* Please readthebackofthisleaflet. � � � If youandyourdoctordecidethatshouldtakethismedicinetowards theend feeding. Do nottakethismedicineifyouarepregnant,mightbecomepregnantorbreast- Pregnancy andbreast-feeding doctor whenexperiencingsuchsymptoms. relatives tobeawareofthesignsandsymptomsstatedabove.Contactyour doctor’s doserecommendationclosely.Itcouldbehelpfultoinformfriendsor Please tellyourdoctoraboutallopioidmedicinesyouaretaking,andfollow and durationofconcomitanttreatmentshouldbelimitedbyyourdoctor. However ifyourdoctordoesprescribethisproducttogetherwithopioidsthedose options arenotpossible. Because ofthis,concomitantuseshouldonlybeconsideredwhenothertreatment difficulties inbreathing(respiratorydepression),comaandmaybelife-threatening. substitution therapyandsomecoughmedicines)increasestheriskofdrowsiness, Concomitant useofthisproductandopioids(strongpainkillers,medicinesfor � � � � � � � � � medicines, includingmedicinesobtainedwithoutaprescription.Especially: Tell yourdoctororpharmacistifyouaretakinghaverecentlytakenanyother Taking othermedicines � � � Other considerations increase thesedativeeffectsofOxazepamtabletsandmakeyouverysleepy. Do notdrinkalcoholwhileyouaretakingOxazepamtablets.Alcoholmay Taking Oxazepamwithalcohol a greaterriskoffalling(seesection4). Oxazepam maycausemusclerelaxationandcautionisadvisedasyoubeat � � � � � � � � Talk toyourdoctororpharmacist: � � � � � � Do nottakeOxazepamTablets andtellyourdoctor: 2. The riskisgreater ifyouhaveeverhadahistoryofalcoholordrugabuse. the medicine).Theriskincreases withthedoseandlengthoftreatment period. When takingthismedicinethere isariskofdependence(aneedtokeeptaking of becomingdependantorhavingproblems whenyoustoptakingit. used formore thanfourweeks.Ifusedfortoolongwithoutabreak, there isarisk This medicineshouldbeusedforasshortatimepossibleandnot distressing andmaybeassociatedwithsleeplessnessorotherillnesses. short term(maximumof2-4weeks)treatment ofanxiety, whichisdisablingor group ofmedicinescalled‘benzodiazepines’.Oxazepamisprescribed forthe The nameofyourmedicineisOxazepamTablets. Oxazepamisamemberof 1. - - - because itcontainsimportantinformationforyou. Read allofthisleafletcarefullybeforeyoustarttakingmedicine The medicinecanaffectyourabilitytodriveasitmaymakeyoufeelsleepy ordizzy and operatingmachinery. concentration. Thismayaffectyourperformanceatskilledtaskssuch asdriving Oxazepam maymakeyoufeeldizzyorsleepyduringtheday, affectyour Driving andusingmachines baby maygetwithdrawalsymptoms. feeding. Also,ifyoutakethismedicineregularlyduringyourpregnancy, your have alowbodytemperature,belistless,breathingproblemsor difficultyin of yourpregnancy(orduringlabour)thismayharmbaby.Thebaby may Further Information 6. Further 5. side-effects 4. Possible 3. 2. 1. What isinthisleaflet - Trademark ○ The medicinehasbeenprescribed totreatamedicalordentalproblemand However, youwouldnotbecommitting anoffenceif: It isanoffencetodriveifthismedicine affectsyourabilitytodrive. Do notdrivewhiletakingthismedicine untilyouknowhowitaffectsyou. not workaswell). Levodopa (totreatParkinson’sDisease)asOxazepammaycauselevodopato Medicines usedtoinhibitliverenzymes(increaseseffectsofOxazepam) Medicines tolowerhighbloodpressure(increasedeffect) remain inthebodylongerthanusual) usual whenusedwithOxazepam)andRitonavir(thiscancauseOxazepamto Antiviral