttOlactose SHOULDnOTEThatTeMAzEPAMTABLETSCONTAINaSMALLAMOUNtOF
LACTOSE)FYOURDOCTORHASTOLDYOUTHATYOUHAVEANINTOLERANCETOSOMESUgarS CONTACTYOURDOCTOR
BEFORETAKINGTHISMEDICINALPRODUCT
Important safety messages about Temazepam:
s 7HENTAKINGTHISMEDICINETHEREISARISKOFDEPENDENCEANEEDTOKEEPTAKINGTHEMEDICINE 4HERISK
INCREASESWITHTHEDOSEANDLENGTHOFTREATMENTPERIOD4HERISKISGREATERIFYOUHAVEEVERHADA
HISTORYOFALCOHOLORDRUGABUSE ORSUFFERFROMAPErSONALITYDISORDEr
s #LOSEMEDICALSUPERVISIONISREQUIREDWHENTAKINGTHISMEDICINEYOURDOCTORWILLENSURETHATYOU
taKETHELOWESTEFFECTiVEDOSEANDTHISSHOULDBETAKENFORTHESHOrTESTPOSSIBLETIMEANDNOTEXCEED
WEEKS
s YOUMAYBECOMETOLERANTTOTHEEFFECTSOFTEMAzEPAMAFTERYOUHAVEBEENTAKINGITREPEATEDLYFORA
FEWWEEKSSEESECTION How to take Temazepam)
s 7HENSTOPPINGTHISMEDICINEYOUMAYEXPERIENCEWITHDRAWALEFFECTSSEESECTION If you stop
taking Temazepam)
s "EHAVIOURALEFFECTSMAYOCCURWHILETAKINGTEMAzEPAMSEESECTION Possible Side Effects)
s TOreDUceTHERISKOFAMNESIaLOSSOFMEMORY) yOUSHOULDMaKEsUREthaTyOUAReABLEtOHaveAN
UNINTErRUPTEDSLEEPOFATLEAST7 HOUrs
s )FYOUHAVEBEENGivenTEMAzEPAMFORPREMEDICATION YOUSHOULDBEACCOMPANIEDHOME
Taking Temazepam with food and drink
$O.O4DRINKALCOHOLWHILETAKINGTHESETABLETS ASTAKENTOGETHERTHEYCOULDMAKEYOUFEELVERY
DROWSYWHIcHCOULDBEDANGEROUS

Pregnancy and breast-feeding
)FYOUAREPREGNANT PLANNINGTOBECOMEPREGNANTORBREAST FEEDING ASKYOURDOCTORORPHARMACISTFOR
ADVICEBEFORETAKINGTHISMEDICINE
)FYOURDOCTORHASDECIDEDTHATYOUSHOULDRECEiVETHISMEDICINEDURINGLATEPREGNANCYORDURING
LABOUr YOURBABYMIGHTHAVEALOWBODYTEMPERATURE FLOPPINESS ANDBREATHINGANDFEEDING
DIFFicULTiES)FTHIsMEDICINEIStaKeNReGULarLYInLatepregnancy yOURBABYMaYDEVELOPWItHDRAWaL
SYMPTOMS
Driving and using machines
YOURTABLETSMAYMAKEYOUFEELDROWSYDURINGTHEDAy MAKEYOUFORGETFULANDIMPAIRYOUR
CONCENTRATION VISIONANDMUSCLEFUNCTION!LSOYOUWILLBELESSALErTIFYOUHAVENOTBEENABLETOSLEEP
FORLONGENOUGH)FAFFECTED DO.O4DRiVEOROPERATEMAchinery.
4HEMEDICINECANAFFECTYOURABILITYTODRiVEASITMAYMAKEYOUSLEEPYORDIZZy
s $ONOTDRiVEWHILETAKINGTHISMEDICINEUNTILYOUKNOWHOWITAFFECTSYOU
s )TISANOFFENCETODRiVEIFTHISMEDICINEAFFECTSYOURABILITYTODRiVE
(OWEVEr YOUWOULDNOTBECOMMItTINGANOFFENCEIF
s 4HEMEDICINEHASBEENPRESCRIBEDTOTREATAMEDICALORDENTALPROBLEMAND
s YOUHAVETAKENITACCORDINGTOTHEINSTRUCTIONSGiVENBYTHEPRESCRIBERORINTHEINFORMATIONPROVIDED
WITHTHEMEDICINEAND
s )TWASNOTAFFECTINGYOURABILITYTODRiVESAFELy
TALKTOYOURDOCTORORPHARMACISTIFYOUARENOTSUREWHETHERITISSAFEFORYOUTODRiVEWHILETAKINGTHIS
MEDICINE

BRAILLE READS: temazepam #10 mg Tablets

REG0068728

Version:

Leaflet inside (Sekunda)

Temazepam

EXP.:

mg

30 mm

LOT.:

10

PL 00289/0148
60838-Z

Oral Use

MA Holder:
TEVA UK Limited,
Eastbourne, BN22 9AG.

10 mg Tablets

10 mm
Glue

UK Reg'd T.M.

124 mm

Temazepam

Each tablet contains 10 mg of temazepam. Also contains lactose.
DOSAGE: Use as directed by the doctor. Read the package leaflet
before use. This medicine can make you feel sleepy. Do not
drive while taking this medicine until you know how it makes you
feel. See the leaflet inside for more information.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in a dry place. Protect from light.

11 mm
Tab/Glue

Tablets

ccllabel.dk

Oral Use

5 017007 364139

10 mg Tablets

PL 00289/0148
60838-Z

Temazepam

10 mm
Glue

MA Holder:
TEVA UK Limited,
Eastbourne, BN22 9AG.

Peel Here

134 mm
Front page outside

temazepam
#10 mg
tablets

20 mm

1

Leaflet outside (Prima)
11 mm
Tab

Base label (Selfadhesive)

Version:

231-30-60838-Z LBL TEMAZEPAM 10mg TAB 500 TUK
Each tablet contains 10 mg of temazepam. Also contains lactose.
DOSAGE: Use as directed by the doctor. Read the package leaflet
before use. This medicine can make you feel sleepy. Do not
drive while taking this medicine until you know how it makes you
feel. See the leaflet inside for more information.
KEEP OUT OF THE SIGHT AND REACH OF CHILDREN.
Store in a dry place. Protect from light.

TEVA UK Ref:

Version 1.2

Approved

Page 1 of 2

3

HOW TO TAKE TEMAZEPAM

!LWAYSTAKeTEMAzEPAMEXACTLYASYOURDOCTORHASTOLDYOUYOUWILLBEGiVENTHELOWESTEFFECTiVEDOSE
FORTHESHOrTESTPOSSIBLETIME)FTHEREISAnYTHINGYOUARENOTSUREABOUTchecKWITHYOURDOCTOROR
PHARMACIST

11 mm
Tab/Glue

THIS IS A REPRESENTATION OF AN ELECTRONIC RECORD THAT WAS SIGNED ELECTRONICALLY AND THIS
PAGE IS THE MANIFESTATION OF THE ELECTRONIC SIGNATURE

Teva Pharmaceuticals Europe B.V
1.3.2 mockup-label-pil-uk-pl-00289-0148-temazepam-10mg-tablets

APPROVALS
Signed by
Annette Huggett

REG0068728

Meaning of Signature
Regulatory Affairs Approval

Version 1.2

Approved

Server Date
12-Jan-2015 01:38:15 PM

Page 2 of 2

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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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