Finasteride 5mg Tablets - Summary of Product Characteristics ...

The recommended adult dose is one 5mg tablet daily, with or without food. Finasteride can be administered alone or in combination with the alpha-blocker ... Skiptomaincontent Finasteride5mgTablets Backtotop Dr.Reddy'sLaboratories(UK)Ltdcontactdetails Activeingredient finasteride LegalCategory POM:Prescriptiononlymedicine ReportSideEffect RelatedMedicines Sameactiveingredients Samecompany Bookmark Email Lastupdatedonemc:17Oct2018 Viewchanges Print Showtableofcontents Hidetableofcontents 1.Nameofthemedicinalproduct2.Qualitativeandquantitativecomposition3.Pharmaceuticalform4.Clinicalparticulars4.1Therapeuticindications4.2Posologyandmethodofadministration4.3Contraindications4.4Specialwarningsandprecautionsforuse4.5Interactionwithothermedicinalproductsandotherformsofinteraction4.6Fertility,pregnancyandlactation4.7Effectsonabilitytodriveandusemachines4.8Undesirableeffects4.9Overdose5.Pharmacologicalproperties5.1Pharmacodynamicproperties5.2Pharmacokineticproperties5.3Preclinicalsafetydata6.Pharmaceuticalparticulars6.1Listofexcipients6.2Incompatibilities6.3Shelflife6.4Specialprecautionsforstorage6.5Natureandcontentsofcontainer6.6Specialprecautionsfordisposalandotherhandling7.Marketingauthorisationholder8.Marketingauthorisationnumber(s)9.Dateoffirstauthorisation/renewaloftheauthorisation10.Dateofrevisionofthetext Thisinformationisintendedforusebyhealthprofessionals 1.Nameofthemedicinalproduct Finasteride5mgTablets 2.Qualitativeandquantitativecomposition Eachtabletcontains5mgoffinasteride. Excipient(s): Eachtabletalsocontains83.5mgoflactoseand6.6mgofsodium. Forafulllistofexcipients,seesection6.1. 3.Pharmaceuticalform Film-coated-tablet Blue,ovalbiconvextabletsmarkedwith'FIN'ononesideand'5'ontheotherside. 4.Clinicalparticulars 4.1Therapeuticindications Finasterideisindicatedforthetreatmentandcontrolofbenignprostatichyperplasia(BPH)inpatientswithanenlargedprostateto: -causeregressionoftheenlargedprostate,improveurinaryflowandimprovethesymptomsassociatedwithBPH. -reducetheincidenceofacuteurinaryretentionandtheneedforsurgeryincludingtransurethralresectionoftheprostate(TURP)andprostatectomy. 4.2Posologyandmethodofadministration Therecommendedadultdoseisone5mgtabletdaily,withorwithoutfood.Finasteridecanbeadministeredaloneorincombinationwiththealpha-blockerdoxazosin(seesection5.1'Pharmacodynamicproperties'). Althoughearlyimprovementinsymptomsmaybeseen,treatmentforatleastsixmonthsmaybenecessarytoassesswhetherabeneficialresponsehasbeenachieved.Thereafter,treatmentshouldbecontinuedlongterm. Nodosageadjustmentisrequiredintheelderlyorinpatientswithvaryingdegreesofrenalinsufficiency(creatinineclearancesaslowas9ml/min). Therearenodataavailableinpatientswithhepaticinsufficiency. Finasterideiscontra-indicatedinchildren. 4.3Contraindications Finasterideisnotindicatedforuseinwomenorchildren. Finasterideiscontraindicatedinthefollowing: -Hypersensitivitytoanycomponentofthisproduct -Pregnancy-Useinwomenwhentheyareormaypotentiallybepregnant(see4.6Pregnancyandlactation,Exposuretofinasteride-risktomalefoetus). 