medication,egZidovudine(thismayremaininthebodylongerthan body morequicklythanusual. Rifampicin (anantibiotic)asthiscancauseOxazepamtoberemovedfromthe effective. Oestrogen-containing contraceptives,asthesecancauseOxazepamtobeless (Oxazepam maymakesideeffectsmorelikely). Medicines forepilepsyeghydantoins,inparticularphenytoin,orbarbiturates medicines (dependency)orcanmakeyouverysleepy. taken withOxazepam,whichcanincreaseyourdesiretocontinuetakingthese Some strongpainkillersmaygiveyouaheightenedsenseofwellbeingwhen make youverysleepy. medicines containingalcohol.TakingthesewithOxazepamcould muscle relaxants(egbaclofen,tizanidine),probenecid(usedtotreatgout)or and vomiting),hypnotics(tohelpyousleep),alphablockersormoxonidine, help relievesymptomswhenyoustoptakingopioids),nabilone(totreatnausea antihistamines egchlorphenamine(totreatallergies),anaesthetics,lofexidine Antidepressants, antipsychotics(totreatmentalproblems),sedative periods oftime.SeeSection3,‘IfyoustoptakingOxazepamtablets’. occur withOxazepamtabletsevenwhennormaldosesaregivenforshort Withdrawal –treatmentshouldgraduallybewithdrawn.symptoms history ofalcoholismanddrugabuse. increases withthedoseanddurationoftreatmentalsoinpatientsa Dependance –whentakingthismedicinethereisariskofdependence,which if youaresufferingfromaneyeproblemcalledglaucoma. if yousufferfrombreathingproblems if youhaveapersonalitydisorder treatment withoxazepam if youhavesufferedfromdepressionbefore,sinceitcouldrecurduring feelings whichyoumayhave if youaresufferingfromdepression,sinceoxazepammayincreaseanysuicidal if youhaveanylung,kidneyorliverproblems if youabuseorhaveinthepastabuseddrugsalcohol if youarepregnant,ortryingtobecomepregnant(seebelow) if youhaveseriousliverproblems if youhavemyastheniagravis(veryweakortiredmuscles) if yousufferfromsleepapnoea(breathingproblemswhenareasleep) if youhaveseverebreathingorchestproblems mental illness have aphobia(afearofparticularobjectorsituation),obsessionsother medicines oranyoftheingredientsinyourtablets(seesection6) if youareallergic(hypersensitive)toOxazepamorotherbenzodiazepine This medicinehasbeenprescribedforyouonly.Donotpassitontoothers. If youhaveanyfurtherquestions,askyourdoctororpharmacist. Keep thisleaflet.Youmayneedtoreaditagain. Tolerance How tostore How totakeOxazepamTablets Before youtakeOxazepamTablets What OxazepamTabletsareandwhattheyusedfor possible side-effectsnotlistedinthisleaflet. If yougetanyside-effects,talktoyourdoctororpharmacist.Thisincludes It mayharmthem,eveniftheirsignsofillnessarethesameasyours. well astheydidwhenyoufirststartedtreatment,shouldspeaktoyourdoctor. WHAT OXAZEPAMTABLETSAREANDTHEYUSEDFOR BEFORE YOUTAKEOXAZEPAMTABLETS You havetakenitaccordingtothe instructionsgivenbytheprescriberorin the informationprovidedwithmedicine and Oxazepam 10mgand15mgTablets – if,afterafewweeks,younoticethatthetabletsarenotworkingas PATIENT INFORMATIONLEAFLET Oxazepam 92793421808
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MHRA Header Box PCP Header Box
Oxazepam 10mg and 15mg Tablets Colours Used Fonts Used Point Sizes Used Approved by Product Title Min Max Operator EBR Date Helvetica Neue 8.5pt 13pt Process Black Artwork No. 976861 Component Lea et Lucida Grande 8.5pt 8.5pt Keyline (Non-printing) CRN 14902 Su x C Pack Size 28's Reason for Safety update - addition of IG Code 92793421808 Change concomitant use of benzodiaze- Dimensions 420 x 120mm pines/opioids wording
