Livial (Tibolone 2.5 mg) Drug / Medicine Information - News ...

Livial tablets contain the active ingredient tibolone, which is a synthetic steroid medicine used for hormone replacement therapy (HRT). Weusecookiestoenhanceyourexperience.Bycontinuingtobrowsethissiteyouagreetoouruseofcookies. Moreinfo. Accept CookieSettings Livial DownloadPDFCopy NOTICE:ThisConsumerMedicineInformation(CMI)isintendedforpersonslivinginAustralia. LIVIAL®TABLETS Tibolone2.5mg ConsumerMedicineInformation Whatisinthisleaflet ThisleafletanswerssomecommonquestionsaboutLivial.Itdoesnotcontainallthe availableinformation. Itdoesnottaketheplaceoftalkingtoyourdoctororpharmacist. Allmedicineshaverisksandbenefits.Yourdoctorhasweighedtherisksofyoutaking Livialagainstthebenefitstheyexpectitwillhaveforyou. Ifyouhaveanyconcernsabouttakingthismedicine,askyourdoctororpharmacist. Keepthisinformationwiththepack. Youmaywishtoreaditagain. WhatLivialisusedfor Livialtabletscontaintheactiveingredienttibolone,whichisasyntheticsteroid medicineusedforhormonereplacementtherapy(HRT).Itmimicstheactivityofthe femalesexhormonesinthebody. Livialcontainstibolone,asubstancethathasfavourableeffectsondifferenttissues inthebody,suchasbrain,vaginaandbone.Livialisusedinpostmenopausalwomen atleast12monthssincetheirlastnaturalperiod. Livialisusedfor: Reliefofsymptomsoccurringaftermenopause Duringthemenopause,theamountofestrogenproducedbyawoman'sbodydrops.This cancausesymptomssuchashotface,neckandchest("hotflushes").Livialalleviates thesesymptomsaftermenopause.YouwillonlybeprescribedLivialifyoursymptoms seriouslyhinderyourdailylife. Preventionofosteoporosis Afterthemenopausesomewomenmaydevelopfragilebones(osteoporosis).Youshould discussallavailableoptionswithyourdoctor. Ifyouareatanincreasedriskoffracturesduetoosteoporosisandothermedicines arenotsuitableforyou,youcantakeLivialtopreventosteoporosisaftermenopause. Livialisnotacontraceptive. Livialhasnoeffectonalertnessandconcentrationasfarasisknown. Adoctor'sprescriptionisrequiredtoobtainthismedicine. BeforeyouuseLivial Whenyoumustnottakeit DonottakeLivialif: youarepregnantorthinkyoumaybepregnant youarebreastfeeding youhaveorhaveeverhadbreastcancer,orifyouaresuspectedofhavingit youhavecancerwhichissensitivetoestrogens,suchascancerofthewomblining (endometrium),orifyouaresuspectedofhavingit youhaveanyunexplainedvaginalbleeding youhaveexcessivethickeningofthewomblining(endometrialhyperplasia)thatis notbeingtreated youhaveorhaveeverhadabloodclotinavein(thrombosis),suchasinthelegs (deepvenousthrombosis)orthelungs(pulmonaryembolism) youhaveabloodclottingdisorder(suchasproteinC,proteinS,orantithrombin deficiency) youhaveorrecentlyhavehadadiseasecausedbybloodclotsinthearteries,such asaheartattack,strokeorangina youhaveorhaveeverhadliverdiseaseandyourliverfunctiontestshavenotreturned tonormal youhaveararebloodproblemcalledporphyriawhichispasseddowninfamilies(inherited) youareallergic(hypersensitive)totiboloneoranyoftheingredientsofLivial listedattheendofthisleaflet Someofthesymptomsofanallergicreactionmayinclude: shortnessofbreath wheezingortroubledbreathing swellingoftheface,lips,tongueorotherpartsofthebody rash,itchingorhivesontheskin. IfanyoftheaboveconditionsappearforthefirsttimewhiletakingLivial,stop takingitatonceandconsultyourdoctorimmediately. Medicalhistoryandregularcheck-ups