4.4Specialwarningsandprecautionsforuse General Toavoidobstructivecomplicationsitisimportantthatpatientswithlargeresidualurineand/orheavilydecreasedurinaryflowarecarefullycontrolled.Thepossibilityofsurgeryshouldbeanoption. EffectsonPSAandprostatecancerdetection Noclinicalbenefithasyetbeendemonstratedinpatientswithprostatecancertreatedwith'Finasteride'.PatientswithBPHandelevatedserumprostatespecificantigen(PSA)weremonitoredincontrolledclinicalstudieswithserialPSAsandprostatebiopsies.IntheseBPHstudies,'Finasteride'didnotappeartoaltertherateofprostatecancerdetection,andtheoverallincidenceofprostatecancerwasnotsignificantlydifferentinpatientstreatedwith'Finasteride'orplacebo. Digitalrectalexaminationsaswellasotherevaluationsforprostatecancerarerecommendedpriortoinitiatingtherapywith'Finasteride'andperiodicallythereafter.SerumPSAisalsousedforprostatecancerdetection.GenerallyabaselinePSA>10ng/mL(Hybritech)promptsfurtherevaluationandconsiderationofbiopsy;forPSAlevelsbetween4and10ng/mL,furtherevaluationisadvisable.ThereisconsiderableoverlapinPSAlevelsamongmenwithandwithoutprostatecancer.Therefore,inmenwithBPH,PSAvalueswithinthenormalreferencerangedonotruleoutprostatecancer,regardlessoftreatmentwith'Finasteride'.AbaselinePSA<4ng/mLdoesnotexcludeprostatecancer. 'Finasteride'causesadecreaseinserumPSAconcentrationsbyapproximately50%inpatientswithBPH,eveninthepresenceofprostatecancer.ThisdecreaseinserumPSAlevelsinpatientswithBPHtreatedwith'Finasteride'shouldbeconsideredwhenevaluatingPSAdataanddoesnotruleoutconcomitantprostatecancer.ThisdecreaseispredictableovertheentirerangeofPSAvalues,althoughitmayvaryinindividualpatients.Inpatientstreatedwith'Finasteride'forsixmonthsormore,PSAvaluesshouldbedoubledforcomparisonwithnormalrangesinuntreatedmen.ThisadjustmentpreservesthesensitivityandspecificityofthePSAassayandmaintainsitsabilitytodetectprostatecancer. AnysustainedincreaseinPSAlevelsofpatientstreatedwithfinasteride5mgshouldbecarefullyevaluated,includingconsiderationofnon-compliancetotherapywith'Finasteride'. Drug/laboratorytestinteractions EffectonlevelsofPSA SerumPSAconcentrationiscorrelatedwithpatientageandprostaticvolume,andprostaticvolumeiscorrelatedwithpatientage.WhenPSAlaboratorydeterminationsareevaluated,considerationshouldbegiventothefactthatPSAlevelsdecreaseinpatientstreatedwith'Finasteride'.Inmostpatients,arapiddecreaseinPSAisseenwithinthefirstmonthsoftherapy,afterwhichtimePSAlevelsstabilisetoanewbaseline.Thepost-treatmentbaselineapproximateshalfofthepre-treatmentvalue.Therefore,intypicalpatientstreatedwith'Finasteride'forsixmonthsormore,PSAvaluesshouldbedoubledforcomparisontonormalrangesinuntreatedmen.Forclinicalinterpretation,see4.4Specialwarningsandprecautionsforuse,EffectsonPSAandprostatecancerdetection. PercentfreePSA(freetototalPSAratio)isnotsignificantlydecreasedby'Finasteride'.TheratiooffreetototalPSAremainsconstantevenundertheinfluenceof'Finasteride'.WhenpercentfreePSAisusedasanaidinthedetectionofprostatecancer,noadjustmenttoitsvalueisnecessary. Breastcancerinmen Breastcancerhasbeenreportedinmentakingfinasteride5mgduringclinicaltrialsandthepost-marketingperiod.Physiciansshouldinstructtheirpatientstopromptlyreportanychangesintheirbreasttissuesuchaslumps,pain,gynaecomastiaornippledischarge. Pediatricuse 'Finasteride'isnotindicatedforuseinchildren. Safetyandeffectivenessinchildrenhavenotbeenestablished. Lactose Thetabletcontainslactosemonohydrate.Patientswithanyofthefollowinggeneticdeficienciesshouldnottakethisdrug:galactoseintolerance,totallactasedeficiencyorglucose-galactosemalabsorption. Hepaticinsufficiency Theeffectofhepaticinsufficiencyonthepharmacokineticsoffinasteridehasnotbeenstudied. Moodalterationsanddepression Moodalterationsincludingdepressedmood,depressionand,lessfrequently,suicidalideationhavebeenreportedinpatientstreatedwithfinasteride5mg.Patientsshouldbemonitoredforpsychiatricsymptomsandiftheseoccur,thepatientshouldbeadvisedtoseekmedicaladvice. 