Felimazole

Main information

  • Trade name:
  • Felimazole 2.5mg Coated Tablet
  • Pharmaceutical form:
  • Coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Felimazole 2.5mg Coated Tablet
    Ireland
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0198/002
  • Authorization date:
  • 03-07-2012
  • EU code:
  • UK/V/0198/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

ANNEXI

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Felimazole2.5mgCoatedTabletsforCats

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

Donotuseincatssufferingfromsystemicdiseasesuchasprimaryliverdiseaseordiabetes

mellitus.

Donotuseincatsshowingsignsofautoimmunedisease.

Donotuseinanimalswithdisordersofwhitebloodcells,suchasneutropeniaand

lymphopenia.

Donotuseinanimalswithplateletdisordersandcoagulopathies(particularly

thrombocytopenia).

Donotuseincatswithhypersensitivitytothiamazoleortheexcipient,polyethyleneglycol.

Donotuseinpregnantorlactatingfemales.

Pleaserefertosection4.7.

4.4 Specialwarnings

Asthiamazolecancausehaemoconcentration,catsshouldalwayshaveaccesstodrinking

water.

4.5 Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularlycarefully.

Useoftheproductincatswithrenaldysfunctionshouldbesubjecttocarefulrisk:benefit

assessmentbytheclinician.Duetotheeffectthiamazolecanhaveonreducingtheglomerular

filtrationrate,theeffectoftherapyonrenalfunctionshouldbemonitoredcloselyas

deteriorationofanunderlyingconditionmayoccur.

Haematologymustbemonitoredduetoriskofleucopeniaorhaemolyticanaemia.

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyarefebrile,

shouldhaveabloodsampletakenforroutinehaematologyandbiochemistry.Neutropenic

animals(neutrophilcounts<2.5x10 9 /l)shouldbetreatedwithprophylacticbactericidal

antibacterialdrugsandsupportivetherapy.

Pleaserefertosection4.9formonitoringinstructions.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteruse.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthepackage

insertorthelabeltothephysician.

Thiamazolemaycausevomiting,epigastricdistress,headache,fever,arthralgia,pruritusand

pancytopaenia.Treatmentissymptomatic.

Washhandswithsoapandwaterafterhandlinglitterusedbytreatedanimals.

Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Donothandlethisproductifyouareallergictoantithyroidproducts.Ifallergicsymptoms

develop,suchasaskinrash,swellingoftheface,lipsoreyesordifficultyinbreathing,you

shouldseekmedicalattentionimmediatelyandshowthepackageleafletorlabeltothedoctor.

Donotbreakorcrushtablets.

Asthiamazoleisasuspectedhumanteratogen,womenofchild-bearingageandpregnant

womenshouldweargloveswhenhandlinglitteroftreatedcats.

Pregnantwomenshouldweargloveswhenhandlingtheproduct.

4.6 Adversereactions(frequencyandseriousness)

Adversereactionshavebeenreportedfollowinglongtermcontrolofhyperthyroidism.In

manycases,signsmaybemildandtransitoryandnotareasonforwithdrawaloftreatment.

Themoreseriouseffectsaremainlyreversiblewhenmedicationisstopped.

Adversereactionsareuncommon.Themostcommonclinicalsideeffectsthatarereported

includevomiting,inappetance/anorexia,lethargy,severepruritusandexcoriationsofthehead

andneck,bleedingdiathesisandicterusassociatedwithhepatopathy,andhaematological

abnormalities(eosinophilia,lymphocytosis,neutropenia,lymphopenia,slightleucopenia,

agranulocytosis,thrombocytopeniaorhaemolyticanaemia).Thesesideeffectsresolvewithin

7-45daysaftercessationofthiamazoletherapy.

Possibleimmunologicalsideeffectsincludeanaemia,withraresideeffectsincluding

thrombocytopeniaandserumanti-nuclearantibodies,and,veryrarely,lymphadenopathycan

occur.Treatmentshouldbestoppedimmediatelyandalternativetherapyconsideredfollowinga

suitableperiodforrecovery.

Followinglong-termtreatmentwiththiamazoleinrodents,anincreasedriskofneoplasiain

thethyroidglandhasbeenshowntooccur,butnoevidenceisavailableincats.

4.7 Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicandembryotoxic

effectsofthiamazole.Thesafetyoftheproductwasnotassessedinpregnantorlactatingcats.

Donotuseinpregnantorlactatingfemales.

4.8 Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrenttreatmentwithphenobarbitalmayreducetheclinicalefficacyofthiamazole.

Thiamazoleisknowntoreducethehepaticoxidationofbenzimidazolewormersandmaylead

toincreasesintheirplasmaconcentrationswhengivenconcurrently.

Thiamazoleisimmunomodulatory,thereforethisshouldbetakenintoaccountwhenconsidering

vaccinationprogrammes.

