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TEMAZEPAM 20 MG TABLETS

Active substance(s): TEMAZEPAM

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231-30-60844-Z LBL TEMAZEPAM 20mg TAB 250 TUK
1

21 November 2014

For proofreading of Braille

TEVA UK Ref:

mg

New advice for drivers - see leaflet inside

250

Braille placement only

20
temazepam
#20 mg mg
tablets
New advice for drivers - see leaflet inside

250

Tablets

30 mm

21 November 2014

TEVA UK Ref:

124 mm
Page 6

134 mm
Page 7

4HETABLETSSHOULDBESWALLOWEDPREFERABLYWITHAGLASSOFWATER
9OURDOCTORWILLDECIDETHECORRECTDOSAGETHEUSUALDOSEIS
Insomnia
s Adults MGSHOULDBETAKENWHENGOINGTOBEDORUPTOMINUTESBEFOREGOINGTO
BED6ERYOCCASIONALLY THEDOSEMAYBEINCREASEDTO MGDAILY
s Elderly patientsTHEDOSEISMGDAILY6ERYOCCASIONALLY THISMAYBEINCREASEDTOMG
DAILY
s Children4EMAZEPAMIS./4RECOMMENDEDFORUSEINCHILDRENUNDERTHEAGEOFYEARS
&ORPATIENTSWHOHAVECERTAINPROBLEMSWITHBLOODVESSELSORTHEIRLIVERTHEDOSAGEMAYBELOWER
Do NOT change the dose yourself.
Premedication
s Adults MGSHOULDBETAKEN MINUTESBEFORESURGERY
s Elderly,OWERDOSESMAYBEREQUIREDBYELDERLYPATIENTS UPTOHALFTHENORMALADULTDOSE
MAYBEADEQUATE
s Children4EMAZEPAMISNOTRECOMMENDEDFORUSEINCHILDRENUNDERTHEAGEOFYEARS
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
9OUWILLBETOLDBYYOURDOCTORTOSTOPTAKINGTHETABLETSASSOONASISPOSSIBLEANDTHEDOSEWILLBE
REDUCEDGRADUALLY9OUSHOULDNOTSTOPTAKINGTHETABLETSSUDDENLYORWITHOUTMEDICALADVICE)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
)FYOUEXPERIENCETHESEORANYOTHERUNUSUALEFFECTSWHENYOUSTOPTAKING4EMAZEPAM SPEAKTOYOUR
DOCTOR





)FYOUHAVEANYFURTHERQUESTIONSONTHEUSEOFTHISPRODUCT ASKYOURDOCTORORPHARMACIST

134 mm
Page 1

TEMAZEPAM 20 mg TABLETS
UK Reg'd T.M.

20 mg Tablets
Oral Use

10 mm
Glue

0!#+!'%,%!&,%4).&/2-!4)/.&/24(%53%2
Read all of this leaflet carefully before you start taking this medicine.
s +EEPTHISLEAFLET9OUMAYNEEDTOREADITAGAIN
s )FYOUHAVEANYFURTHERQUESTIONS ASKYOURDOCTORORPHARMACIST
s 4HISMEDICINEHASBEENPRESCRIBEDFORYOU$ONOTPASSITONTOOTHERS)TMAYHARMTHEM EVENIFTHEIR
SYMPTOMSARETHESAMEASYOURS
s )FYOUGETANYSIDEEFFECTS TALKTOYOURDOCTOR PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLESIDE
EFFECTSNOTLISTEDINTHISLEAFLET3EESECTION

).4()3,%!&,%4
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 00289/0149
60844-Z

