Felidale

Main information

  • Trade name:
  • Felidale 2.5mg and 5mg coated tablets for cats
  • Pharmaceutical form:
  • Coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Felidale 2.5mg and 5mg coated tablets for cats
    Ireland
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • thiamazole
  • Therapeutic area:
  • Cats

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0415/001
  • Authorization date:
  • 22-02-2012
  • EU code:
  • UK/V/0415/001
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:May2012

AN:00442/2011

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Felidale2.5mgCoatedTabletsforCats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Thiamazole 2.5mg

Excipients:

TitaniumDioxide(E171) 1.12mg

Erythrosine(E127) 0.01mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Coatedtablet.

Pinksugar-coatedbiconvextablets,5.5mmdiameter.

4. CLINICALPARTICULARS

4.1 Targetspecies

Cats.

4.2 Indicationsforuse,specifyingthetargetspecies

Forthestabilisationofhyperthyroidismincatspriortosurgicalthyroidectomy.

Forthelong-termtreatmentoffelinehyperthyroidism.

4.3 Contraindications

Donotuseincatssufferingfromsystemicdiseasesuchasprimaryliverdisease

ordiabetesmellitus.

Donotuseincatsshowingsignsofautoimmunedisease.

Donotuseinanimalswithdisordersofwhitebloodcells,suchasneutropenia

andlymphopenia.

Donotuseinanimalswithplateletdisordersandcoagulopathies(particularly

thrombocytopenia).

Donotuseincatswithhypersensitivitytothiamazoleortheexcipient,

polyethyleneglycol.

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Donotuseinpregnantorlactatingfemales.

Pleaserefertosection4.7.

4.4 Specialwarnings

Asthiamazolecancausehaemoconcentration,catsshouldalwayshaveaccess

todrinkingwater.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularly

carefully.

Useoftheproductincatswithrenaldysfunctionshouldbesubjecttocarefulrisk:

benefitassessmentbytheclinician.Duetotheeffectthiamazolecanhaveon

reducingtheglomerularfiltrationrate,theeffectoftherapyonrenalfunction

shouldbemonitoredcloselyasdeteriorationofanunderlyingconditionmay

occur.

Haematologymustbemonitoredduetoriskofleucopeniaorhaemolytic

anaemia.

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyare

febrile,shouldhaveabloodsampletakenforroutinehaematologyand

biochemistry.Neutropenicanimals(neutrophilcounts<2.5x10 9

/l)shouldbe

treatedwithprophylacticbactericidalantibacterialdrugsandsupportivetherapy.

Pleaserefertosection4.9formonitoringinstructions.

Specialprecautionstobetakenbythepersonadministeringthe

veterinarymedicinalproducttoanimals

Washhandsafteruse.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshow

thepackageleafletorthelabeltothephysician.

Thiamazolemaycausevomiting,epigastricdistress,headache,fever,arthralgia,

pruritusandpancytopaenia.Treatmentissymptomatic.

Washhandswithsoapandwaterafterhandlinglitterusedbytreatedanimals.

Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Donothandlethisproductifyouareallergictoantithyroidproducts.Ifallergic

symptomsdevelop,suchasaskinrash,swellingoftheface,lipsoreyesor

difficultyinbreathing,youshouldseekmedicalattentionimmediatelyandshow

thepackageleafletorlabeltothedoctor.

Donotbreakorcrushtablets.

Asthiamazoleisasuspectedhumanteratogen,womenofchild-bearingageand

pregnantwomenshouldweargloveswhenhandlinglitteroftreatedcats.

Pregnantwomenshouldweargloveswhenhandlingtheproduct.

4.6 Adversereactions(frequencyandseriousness)

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Adversereactionshavebeenreportedfollowinglongtermcontrolof

hyperthyroidism.Inmanycases,signsmaybemildandtransitoryandnota

reasonforwithdrawaloftreatment.Themoreseriouseffectsaremainly

reversiblewhenmedicationisstopped.

Adversereactionsareuncommon.Themostcommonclinicalsideeffectsthat

arereportedincludevomiting,inappetance/anorexia,lethargy,severepruritus

andexcoriationsoftheheadandneck,bleedingdiathesisandicterusassociated

withhepatopathy,andhaematologicalabnormalities(eosinophilia,

lymphocytosis,neutropenia,lymphopenia,slightleucopenia,agranulocytosis,

thrombocytopeniaorhaemolyticanaemia).Thesesideeffectsresolvewithin7-45

daysaftercessationofthiamazoletherapy.

Possibleimmunologicalsideeffectsincludeanaemia,withraresideeffects

includingthrombocytopeniaandserumanti-nuclearantibodies,and,veryrarely,

lymphadenopathycanoccur.Treatmentshouldbestoppedimmediatelyand

alternativetherapyconsideredfollowingasuitableperiodforrecovery.

Followinglong-termtreatmentwiththiamazoleinrodents,anincreasedriskof

neoplasiainthethyroidglandhasbeenshowntooccur,butnoevidenceis

availableincats.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicand

embryotoxiceffectsofthiamazole.Thesafetyoftheproductwasnotassessedin

pregnantorlactatingcats.Donotuseinpregnantorlactatingfemales.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrenttreatmentwithphenobarbitalmayreducetheclinicalefficacyof

thiamazole.