4.5Interactionwithothermedicinalproductsandotherformsofinteraction Nodruginteractionsofclinicalimportancehavebeenidentified.Finasterideismetabolizedprimarilyvia,butdoesnotappeartoaffectsignificantly,thecytochromeP4503A4system.Althoughtheriskforfinasteridetoaffectthepharmacokineticsofotherdrugsisestimatedtobesmall,itisprobablethatinhibitorsandinducersofcytochromeP4503A4willaffecttheplasmaconcentrationoffinasteride.However,basedonestablishedsafetymargins,anyincreaseduetoconcomitantuseofsuchinhibitorsisunlikelytobeofclinicalsignificance.Compoundswhichhavebeentestedinmanhaveincludedpropranolol,digoxin,glibenclamide,warfarin,theophylline,andphenazoneandnoclinicallymeaningfulinteractionswerefound. 4.6Fertility,pregnancyandlactation Pregnancy: 'Finasteride'iscontra-indicatedinwomenwhentheyareormaypotentiallybepregnant(see4.3Contraindications). BecauseoftheabilityoftypeII5α-reductaseinhibitorstoinhibitconversionoftestosteronetodihydrotestosterone,thesedrugs,includingfinasteride,maycauseabnormalitiesoftheexternalgenitaliaofamalefoetuswhenadministeredtoapregnantwoman. Inanimaldevelopmentalstudies,dose-dependentdevelopmentofhypospadiaswereobservedinthemaleoffspringofpregnantratsgivenfinasterideatdosesrangingfrom100μg/kg/dayto100mg/kg/day,atanincidenceof3.6%to100%.Additionally,pregnantratsproducedmaleoffspringwithdecreasedprostaticandseminalvesicularweights,delayedpreputialseparation,transientnippledevelopmentanddecreasedanogenitaldistance,whengivenfinasterideatdosesbelowtherecommendedhumandose.Thecriticalperiodduringwhichtheseeffectscanbeinducedhasbeendefinedinratsasdays16-17ofgestation. ThechangesdescribedaboveareexpectedpharmacologicaleffectsofTypeII5α-reductaseinhibitors.Manyofthechanges,suchashypospadias,observedinmaleratsexposedinuterotofinasteridearesimilartothosereportedinmaleinfantswithageneticdeficiencyofTypeII5α-reductase.Itisforthesereasonsthat'Finasteride'iscontra-indicatedinwomenwhoareormaypotentiallybepregnant. Noeffectswereseeninfemaleoffspringexposedinuterotoanydoseoffinasteride. Exposuretofinasteride-risktomalefoetus Womenshouldnothandlecrushedorbrokentabletsof'Finasteride'whentheyareormaypotentiallybepregnantbecauseofthepossibilityofabsorptionoffinasterideandthesubsequentpotentialrisktoamalefoetus(see4.6PregnancyandLactation'Pregnancy').'Finasteride'tabletsarecoatedandwillpreventcontactwiththeactiveingredientduringnormalhandling,providedthatthetabletshavenotbeenbrokenorcrushed. Smallamountsoffinasteridehavebeenrecoveredfromthesemeninsubjectsreceivingfinasteride5mg/day.Itisnotknownwhetheramalefoetusmaybeadverselyaffectedifhismotherisexposedtothesemenofapatientbeingtreatedwithfinasteride.Whenthepatient'ssexualpartnerisormaypotentiallybepregnant,thepatientisrecommendedtominimiseexposureofhispartnertosemen. Lactation: 'Finasteride'isnotindicatedforuseinwomen.Itisnotknownwhetherfinasterideisexcretedinhumanmilk. 4.7Effectsonabilitytodriveandusemachines Therearenodatatosuggestthat'Finasteride'affectstheabilitytodriveorusemachines. 4.8Undesirableeffects Themostfrequentadversereactionsareimpotenceanddecreasedlibido.Theseadversereactionsoccurearlyinthecourseoftherapyandresolvewithcontinuedtreatmentinthemajorityofpatients. Theadversereactionsreportedduringclinicaltrialsand/orpost-marketingusearelistedinthetablebelow. Frequencyofadversereactionsisdeterminedasfollows: Verycommon(≥1/10),Common(≥1/100to<1/10),Uncommon(≥1/1,000to<1/100),Rare(≥1/10,000to<1/1,000),Veryrare(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata). Thefrequencyofadversereactionsreportedduringpost-marketingusecannotbedeterminedastheyarederivedfromspontaneousreports. SystemOrganClass Frequency:adversereaction Immunesystemdisorders