Aswellasbenefits,HRTorLivialhassomeriskswhichneedtobeconsideredwhen decidingwhethertostartingtakingit,orwhethertocarryontakingit. Theexperienceintreatingwomenwithaprematuremenopause(duetoovarianfailure orsurgery)islimited.IfyouhaveaprematuremenopausetherisksofusingHRTor Livialmaybedifferent.Pleasetalktoyourdoctor. Beforeyoustart(orrestart)HRTorLivial,yourdoctorwillaskyouaboutyourown andyourfamily'smedicalhistory.Yourdoctormaydecidetoperformaphysicalexamination. Thismayincludeanexaminationofyourbreastsand/oraninternalexamination,if necessary. OnceyouhavestartedonLivial,youshouldseeyourdoctorforregularcheck-ups (atleastonceayear).Atthesecheck-ups,discusswithyourdoctorthebenefits andrisksofcontinuingwithLivial. Goforregularbreastscreening,asrecommendedbyyourdoctor. WhentotakespecialcarewithLivial Tellyourdoctorifyouhaveeverhadanyofthefollowingconditionsbeforeyoustart thetreatment,asthesemayreturnorbecomeworseduringtreatmentwithLivial.If so,youshouldseeyourdoctormoreoftenforcheck-ups: fibroidsinsideyourwomb growthofthewombliningoutsideyourwomb(endometriosis)orahistoryofexcessive growthofthewomblining(endometrialhyperplasia) increasedriskofdevelopingbloodclots(see"Bloodclotsinavein(thrombosis)") increasedriskofgettinganestrogen-sensitivecancer(suchashavingamother,sister orgrandmotherwhohashadbreastcancer) highbloodpressure aliverdisorder,suchasabenignlivertumour diabetes gallstones migraineorsevereheadaches adiseaseoftheimmunesystemthataffectsmanyorgansofthebody(systemiclupus erythematosus,SLE) epilepsy asthma adiseaseaffectingtheeardrumandhearing(otosclerosis) averyhighleveloffatinyourblood(triglycerides) fluidretentionduetocardiacorkidneyproblems TellyourdoctorifyounoticeanychangeinyourconditionwhilstusingLivial. StoptakingLivialandseeadoctorimmediatelyifyounoticeanyofthefollowing whentakingHRTorLivial: anyoftheconditionsmentionedinthe"DonottakeLivial"section yellowingofyourskinorthewhitesofyoureyes(jaundice).Thesemaybesignsof aliverdisease alargeriseinyourbloodpressure(symptomsmaybeheadache,tiredness,dizziness) migraine-likeheadacheswhichhappenforthefirsttime ifyoubecomepregnant ifyounoticesignsofabloodclot,suchas: painfulswellingandrednessofthelegs suddenchestpain difficultyinbreathing Formoreinformation,see"Bloodclotsinavein(thrombosis)" HRTandcancer Excessivethickeningoftheliningofthewomb(endometrialhyperplasia)andcancer oftheliningofthewomb(endometrialcancer) Therehavebeenreportsandstudiesofanincreasedcellgrowthorcancerofthelining ofthewombinwomenusingLivial.Theriskofcanceroftheliningofthewombincreases withthedurationofuse. Irregularbleeding Youmayhaveirregularbleedingordropsofblood(spotting)duringthefirst3-6 monthsoftakingLivial. However,iftheirregularbleeding: carriesonformorethanthefirst6months startsafteryouhavebeentakingLivialformorethan6months carriesonafteryouhavestoppedtakingLivial seeyourdoctorassoonaspossible. Breastcancer Takingestrogen,estrogen-progesteronecombinedHRTorLivialforseveralyearsincreases theriskofbreastcancer.TheriskincreaseswiththedurationofHRTuseandreturns tonormalwithinabout5yearsafterstoppingHRT. WomentakingLivialhavealowerriskthanwomenusingcombinedHRTandacomparable riskwithestrogen-onlyHRT. Regularlycheckyourbreasts.Seeyourdoctorifyounoticeanychangessuchas: dimplingorsinkingoftheskin changesinthenipple anylumpsyoucanseeorfeel