Felimazole 1.25 coated tablets for cats

Main information

  • Trade name:
  • Felimazole 1.25
  • Pharmaceutical form:
  • Tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Felimazole 1.25
    Germany
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • thiamazole
  • Therapeutic area:
  • Cats Non Food

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0198/003
  • Authorization date:
  • 31-07-2013
  • EU code:
  • UK/V/0198/003
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:September2013

AN:00700/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Felimazole1.25mgCoatedTabletsforCats

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

1tabletcontains:

Activesubstance:

Thiamazole 1.25mg

Excipients:

TitaniumDioxide(E171) 0.51mg

DispersedPonceau4RLake(E124) 1.35mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Coatedtablet.

Redsugar-coatedbiconvextablets5.5mmdiameter.

4. CLINICALPARTICULARS

4.1Targetspecies

Cats.

4.2Indicationsforuse,specifyingthetargetspecies

Forthestabilisationofhyperthyroidismincatspriortosurgicalthyroidectomy.

Forthelong-termtreatmentoffelinehyperthyroidism.

4.3Contraindications

Donotuseincatssufferingfromsystemicdiseasesuchasprimaryliverdiseaseor

diabetesmellitus.

Donotuseincatsshowingsignsofautoimmunedisease.

Donotuseinanimalswithdisordersofwhitebloodcells,suchasneutropeniaand

lymphopenia.

Donotuseinanimalswithplateletdisordersandcoagulopathies(particularly

thrombocytopenia).

Donotuseincatswithhypersensitivitytothiamazoleortheexcipient,polyethylene

glycol.

Donotuseinpregnantorlactatingfemales.

Pleaserefertosection4.7.

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4.4Specialwarnings

Asthiamazolecancausehaemoconcentration,catsshouldalwayshaveaccessto

drinkingwater.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularly

carefully.

Useoftheproductincatswithrenaldysfunctionshouldbesubjecttocarefulrisk:benefit

assessmentbytheclinician.Duetotheeffectthiamazolecanhaveonreducingthe

glomerularfiltrationrate,theeffectoftherapyonrenalfunctionshouldbemonitored

closelyasdeteriorationofanunderlyingconditionmayoccur.

Haematologymustbemonitoredduetoriskofleucopeniaorhaemolyticanaemia.

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyarefebrile,

shouldhaveabloodsampletakenforroutinehaematologyandbiochemistry.

Neutropenicanimals(neutrophilcounts<2.5x10 9 /l)shouldbetreatedwithprophylactic

bactericidalantibacterialdrugsandsupportivetherapy.

Pleaserefertosection4.9formonitoringinstructions.

Specialprecautionstobetakenbythepersonadministeringtheveterinarymedicinal

producttoanimals

Washhandsafteruse.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageinsertorthelabeltothephysician.

Thiamazolemaycausevomiting,epigastricdistress,headache,fever,arthralgia,

pruritusandpancytopenia.Treatmentissymptomatic.

Washhandswithsoapandwaterafterhandlinglitterusedbytreatedanimals.

Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Donothandlethisproductifyouareallergictoantithyroidproducts.Ifallergicsymptoms

develop,suchasaskinrash,swellingoftheface,lipsoreyesordifficultyinbreathing,

youshouldseekmedicalattentionimmediatelyandshowthepackageleafletorlabelto

thedoctor.

Donotbreakorcrushtablets.

Asthiamazoleisasuspectedhumanteratogen,womenofchild-bearingageand

pregnantwomenshouldweargloveswhenhandlinglitteroftreatedcats.

Pregnantwomenshouldweargloveswhenhandlingtheproduct.

4.6Adversereactions(frequencyandseriousness)

Adversereactionshavebeenreportedfollowinglongtermcontrolofhyperthyroidism.In

manycases,signsmaybemildandtransitoryandnotareasonforwithdrawalof

treatment.Themoreseriouseffectsaremainlyreversiblewhenmedicationisstopped.

Adversereactionsareuncommon.Themostcommonclinicalsideeffectsthatare

reportedincludevomiting,inappetance/anorexia,lethargy,severepruritusand

excoriationsoftheheadandneck,bleedingdiathesisandicterusassociatedwith

hepatopathy,andhaematologicalabnormalities(eosinophilia,lymphocytosis,

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neutropenia,lymphopenia,slightleucopenia,agranulocytosis,thrombocytopeniaor

haemolyticanaemia).Thesesideeffectsresolvewithin7-45daysaftercessationof

thiamazoletherapy.

Possibleimmunologicalsideeffectsincludeanaemia,withraresideeffectsincluding

thrombocytopeniaandserumanti-nuclearantibodies,and,veryrarely,lymphadenopathy

canoccur.Treatmentshouldbestoppedimmediatelyandalternativetherapy

consideredfollowingasuitableperiodforrecovery.

