Forzepril

Main information

  • Trade name:
  • Forzepril Tablets 5 mg
  • Pharmaceutical form:
  • Film coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Forzepril Tablets 5 mg
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • benazepril
  • Therapeutic area:
  • Dogs Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • IE/V/0294/002
  • Authorization date:
  • 27-06-2012
  • EU code:
  • IE/V/0294/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

SummaryofProductCharacteristics

1NAMEOFTHEVETERINARYMEDICINALPRODUCT

Forzepril5mgfilm-coatedtabletfordogs.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activesubstance:

Eachtabletcontains:

Benazepril4.6mg

(equivalenttoBenazeprilHydrochloride5mg)

Excipient:

TitaniumDioxide(E171)

IronOxideYellow(E172)

QuinolineYellowAluminumLake(E104)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablets.

Aroundyellowbiconvextabletwithbreaklineononeside.Thetabletscanbedividedintoequalhalves.

4CLINICALPARTICULARS

4.1TargetSpecies

Dogs.

4.2Indicationsforuse,specifyingthetargetspecies

Indogsweighingmorethan10kg:

Treatmentofcongestiveheartfailureassociatedwith,inparticular,dilatedcardiomyopathyand/ormitral

insufficiency.

4.3Contraindications

Donotuseinanydogthathasevidenceofcardiacoutputfailuredue,forexample,toaorticstenosis.

Donotuseinanimalsknowntobehypersensitivetotheactivesubstanceortoanyoftheexcipient(s).

Seesection4.7.

4.4Specialwarningsforeachtargetspecies

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4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Noevidenceofrenaltoxicitytotheproducthasbeenobservedindogsduringclinicaltrials.However,asisroutinein

casesofrenalinsufficiency,itisrecommendedtomonitorplasmacreatinineandureaduringtherapy.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinalproducttoanimals

Washhandsafteruse.

Incaseofaccidentaloralingestion,seekmedicaladviceandshowthelabelorthepackageleaflettothephysician.

PregnantwomenshouldtakespecialcaretoavoidaccidentaloralexposurebecauseACEinhibitorshavebeenfoundto

affecttheunbornchildduringpregnancyinhumans.

4.6Adversereactions(frequencyandseriousness)

Onrareoccasionstransientsignsofhypotension,suchaslethargyandataxiamayoccur.

4.7Useduringpregnancy,lactationorlay

Donotuseinpregnantornursingbitchesorinbitchesintendedforbreeding.

Studiesinlaboratoryanimalshaveshownembryotoxiceffectsofbenazeprilatnon-maternotoxicdoses(urinarytract

abnormalitiesinthefoetus).Thesafetyoftheproducthasnotbeenassessedduringpregnancyandlactationindogs.

Laboratorystudiesinratsandobservationsinhumanshaveproducedevidenceofteratogeniceffects.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Indogswithheartfailure,Benazeprilhasbeengivenincombinationwithdigoxin,diureticsandanti-arrythmicdrugs

withoutdemonstrableadverseinteractions.

Inman,thecombinationofACEinhibitorsandNSAIDscanleadtoreducedanti-hypertensiveefficacyorimpaired

renalfunction.ThecombinationofBenazeprilandotheranti-hypertensiveagents(e.g.calciumchannelblockers,P-

blockersordiuretics),anaestheticsorsedativesmayleadtoadditivehypotensiveeffects.Thereforeconcurrentuseof

NSAIDsorothermedicationswithahypotensiveeffectshouldbeconsideredwithcare.

Renalfunctionandsignsofhypotension(lethargy,weaknessetc)shouldbemonitoredcloselyandtreatedasnecessary.

Interactionswithpotassiumpreservingdiureticslikespironolactone,triamtereneoramiloridecannotberuledout.Itis

recommendedtomonitorplasmapotassiumlevelswhenusingbenazeprilincombinationwithapotassiumsparing

diureticaslife-threateningreactionsarepossible.AswithotherACEInhibitors,theuseofhypotensivemedicinal

productsoranaestheticswithahypotensiveeffectmayaddtotheanti-hypertensiveeffectofbenazepril.

4.9Amountstobeadministeredandadministrationroute

Fororaluseonlyindogs.

Therecommendedoraldoseis0.23mgofbenazeprilperkgbodyweightperday,equivalentto0.25mgofbenazepril

hydrochlorideperkgbodyweightperday,asoneadministration.Thedosemaybedoubled,stilladministeredonce

daily,ifjudgedclinicallynecessaryandadvisedbytheveterinarysurgeon.

Benazeprilshouldbegivenorallyoncedaily,withorwithoutfood.Thedurationoftreatmentisunlimited.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Innormaldogs,overdosageupto200-foldwasasymptomatic.Transientreversiblehypotensionmayoccurincasesof

accidentaloverdosage.Therapyshouldconsistofintravenousinfusionofwarmisotonicsaline.

