FAMVIR

Main information

  • Trade name:
  • FAMVIR Coated Tablets 750 Milligram
  • Dosage:
  • 750 Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FAMVIR Coated Tablets 750 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0013/106/004
  • Authorization date:
  • 21-10-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0013/106/004

CaseNo:2042380

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

NovartisPharmaceuticalsUKLtd

FrimleyBusinessPark,Frimley,Camberley,Surrey,GU167SR,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Famvir750mgFilm-CoatedTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom30/06/2009.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 09/07/2009 CRN 2042380 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Famvir750mgFilm-CoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Theactiveingredientisfamciclovir.

Eachtabletcontainsfamciclovir750mg.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablet

White,ovalfilm-coatedtablet,biconvex,bevellededges,debossedwith“FAMVIR750”ononesideandplainonthe

reverseside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

‘Famvir’isindicatedforthetreatmentofherpeszoster(shingles)infection.

4.2Posologyandmethodofadministration

Dosage:

Adults:

Oraladministration,one750mgtabletonceadayforsevendays.Thetabletsshouldbetakenatapproximatelythe

sametimeeachday.Treatmentshouldbeinitiatedasearlyaspossibleinthecourseofthedisease,promptlyafter

diagnosis.

Elderly:

Dosagemodificationisnotrequiredunlessrenalfunctionisimpaired.

Renallyimpaired:

Asreducedclearanceofpenciclovirisrelatedtoreducedfunction,asmeasuredbycreatinineclearance,special

attentionshouldbegiventodosagesinpatientswithimpairedrenalfunction.(Seesection4.9)Thefollowing

modificationsindosagearerecommended.

Forthetreatmentofherpeszosterinfections:

Whenonlyserumcreatinineisavailable,anomogramofthefollowingformula(CockcroftandGault)shouldbeused

toestimatecreatinineclearance). Creatinineclearance

(ml/min/1.73m2) Dosage

750mgO.D.or250mgT.I.D.

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Formulatoestimatecreatinineclearance(ml/min/1.73m 2

Renallyimpairedpatientsonhaemodialysis:

Forapatientonhaemodialysis,adosageintervalof48hoursisrecommendedforperiodsbetweendialysis.Sincefour

hourshaemodialysisresultsinapproximately75%reductioninplasmaconcentrationsofpenciclovir,thefulldoseof

famciclovirshouldbeadministeredimmediatelyfollowingdialysis.

Hepaticallyimpaired:

Dosagemodificationisnotrequired.

Children:

Therearecurrentlyinsufficientdataonthesafetyandefficacyof‘Famvir’inchildren.

Administration:

Oral.

4.3Contraindications

‘Famvir’iscontra-indicatedinpatientswithknownhypersensitivitytofamciclovirorotherconstituentsof‘Famvir’.It

isalsocontra-indicatedinthosepatientswhohaveshownhypersensitivitytopenciclovir.

4.4Specialwarningsandprecautionsforuse

Specialattentionshouldbepaidtopatientswithimparedrenalfunctionasdosageadjustmentmaybenecessary(see

sections4.2and4.9).Nospecialprecautionsarerequiredforhepaticallyimparedorelderlypatientswithnormalrenal

function.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noclinicallysignificantinteractionshavebeenidentified.Probenecidandotherdrugsthataffectrenalphysiology

couldaffectplasmalevelsofpenciclovir.

4.6Pregnancyandlactation

Pregnancy:

Althoughanimalstudieshavenotshownanyembryotoxicorteratogeniceffectswithfamciclovirorpenciclovir,the

safetyofFamvirinhumanpregnancyhasnotbeenestablished.Famvirshould,therefore,notbeusedduringpregnancy

orinnursingmothersunlessthepotentialbenefitsoftreatmentoutweighanypossiblerisk.

Lactation:

Studiesinratsshowthatpenciclovirisexcretedinthebreastmilkoflactatingfemalesgivenoralfamciclovir.Thereis

noinformationonexcretioninhumanmilk.

4.7Effectsonabilitytodriveandusemachines

Thereisnoevidencethatfamciclovir(Famvir)willaffecttheabilityofapatienttodriveortousemachines.However,

patientswhoexperiencedizziness,somnolence,confusionorothercentralnervoussystemdisturbanceswhiletaking

[140–ageinyears]xweight(kg)xeither88.5(formales)or75.2(forfemales)

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4.8Undesirableeffects

Famciclovirhasbeenwelltoleratedinhumanstudies.Headacheandnauseahavebeenreportedinclinicaltrials.These

weregenerallymildormoderateinnatureandoccurredatasimilarincidenceinpatientsreceivingplacebotreatment.

Thefollowingtablespecifiestheestimatedfrequencyofadversereactionbasedonallthespontaneousreportsand

literaturecasesthathavebeenreportedforFamvirsinceitsintroductiontothemarket.

Adversereactions(Table1)arerankedunderheadingsoffrequency,usingthefollowingconvention:verycommon

(>1/10)common(1/100,1/10),uncommon(1/1,000,1/100);rare(1/10,000,1/1,000);veryrare(<1/10,000),

includingisolatedreports.

Table1

Famciclovirhasalsobeenwelltoleratedinimmunocompromisedpatients.Undesirableeffectsreportedfromclinical

studiesweresimilartothosereportedintheimmunocompetentpopulation.

