FENTAZIN 2MG COATED TABLETS

Main information

  • Trade name:
  • FENTAZIN 2MG COATED TABLETS
  • Dosage:
  • 2 Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FENTAZIN 2MG COATED TABLETS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0899/029/001
  • Authorization date:
  • 26-08-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0899/029/001

CaseNo:2043122

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GoldshieldPharmaceuticalsLtd

NLATower,12-16AddiscombeRoad,Croydon,Croydon,SurreyCRO0XT,England

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Fentazin2mgCoatedTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom27/11/2007until17/09/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 29/11/2007 CRN 2043122 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Fentazin2mgCoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains2mgPerphenazine.

Excipients: Lactosemonohydrate130.95mg

Sucrose128.72mg

Butylparahydroxybenzoate6micrograms

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

CoatedTablet

Biconvex,white,sugar-coatedtabletswiththecode‘1C’ononeface.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanadjuncttotheshorttermmanagementofanxiety,severepsychomotoragitation,excitement,violentor

dangerouslyimpulsivebehaviour,schizophrenia,treatmentofsymptomsandpreventionofrelapse,otherpsychoses

especiallyparanoid,maniaandhypomania,nauseaandvomiting.

Becauseofthehazardofsevereextra-pyramidalreactions,Fentazinisnotindicatedforthetreatmentofagitationand

restlessnessintheelderly.

4.2Posologyandmethodofadministration

ForOralAdministrationonly.

Adults:

Theusualtotaldailydoseis12mggivenindivideddoses.Astheremaybevariabilityofindividualresponseand

dosagerequirement,thedosemaybeadjustedupwardsordownwardsaccordingtopatientresponse.Themaximum

dosein24hoursshouldnotexceed24mg.

Treatmentshouldbestartedanddosageincreasedunderclosesupervision.

Dosageshouldbereviewedatregularintervalstoavoidindiscriminateorundulyprolongeduse.

Elderly:

Onequarteroronehalfoftherecommendedadultdoseforadultsmaybesufficientforatherapeuticresponseinthe

elderly.

Children:

Fentazinshouldnotbegiventochildrenundertheageof14years.

Methodofadministration:

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4.3Contraindications

Useinpatientswithahistoryofjaundiceorwithexistentliverdysfunction.

Useinpatientswithuncontrolledcardiacdecompensation.

Useinpatientshypersensitivetotheactiveingredient.

Fentazinshouldnotbeadministeredtopatientswithleucopenia,orinassociationwithdrugsliabletocausebone

marrowdepression.Itshouldnotbegiventopatientsinacomatosestate.

4.4Specialwarningsandprecautionsforuse

Acutewithdrawalsymptomsincludingnausea,vomitingandinsomniahavebeenreportedafterabruptcessationof

highdosesofphenothiazines,andgradualwithdrawalisadvised.

Patientsreceivingphenothiazinesoveraprolongedperiodrequireregularandcarefulsurveillancewithparticular

attentionfortheirpotentialforinducingeyechanges,effectsonhaemopoiesis,liverdysfunction,myocardial

conductioneffects,particularlyifotherconcurrentlyadministereddrugsalsohavepotentialeffectsonthesesystems.

Prolongedadministrationofphenothiazinesmayresultinpersistentortardivedyskinesias,particularlyintheelderly.

Phenothiazineshouldonlybeusedwithgreatcautioninpatientswithcoronaryinsufficiencyorcardiacdisease.

CautionisindicatedinpatientswithcardiovasculardiseaseorfamilyhistoryofQTprolongation.BaselineECGis

recommendedinthesepatientsbeforeinitiationoftherapywithFentazin.Duringthetherapy,theneedforECG

monitoringshouldbeassessedonindividualpatientbasis.Whilstontherapy,reducedoseifQTisprolongedand

discontinueifQTc>500ms.Periodicelectrolytemonitoringofpatientisrecommendedanduseofconcomitant

antipsychoticsshouldbeavoided.

Usewithcautioninpatientswithepilepsyorpredisposedtoepilepsy.

Perphenazinerarelycausesincreasedsusceptibilitytosunburnandpatientsshouldbewarnedtoavoidexcessexposure.

Skinrasheshavebeenreportedrarely.Finedepositsinthecorneaandlensandpigmentedretinopathyhavebeen

reportedafterlong-termtherapy.

Perphenazinemayimpairbodytemperatureregulationandcasesofseverehypothermiaorhyperpyrexiahavebeen

reportedusuallyinassociationwithmoderateorhighdosageofphenothiazines.Theelderlyorhypothyroidpatientmay

besusceptibletohypothermia.Thehazardofhyperthermiamaybeincreasedbyespeciallyhotorhumidweatherorby

drugs,suchasanti-Parkinsonianagents,whichimpairsweating.

Perphenazinecanveryrarelycauseobstructivejaundiceassociatedwithstasisinbiliarycanaliculi.Ithasbeenthought

tobeahypersensitivityreaction.

Transientabnormalitiesofliverfunctiontestsmayoccurintheabsenceofjaundice.

Adynamicileusrarelyoccurswithphenothiazinetherapy,butisofparticularconcerninpsychiatricpatientswhomay

failtoseektreatmentofthecondition.

Hormonaleffectsofantipsychoticneurolepticdrugsincludehyperprolactinaemia,whichmaycausegalactorrhoea,

gynaecomastiaandoligooramenorrhoea.Sexualfunctionincluding,erectionandejaculationissometimesimpairedby

perphenazine.Weightgainmayoccur.Oedemahasbeenreportedwithphenothiazinemedication.Perphenazinemay

alsoresultinfalse-pregnancytests.

Approximately3-foldincreasesofcerebrovascularadverseeventshavebeenseeninrandomisedplacebo-controlled

clinicaltrialsindementiapopulationwithsomeatypicalantipsychotics.Themechanismforthisincreasedriskisnot

known.Anincreasedriskcannotbeexcludedforotherantipsychoticsorotherpatientpopulations.Fentazinshouldbe

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Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

FentazincanincreasethecentralnervoussystemdepressionproducedbyotherCNSdepressantsincludingalcohol,

hypnotics,sedativesorstronganalgesics.

Itmayantagonisetheactionofadrenalineandothersympathomimeticagentsandreversesthebloodpressurelowering

effectsofadrenergicblockingagentssuchasguanethidineandclonidine.Itmayimpairthemetabolismoftricyclic

antidepressants,theantiparkinsoneffectsoflevodopa,andanti-convulsants.

Undesirableanticholinergiceffectscanbeenhancedbyantiparkinsonorotheranti-cholinergicdrugs.

Phenothiazinesmayenhancethecardiacdepressanteffectsofquinidine,theeffectofdiazoxide,theeffectof

neuromuscularblockingagents,andtheabsorptionofcorticosteroidsanddigoxin.

Fentazinmayaffectdiabeticcontrolandanticoagulanttherapy.Interactionwithlithiummustbeconsideredwhenusing

Fentazin.

Fentazinshouldnotbetakenwithteaorcoffeebecauseabsorptionmaybeimpairedbytheformationofinsoluble

precipitates.Absorptionmaybeimpairedbyantacids.

FentazinshouldbeadministeredwithcautionwhenconcomitantlygivenwithdrugswhichprolongQTintervalor

causeelectrolyteimbalance.

PropercareshouldbetakeninconsumingthedrugswhichmayinhibitthemetabolismofFentazin.

4.6Pregnancyandlactation

ThesafetyofFentazinduringpregnancyhasnotbeenestablished.Phenothiazinesshouldonlybeusedduring

pregnancyifitisconsideredessentialbythephysician.

Perphenazineisexcretedinthebreastmilkandamotheronperphenazineshouldnotbreastfeed.

4.7Effectsonabilitytodriveandusemachines

Fentazinmayinducedrowsiness.Personstakingthesedrugsshouldnotdriveoroperatemachineryunlessthedrughas

beenshownnottointerferewithphysicalormentalability.

4.8Undesirableeffects

Drowsiness,sedation,drymouth,posturalhypotension,blurredvision,constipation,urinaryretention,nausea,

headache,eyechanges,hormonaleffects,agranulocytosis,raisedcholesterolandglucoselevels,skinrashes,

photosensitivity,lensdeposits,hypothermia,obstructivejaundice,oculogyriccrisis,nasalstuffinessandECGchanges

likeQTprolongation,ventriculararrhythmias-VF,VT,suddenunexplaineddeath,cardiacarrest&Torsadesde

pointes.

Useofphenothiazinesathigh(relativeorabsolute)dosesmayinduceextrapyramidalside-effects,dyskinesia,

akathisia,dystonia.Thesearelikelytobeparticularlysevereinchildren.