Ovariancancer Ovariancancerisrare.Anincreasedriskofovariancancerhasbeenreportedinwomen takingHRTafter5yearsofuse. Forwomenaged50to54whoarenottakingHRT,about2womenin2000willbediagnosed withovariancancerovera5-yearperiod.ForwomenwhohavebeentakingHRTfor5 years,therewillbe1extracaseper2000users.WithuseofLivial,theincreased riskofovariancancerforwomentakingLivialfor5yearsis1extracaseper2500 users. EffectsofHRTonheartorcirculation Heartdisease(heartattack) ThereisnoevidencethatHRTorLivialwillpreventaheartattack. Womenovertheageof60whouseestrogen-progestogenHRTareslightlymorelikely todevelopheartdiseasethanthosenottakinganyHRT.Astheriskofheartdisease stronglydependsonage,thenumberofextracasesofheartdiseaseduetouseof estrogen-progestogenHRTisverylowinhealthywomenclosetomenopause,butwill risewithmoreadvancedage. ThereisnoevidencetosuggestthattheriskofmyocardialinfarctionwithLivial isdifferenttotheriskofotherHRT. SeeadoctorassoonaspossibleanddonottakeanymoreLivialifyougetapain inyourchestthatspreadstoyourarmorneck. Thispaincouldbeasignofheartdisease. Stroke RecentresearchsuggeststhatHRTandLivialincreasestheriskofhavingastroke. Thisincreasedriskhasmainlybeenobservedinelderlypostmenopausalwomenabove 60yearsofage. Lookingatwomenintheir50swhoarenottakingLivial-onaverage,overa5-year period,3in1000wouldbeexpectedtohaveastroke.Forwomenintheir50swhoare takingLivial,thefigurewouldbe7in1000(i.e.anextra4cases). Lookingatwomenintheir60swhoarenottakingLivial-onaverage,overa5-year period,11in1000wouldbeexpectedtohaveastroke.Forwomenintheir60swho aretakingLivial,thefigurewouldbe24in1000(i.e.anextra13cases). Ifyouareworriedaboutanyofthesethings,orifyouhavehadastrokeinthepast, talktoyourdoctortoseeifyoushouldtakeLivial. SeeadoctorassoonaspossibleanddonottakeanymoreLivialuntilyourdoctor saysyoucanifyougetanyunexplainedmigraine-typeheadacheswithorwithoutdisturbed vision. Theseheadachesmaybeanearlywarningsignofastroke. Bloodclotsinavein(Thrombosis) Estrogenandestrogen-progestogencombinedHRTmayincreasetheriskofbloodclots intheveins(alsocalleddeepveinthrombosis,orDVT),especiallyduringthe1st yearoftakingit.ItisunknownifLivialincreasestheriskinthesameway. Bloodclotscanbeserious,andifonetravelstothelungs,itcancausechestpain, breathlessness,faintingorevendeath.Youaremorelikelytogetabloodclotin yourveinsasyougetolderandifanyofthefollowingappliestoyou.Informyour doctorifanyofthesesituationsapplytoyou: youarepregnantorrecentlyhadababy youuseestrogens youareunabletowalkforalongtimebecauseofmajorsurgery,injuryorillness (seealso"Ifyouneedtohavesurgery") youareseriouslyoverweight(BMIgreaterthan30kgpersquaremetre) youhaveanybloodclottingproblemthatneedslong-termtreatmentwithamedicine usedtopreventbloodclots ifanyofyourcloserelativeshaseverhadabloodclotintheleg,lungoranother organ youhavesystemiclupuserythematosus(SLE,adiseaseofyourimmunesystem) youhavecancer Ifanyoftheseapplytoyou,talktoyourdoctoraboutwhetheryoushoulduseLivial. Forsignsofabloodclot,see"StoptakingLivialandseeadoctorimmediately". Lookingatwomenintheir50swhoarenottakingHRT,onaverage,overa5-yearperiod, 4to7in1000wouldbeexpectedtogetabloodclotinavein. Forwomenintheir50swhohavebeentakingestrogen-progestogenHRTforover5years, therewillbe9to12casesin1000users(i.e.anextra5cases). WithuseofLivial,theincreasedriskofgettingabloodclotinaveinislower