Proof No. 2 Date 29.08.2018
Issued by Date MHRA/IMB submission Yes required excitement ordepressionwithsuicidalthoughtsactions. Withdrawal mayalsocauseunusualbehaviourincludingaggressiveoutbursts, in yourears),shaking,fasterheartbeatorfits. Oxazepam, youmayexperienceconfusion,hallucinations,tinnitus(ringingsounds If youstoptakingthesetabletssuddenlyafterbeingtreatedwithhighdosesof taking lowdosesforashortperiodoftime. muscle pains,andchangesinsleeppatterns.Theseeffectsmayoccurevenafter You mayalsoexperiencemoodchanges,anxiety,restlessness,headaches, � � � � � � � you mayexperiencethefollowingwithdrawaleffects: tells youhowtoreducethedoseslowly.Ifstoptakingtabletssuddenly This medicineshouldnotbestoppedsuddenly;keeptakingituntilyourdoctor If youstoptakingOxazepamTablets usually takeyourtablet,justnexttabletwhenitisdue. 3 hourssinceyourusualtime.Ifmorethanhaspassedfromwhenyou a tabletforanxiety,youshouldtakeitassoonrememberifislessthan Do nottakeadoubledosetomakeupforforgottentablet.Ifyouforget If youforgettotakeOxazepamTablets medicine containerwithyou,eveniftherearenotabletsleft. doctor, orgoingtothenearestcasualtydepartment.Alwaystakelabelled doctor hasprescribed),seekmedicalhelpimmediately,eitherbycallingyour If anyonehastakenanoverdoseofOxazepamTablets(thatismorethanthe If youtakemoreOxazepamTabletsthanshould you stoptakingthem.(See‘IfOxazepamTablets’section). becoming dependentonOxazepamTablets,orsufferingunpleasanteffectswhen days to4weeksincludingadosereductionattheend.Thisreducesriskof Oxazepam isusuallyprescribedforshortcoursesoftreatment,lastingfromafew � Contact yourdoctorimmediatelyifthefollowingsymptomsoccur: everybody getsthem. Like allmedicines,OxazepamTabletscancauseside-effects,althoughnot SIDE-EFFECTS 4. POSSIBLE Oxazepam Tabletsarenotrecommendedforusebychildrenunder18yearsofage - Adults should aimtohave7-8hoursofundisturbedsleepaftertakingyourtablets. not sure.OxazepamTabletsshouldbeswallowedwithwater.Wherepossible,you should alsotellyou.Youcheckwithyourdoctororpharmacistifyouare not takeOxazepamTabletsforlongerthan4weeks.Thelabelonyourmedicine Always takeOxazepamTabletsexactlyasyourdoctorhastoldyou.Youshould 3. medicinal product. have anintolerancetosomesugars,contactyourdoctorbeforetakingthis you to.Donotthrowawayanymedicinesviawastewaterorhouseholdwaste. Return anyunusedtabletstoyourpharmacist.Onlykeepthemifdoctortells Store below25°Cinadryplace. and blisterafterEXP.Theexpirydatereferstothelastdayofmonth. Do nottakeOxazepamTabletsaftertheexpirydatewhichisstatedoncarton Keep thismedicineoutofthesightandreachchildren. 5. effects youcanhelpprovidemoreinformationonthesafetyofthismedicine. ‘MHRA YellowCard’intheGooglePlayorAppleAppStore.Byreportingside This leafletwaslastrevisedinAugust 2018. Haupt PharmaMünsterGmbH,Schleebrüggenkamp 15,48159Münster,Germany. Manufacturer: Genus Pharmaceuticals,Linthwaite, Huddersfield,HD75QH,UK. Marketing AuthorisationHolder: PL 17225/0015 PL 17225/0014 They aresuppliedinblisterpacksandcartonsof28tablets. A breakbarcanbeseenononesidewiththeimprint‘10’or‘15’ other. - What OxazepamTabletscontain: INFORMATION 6. FURTHER measures willhelpprotecttheenvironment. Ask yourpharmacisthowtothrowawaymedicinesyounolongeruse.These - - This medicinecontainslactose.Ifyouhavebeentoldbyyourdoctorthat Important