Thiamazoleisknowntoreducethehepaticoxidationofbenzimidazolewormers

andmayleadtoincreasesintheirplasmaconcentrationswhengiven

concurrently.

Thiamazoleisimmunomodulatory,thereforethisshouldbetakenintoaccount

whenconsideringvaccinationprogrammes.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministrationonly.

Forthestabilisationoffelinehyperthyroidismpriortosurgicalremovalofthe

thyroidgland,one2.5mgtabletmorningandevening.Thisshouldensure

euthyroidismwithin3weeksinmostcases.

Forlong-termtreatmentofhyperthyroidism,thestartingdoseshouldbe2.5mg

twicedaily.After3weeks,thedoseshouldbetitratedtoeffectaccordingtothe

serumtotalT4.Doseadjustmentsshouldbemadebyincrementsof2.5mg.

Whereverpossible,thetotaldailydoseshouldbedividedintotwoand

administeredmorningandevening.Tabletsshouldnotbesplit.Theaimshould

betoachievethelowestpossibledoserate.

If,forreasonsofcompliance,oncedailydosingwitha5mgtabletispreferable,

thenthisisacceptablealthoughreducedefficacycanbeexpectedcomparedtoa

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twicedailyregime.The5mgtabletisalsosuitableforcatsrequiringhigherdose

rates.

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularly

carefully.Thedoseadministeredmustnotexceed20mg/day.

Forlong-termtreatmentofhyperthyroidismtheanimalshouldbetreatedfor

life.

Haematology,biochemistryandserumtotalT4shouldbeassessedbefore

initiatingtreatmentandafter3weeks,6weeks,10weeks,20weeks,and

thereafterevery3monthsandthedosetitratedasnecessary.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intolerancestudiesinyounghealthycats,thefollowingdose-relatedclinicalsigns

occurredatdosesofupto30mg/animal/day:anorexia,vomiting,lethargy,

pruritusandhaematologicalandbiochemicalabnormalitiessuchasneutropenia,

lymphopenia,reducedserumpotassiumandphosphoruslevels,increased

magnesiumandcreatininelevelsandtheoccurrenceofanti-nuclearantibodies.

Atadoseof30mg/daysomecatsshowedsignsofhaemolyticanaemiaand

severeclinicaldeterioration.Someofthesesignsmayalsooccurinhyperthyroid

catstreatedatdosesofupto20mgperday.

Excessivedosesinhyperthyroidcatsmayresultinsignsofhypothyroidism.This

ishoweverunlikely,ashypothyroidismisusuallycorrectedbynegativefeedback

mechanisms.PleaserefertoSection4.6Adversereactions.

Ifoverdosageoccurs,stoptreatmentandgivesymptomaticandsupportive

care.

4.11Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPARTICULARS

Pharmacotherapeuticgroup:antithyroidpreparations:sulphur-containing

imidazolederivatives.

ATCVetCode:QH03BB02.

5.1 Pharmacodynamicproperties

Thiamazoleactsbyblockingthebiosynthesisofthyroidhormoneinvivo.The

primaryactionistoinhibitbindingofiodidetotheenzymethyroidperoxidase,

therebypreventingthecatalysediodinationofthyroglobulinandT

andT

synthesis.

5.2 Pharmacokineticparticulars

Followingoraldosinginhealthycats,thiamazoleisrapidlyandcompletely

absorbedwithabioavailabilityof>75%.However,thereisaconsiderable

variationbetweenanimals.Eliminationofthedrugfromcatplasmaisrapidwith

ahalflifeof3.5-4.0hours.Peakplasmalevelsoccurapproximately1-2hours

afterdosing.Cmaxisapproximately0.8µg/ml.

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Inratsthiamazolehasbeenshowntobepoorlyboundtoplasmaprotein(5%);

40%wasboundtoredbloodcells.Themetabolismofthiamazoleincatshas

notbeeninvestigated,however,inratsthiamazoleisrapidlymetabolisedinthe

thyroidgland,withabout64%oftheadministereddosebeingeliminatedinthe

urineandonly7.8%excretedinfaeces.Thisisincontrastwithmanwherethe

liverisimportantforthemetabolicdegradationofthecompound.Thedrug

residencetimeinthethyroidglandisassumedtobelongerthanintheplasma.

Frommanandratsitisknownthatthedrugcancrosstheplacentaand

concentratesinthefoetalthyroidgland.Thereisalsoahighrateoftransferinto

breastmilk.

6. PHARMACEUTICALPARTICULARS

6.1 Listofexcipients

Tabletcore:

Lactosemonohydrate

Povidone

Sodiumstarchglycollate

Magnesiumstearate

Coating:

Sucrose

Povidone

Erythrosine

Macrogol

Purifiedtalc

Whitebeeswax

Carnaubawax

Shellac

Titaniumdioxide(E171)

Sodiummethylparahydroxybenzoate(E219)

6.2 Incompatibilities

Notapplicable

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4 Specialprecautionsforstorage

Donotstoreabove25ºC.

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

Keepthecontainerintheoutercarton.

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6.5 Natureandcontentsofimmediatepackaging

Whitepolypropylenetubwithwhitelowdensitypolyethylenetamperevidentlid

containing100tablets.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UK

8. MARKETINGAUTHORISATIONNUMBERS

Vm10434/4075

9. DATEOFFIRSTAUTHORISATION

1May2012

10. DATEOFANYREVISIONOFTHETEXT

May2012