thanwithothertypesofHRT. Otherconditions HRTwillnotpreventmemoryloss.Thereissomeevidenceofahigherriskofmemory lossinwomenwhostartusingHRTaftertheageof65.Speaktoyourdoctorforadvice. Tellyourdoctorifyoubecomepregnantorarebreast-feeding. Livialisforuseinpostmenopausalwomenonly.Ifyouarepregnantorbreast-feeding orthinkyoumaybepregnant,donottakeLivial. TellyourdoctorifyoureactbadlytolactoseormilkbeforeyoustarttakingLivial. Livialtabletscontainlactose. Takingothermedicines Tellyourdoctororpharmacistifyouaretakinganyothermedicines,includingmedicines thatyougetwithoutaprescription,herbalmedicinesorothernaturalproductsfrom yourpharmacy,supermarketorhealthfoodshop. SomemedicinesmayinterferewiththeeffectofLivial. Thisappliestothefollowingmedicines: medicinesagainstbloodclotting(suchaswarfarin) medicinesforepilepsy(suchasphenobarbitone,phenytoinandcarbamazepine) medicinesfortuberculosis(suchasrifampicin) herbalremediescontainingStJohn'sWort(hypericumperforatum) Yourdoctormayneedtoadjustthedoseofthesemedicines. Askyourdoctororpharmacistforadvicebeforetakinganymedicine. HowtotakeLivial Whentostartit Livialshouldnotbetakenuntil12monthsafteryourlastnaturalmenstrualbleed. IfLivialistakensoonerthanthis,thechanceofirregularvaginalbleedingmay beincreased. Womenwhohaveundergoneprematuremenopause(surgicalremovalofovaries)canstart takingLivialimmediately. IfyouarealreadyusingadifferenttypeofHRT,yourdoctorwilladviseyouwhen toswitchtoLivial. Howtotakeit TakeLivialasdirectedbyyourdoctor.Youshouldalsoreadtheinstructionsgiven inthisleafletforyourmedicine.IfyouarenotsurehowtotakeLivialaskyour doctororpharmacist. Takeonetabletdaily,ataboutthesametimeeachday.Swallowthetabletwithsome waterorothernon-alcoholicdrink. TheLivialpackcontains28whitetablets.ThestripswithLivialaremarkedwith thedaysoftheweek.Startbytakingthetabletmarkedwiththatday.Forexample, ifitisaMonday,takeatabletmarkedMondayontheupperrowofthestrip.Follow thedaysoftheweekuntilthestripisempty.Startthenextstripthenextday. Donotleaveabreakbetweenstripsorpacks. Howlongtouseit HRTshouldbeprescribedatthelowesteffectivedoseandfortheshortestduration necessary.YourdoctorcanadviseyouhowlongyoumayneedtotakeLivial. Ifyouforgettotakeit Ifyouforgettotakeatablet,takeitassoonasyouremember,unlessyouaremore than12hourslate.Ifyouaremorethan12hourslate,skipthedoseyoumissedand takeyournextdosewhenyouaremeantto. Donottakeadoubledosetomakeupfortheforgottendose. Ifyoutaketoomuch(overdose) Ifyouhavetakenmoretabletsthanyouhavebeenprescribed,immediatelytelephone yourdoctororthePoisonsInformationCentreon131126,foradvice. Signsofanoverdosemayincludefeelingsickorvomiting.Vaginalbleedingmayalso occurafterafewdays. Ifyouneedtohavesurgery TellyourdoctorandyoursurgeonthatyouaretakingLivialifyouaregoingtohave surgery. YoumayneedtostoptakingLivialabout4-6weeksbeforetheoperationtoreduce theriskofabloodclot(see"Bloodclotsinavein").Askyourdoctorwhenyoucan starttakingLivialagain. SideEffects Tellyourdoctororpharmacistassoonaspossibleifyoudonotfeelwellwhileyou aretakingLivial. ThefollowingdiseasesarereportedmoreofteninwomenusingHRTcomparedtowomen notusingHRT: breastcancer abnormalgrowthorcanceroftheliningofthewomb(endometrialhyperplasiaorcancer) ovariancancer bloodclotsintheveinsofthelegsorlungs(venousthromboembolism) heartdisease stroke