Livial 2.5mg tablets - Patient Information Leaflet (PIL) - (emc)

Livial contains tibolone, a substance that has beneficial effects on different tissues in the body, such as the brain, vagina and bone. This results in the ... Skiptomaincontent Livial2.5mgtablets Backtotop OrganonPharma(UK)Limitedcontactdetails Activeingredient tibolone LegalCategory POM:Prescriptiononlymedicine ATCcode G03CX01 Findsimilarproducts ReportSideEffect RelatedMedicines Sameactiveingredients Samecompany Bookmark Email Lastupdatedonemc:24Mar2021 Viewchanges PrintPDF Printtextonly Printlargetext WhatisaPatientInformationLeafletandwhyisituseful? ThePatientInformationLeaflet(PIL)istheleafletincludedinthepackwithamedicine.Itiswrittenforpatientsandgivesinformationabouttakingorusingamedicine.Itispossiblethattheleafletinyourmedicinepackmaydifferfromthisversionbecauseitmayhavebeenupdatedsinceyourmedicinewaspackaged. DownloadLeaflet ViewthepatientleafletinPDFformat BelowisatextonlyrepresentationofthePatientInformationLeaflet. Theoriginalleafletcanbeviewedusingthelinkabove. Thetextonlyversionmaybeavailableinlargeprint,BrailleoraudioCD. Forfurtherinformationcallemcaccessibilityon0800 198 5000. Theproductcode(s)forthisleafletis:PL00025/0599. Livial2.5mgtabletsPackageleaflet:InformationfortheuserLivial®2.5mgtabletsTIBOLONEReadallofthisleafletcarefullybeforeyoustarttakingthismedicinebecauseitcontainsimportantinformationforyou.Keepthisleaflet.Youmayneedtoreaditagain.Ifyouhaveanyfurtherquestions,askyourdoctor,pharmacistornurse.Thismedicinehasbeenprescribedforyouonly.Donotpassitontoothers.Itmayharmthem,eveniftheirsignsofillnessarethesameasyours.Ifyougetanysideeffectstalktoyourdoctor,pharmacistornurse.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.Seesection4.Inthisleaflet:1.WhatLivialisandwhatitisusedfor2.WhatyouneedtoknowbeforeyoutakeLivial3.HowtotakeLivial4.Possiblesideeffects5.HowtostoreLivial6.Contentsofthepackandotherinformation1.WhatLivialisandwhatitisusedforLivial2.5mgtabletTheactivesubstanceis:tibolone.Thismedicineisahormonereplacementtherapy(HRT).Itcontainstibolone,asubstancethathasfavourableeffectsondifferenttissuesinthebody,suchasbrain,vaginaandbone.Thismedicineisusedinpostmenopausalwomenwithatleast12months(1year)sincetheirlastnaturalperiod.Thismedicineisusedfor:ReliefofsymptomsoccurringaftermenopauseDuringthemenopause,theamountoftheoestrogenproducedbyawoman’sbodydrops.Thiscancausesymptomssuchashotface,neckandchest("hotflushes").Livialalleviatesthesesymptomsaftermenopause.Youwillonlybeprescribedthismedicineifyoursymptomsseriouslyhinderyourdailylife.PreventionofosteoporosisAfterthemenopausesomewomenmaydevelopfragilebones(osteoporosis).Youshoulddiscussallavailableoptionswithyourdoctor.Ifyouareatanincreasedriskoffracturesduetoosteoporosisandothermedicinesarenotsuitableforyou,youcanuseLivialtopreventosteoporosisaftermenopause.TherearethreedifferentkindsofHRT:Oestrogen-onlyHRTCombinedHRT,containingtwokindsoffemalehormone,anoestrogenandaprogestogen.Livial,whichcontainsasubstancecalledtiboloneLivialisdifferentfromotherHRT.Insteadofactualhormones(suchasoestrogenandprogestogen)itcontainstibolone.Yourbodybreaksdowntibolonetomakehormones.ItseffectsandbenefitsaresimilartocombinedHRT.Insection6,‘Contentsofthepackandotherinformation’youcanfindmoreinformationaboutLivialandwhatitisusedfor.2.WhatyouneedtoknowbeforeyoutakeLivialForinformationonwhenyoucanstarttakingLivial,(includingafterahysterectomy)seesection3.1(overleaf).MedicalHistoryandregularcheck-upsTheuseofHRTorLivialcarriesrisksthatneedtobeconsideredwhendecidingwhethertostarttakingit,orwhethertocarryontakingit.Thisisespeciallyimportantifyouaremorethan60yearsold.Theexperienceintreatingwomenwithaprematuremenopause(duetoovarianfailureorsurgery)islimited.IfyouhaveaprematuremenopausetherisksofusingHRTorLivialmaybedifferent.Pleasetalktoyourdoctor.BeforeyoustarttakingorrestartHRTorLivialYourdoctorwillaskaboutyourownandyourfamily’smedicalhistory.Yourdoctormaydecidetoperformaphysicalexamination.Thismayincludeanexaminationofyourbreastsand/oraninternalexamination,ifnecessary.Tellyourdoctorifyouhaveanymedicalproblemsorillnesses.Regularcheck-upsOnceyouhavestartedonLivial,youshouldseeyourdoctorforregularcheck-ups(atleastonceayear).Atthesecheck-ups,discusswithyourdoctorthebenefitsandrisksofcontinuingwithLivial.Goforregularbreastscreening,asrecommendedbyyourdoctor.Besuretogoforregularbreastscreeningandcervicalsmeartestsregularlycheckyourbreastsforanychangessuchasdimplingoftheskin,changesinthenipple,oranylumpsyoucanseeorfeel.2.1SomewomenshouldnottakeLivialDonottakeLivialIfanyofthefollowingappliestoyou.Ifyouarenotsureaboutanyofthepointsbelow,talktoyourdoctorbeforetakingLivialIfyouhaveorhaveeverhadbreastcancer,orifyouaresuspectedofhavingitIfyouhavecancerwhichissensitivetooestrogens,suchascancerofthewomblining(endometrium),orifyouaresuspectedofhavingitIfyouhaveanyunexplainedvaginalbleedingIfyouhaveexcessivethickeningofthewomblining(endometrialhyperplasia)thatisnotbeingtreated.Ifyouhaveorhaveeverhadabloodclotinavein(thrombosis),suchasinthelegs(deepvenousthrombosis)orthelungs(pulmonaryembolism)Ifyouhaveabloodclottingdisorder(suchasproteinC,proteinS,orantithrombindeficiency)Ifyouhaveorrecentlyhavehadadiseasecausedbybloodclotsinthearteries,suchasaheartattack,strokeoranginaIfyouhaveorhaveeverhadaliverdiseaseandyourliverfunctiontestshavenotreturnedtonormalIfyouhaveararebloodproblemcalled“porphyria”whichispasseddowninfamilies(inherited)Ifyouareallergictotiboloneoranyoftheotheringredientsofthismedicine(listedinsection6)Ifyouarepregnantorthinkyoumightbepregnant.Ifyouarebreastfeeding.IfanyoftheaboveconditionsappearforthefirsttimewhiletakingLivial,stoptakingitatonceandconsultyourdoctorimmediately.IfyouhavestartedthemenopauseyoushouldnottakeLivialuntil12monthsafteryourlastnaturalperiod.Ifyoutakeitsoonerthanthisyoumayhaveirregularbleeding.2.2WarningandprecautionsTalktoyourdoctor,pharmacistornursebeforetakingLivial.Ifyouhaveeverhadanyofthefollowingproblems,tellyourdoctorbeforeyoustartthetreatment,asthesemayreturnorbecomeworseduringtreatmentwithLivial.Ifso,youshouldseeyourdoctormoreoftenforcheck-ups:fibroidsinsideyourwombgrowthofthewombliningoutsideyourwomb(endometriosis)orahistoryofexcessivegrowthofthewomblining(endometrialhyperplasia)increasedriskofdevelopingbloodclots(see“Bloodclotsinavein(thrombosis)”)increasedriskofgettinganoestrogen-sensitivecancer(suchashavingamother,sisterorgrandmotherwhohashadbreastcancer)highbloodpressurealiverdisorder,suchasabenignlivertumourdiabetesgallstonesmigraineorsevereheadachesadiseaseoftheimmunesystemthataffectsmanyorgansofthebody(systemiclupuserythematosus,SLE)epilepsyasthmaadiseaseaffectingtheeardrumandhearing(otosclerosis)averyhighleveloffatinyourblood(triglycerides)fluidretentionduetocardiacorkidneyproblems2.3StoptakingLivialandseeadoctorimmediatelyIfyounoticeanyofthefollowingwhentakingLivial:anyoftheconditionsmentionedinthe"DonottakeLivial"sectionyellowingofyourskinorthewhitesofyoureyes(jaundice).Thesemaybesignsofaliverdiseasealargeriseinyourbloodpressure(symptomsmaybeheadache,tiredness,dizziness)migraine-likeheadacheswhichhappenforthefirsttimeifyoubecomepregnantifyounoticesignsofabloodclot,suchas: painfulswellingandrednessofthelegssuddenchestpaindifficultyinbreathingFormoreinformation,see“Bloodclotsinavein(thrombosis)”.Note:Livialisnotacontraceptive.Ifitislessthan12monthssinceyourlastmenstrualperiodoryouareunder50yearsold,youmaystillneedtouseadditionalcontraceptiontopreventpregnancy.Speaktoyourdoctorforadvice.2.4HRTandCancerExcessivethickeningoftheliningofthewomb(endometrialhyperplasia)andcanceroftheliningofthewomb(endometrialcancer)TherehavebeenreportsofanincreasedcellgrowthorcanceroftheliningofthewombinwomenusingLivial.Theriskofcanceroftheliningofthewombincreasesthelongeryoutakethemedicine.IrregularbleedingYoumayhaveirregularbleedingordropsofblood(spotting)duringthefirst3-6monthsoftakingLivial.Butifthebleedingorspotting:Carriesonformorethanthefirst6monthsStartsafteryouhavebeentakingLivialformorethan6monthsCarriesonevenafteryou’vestoppedtakingLivialseeyourdoctorassoonaspossible.BreastcancerEvidenceshowsthattakingtiboloneincreasestheriskofbreastcancer.Theextrariskdependsonhowlongyouusetibolone.InstudieswithHRT,afterstoppingHRTtheextrariskdecreasedwithtime,buttheriskmaypersistfor10yearsormorewhenwomenhaveusedHRTformorethan5years.Nodataforpersistenceofriskafterstoppingareavailablefortibolone,butasimilarpatterncannotberuledout.CompareWomentakingLivialhavealowerriskthanwomenusingcombinedHRTandacomparableriskwithoestrogen-onlyHRT.Regularlycheckyourbreasts.Seeyourdoctorifyounoticeanychangessuchas: dimplingorsinkingoftheskinchangesinthenippleanylumpsyoucanseeorfeelMakeanappointmenttoseeyourdoctorassoonaspossibleOvariancancerOvariancancerisrare–muchrarerthanbreastcancer.Theuseofoestrogen-onlyorcombinedoestrogen-progestagenHRThasbeenassociatedwithaslightlyincreasedriskofovariancancer.Theriskofovariancancervarieswithage.Forexample,inwomenaged50to54whoarenottakingHRT,about2womenin2000willbediagnosedwithovariancancerovera5-yearperiod.ForwomenwhohavebeentakingHRTfor5years,therewillbeabout3casesper2000users(i.e.about1extracase).WithuseofLivial,theincreasedriskofovariancancerissimilartoothertypesofHRT.2.5EffectofHRTonheartandcirculationBloodclotsinavein(thrombosis)Theriskofbloodclotsintheveinsisabout1.3to3-timeshigherinHRTusersthaninnon-users,especiallyduringthefirstyearoftakingit.Bloodclotscanbeserious,andifonetravelstothelungs,itcancausechestpain,breathlessness,faintingorevendeath.Youaremorelikelytogetabloodclotinyourveinsasyougetolderandifanyofthefollowingappliestoyou.Informyourdoctorifanyofthesesituationsapplytoyou:youarepregnantorrecentlyhadababyyouuseoestrogensyouareunabletowalkforalongtimebecauseofmajorsurgery,injuryorillness(seealsosection3,Ifyouneedtohavesurgery)youareseriouslyoverweight(BMI>30kg/m2)youhaveanybloodclottingproblemthatneedslong-termtreatmentwithamedicineusedtopreventbloodclotsifanyofyourcloserelativeshaseverhadabloodclotintheleg,lungoranotherorganyouhavesystemiclupuserythematosus(SLE)youhavecancer.Forsignsofabloodclot,see“StoptakingLivialandseeadoctorimmediately”.CompareLookingatwomenintheir50swhoarenottakingHRT,onaverage,overa5yearperiod,4to7in1000wouldbeexpectedtogetabloodclotinavein.Forwomenintheir50swhohavebeentakingoestrogen-progestogenHRTforover5years,therewillbe9to12casesin1000users(i.e.anextra5cases).WithuseofLivial,theincreasedriskofgettingabloodclotinaveinislowerthanwithothertypesofHRT.Heartdisease(heartattack)ThereisnoevidencethatHRTorLivialwillpreventaheartattack.Womenovertheageof60whouseoestrogen-progestogenHRTareslightlymorelikelytodevelopheartdiseasethanthosenottakinganyHRT.Astheriskofheartdiseasestronglydependsonage,thenumberofextracasesofheartdiseaseduetouseofoestrogen-progestogenHRTisverylowinhealthywomenclosetomenopause,butwillrisewithmoreadvancedage.ThereisnoevidencetosuggestthattheriskofmyocardialinfarctionwithLivialisdifferenttotheriskofotherHRT.StrokeRecentresearchsuggeststhatHRTandLivialslightlyincreasestheriskofhavingastroke.Theincreasedriskisseenmainlyinwomenover60yearsold.Otherthingsthatcanincreasetheriskofstrokeinclude:GettingolderHighbloodpressureSmokingDrinkingtoomuchalcoholAnirregularheartbeatIfyouareworriedaboutanyofthesethings,talktoyourdoctortoseeifyoushouldtakeHRTCompareLookingatwomenintheir50swhoarenottakingLivial–onaverage,overa5-yearperiod,3in1000wouldbeexpectedtohaveastroke.Forwomenintheir50swhoaretakingLivial,thefigurewouldbe7in1000(i.e.anextra4cases).Lookingatwomenintheir60swhoarenottakingLivial–onaverage,overa5-yearperiod,11in1000wouldbeexpectedtohaveastroke.Forwomenintheir60swhoaretakingLivial,thefigurewouldbe24in1000(i.e.anextra13cases).2.6OtherconditionsHRTwillnotpreventmemoryloss.ThereissomeevidenceofahigherriskofmemorylossinwomenwhostartusingHRTaftertheageof65.Speaktoyourdoctorforadvice.Livialisnotintendedforcontraceptiveuse.TreatmentwithLivialresultsinamarkeddose-dependentdecreaseinHDLcholesterol(from-16.7%witha1.25mgdoseto-21.8%forthe2.5mgdoseafter2years).Totaltriglyceridesandlipoprotein(a)levelswerealsoreduced.ThedecreaseintotalcholesterolandVLDL-Clevelswasnotdose-dependent.LevelsofLDL-Cwereunchanged.Theclinicalimplicationofthesefindingsisnotyetknown.Oestrogensmaycausefluidretention,andthereforepatientswithcardiacorrenaldysfunctionshouldbecarefullyobserved.Womenwithpre-existinghypertriglyceridaemiashouldbefollowedcloselyduringoestrogenreplacementorhormonereplacementtherapy,sincerarecasesoflargeincreasesofplasmatriglyceridesleadingtopancreatitishavebeenreportedwithoestrogentherapyinthiscondition.TreatmentwithLivialresultsinaveryminordecreaseofthyroidbindingglobulin(TBG)andtotalT4.LevelsoftotalT3areunaltered.Livialdecreasesthelevelofsex-hormone-bindingglobulin(SHBG),whereasthelevelsofcorticoidbindingglobulin(CBG)andcirculatingcortisolareunaffected.2.7OthermedicinesandLivialSomemedicinesmayinterferewiththeeffectofLivial.Thismightleadtoirregularbleeding.Thisappliestothefollowingmedicines:Medicinesagainstbloodclotting(suchaswarfarin)Medicinesforepilepsy(suchasphenobarbital,phenytoinandcarbamazepine)Medicinesfortuberculosis(suchasrifampicin)HerbalremediescontainingStJohn’sWort(Hypericumperforatum).Tellyourdoctororpharmacistifyouaretaking,haverecentlytakenormighttakeanyothermedicines.Thisincludesmedicinesobtainedwithoutaprescription,herbalmedicinesorothernaturalproducts.2.8HavinganOperationIfyouaregoingtohaveanoperation,makesureyourdoctorknowsaboutit.YoumayneedtostoptakingHRTabout4to6weeksbeforetheoperation,toreducetheriskofabloodclot.YourdoctorwilltellyouwhenyoucanstarttakingHRTagain.2.9LivialwithfoodanddrinkYoucaneatordrinknormallywhileyouaretakingLivial.2.10Pregnancyandbreast-feedingLivialisforuseinpostmenopausalwomenonly.Ifyoubecomepregnant,stoptakingLivialandcontactyourdoctor.Ifyouarepregnantorbreast-feeding,thinkyoumaybepregnantorareplanningtohaveababy,askyourdoctororpharmacistforadvicebeforetakingthismedicine.2.11DrivingandusingmachinesLivialhasnoknowneffectontheabilitytodriveorusemachines.2.12LivialcontainsLactosePatientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactosemalabsorptionshouldnottakethismedicine.Ifyouhavebeentoldbyyourdoctorthatyouhaveanintolerancetosomesugars,contactyourdoctorbeforeusingLivial.Ifyouareworriedaboutanythinginthissection,talktoyourdoctorabouttherisksandbenefitsofHRT.3.HowtotakeLivial3.1WhencanyoustarttakingLivial?WaitbeforetakingLivial(seesection2.1)Ifitisnotyet12monthssinceyourlastnaturalperiodStarttakingLivialstraightawayIfyouarechangingoverfromaperiodfreeHRT…(seenotebelow)…IfyouhaveneverusedHRTbeforeIfyouwereprescribedHRTbecauseyouhavehadahysterectomy…Ifyouarebeingtreatedforendometriosis(aconditioninwhichpartsofthewombliningmovearoundthebody)…Waitforyournextperiod.StarttakingLivialassoonasyourperiodendsIfyouarechangingoverfromanothertypeofHRTwithwhichyouhaveperiods…(seethenotebelow)…IfyouarechangingoverfromanothertypeofHRTThereareseveraldifferenttypesofHRT,suchastablets,patchesandgels.Mostcontaineitheroestrogen,oroestrogenandprogestogen.Withsomeyoustillhaveperiods,andwithsomeyoudon’t(thesearecalledperiod-freeHRT).3.2HowtotakeLivialAlwaystakethismedicineexactlyasyourdoctororpharmacisthastoldyou.Checkwithyourdoctororpharmacistifyouarenotsure.Therecommendeddoseisonetableteveryday.Takethisdoseunlessyourdoctororpharmacisttoldyoutodosomethingdifferent.Pressthetabletsothatitcomesthroughthefoil.Swallowthetabletwithsomewaterorotherdrink,withoutchewing.TakeLivialatthesametimeeachday.Thestripsoftabletsaremarkedwiththedaysoftheweek.Startbytakingatabletmarkedwiththecurrentday.Forexample,ifitisMonday,takeatabletmarkedMondayonthetoprowofthestrip.Followthearrowsuntilthestripisempty.Startthenextstripthenextday.Donotleaveabreakbetweenstripsorpacks.Yourdoctorwillaimtoprescribethelowestdosetotreatyoursymptomsforasshortasnecessary.Speaktoyourdoctorifyouthinkthisdoseistoostrongornotstrongenough.3.3IfyoutakemoreLivialthanyoushouldItisunlikelythattakingmorethanonetabletwilldoyouanyharm,butyoumayfeelsick,besickorhavesomevaginalbleeding.3.4IfyouforgettotakeLivialIfyouforgettotakeatablet,takeitassoonasyouremember,unlessyouaremorethan12hourslate.Ifyouaremorethan12hourslate,justskipit,andtakeyournexttabletattheusualtime.Don'ttakeadoubledose.3.5IfyouneedtohavesurgeryIfyouaregoingtohavesurgery,tellthesurgeonthatyouaretakingLivial.YoumayneedtostoptakingLivialabout4to6weeksbeforetheoperationtoreducetheriskofabloodclot(seesection2,'Bloodclotsinavein').AskyourdoctorwhenyoucanstarttakingLivialagain.4.PossiblesideeffectsThefollowingdiseasesarereportedmoreofteninwomenusingHRTcomparedtowomennotusingHRT:breastcancerabnormalgrowthorcanceroftheliningofthewomb(endometrialhyperplasiaorcancer)ovariancancerbloodclotsintheveinsofthelegsorlungs(venousthromboembolism)heartdiseasestrokeprobablememorylossifHRTisstartedovertheageof65Formoreinformationaboutthesesideeffects,seesection2.Likeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.Mostsideeffectsaremild.TellyourdoctororpharmacistifyouareworriedaboutanysideeffectswhichyouthinkmaybeduetoLivial.(seealsosection2.3,'StoptakingLivialandseeadoctorimmediately')4.1Serioussideeffects–seeadoctorstraightawayIfyouthinkyoumayhavesignsofaserioussideeffect,seeadoctorstraightaway.YoumayneedtostoptakingLivial:IfyourbloodpressurerisesIfyourskinorthewhitesofyoureyesgoyellow(jaundice)Ifyousuddenlyhavemigraine-typeheadaches(seesection2.5above)Ifyouhavesignsofabloodclot(seesection2.5above)Ifyougetanyoftheproblemslistedinsection2.1(DonottakeLivial)4.2OthersideeffectsCommon(mayaffectupto1in10women):breastpainstomachorpelvicpainunusualhairgrowthvaginalbleedingorspotting.ThisisusuallynothingtoworryaboutinthefirstfewmonthsoftakingHRT.Ifbleedingcontinues,orstartsafteryouhavebeenonHRTforawhileseesection2.4.vaginalproblemssuchasmoresecretions,itching,irritationandthrushthickeningoftheliningofthewombortheliningofthecervixweightgain.Uncommon(mayaffectupto1in100women):swollenhands,anklesorfeet–asignoffluidretentionstomachupsetacnepainfulnipplesorbreastsfeelinguncomfortablevaginalinfectionsRare(mayaffectupto1in1000women):itchyskinSomewomentakingLivialhavealsoreported:depression,dizziness,headachejointpainormusclepainskinproblemssuchasrashoritchinglossofvisionorblurredvisionchangesinlivertestsTherehavebeenreportsofbreastcancerandofanincreasedcellgrowthorcanceroftheliningofthewombinwomenusingLivial.Tellyourdoctorifanyoftheabovementionedsideeffectscontinuesorbecomestroublesome.ThefollowingsideeffectshavebeenreportedwithotherHRTs:gallbladderdiseasevariousskindisorders: discolourationoftheskinespeciallyofthefaceorneckknownas“pregnancypatches”(chloasma)painfulreddishskinnodules(erythemanodosum)rashwithtarget-shapedreddeningorsores(erythemamultiforme)ReportingofsideeffectsIfyougetanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviatheYellowCardSchemeat:www.mhra.gov.uk/yellowcardorsearchforMHRAYellowCardintheGooglePlayorAppleappStore.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.5.HowtostoreLivialKeepthismedicineoutofthesightandreachofchildren.Donotusethismedicineaftertheexpirydatewhichisstatedonthecartonafter‘EXP’.Theexpirydatereferstothelastdayofthatmonth.Storebelow25°C.Donotrefrigerate.Storeintheoriginalpackage.Keeptheblisterintheoutercarton,inordertoprotectfromlightandmoisture.Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrowawaymedicinesyounolongeruse.Thesemeasureswillhelpprotecttheenvironment.6.ContentsofthepackandotherinformationWhatLivialcontainsTheactivesubstanceistibolone.Theotheringredientsarepotatostarch,lactosemonohydrate,ascorbylpalmitateandmagnesiumstearate.WhatLiviallookslikeandthecontentsofthepackLivialtabletsarewhite,andmarkedOrganon*ononeside,and“MK2”ontheotherside.Theycomeinpacksofoneorthreestripsof28tablets.TheMarketingAuthorisationHolderis:OrganonPharma(UK)LimitedHertfordRoadHoddesdonHertfordshireEN119BUUKThemanufactureris:NVOrganonPOBox205340BHOssNetherlandsThisleafletwasrevisedinFebruary2021.MoreaboutLivialThemostimportantnaturalsexhormonesinwomenareoestrogensandprogesterone.Thesehormonesareproducedintheovaries.Theyareneededfornormalsexualdevelopmentandcontrolthemenstrualcycle.Themenopauseisthetime(usuallyaroundtheageof50)whentheovariesgraduallystopproducingoestrogens.Iftheovariesareremovedsurgicallybeforethemenopause,thedecreaseinhormoneproductionoccursveryquickly.Thedecreaseinhormoneproductionoftenleadstosymptomssuchashotflushesandnightsweats.Theshortageofsexhormonesmayalsocausetheliningofthevaginatobecomethinanddry.Sosexualintercoursemaybepainfulandvaginalinfectionsmayoccurmorefrequently.Somewomenalsoexperiencemoodchanges,nervousness,depression,irritabilityandlossofsexualdesire.Oestrogensarealsoimportantforboneformation.Boneisbuiltupduringyouth,andpeakbonemassisreachedbetweentheageof20and30.Afterthat,bonemassdecreases,atfirstslowly,butlaterinlifemorequickly,especiallyafterthemenopause.Gradually,thebonesbecomebrittleandmayeasilybreak(osteoporosis),especiallyinyourspine,hipandwrists.Osteoporosismayalsocausebackpain,lossofheightandacurvedback.Livialcontainstibolone,asubstancethathasbeneficialeffectsondifferenttissuesinthebody,suchasthebrain,vaginaandbone.Thisresultsinthereliefofsymptomssuchashotflushesandnightsweats,andanimprovementintheliningofthevagina,moodandsexualdesire.Livialcanalsostoptheprocessofbonelossthatoccursinyourspine,hipandwristsafterthemenopause.Unlikesomehormonereplacementtherapies,Livialdoesnotstimulatetheliningofthewomb.SotreatmentwithLivialdoesnotcausemonthlyvaginalbleeding.TolistentoorrequestacopyofthisleafletinBraille,largeprintoraudiopleasecall,freeofcharge:08001985000(UKonly)Pleasebereadytogivethefollowinginformation:Productname:Livial2.5mgtabletsReferencenumber:PL00025/0599ThisisaserviceprovidedbytheRoyalNationalInstituteforBlindPeople.©OrganonPharma(UK)Limited,2021.Allrightsreserved.PIL.LIV.20.UK.7534.IA-ORG.NoRCN ReportSideEffect RelatedMedicines Sameactiveingredients Samecompany Bookmark Email Lastupdatedonemc:24Mar2021 Viewchanges PrintPDF Printtextonly Printlargetext Companycontactdetails OrganonPharma(UK)Limited Address TheHewettBuilding,14HewettStreet,London,EC2A3NP,UK Telephone +44(0)2081593593 CustomerCaredirectline +44(0)2081593500 WWW https://www.organon.com/uk/ MedicalInformatione-mail [email protected] × Bookmarkthismedicine Tobookmarkamedicineyoumustsignupandlogin. 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