4.9Overdose

WithoralpreparationsofFentazin,gastriclavageisrecommended.

EmeticsarelikelytobeoflittlevaluebecauseFentazinhaspotentantiemeticactivityofthedrug.

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requirefluidinfusiontherapy.

Ifavasopressorisrequired,norepinephrinemaybeused.

Centralnervoussystemdepressionisbesttreatedconservatively.

Analepticsshouldnotbeused.

Rewarmingmeasuresshouldnotbeemployedunlessthebodytemperaturefallsbelow30 °

Convulsionsmaybecontrolledwithbystandardmethods,buttheuseofbarbituratesshouldbeavoided.

Cardiacmonitoringforatleast48hoursisrecommended.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Perphenazineisaphenothiazinewithpotenttranquilliserandanti-emeticproperties.Itisaneurolepticphenothiazine

andithasantagonisticactivity,inapproximatelythefollowingorderofpotency,againsta-receptoragonists,dopamine,

serotonin,histamine(H

-receptoragonists),muscarinicagonistsandbradykinininperipheraltissuesandpresumably,

inthecentralnervoussystem.

Neurotransmissiondependingonanyoneoftheabovereceptorsisimpaired.Inaddition,thereisimpairmentof

transmitterreleasefromadrenergicnerves;however,theneuronaluptakeofmonoaminesisalsoinhibitedandthis

tendstofacilitatetransmission.Itisnotcleartowhatextenditscentraleffectsareattributabletoanyone,ora

combinationoftheseactions.

Ithasbeensuggestedthatthetranquillisingactionisduetoblockadeofcentraladrenergictransmission,butthereis

evidencetosuggestthatblockadeofserotoninergicanddopaminergictransmissionmayunderlieitsantischizophrenic

activity,andblockadeofdopaminereceptorsappearstobeinvolvedinitsantiemeticeffectandtheproductionof

extrapyramidalside-effects.

5.2Pharmacokineticproperties

Perphenazineundergoesextensivefirst-passmetabolismbytheliver,afteroraladministration.Thehalflifeof

Perphenazineisestimatedat8-12hoursbuttheremaybeaprolongedeliminationphaseofuptothreeweeks.

TheeliminationofPerphenazineismainlybymetabolismintheliver.Itisabletocrossthebloodbrainandplacental

barriers.TheexcretionofPerphenazineisdetectableinthebreastmilkofnursingmothers.

5.3Preclinicalsafetydata

Acuteshort-termtoxicityisavailableforPerphenazineinboththeratandthemouse,atdosesexceedingthose

prescribed.Oralacutetoxicitystudiesintherathaveshownanotoxiceffectlevelof318mg/kg.Inmice,studieshave

shownthatthelevelatwhichnotoxiceffectwasobservedat120mg/kgafterasingleoraldose.ThusPerphenazine

appearstoexhibitlowacutesystemictoxicity.

Reproductivestudieshavebeenoutcarriedinbothratsandmiceandshowthatspecificabnormalitiesarefoundand

effectsonthereductioninfertilityhavebeenobserved.Craniofacialabnormalitieshavebeenobservedinmiceatdoses

of30mg/kgandintheratat90mg/kg.Thespecificmechanismofthishasnotbeenfullyelucidated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

Lactosemonohydrate

Magnesiumstearate

Maizestarch

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Tabletcoating:

DewaxedShellac

Acacia

Sucrose

Butylparahydroxybenzoate

Gelatin

Calciumphosphate

Maizestarch

Titaniumdioxide(E171)

Talc

Opaglos6000:

BleachedShellac

Beeswax,white

Carnaubawax

Printingink:

OpacodeBlackcontaining:

DewaxedShellac

Ironoxideblack(E172)

Lecithin(Soya)

Dimeticone(AntifoamDC1510(foodgrade))

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalpackage.

Keepcontainerintheoutercarton.

6.5Natureandcontentsofcontainer

Thetabletsaresuppliedinaluminiumfoilstripscontaining10tablets,tenfoilstrips(100tablets)arepresentedina

outercarton.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

GoldshieldPharmaceuticalsLimited

NLATower

12-16AddiscombeRoad

Surrey

CroydonCR00XT

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA899/29/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14July1993

Dateoflastrenewal:18September2005

10DATEOFREVISIONOFTHETEXT

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