Unknown:hypersensitivityreactionsincludingswellingofthelips,tongue,throatandface;angioedema(includingswellingoflips,tongue,throatandface) Psychiatricdisorders Common:decreasedlibido Unknown:decreasedlibidothatmaycontinueafterdiscontinuationoftherapy,depression,anxiety Cardiacdisorders Unknown:palpitation Hepatobiliarydisorders Unknown:increasedhepaticenzymes Skinandsubcutaneoustissuedisorders Uncommon:rash Unknown:pruritus,urticaria Reproductivesystemandbreastdisorders Common:impotence Uncommon:ejaculationdisorder,breasttenderness,breastenlargement. Unknown:testicularpain,sexualdysfunction(erectiledysfunctionandejaculationdisorder)whichmaycontinueafterdiscontinuationoftreatment;maleinfertilityand/orpoorseminalquality.Normalizationorimprovementofseminalqualityhasbeenreportedafterdiscontinuationoffinasteride. Investigations Common:decreasedvolumeofejaculate Inaddition,thefollowinghasbeenreportedinclinicaltrialsandpost-marketinguse:malebreastcancer(see4.4Specialwarningsandprecautionsforuse). MedicalTherapyofProstateSymptoms(MTOPS) TheMTOPSstudycomparedfinasteride5mg/day(n=768),doxazosin4or8mg/day(n=756),combinationtherapyoffinasteride5mg/dayanddoxazosin4or8mg/day(n=786),andplacebo(n=737).Inthisstudy,thesafetyandtolerabilityprofileofthecombinationtherapywasgenerallyconsistentwiththeprofilesoftheindividualcomponents.Theincidenceofejaculationdisorderinpatientsreceivingcombinationtherapywascomparabletothesumofincidencesofthisadverseexperienceforthetwomonotherapies. OtherLong-TermData Ina7-yearplacebo-controlledtrialthatenrolled18,882healthymen,ofwhom9060hadprostateneedlebiopsydataavailableforanalysis,prostatecancerwasdetectedin803(18.4%)menreceiving'Finasteride'and1147(24.4%)menreceivingplacebo.Inthe'Finasteride'group,280(6.4%)menhadprostatecancerwithGleasonscoresof7-10detectedonneedlebiopsyvs.237(5.1%)menintheplacebogroup.Additionalanalysessuggestthattheincreaseintheprevalenceofhigh-gradeprostatecancerobservedinthe'Finasteride'groupmaybeexplainedbyadetectionbiasduetotheeffectof'Finasteride'onprostatevolume.Ofthetotalcasesofprostatecancerdiagnosedinthisstudy,approximately98%wereclassifiedasintracapsular(stageT1orT2).Therelationshipbetweenlong-termuseof'Finasteride'andtumourswithGleasonscores7-10isunknown. LaboratoryTestFindings WhenPSAlaboratorydeterminationsareevaluated,considerationshouldbegiventothefactthatPSAlevelsaredecreasedinpatientstreatedwith'Finasteride'(seesection4.4Specialwarningsandprecautionsforuse).Inmostpatients,arapiddecreaseinPSAisseenwithinthefirstmonthsoftherapy,afterwhichtimePSAlevelsstabilisetoanewbaseline.Thepost-treatmentbaselineapproximateshalfofthepre-treatmentvalue.Therefore,intypicalpatientstreatedwith'Finasteride'forsixmonthsormore,PSAvaluesshouldbedoubledforcomparisontonormalrangesinuntreatedmen. Forclinicalinterpretationsee'Specialwarningsandprecautionsforuse',Effectsonprostate-specificantigen(PSA)andprostatecancerdetection. Nootherdifferencewasobservedinpatientstreatedwithplaceboor'Finasteride'instandardlaboratorytests. Reportingofsuspectedadversereactions Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinuedmonitoringofthebenefit/riskbalanceofthemedicinalproduct.HealthcareprofessionalsareaskedtoreportanysuspectedadversereactionsviatheYellowCardSchemewebsite:www.mhra.gov.uk/yellowcardorsearchforMHRAYellowCardintheGooglePlayorAppleAppStore. 4.9Overdose Nospecifictreatmentofoverdosagewith'Finasteride'isrecommended.Patientshavereceivedsingledosesof'Finasteride'upto400mgandmultipledosesof'Finasteride'upto80mg/dayforuptothreemonthswithoutanyadverseeffects. 