informationaboutsomeoftheingredientsOxazepamTablets directly viatheYellowCardSchemeatwww.mhra.gov.uk/yellowcardorsearchfor any possiblesideeffectsnotlistedinthisleaflet.Youcanalsoreport If yougetanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludes Reporting ofsideeffects possible side-effectsnotlistedinthisleaflet. If yougetanysideeffects,talktoyourdoctororpharmacist.Thisincludes Withdrawal symptoms:seeSection3,‘IfyoustoptakingOxazepamtablets’. � � � � � � � effects notlisted: Tell yourdoctorifyounoticeanyofthefollowingsideeffectsorother Oxazepam Tabletsarewhite,roundtabletswithaflatfaceandbevelled edges. What OxazepamTabletslooklikeandthecontentsofpack - * POM Trademark or thesymptomsyouarebeingtreatedforcancomebackworsethanbefore. upset stomach/diarrhoea, sweating, irritability, difficulty insleeping, nervousness, depression, restlessness, agitation,irritability,aggressiveness,delusion,experiencingrages, Anxiety: Theusualdoseisonetotwo15mgtabletsthreeorfourtimesdaily. The activesubstanceisoxazepam.Eachtabletcontainseither10mg or15mg suffer fromkidneyorliverproblems. Adults withliverorkidneyproblems:Yourdosagemaybereducedifyou increase thisuptoamaximumof50mg. Sleeping problems:15-25mgonehourbeforegoingtobed,yourdoctormay Your doctorwilltellyouhowoftentotakeyourtablets. to drivewhiletakingthismedicine. Talk toyourdoctororpharmacistifyouarenotsurewhetheritissafefor ○ seen intests,difficulty passingurine,waterretention, incontinence. yellowing oftheskinorwhiteseyes(jaundice),increased liverenzymes stomach upsetsorcramps,feelingsick,changesinsaliva or doublevision,lowbloodpressure,muscleweakness,tremor,fever,tiredness have abloodtest,reductioninwhitecells,changessexdrive,blurred abnormal palenessoftheskin,youshouldtellyourdoctorwhomaywantto throats, infections,excessivetiredness,breathlessnessonexertion,or changes inbloodcells,ifyounoticeincreasedbruising,nosebleeds,sore increased riskoffalling control/co-ordination, difficultyincontrollingmovements,changesperception, emotions, slurredspeechordisorder,lossofmemory,lackmuscle becoming lessalert,disorientation,dreams,confusion,excitement,numbed or withoutdrowsiness,tiredness dizziness, fainting,lossofco-ordination,‘spinning’sensationorheadachewith allergic reaction:skinrashes,itching treatment mild drowsinessandlight-headednessmayoccurduringthefirstfewdaysof occur inchildrenandtheelderly),depressionwithfeelingsofsuicide. psychoses (lossofcontactwithreality),inappropriatebehaviour(morelikelyto nightmares, hallucinations(seeingorhearingthingsthatarenotthere), The otheringredientsare:lactose,maizestarchandmagnesiumStearate. of oxazepam. HOW TOSTORE HOW TOTAKEOXAZEPAMTABLETS It wasnotaffectingyourabilitytodrivesafely.
Oxazepam 15mgTablets Oxazepam 10mgTablets
51737329. Code1211 92793421808
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MHRA Header Box PCP Header Box
Oxazepam 10mg and 15mg Tablets Colours Used Fonts Used Point Sizes Used Approved by Product Title Min Max Operator EBR Date Helvetica Neue 8.5pt 13pt Process Black Artwork No. 976861 Component Lea et Lucida Grande 8.5pt 8.5pt Keyline (Non-printing) CRN 14902 Su x C Pack Size 28's Reason for Safety update - addition of IG Code 92793421808 Change concomitant use of benzodiaze- Dimensions 420 x 120mm pines/opioids wording
Proof No. 2 Date 29.08.2018
Issued by Date MHRA/IMB submission Yes required