Tablets

124 mm

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

250

11 mm
Tab/Glue

Each tablet contains 20 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

1

1

21 November 2014

4

134 mm
Page 8

POSSIBLE SIDE EFFECTS

,IKEALLMEDICINES 4EMAZEPAMCANCAUSESIDEEFFECTS ALTHOUGHNOTEVERYBODYGETSTHEM
)FTHEFOLLOWINGHAPPENS STOPTAKINGTHETABLETSANDTELLYOURDOCTORIMMEDIATELYORGOTOTHECASUALTY
DEPARTMENTATYOURNEARESTHOSPITAL
s ANALLERGICREACTIONSWELLINGOFTHELIPS FACEORNECKLEADINGTOSEVEREDIFFICULTYINBREATHINGSKIN
RASHORHIVES 
4HISISAVERYSERIOUSBUTRARESIDEEFFECT9OUMAYNEEDURGENTMEDICALATTENTIONORHOSPITALISATION
4ELLYOURDOCTORIMMEDIATELYIFYOUSUFFERFROM
s BEHAVIOURALCHANGESSUCHASRESTLESSNESS AGITATION IRRITABILITY AGGRESSIVENESS DELUSIONS EXCITEMENT
RAGES NIGHTMARES HALLUCINATIONS CONFUSION PSYCHIATRICDISORDERSANDINAPPROPRIATEBEHAVIOUR AS
YOURTREATMENTMAYBESTOPPEDYOUAREMORELIKELYTOSUFFERTHESEEFFECTSIFYOUAREELDERLY

WHAT TEMAZEPAM IS AND WHAT IT IS USED FOR

4EMAZEPAMISANANTI ANXIETYDRUGWHICHISUSEDINTHESHORT TERMTOHELPPEOPLESLEEP)TBELONGSTOA
GROUPOFDRUGSCALLEDBENZODIAZEPINES
4EMAZEPAMISUSEDFOR
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 TOTEMAZEPAMOROTHERBENZODIAZEPINESEGDIAZEPAM ORANYOFTHEOTHER
INGREDIENTSOFTHISMEDICINESEESECTION
s HAVEDIFFICULTYINBREATHINGORLUNGPROBLEMS
s HAVEACONDITIONCALLEDSLEEPAPNOEASYNDROMEWHEREBREATHINGSTOPSDURINGSLEEP
s HAVEMYASTHENIAGRAVISACONDITIONWHERETHEMUSCLESBECOMEWEAKANDTIREEASILY
s HAVESEVERELIVERPROBLEMS
s HAVEAHISTORYOFMENTALILLNESS SUCHASOBSESSIONSORPHOBIASIRRATIONALFEARS
s SUFFERFROMANXIETYORPSYCHOTICILLNESS4EMAZEPAMTABLETSMAYUNMASKORWORSENSYMPTOMS
s AREBREAST FEEDING
s AREACHILDUNDERTHEAGEOFYEARS
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 HAVEHISTORYOFBREATHINGPROBLEMS7HILSTTAKING4EMAZEPAMTABLETSYOURBREATHINGMAYBECOME
LESSFORCEFUL
s HAVEAHISTORYOFPROBLEMSWITHALCOHOLORDRUGABUSEYOURRISKOFDEPENDENCEISHIGHER
s SUFFERFROMMENTALILLNESS DEPRESSIONORDEPRESSIONWITHANXIETY
s HAVERECENTLYSUFFEREDABEREAVEMENTIF4EMAZEPAMISTAKENTOHELPSLEEPDURINGPERIODSOF
BEREAVEMENTITMAYSTOPYOUCOMINGTOTERMSWITHTHELOSS
s AREORSUSPECTTHATYOUAREPREGNANT
Taking other medicines
4ELLYOURDOCTORORPHARMACISTIFYOUARETAKINGORHAVERECENTLYTAKENANYOTHERMEDICINEINCLUDING
MEDICINESOBTAINEDWITHOUTAPRESCRIPTION4EMAZEPAMTABLETSMAYINFLUENCETHEEFFECTANDORSIDE

134 mm
Page 3
EFFECTSOFOTHERMEDICINES)FYOUSEEANOTHERDOCTORORGOINTOHOSPITAL PARTICULARLYIFYOUAREHAVING
ANOPERATIONUNDERANAESTHESIATELLTHEDOCTORWHICHMEDICINESYOUUSE
4HEFOLLOWINGMEDICINESMAYINCREASETHESEDATINGEFFECTOF4EMAZEPAMTABLETS
s MEDICINESTOTREATMENTALILLNESSANTIPSYCHOTICS
s MEDICINESTOTREATDEPRESSION SUCHASPHENELZINEANDAMITRIPTYLINE
s OTHERSLEEPINGPILLS SUCHASZOPICLONE
s ANXIOLYTICORSEDATIVEDRUGS SUCHASDIAZEPAM
s NARCOTICSSTRONGPAINKILLERS SUCHASCODEINE MORPHINE&EELINGSOFEXCITEMENTEUPHORIA 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

