Finasteride 5mg Tablets - Patient Information Leaflet (PIL) - eMC

Finasteride 5 mg Tablets contain a medicine called finasteride. This belongs to a group of medicines called '5-alpha-reductase inhibitors'. Skiptomaincontent Finasteride5mgTablets Backtotop Dr.Reddy'sLaboratories(UK)Ltdcontactdetails Activeingredient finasteride LegalCategory POM:Prescriptiononlymedicine ReportSideEffect RelatedMedicines Sameactiveingredients Samecompany Bookmark Email Lastupdatedonemc:16Oct2018 Viewchanges PrintPDF Printtextonly WhatisaPatientInformationLeafletandwhyisituseful? ThePatientInformationLeaflet(PIL)istheleafletincludedinthepackwithamedicine.Itiswrittenforpatientsandgivesinformationabouttakingorusingamedicine.Itispossiblethattheleafletinyourmedicinepackmaydifferfromthisversionbecauseitmayhavebeenupdatedsinceyourmedicinewaspackaged. DownloadLeaflet ViewthepatientleafletinPDFformat BelowisatextonlyrepresentationofthePatientInformationLeaflet. Theoriginalleafletcanbeviewedusingthelinkabove. Thetextonlyversionmaybeavailableinlargeprint,BrailleoraudioCD. Forfurtherinformationcallemcaccessibilityon0800 198 5000. Theproductcode(s)forthisleafletis:PL08553/0261. Finasteride5mgTabletsPACKAGELEAFLET:INFORMATIONFORTHEUSERFinasteride5mgTabletsThismedicineisforuseinmenonly.Readallofthisleafletcarefullybeforeyoustarttakingthismedicinebecauseitcontainsimportantinformationforyou.Keepthisleaflet.Youmayneedtoreaditagain.Ifyouhaveanyfurtherquestions,askyourdoctororpharmacist.Thismedicinehasbeenprescribedforyouonly.Donotpassitontoothers.Itmayharmthem,eveniftheirsignsofillnessarethesameasyours.Ifyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.Seesection4.Inthisleaflet:1.WhatFinasteride5mgTabletsareandwhattheyareusedfor 2.WhatyouneedtoknowbeforeyoutakeFinasteride5mgTablets 3.HowtotakeFinasteride5mgTablets 4.Possiblesideeffects 5.HowtostoreFinasteride5mgTablets 6.Contentsofthepackandotherinformation1.WhatFinasteride5mgTabletsareandwhattheyareusedforFinasteride5mgTabletscontainamedicinecalledfinasteride.Thisbelongstoagroupofmedicinescalled‘5-alpha-reductaseinhibitors’.Finasteride5mgTabletsshrinktheprostateglandinmenwhenitisswollen.Theprostateglandisfoundunderneaththebladder(butonlyinmen).Itproducesthefluidfoundinsemen.Aswollenprostateglandcanleadtoaconditioncalled‘benignprostatichyperplasia’orBPH.WhatisBPH?IfyouhaveBPHitmeansthatyourprostateglandisswollen.Itcanpressonthetubethaturinepassesthrough,onitswayoutofyourbody.Thiscanleadtoproblemssuchas:feelinglikeyouneedtopassurinemoreoften,especiallyatnightfeelingthatyoumustpassurinerightawayfindingitdifficulttostartpassingurinewhenyoupassurinetheflowofurineisweakwhenyoupassurinetheflowstopsandstartsfeelingthatyoucannotemptyyourbladdercompletely.Insomemen,BPHcanleadtomoreseriousproblems,suchas:urinarytractinfectionsasuddeninabilitytopassurinetheneedforsurgery.WhatelseshouldyouknowaboutBPH?BPHisnotcanceranddoesnotleadtocancer,butthetwoconditionscanbepresentatthesametime.BeforeyoustartFinasteride5mgTablets,yourdoctorwilldosomesimpleteststocheckwhetheryouhaveprostatecancer.Talktoyourdoctorifyouhaveanyquestionsaboutthis.2.WhatyouneedtoknowbeforeyoutakeFinasteride5mgTabletsDonottakeFinasteride5mgTablets:ifyouareawoman(becausethismedicineisformen)ifyouareallergic(hypersensitive)tofinasterideoranyoftheotheringredientsofthismedicine(listedinSection6).DonottakeFinasteride5mgTabletsifanyoftheaboveapplytoyou.Ifyouarenotsure,talktoyourdoctororpharmacist.WarningsandprecautionsTalktoyourdoctororpharmacistbeforetakingFinasteride5mgTabletsif:yourpartnerispregnantorplanningtobecomepregnant.YoushoulduseacondomorotherbarriermethodofcontraceptionwhentakingFinasteride5mgTablets.Thisisbecauseyoursemencouldcontainatinyamountofthedrugandmayaffectthenormaldevelopmentofthebaby’ssexorgansyouaregoingtohaveabloodtestcalledPSA.ThisisbecauseFinasteride5mgTabletscanaffecttheresultsofthistest.Ifyouarenotsure,talktoyourdoctororpharmacistbeforetakingFinasteride5mgTablets.MoodalterationanddepressionMoodalterationssuchasdepressedmood,depressionand,lessfrequently,suicidalthoughtshavebeenreportedinpatientstreatedwithFinasteride5mgTablets.Ifyouexperienceanyofthesesymptomscontactyourdoctorforfurthermedicaladviceassoonaspossible.ChildrenFinasteride5mgTabletsshouldnotbeusedinchildren.TakingothermedicinesTellyourdoctororpharmacistifyouaretaking,haverecentlytakenormighttakeanyothermedicines.Finasteride5mgTabletsdonotusuallyaffectothermedicines.TakingFinasteride5mgTabletswithfoodanddrinkFinasteride5mgTabletscanbetakenwithorwithoutfood.PregnancyandbreastfeedingFinasterideTabletsshouldnotbetakenbywomen.DonottouchcrushedorbrokenFinasterideTabletsifyouareawomanwhoispregnantorplanningtobecomepregnant(wholetabletsarecoatedtostopcontactwiththemedicineduringnormaluse).Thisisbecausethismedicinemayaffectthenormaldevelopmentofthebaby’ssexorgans.IfawomanwhoispregnantcomesintocontactwithcrushedorbrokenFinasterideTablets,speaktoyourdoctor.DrivingandusingmachinesFinasteride5mgTabletsarenotlikelytoaffectyoubeingabletodrive,usetoolsormachines.Finasteride5mgTabletscontainLactose.Thisisatypeofsugar.Ifyouhaveeverbeentoldbyyourdoctorthatyoucannottolerateordigestsomesugars(haveanintolerancetosomesugars),talktoyourdoctororpharmacistbeforetakingthismedicine. Thosepatientsonasodiumcontrolleddietshouldbeawarethateachtabletcontains6.6mgofsodium.3.HowtotakeFinasteride5mgTabletsAlwaystakethismedicineexactlyasyourdoctororpharmacisthastoldyou.Checkwithyourdoctororpharmacistifyouarenotsure.TakingthismedicineTheusualdoseisonetableteachday.Takethismedicinebymouth.YourdoctormayprescribeFinasteride5mgTabletsalongwithanothermedicine(calleddoxazosin)tohelpcontrolyourBPH.IfyoutakemoreFinasteride5mgTabletsthanyoushouldIfyoutaketoomanytabletsbymistake,contactyourdoctorimmediately.IfyouforgettotakeFinasteride5mgTabletsIfyouforgettotakeatablet,skipthemisseddose.Takethenextdoseasusual.Donottakeadoubledosetomakeupforaforgottendose.IfyoustoptakingFinasteride5mgTabletsYourconditionmayshowanearlyimprovementaftertakingFinasteride5mgTablets.However,itmaytakeatleastsixmonthsforthefulleffecttodevelop.ItisimportanttokeeptakingFinasteride5mgTabletsforaslongasyourdoctortellsyou,evenifyoudonotfeelanybenefitstraightaway.Ifyouhaveanyfurtherquestionsontheuseofthismedicine,askyourdoctororpharmacist.4.PossiblesideeffectsLikeallmedicines,thismedicinecancausesideeffects,althoughnoteverybodygetsthem.Thefollowingsideeffectsmayhappenwiththismedicine.Allergicreactions:StopusingFinasteride5mgTabletsandimmediatelycontactadoctorifyouexperienceanyofthefollowingsymptoms:swellingofface,lips,tongueorthroat,difficultyswallowingandbreathingdifficulties(angioedema)skinrashes,itching,orlumpsunderyourskin(hives).Othersideeffectsmayinclude:youmaybeunabletohaveanerection(impotence)youmayhavelessdesiretohavesexyoumayhaveproblemswithejaculation,forexampleadecreaseintheamountofsemenreleasedduringsex.Thisdecreaseintheamountofsemendoesnotappeartoaffectnormalsexualfunction.ThesesideeffectsabovemaydisappearafterawhileifyoucontinuetakingFinasteride5mgTablets.Ifnot,theyusuallyresolveafterstoppingFinasteride5mgTablets.Othersideeffectsreportedinsomemenare:breastswellingortendernesspalpitations(feelingyourheartbeat)changesinthewayyourliverisworking,whichcanbeshownbyabloodtestpaininyourtesticlesaninabilitytohaveanerectionwhichmaycontinueafterstoppingthemedicationmaleinfertilityand/orpoorqualityofsemen.Improvementinthequalityofthesemenhasbeenreportedafterstoppingmedicationdepressionanxietydecreaseinsexdrivethatmaycontinueafterstoppingthemedicationproblemswithejaculationthatmaycontinueafterstoppingthemedication.Youshouldpromptlyreporttoyourdoctoranychangesinyourbreasttissuesuchaslumps,pain,enlargementornippledischargeasthesemaybesignsofaseriouscondition,suchasbreastcancer.Ifanyofthesideeffectsgetserious,orifyounoticeanysideeffectsnotlistedinthisleafletpleasetellyourdoctororpharmacist.Itwillhelpifyoumakeanoteofwhathappened,whenitstartedandhowlongitlasted.WhatelseshouldyouknowaboutFinasteride5mgTablets?Finasteride5mgTabletsarenotlicensedtotreatprostatecancer.Informationcollectedforaclinicaltrialinmentakingfinasteridefor7yearsshowed:Thenumberofmenwhodevelopedprostatecancerwaslowerinmentakingfinasteridecomparedwiththosetakingnothing.Thenumberofmenwhohadahighscoreinatumourgradingsystemwashigherinsomeofthosetakingfinasteridecomparedtothosetakingnothing.Theeffectoflong-termuseoffinasterideontumoursofthiskindisnotknown.Ifyouwouldlikefurtherinformationaboutthetumourgradingsystemorthistrial,pleasetalktoyourdoctor.ReportingofsideeffectsIfyougetanysideeffects,talktoyourdoctor,pharmacistornurse.Thisincludesanypossiblesideeffectsnotlistedinthisleaflet.YoucanalsoreportsideeffectsdirectlyviatheYellowCardSchemewebsite:www.mhra.gov.uk/yellowcard.orsearchforMHRAYellowCardintheGooglePlayorAppleAppStore.Byreportingsideeffectsyoucanhelpprovidemoreinformationonthesafetyofthismedicine.5.HowtostoreFinasteride5mgTabletsKeepthismedicineoutofthesightandreachofchildren.Donotstoreyourtabletsabove30°C.Keepthemintheoriginalpackage.DonotuseFinasteride5mgTabletsaftertheexpirydatewhichisstatedonthecartonafterthelettersEXP.Theexpirydatereferstothelastdayofthatmonth.Donotthrowawayanymedicinesviawastewaterorhouseholdwaste.Askyourpharmacisthowtothrowawaymedicinesyounolongeruse.Thesemeasureswillhelptoprotecttheenvironment.6.ContentsofthepackandotherinformationWhatFinasteride5mgTabletscontainTheactivesubstanceinyourmedicineisfinasteride.Eachtabletcontains5mgfinasteride.Theotheringredientsare:lactosemonohydrate,cellulosemicrocrystalline(E460),starchpregelatinised,sodiumstarchglycolate(TypeA),magnesiumstearate(E470b),docusatesodium.Thecoatingofthesetabletscontainshypromellose(E464),titaniumdioxide(E171),macrogolandindigocarmine(E132).Thesodiumcontentofeachtabletis6.6mg.WhatFinasteride5mgTabletslooklikeandthecontentofthepackFinasteride5mgTabletsareblue,oval,film-coatedtabletswiththefollowingmarkings:‘FIN’ononesideand‘5’ontheotherside.Thetabletsarepresentedinblisterstripscontaining28,30,50or100tablets.Notallpacksizesmaybemarketed.MarketingAuthorisationHolderandManufacturerDr.Reddy’sLaboratories(UK)Ltd6RiverviewRoadBeverleyHU170LDUKThismedicineisauthorisedinMemberStatesoftheEEAunderthefollowingnames:UK:Finasteride5mgTablets(PL08553/0261)Thisleafletwaslastrevisedin08/2018ThisleafletgivesyousomeimportantpatientinformationaboutFinasteride5mgTablets.Ifyouhavequestionsafteryoureaditaskyourdoctororpharmacist,whowillgiveyoufurtherinformation. ReportSideEffect RelatedMedicines Sameactiveingredients Samecompany Bookmark Email Lastupdatedonemc:16Oct2018 Viewchanges PrintPDF Printtextonly 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. SignUp LogIn Cancel × Emailthismedicine Toemailamedicineyoumustsignupandlogin. SignUp LogIn Cancel × Viewmedicinechanges Toviewthechangestoamedicineyoumustsignupandlogin. SignUp LogIn Cancel × Findsimilarproducts Tofindsimilarproductsyoumustsignupandlogin. SignUp LogIn Cancel