5.Pharmacologicalproperties 5.1Pharmacodynamicproperties FinasterideisacompetitiveinhibitorofhumanTypeII5-alphareductase,anintracellularenzymewhichmetabolisestestosteroneintothemorepotentandrogen,dihydrotestosterone(DHT).Inbenignprostatichyperplasia(BPH),enlargementoftheprostateglandisdependentupontheconversionoftestosteronetoDHTwithintheprostate.'Finasteride'ishighlyeffectiveinreducingcirculatingandintraprostaticDHT.Finasteridehasnoaffinityfortheandrogenreceptor. InclinicalstudiesofpatientswithmoderatetoseveresymptomsofBPH,anenlargedprostateondigitalrectalexaminationandlowresidualurinaryvolumes,'Finasteride'reducedtheincidenceofacuteretentionofurinefrom7/100to3/100overfouryearsandtheneedforsurgery(TURPorprostatectomy)from10/100to5/100.Thesereductionswereassociatedwitha2-pointimprovementinQUASI-AUAsymptomscore(range0-34),asustainedregressioninprostatevolumeofapproximately20%andasustainedincreaseinurinaryflowrate. Medicaltherapyofprostaticsymptoms TheMedicalTherapyofProstaticSymptoms(MTOPS)Trialwasa4-to6-yearstudyin3047menwithsymptomaticBPHwhowererandomisedtoreceivefinasteride5mg/day,doxazosin4or8mg/day*,thecombinationoffinasteride5mg/dayanddoxazosin4or8mg/day∗,orplacebo.TheprimaryendpointwastimetoclinicalprogressionofBPH,definedasa≥4pointconfirmedincreasefrombaselineinsymptomscore,acuteurinaryretention,BPH-relatedrenalinsufficiency,recurrenturinarytractinfectionsorurosepsis,orincontinence.Comparedtoplacebo,treatmentwithfinasteride,doxazosin,orcombinationtherapyresultedinasignificantreductionintheriskofclinicalprogressionofBPHby34(p=0.002),39(p<0.001),and67%(p<0.001),respectively.Themajorityoftheevents(274outof351)thatconstitutedBPHprogressionwereconfirmed≥4pointincreasesinsymptomscore;theriskofsymptomscoreprogressionwasreducedby30(95%CI6to48%),46(95%CI25to60%),and64%(95%CI48to75%)inthefinasteride,doxazosin,andcombinationgroups,respectively,comparedtoplacebo.Acuteurinaryretentionaccountedfor41ofthe351eventsofBPHprogression;theriskofdevelopingacuteurinaryretentionwasreducedby67(p=0.011),31(p=0.296),and79%(p=0.001)inthefinasteride,doxazosin,andcombinationgroups,respectively,comparedtoplacebo.Onlythefinasterideandcombinationtherapygroupsweresignificantlydifferentfromplacebo. ∗Titratedfrom1mgto4or8mgastoleratedovera3-weekperiod 5.2Pharmacokineticproperties Afteranoraldoseof14C-finasterideinman,39%ofthedosewasexcretedintheurineintheformofmetabolites(virtuallynounchangeddrugwasexcretedintheurine),and57%oftotaldosewasexcretedinthefaeces.TwometaboliteshavebeenidentifiedwhichpossessonlyasmallfractionoftheTypeII5alpha-reductaseactivityoffinasteride. Theoralbioavailabilityoffinasterideisapproximately80%,relativetoanintravenousreferencedose,andisunaffectedbyfood.Maximumplasmaconcentrationsarereachedapproximatelytwohoursafterdosingandtheabsorptioniscompletewithin6-8hours.Proteinbindingisapproximately93%.Plasmaclearanceandthevolumeofdistributionareapproximately165ml/minand761,respectively. Intheelderly,theeliminationrateoffinasterideissomewhatdecreased.Half-lifeisprolongedfromameanhalf-lifeofapproximately6hoursinmenaged18-60yearsto8hoursinmenagedmorethan70years.Thisisofnoclinicalsignificanceanddoesnotwarrantareductionindosage. Inpatientswithchronicrenalimpairment,whosecreatinineclearancerangedfrom9-55ml/min,thedispositionofasingledoseof14C-finasteridewasnotdifferentfromthatinhealthyvolunteers.Proteinbindingalsodidnotdifferinpatientswithrenalimpairment.Aportionofthemetaboliteswhichnormallyisexcretedrenallywasexcretedinthefaeces.Itthereforeappearsthatfaecalexcretionincreasescommensuratetothedecreaseinurinaryexcretionofmetabolites.Dosageadjustmentinnon-dialysedpatientswithrenalimpairmentisnotnecessary. Therearenodataavailableinpatientswithhepaticinsufficiency. Finasteridehasbeenfoundtocrosstheblood-brainbarrier.Smallamountsoffinasteridehavebeenrecoveredintheseminalfluidoftreatedpatients. 