4HEFOLLOWINGSIDEEFFECTSARECOMMONATTHEBEGINNINGOFTHERAPY4HESEEFFECTSAREOFTENMILDAND
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 PHARMACISTORNURSE4HISINCLUDESANYPOSSIBLESIDE
EFFECTSNOTLISTEDINTHISLEAFLET9OUCANALSOREPORTSIDEEFFECTSDIRECTLYVIATHE9ELLOW#ARD3CHEMEAT
WWWMHRAGOVUKYELLOWCARD
"YREPORTINGSIDEEFFECTSYOUCANHELPPROVIDEMOREINFORMATIONONTHESAFETYOFTHISMEDICINE

5

HOW TO STORE TEMAZEPAM

Keep out of the sight and reach of children.
4HESETABLETSSHOULDBESTOREDINADRYPLACE PROTECTEDFROMLIGHTINTHEPACKAGEORCONTAINERSUPPLIED
$ONOTTRANSFERTHEMTOANOTHERCONTAINER
$ONOTUSE4EMAZEPAMAFTERTHEEXPIRYDATETHATISSTATEDONTHEOUTERPACKAGING4HEEXPIRYDATEREFERS
TOTHELASTDAYOFTHATMONTH
-EDICINESSHOULDNOTBEDISPOSEDOFVIAWASTEWATERORHOUSEHOLDWASTE
!SKYOURPHARMACISTHOWTODISPOSEOFMEDICINESNOLONGERREQUIRED4HESEMEASURESWILLHELPTO
PROTECTTHEENVIRONMENT

6

FURTHER INFORMATION

What Temazepam Tablets contain:
s 4HEACTIVEINGREDIENTISTEMAZEPAM
s 4HEOTHERINGREDIENTSAREMICROCRYSTALLINECELLULOSE LACTOSEANHYDROUS CROSCARMELLOSESODIUM
MAGNESIUMSTEARATEANDTHECOLOUR TITANIUMDIOXIDE% 
What Temazepam Tablets look like and contents of the pack:
s 4EMAZEPAM4ABLETSMGAREWHITETOPALEYELLOW FLAT BEVELEDGEDTABLETSWITHABREAKLINEONONE
SIDEANDh+vONTHEREVERSE
s 4HEPRODUCTISAVAILABLEINPACKSIZESOF               
  ANDTABLETS.OTALLPACKSIZESMAYBEMARKETED
Marketing Authorisation Holder and Manufacturer
-ARKETING!UTHORISATIONHOLDERANDCOMPANYRESPONSIBLEFORMANUFACTURE4%6!5+,IMITED
%ASTBOURNE ".!'
This leaflet was last revised: December 2014.
0,
 :

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 0ATIENTSWHOAREINTOLERANTTOlactose SHOULDNOTETHAT4EMAZEPAM4ABLETSCONTAINASMALLAMOUNTOF
LACTOSE)FYOURDOCTORHASTOLDYOUTHATYOUHAVEANINTOLERANCETOSOMESUGARS CONTACTYOURDOCTOR
BEFORETAKINGTHISMEDICINALPRODUCT
Important safety messages about Temazepam:
s 7HENTAKINGTHISMEDICINETHEREISARISKOFDEPENDENCEANEEDTOKEEPTAKINGTHEMEDICINE 4HERISK
INCREASESWITHTHEDOSEANDLENGTHOFTREATMENTPERIOD4HERISKISGREATERIFYOUHAVEEVERHADA
HISTORYOFALCOHOLORDRUGABUSE ORSUFFERFROMAPERSONALITYDISORDER
s #LOSEMEDICALSUPERVISIONISREQUIREDWHENTAKINGTHISMEDICINE9OURDOCTORWILLENSURETHATYOU
TAKETHELOWESTEFFECTIVEDOSEANDTHISSHOULDBETAKENFORTHESHORTESTPOSSIBLETIMEANDNOTEXCEED
WEEKS
s 9OUMAYBECOMETOLERANTTOTHEEFFECTSOF4EMAZEPAMAFTERYOUHAVEBEENTAKINGITREPEATEDLYFORA
FEWWEEKSSEESECTION How to take Temazepam
s 7HENSTOPPINGTHISMEDICINEYOUMAYEXPERIENCEWITHDRAWALEFFECTSSEESECTION If you stop
taking Temazepam
s "EHAVIOURALEFFECTSMAYOCCURWHILETAKING4EMAZEPAMSEESECTION Possible Side Effects
s 4OREDUCETHERISKOFAMNESIALOSSOFMEMORY YOUSHOULDMAKESURETHATYOUAREABLETOHAVEAN
UNINTERRUPTEDSLEEPOFATLEAST HOURS
s )FYOUHAVEBEENGIVEN4EMAZEPAMFORPREMEDICATION YOUSHOULDBEACCOMPANIEDHOME
Taking Temazepam with food and drink
$O./4DRINKALCOHOLWHILETAKINGTHESETABLETS ASTAKENTOGETHERTHEYCOULDMAKEYOUFEELVERY
DROWSYWHICHCOULDBEDANGEROUS