4.9Overdose

Overdosageexperiencewithfamciclovirislimited.Areportofaccidentalacuteoverdosage(10.5g)was

asymptomatic.Inareportofchronicuse(10g/dayfortwoyears),famciclovirwaswelltolerated.Intheeventofan

overdose,symptomaticandsupportivetherapyshouldbegivenasappropriate.Acuterenalfailurehasbeenreported

rarelyinpatientswithunderlyingrenaldiseasewherethefamciclovir(Famvir)dosagehasnotbeenappropriately

reducedforthelevelofrenalfunction.Penciclovirisdialysableandplasmaconcentrationsarereducedbyapproximately

75%followingfourhours’haemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Oralantiviralagent(ATCcode:JO5AB09).

Famcicloviristheoralformofpenciclovir,convertedinthebodytothisactiveantiviralmoiety.Famciclovirisrapidly

convertedinvivointopenciclovir,whichhasdemonstrableinvivoactivityagainstHerpessimplexviruses(type1and

2)andtheVaricellazostervirus.Theantiviraleffectoforallyadministeredfamciclovirhasbeendemonstratedin

Bloodandlymphaticsystemdisorders

Veryrare: Thrombocytopenia.

Psychiatricdisorders

Rare:

Veryrare: Confusion(predominantlyintheelderly).

Hallucinations.

Nervoussystemdisorders

Rare:

Veryrare: Headache.

Dizziness,somnolence(predominantlyintheelderly).

Gastrointestinaldisorders

Rare:

Veryrare: Nausea.

Vomiting.

Hepatobiliarydisorders

Veryrare: Jaundice.

Skinandsubcutaneoustissuedisorders

Veryrare: Rash,pruritus,urticaria,seriousskinreactions

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Penciclovirtargetsvirus-infectedcellswhereitisrapidlyandefficientlyconvertedintothetriphosphate(mediatedvia

virus-inducedthymidinekinase).Penciclovirtriphosphatepersistsininfectedcellsformorethan12hourswhereit

inhibitsreplicationoftheviralDNA.Inuninfectedcellstreatedwithpenciclovir,concentrationsofpenciclovir-

triphosphateareonlybarelydetectable.Accordingly,uninfectedcellsareunlikelytobeaffectedbytherapeutic

concentrationsofpenciclovir.

5.2Pharmacokineticproperties

Generalcharacteristics

Followingoraladministration,famciclovirisrapidlyandextensivelyabsorbedandrapidlyconvertedtotheactive

compound,penciclovir.BioavailabilityofpenciclovirafteroralFamviris77%.Meanpeakplasmaconcentrationof

penciclovir,followinga750mgoraldoseoffamciclovir,was4.9micrograms/mlandoccurredatamediantimeof50

minutespost-dose.Plasmaconcentration-timecurvesofpencicloviraresimilarfollowingsingleandrepeat(t.i.d.)

dosing.

Theterminalplasmahalf-lifeofpenciclovirafterbothsingleandrepeatdosingwithfamciclovirisapproximately2.0

hours.Thereisnoaccumulationofpenciclovironrepeateddosingwithfamciclovir.Penciclovirandits6-deoxy

precursorarepoorly(>20%)boundtoplasmaproteins.

Famcicloviriseliminatedprincipallyaspenciclovirandits6-deoxyprecursorwhichisexcretedinurineunchanged.

‘Famvir’hasnotbeendetectedinurine.Tubularsecretioncontributestotherenaleliminationofthecompound.

Characteristicsinpatients

Uncomplicatedherpeszosterinfectiondoesnotsignificantlyalterthepharmacokineticsofpenciclovirmeasuredafter

oraladministrationof‘Famvir’.

5.3Preclinicalsafetydata

Carcinogenicity

In2yearstudiestherewerenochangesseenat200mg/kg/d.Atthemaximallytolerateddoseof600mg/kg/dinfemale

ratstherewasanincreasedincidenceofmammaryadenocardinoma,acommontumourinthisstrainofratsusedinthe

studies.Therewasnoeffectontheincidenceofneoplasiainmaleratsorinmiceofeithersex.

Genotoxicity

Additionallyfamciclovirwasnotfoundtobegenotoxicinacomprehensivebatteryofinvivoandinvitrotests

designedtodetectgenemutation,chromosomaldamageandrepairabledamagetoDNA.Penciclovir,incommonwith

otherdrugsofthisclass,hasbeenshowntocausechromosomaldamage,butdidnotinducegenemutationinbacterial

ormammaliancellsystems,norwasthereevidenceofincreasedDNArepairinvitro.

Reproductivetoxicity

Famcicloviriswelltoleratedinlaboratoryanimals.Incommonwithotherdrugsofthisclass,degenerativechangesof

thetesticularepitheliumwerenoted.

Famciclovirhasbeenshowntohavenosignificanteffectsonspermcount,morphology,ormotilityinman.Impaired

fertilitywasobservedinmaleratsgive500mg/kg.Therewerenotsignificanteffectsonfertilityinfemaleratsgiven

famciclovir.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

HydroxypropylCellulose

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SodiumStarchGlycollate

Tabletcoating:

Hypromellose

Macrogol4000

Macrogol6000

TitaniumDioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30°C.

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

White,opaque,PVC/PVdC/Aluminiumfoilblisterpackscontaining1or7tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisPharmaceuticalsUKLimited

FrimleyBusinessPark

Frimley,Camberley

Surrey,GU167SR

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA13/106/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21October1996

Dateoflastrenewal:30June2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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