4.11WithdrawalPeriod(s)

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5PHARMACOLOGICALorIMMUNOLOGICALPROPERTIES

Pharmacotherapeuticgroup:ACEInhibitors,Benazepril,ATCvetcode:QC09AA07.

5.1Pharmacodynamicproperties

Benazeprilhydrochlorideisaprodrughydrolysedinvivotoitsactivemetabolite,benazeprilat.Benazeprilatisa

selectiveinhibitorofangiotensinconvertingenzyme(ACE),thuspreventingtheconversionofinactiveangiotensinIto

activeangiotensinIITherefore,itblockseffectsmediatedbyangiotensinII,includingvasoconstrictionofbotharteries

andveins;retentionofsodiumandwaterbythekidneyandmodellingeffects(includingpathologicalcardiac

hypertrophy).

Theproductcauseslong-lastinginhibitionofplasmaACEactivityindogs,withmorethan95%inhibitionatpeak

effectandsignificantactivity(>80%indogs)persisting24hoursafterdosing.Itreducesthebloodpressureandvolume

loadontheheartindogswithheartfailure.

5.2Pharmacokineticproperties

Afteroraladministrationofbenazeprilhydrochloride,peaklevelsofbenazeprilareattainedrapidly(t

1.74hin

dogs)anddeclinequicklyasthedrugispartiallymetabolisedbyliverenzymestobenazeprilat.Indogs,unchanged

benazeprilandhydrophilicmetabolitesaccountfortheremainder.Indogs,peakbenazeprilatconcentrations(C

35.02ng/mlafteradoseof0.5mg/kgbenazeprilhydrochloride)areachievedwithaT

of1.74h.Thesystemic

bioavailabilityisincomplete(-13%indogs)duetoincompleteabsorption(38%indogs)andfirstpassmetabolism.

Benazeprilatconcentrationsdeclinebiphasically:theinitialfastphase(t

=1.7hindogs)representseliminationoffree

drug,whiletheterminalphase(t1/2=19hindogs)reflectsthereleaseofbenazeprilatthatwasboundtoACE,mainlyin

thetissues.Benazeprilandbenazeprilatareextensivelyboundtoplasmaproteins,andintissuesarefoundmainlyinthe

liverandkidney.

Thereisnosignificantdifferenceinthepharmacokineticsofbenazeprilatwhenbenazeprilhydrochlorideis

administeredtofedorfasteddogs.

Repeatedadministrationof'benazeprilleadstoslightbioaccumulationofbenazeprilat(R=1.47indogswith0.5mg/kg),

steadystatebeingachievedwithinafewdays(4daysindogs).

Benazeprilatisexcreted54%viathebiliaryand46%viatheurinaryrouteindogs.Theclearanceofbenazeprilatisnot

affectedindogswithimpairedrenalfunctionandthereforenoadjustmentofbenazeprildoseisrequiredincasesof

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CoreTablet:

LactoseMonohydrate

MaizeStarch

MicrocrystallineCellulose

Colloidalanhydroussilica

Crospovidone

Talc

MagnesiumStearate

FilmCoat:

OpadryIIYellow

ConsistingofPolyvinylAlcohol,

TitaniumDioxide(E171),

Macrogol3350,

Talc(E553b),

IronOxideYellow(E172)

QuinolineYellowAluminumLake(E104)

GrilledMeatFlavour.

6.2Incompatibilities

Noneknown.

6.3Shelf-life

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:2years

Anydividedtabletportionremainingafter24hoursshouldbediscarded.

6.4Specialprecautionsforstorage

Donotstoreabove25ºC.Storeinoriginalpackageinordertoprotectfromlight.

Eachtimeanunusedhalftabletisstored,itshouldbereturnedtotheopenblisterspaceandinsertedbackintothe

cardboardbox.

6.5Natureandcompositionofimmediatepackaging

Heat-sealedblisterpacksmadeupofaPVC/PE/PVDClaminatewithaluminiumliddingfoilwith14tabletsperstrip.

Packsizes:

Cartonwithblisterstripsof:14,28,42,56,70,84,98,112,128,140,154,168,182,196,210,224,238,252,266,280,

308,350,392,448,546,602,700,798,896,994and1008Tablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinalproductsorwastematerials

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinarymedicinalproductsshouldbe

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7MARKETINGAUTHORISATIONHOLDER

ChanellePharmaceuticalsManufacturingLtd.

Loughrea

Co.Galway

Ireland

8MARKETINGAUTHORISATIONNUMBER(S)

VPA10987/098/002

9DATEOFTHEFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

August2012

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There are no safety alerts related to this product.

26-9-2018

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Elanco GmbH)

FORTEKOR PLUS (Active substance: pimobendan / benazepril) - Centralised - Transfer Marketing Authorisation Holder - Commission Decision (2018)6321 of Wed, 26 Sep 2018 European Medicines Agency (EMA) procedure number: EMEA/V/C/2804/T/11

Europe -DG Health and Food Safety