Pregnancy and breast-feeding
)FYOUAREPREGNANT PLANNINGTOBECOMEPREGNANTORBREAST FEEDING ASKYOURDOCTORORPHARMACISTFOR
ADVICEBEFORETAKINGTHISMEDICINE
)FYOURDOCTORHASDECIDEDTHATYOUSHOULDRECEIVETHISMEDICINEDURINGLATEPREGNANCYORDURING
LABOUR YOURBABYMIGHTHAVEALOWBODYTEMPERATURE FLOPPINESS ANDBREATHINGANDFEEDING
DIFFICULTIES)FTHISMEDICINEISTAKENREGULARLYINLATEPREGNANCY YOURBABYMAYDEVELOPWITHDRAWAL
SYMPTOMS
Driving and using machines
9OURTABLETSMAYMAKEYOUFEELDROWSYDURINGTHEDAY MAKEYOUFORGETFULANDIMPAIRYOUR
CONCENTRATION VISIONANDMUSCLEFUNCTION!LSOYOUWILLBELESSALERTIFYOUHAVENOTBEENABLETOSLEEP
FORLONGENOUGH)FAFFECTED DO./4DRIVEOROPERATEMACHINERY
4HEMEDICINECANAFFECTYOURABILITYTODRIVEASITMAYMAKEYOUSLEEPYORDIZZY
s $ONOTDRIVEWHILETAKINGTHISMEDICINEUNTILYOUKNOWHOWITAFFECTSYOU
s )TISANOFFENCETODRIVEIFTHISMEDICINEAFFECTSYOURABILITYTODRIVE
(OWEVER YOUWOULDNOTBECOMMITTINGANOFFENCEIF
s 4HEMEDICINEHASBEENPRESCRIBEDTOTREATAMEDICALORDENTALPROBLEMAND
s 9OUHAVETAKENITACCORDINGTOTHEINSTRUCTIONSGIVENBYTHEPRESCRIBERORINTHEINFORMATIONPROVIDED
WITHTHEMEDICINEAND
s )TWASNOTAFFECTINGYOURABILITYTODRIVESAFELY
4ALKTOYOURDOCTORORPHARMACISTIFYOUARENOTSUREWHETHERITISSAFEFORYOUTODRIVEWHILETAKINGTHIS
MEDICINE

BRAILLE READS: temazepam #20 mg Tablets

REG0068729

Version:

231-30-60844-Z LBL TEMAZEPAM 20mg TAB 250 TUK
Leaflet inside (Sekunda)

Temazepam

EXP.:

mg

30 mm

LOT.:

20

PL 00289/0149
60844-Z

20 mg Tablets
Oral Use

10 mm
Glue

UK Reg'd T.M.

124 mm

Temazepam

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

11 mm
Tab/Glue

Each tablet contains 20 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.

20 mm

Tablets

ccllabel.dk

20

5 017007 364146

Oral Use

PL 00289/0149
60844-Z

20 mg Tablets

temazepam
#20 mg
tablets

10 mm
Glue

UK Reg'd T.M.

134 mm
Front page outside

Temazepam

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

Peel Here

11 mm
Tab

Base label (Selfadhesive)

Version:

231-30-60844-Z LBL TEMAZEPAM 20mg TAB 250 TUK
Leaflet outside (Prima)

Each tablet contains 20 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

!LWAYSTAKE4EMAZEPAMEXACTLYASYOURDOCTORHASTOLDYOU9OUWILLBEGIVENTHELOWESTEFFECTIVEDOSE
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-00289-0149-temazepam-20mg-tablets

APPROVALS
Signed by
Annette Huggett

REG0068729

Meaning of Signature
Regulatory Affairs Approval

Version 1.2

Approved

Server Date
12-Jan-2015 01:34:50 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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