probablememorylossifHRTisstartedovertheageof65 Livialhelpsmostwomenwithmenopausalsymptoms,butitmayhaveunwantedsideeffects inafewpeople.Allmedicinescanhavesideeffects.Sometimestheyareserious, mostofthetimetheyarenot. Donotbealarmedbythefollowinglistsofsideeffects.Youmaynotexperienceany ofthem. Commonsideeffectsobservedinclinicalstudies(occurringin1-10%ofthewomen usingLivial)were: vaginalbleedingorspotting abdominalpain weightgain breastpain unnaturalhairgrowth vaginalsymptoms,suchasdischarge,itching,andirritation Uncommonsideeffects(occurringin0.1-1%ofthewomenusingLivial)were: acne OthersideeffectsobservedwithLivialinmarketusewere: dizziness,headache,migraine,depression rashoritching visualdisturbances gastro-intestinalupset fluidretention jointpain,musclepain changesinliverfunction Therehavebeenreportsofbreastcancerandofanincreasedcellgrowthorcancer oftheliningofthewombinwomenusingLivial. Tellyourdoctorifvaginalbleedingorspottingoccursorifanyoftheabovementioned sideeffectsworryyouorcontinue. Pleasesee"Medicalhistoryandregularcheck-ups"forconditionswhereLivialshould bestopped. ThefollowingsideeffectshavebeenreportedwithotherHRTs: gallbladderdisease variousskindisorders: discolourationoftheskinespeciallyofthefaceorneckknownas"pregnancypatches" (chloasma) painfulreddishskinnodules(erythemanodosum) rashwithtarget-shapedreddeningorsores(erythemamultiforme) Tellyourdoctororpharmacistifyounoticeanysideeffectsnotmentionedinthis leaflet. AfterUsingLivial Storage KeepyourLivialtabletsinasafeplaceoutofthereachofchildren. KeepyourLivialtabletsintheoriginalpackageinacooldryplacewherethetemperature staysbelow25°C. Donotuseaftertheexpirydatestatedontheblisterandouterbox. Disposal Ifyourdoctortellsyoutostoptakingthismedicineortheexpirydatehaspassed, askyourpharmacistwhattodowithanymedicinethatisleftover. ProductDescription Whatitlookslike Packscontainoneblisterstripof10or28whiteroundflattabletswithbevelled edges.ThetabletsaremarkedOrganonandastarononesideandMKabove2onthe other. Ingredients Livialtabletcontains2.5mgoftheactiveingredientcalledtibolone.Livialalso containsthefollowinginactiveingredients: potatostarch lactosemonohydrate ascorbylpalmitate magnesiumstearate Donotusetheproductiftheblisterpackortabletsaredamagedorappearunusual. Supplier OrganonPharmaPtyLtd BuildingA,26TalaveraRd, MacquarieParkNSW2113 Australia   AUSTR55088   ThisleafletwaspreparedinDecember2020.   CCPPI-MK8471-TB-112012 DownloadPDFCopy TrendingStories LatestInterviews TopHealthArticles PfizerCOVID-19vaccine-associatedtinnitusrespondstotranscranialmagneticstimulationImportantmethodologyfortargetingconservedepitopesofSARS-CoV-2andanimmune-focusedapproachinpan-sarbecoanduniversalCoVvaccinedesignLargeststudytodateontheeffectofvaccinationonlong-COVIDAIpredictsiforwhenapatientcoulddieofcardiacarrestStudydescribesthesymptomprofilesofthemainvariantsofSARS-CoV-2 CompleteAnatomy:AimingforEducationEqualitywiththeWorld’sMostAdvancedFullFemaleAnatomyModel IreneWalshandProfessorClaireSmith Inthisinterview,NewsMedicalspeaktoIreneWalsh,thedirectorofProduct,Design&Content,and3D4Medicalat Elsevier,andProfessorClaireSmith,HeadofAnatomyatBrightonandSussexMedicalSchool,aboutthereal-worldapplicationsoftheCompleteAnatomyfemalemodel,themostadvancedfullfemaleanatomymodelintheworld. 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