5.3Preclinicalsafetydata Non-clinicaldatarevealnospecialhazardforhumansbasedonconventionalstudiesofrepeateddosetoxicity,genotoxicity,andcarcinogenicpotential.Reproductiontoxicologystudiesinmaleratshavedemonstratedreducedprostateandseminalvesicularweights,reducedsecretionfromaccessorygenitalglandsandreducedfertilityindex(causedbytheprimarypharmacologicaleffectoffinasteride).Theclinicalrelevanceofthesefindingsisunclear. Aswithother5-alpha-reductaseinhibitors,femininisationofmaleratfoetuseshasbeenseenwithadministrationoffinasterideinthegestationperiod.Intravenousadministrationoffinasteridetopregnantrhesusmonkeysatdosesupto800ng/dayduringtheentireperiodofembryonicandfoetaldevelopmentresultedinnoabnormalitiesinmalefoetuses.Thisdoseisabout60-120timeshigherthantheestimatedamountinsemenofamanwhohavetaken5mgfinasteride,andtowhichawomancouldbeexposedviasemen.InconfirmationoftherelevanceoftheRhesusmodelforhumanfoetaldevelopment,oraladministrationoffinasteride2mg/kg/day(thesystemicexposure(AUC)ofmonkeyswasslightlyhigher(3x)thanthatofmenwhohavetaken5mgfinasteride,orapproximately1-2milliontimestheestimatedamountoffinasterideinsemen)topregnantmonkeysresultedinexternalgenitalabnormalitiesinmalefoetuses.Nootherabnormalitieswereobservedinmalefoetusesandnofinasteride-relatedabnormalitieswereobservedinfemalefoetusesatanydose. 6.Pharmaceuticalparticulars 6.1Listofexcipients Tabletcore: Lactosemonohydrate Cellulose,Microcrystalline(E460) PregelatinisedMaizeStarch SodiumStarchGlycolate(TypeA) DocusateSodium MagnesiumStearate(E470b) Tabletcoating: IndigoCarmine(E132) Hypromellose(E464) Titaniumdioxide(E171) Macrogol 6.2Incompatibilities Notapplicable. 6.3Shelflife 3years 6.4Specialprecautionsforstorage Donotstoreabove30°C.Keepblisterintheoutercarton. 6.5Natureandcontentsofcontainer BlisterstripsmadeofPVC/PE/PVdCorcoldformablefoilbasesandliddedwithaluminiumfoil.Availablepacksizesare:28,30,50and100tablets,althoughnotallpacksizesmaybemarketed. 6.6Specialprecautionsfordisposalandotherhandling Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirementsandnotviawastewaterorhouseholdwaste.Pharmacistscanadviseofsafedisposaltoprotecttheenvironment. Finasteridetabletshaveafilmcoatingwhichpreventscontactwiththeactiveingredientprovidedthatthetabletshavenotbeenbrokenorcrushed. WomenshouldnothandlecrushedorbrokenfinasterideTabletswhentheyareormaypotentiallybepregnant(see'Contraindications','Pregnancyandlactation',Exposuretofinasteride–risktomalefoetus). 7.Marketingauthorisationholder Dr.Reddy'sLaboratories(UK)Ltd, 6RiverviewRoad, Beverley EastYorkshire HU17OLD UK 8.Marketingauthorisationnumber(s) PL08553/0261 9.Dateoffirstauthorisation/renewaloftheauthorisation 04/06/2012 10.Dateofrevisionofthetext 03/09/2018 ReportSideEffect RelatedMedicines Sameactiveingredients Samecompany Bookmark Email Lastupdatedonemc:17Oct2018 Viewchanges Print Companycontactdetails Dr.Reddy'sLaboratories(UK)Ltd Address 6RiverviewRoad,Beverley,Hull,HU170LD Telephone +44(0)1482860228 MedicalInformationDirectLine +44(0)1748828873 CustomerCaredirectline +44(0)1482389858 WWW http://www.drreddys.com/united-kingdom Fax +44(0)1482860204 MedicalInformatione-mail [email protected] MedicalInformationFax +44(0)1748828801 × Bookmarkthismedicine Tobookmarkamedicineyoumustsignupandlogin. 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