4.9 Amountstobeadministeredandadministrationroute

Fororaladministrationonly.

Forthestabilisationoffelinehyperthyroidismpriortosurgicalthyroidectomyandforthelong

termtreatmentoffelinehyperthyroidism,therecommendedstartingdoseis5mgperday.

Whereverpossible,thetotaldailydoseshouldbedividedintotwoandadministeredmorning

andevening.Tabletsshouldnotbesplit.

If,forreasonsofcompliance,oncedailydosingwitha5mgtabletispreferable,thenthisis

acceptablealthoughthe2.5mgtabletgiventwicedailymaybemoreefficaciousintheshort

term.The5mgtabletisalsosuitableforcatsrequiringhigherdoserates.

Haematology,biochemistryandserumtotalT4shouldbeassessedbeforeinitiatingtreatment

andafter3weeks,6weeks,10weeks,20weeks,andthereafterevery3months.Ateachofthe

recommendedmonitoringintervals,thedoseshouldbetitratedtoeffectaccordingtothetotalT4

andtoclinicalresponsetotreatment.Doseadjustmentsshouldbemadeinincrementsof2.5mg

andtheaimshouldbetoachievethelowestpossibledoserate.

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularlycarefully.

Thedoseadministeredshouldnotexceed20mg/day.

Forlongtermtreatmentofhyperthyroidismtheanimalshouldbetreatedforlife.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intolerancestudiesinyounghealthycats,thefollowingdose-relatedclinicalsignsoccurredat

dosesofupto30mg/animal/day:anorexia,vomiting,lethargy,pruritusandhaematologicaland

biochemicalabnormalitiessuchasneutropenia,lymphopenia,reducedserumpotassiumand

phosphoruslevels,increasedmagnesiumandcreatininelevelsandtheoccurrenceofanti-

nuclearantibodies.Atadoseof30mg/daysomecatsshowedsignsofhaemolyticanaemiaand

severeclinicaldeterioration.Someofthesesignsmayalsooccurinhyperthyroidcatstreatedat

dosesofupto20mgperday.

Excessivedosesinhyperthyroidcatsmayresultinsignsofhypothyroidism.Thisishowever

unlikely,ashypothyroidismisusuallycorrectedbynegativefeedbackmechanisms.Please

refertoSection4.6Adversereactions.

Ifoverdosageoccurs,stoptreatmentandgivesymptomaticandsupportivecare.

4.11 Withdrawalperiods

Notapplicable.

5. PHARMACOLOGICALPARTICULARS

Pharmacotherapeuticgroup:antithyroidpreparations:sulphur-containingimidazolederivatives.

ATCVetCode:QH03BB02.

5.1 Pharmacodynamicproperties

Thiamazoleactsbyblockingthebiosynthesisofthyroidhormoneinvivo.Theprimaryactionis

toinhibitbindingofiodidetotheenzymethyroidperoxidase,therebypreventingthecatalysed

iodinationofthyroglobulinandT

andT

synthesis.

5.2 Pharmacokineticparticulars

Followingoraldosinginhealthycats,thiamazoleisrapidlyandcompletelyabsorbedwitha

bioavailabilityof>75%.However,thereisaconsiderablevariationbetweenanimals.

Eliminationofthedrugfromcatplasmaisrapidwithahalflifeof3.5-4.0hours.Peakplasma

levelsoccurapproximately1-2hoursafterdosing.Cmaxisapproximately0.8µg/ml.

Inratsthiamazolehasbeenshowntobepoorlyboundtoplasmaprotein(5%);40%was

boundtoredbloodcells.Themetabolismofthiamazoleincatshasnotbeeninvestigated,

however,inratsthiamazoleisrapidlymetabolisedinthethyroidgland.About64%ofthe

administereddosebeingeliminatedintheurineandonly7.8%excretedinfaeces.Thisisin

contrastwithmanwheretheliverisimportantforthemetabolicdegradationofthe

compound.Thedrugresidencetimeinthethyroidglandisassumedtobelongerthaninthe

plasma.

Frommanandratsitisknownthatthedrugcancrosstheplacentaandconcentratesinthe

foetalthyroidgland.Thereisalsoahighrateoftransferintobreastmilk.

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

Noneknown.

6.3 Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:3years.

6.4 Specialprecautionsforstorage

Donotstoreabove25ºC.

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

Keepthecontainerintheoutercarton.

6.5 Natureandcontentsofimmediatepackaging

Whitepolypropylenetubwithwhitelowdensitypolyethylenetamperevidentlidcontaining100

tablets.

6.6 Specialprecautionsforthedisposalofunusedveterinarymedicinalproductorwaste

materialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UK

8. MARKETINGAUTHORISATIONNUMBERS

UK:Vm10434/4050

IE:VPA10799/15/001

9. DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

UK:19/11/2004

IE:20/02/2009

10. DATEOFANYREVISIONOFTHETEXT

27.02.12