Followinglong-termtreatmentwiththiamazoleinrodents,anincreasedriskofneoplasia

inthethyroidglandhasbeenshowntooccur,butnoevidenceisavailableincats.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicand

embryotoxiceffectsofthiamazole.Thesafetyoftheproductwasnotassessedin

pregnantorlactatingcats.Donotuseinpregnantorlactatingfemales.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrenttreatmentwithphenobarbitalmayreducetheclinicalefficacyofthiamazole.

Thiamazoleisknowntoreducethehepaticoxidationofbenzimidazolewormersand

mayleadtoincreasesintheirplasmaconcentrationswhengivenconcurrently.

Thiamazoleisimmunomodulatory,thereforethisshouldbetakenintoaccountwhen

consideringvaccinationprogrammes.

4.9Amountstobeadministeredandadministrationroute

Fororaladministrationonly.

Forthestabilisationoffelinehyperthyroidismpriortosurgicalthyroidectomyandforthe

longtermtreatmentoffelinehyperthyroidism,therecommendedstartingdoseis5mg

perday.

Standarddoseadjustmentsshouldbemadeinincrementsof2.5mgandtheaimshould

betoachievethelowestpossibledoserate.

Whereverpossible,thetotaldailydoseshouldbedividedintotwoandadministered

morningandevening.Tabletsshouldnotbesplit.

If,forreasonsofcompliance,oncedailydosingwitha5mgtabletispreferable,thenthis

isacceptablealthoughthe2.5mgtabletgiventwicedailymaybemoreefficaciousin

theshortterm.The5mgtabletisalsosuitableforcatsrequiringhigherdoserates.

1.25mgtabletsareintendedforuseincatsthatrequireparticularlysmalldosesof

thiamazole,andtoassistwithdosageadjustments.

Haematology,biochemistryandserumtotalT4shouldbeassessedbeforeinitiating

treatmentandafter3weeks,6weeks,10weeks,20weeks,andthereafterevery

3months.Ateachoftherecommendedmonitoringintervals,thedoseshouldbetitrated

toeffectaccordingtothetotalT4andtoclinicalresponsetotreatment.Dose

adjustmentsshouldbemadeinincrementsof2.5mgandtheaimshouldbetoachieve

thelowestpossibledoserate.

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularly

carefully.

Thedoseadministeredshouldnotexceed20mg/day.

Forlongtermtreatmentofhyperthyroidism,theanimalshouldbetreatedforlife.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

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Intolerancestudiesinyounghealthycats,thefollowingdose-relatedclinicalsigns

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

haematologicalandbiochemicalabnormalitiessuchasneutropenia,lymphopenia,

reducedserumpotassiumandphosphoruslevels,increasedmagnesiumandcreatinine

levelsandtheoccurrenceofanti-nuclearantibodies.Atadoseof30mg/daysomecats

showedsignsofhaemolyticanaemiaandsevereclinicaldeterioration.Someofthese

signsmayalsooccurinhyperthyroidcatstreatedatdosesofupto20mgperday.

Excessivedosesinhyperthyroidcatsmayresultinsignsofhypothyroidism.Thisis

howeverunlikely,ashypothyroidismisusuallycorrectedbynegativefeedback

mechanisms.PleaserefertoSection4.6:Adversereactions.

Ifoverdosageoccurs,stoptreatmentandgivesymptomaticandsupportivecare.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antithyroidpreparations:sulphur-containingimidazole

derivatives.

ATCVetCode:QH03BB02.

5.1Pharmacodynamicproperties

Thiamazoleactsbyblockingthebiosynthesisofthyroidhormoneinvivo.Theprimary

actionistoinhibitbindingofiodidetotheenzymethyroidperoxidase,thereby

preventingthecatalysediodinationofthyroglobulinandT

andT

synthesis.

5.2Pharmacokineticparticulars

Followingoraldosinginhealthycats,thiamazoleisrapidlyandcompletelyabsorbed

withabioavailabilityof>75%.However,thereisaconsiderablevariationbetween

animals.Eliminationofthedrugfromcatplasmaisrapidwithahalflifeof4.5-5.0hours.

Peakplasmalevelsoccurapproximately1-2hoursafterdosing.C

isbetween1.6-

1.9 μg/ml.

Inratsthiamazolehasbeenshowntobepoorlyboundtoplasmaprotein(5%);40%

wasboundtoredbloodcells.Themetabolismofthiamazoleincatshasnotbeen

investigated,however,inratsthiamazoleisrapidlymetabolisedinthethyroidgland.

About64%oftheadministereddosebeingeliminatedintheurineandonly7.8%

excretedinfaeces.Thisisincontrastwithmanwheretheliverisimportantforthe

metabolicdegradationofthecompound.Thedrugresidencetimeinthethyroidgland

isassumedtobelongerthanintheplasma.

Frommanandratsitisknownthatthedrugcancrosstheplacentaandconcentratesin

thefoetalthyroidgland.Thereisalsoahighrateoftransferintobreastmilk.

6. PHARMACEUTICALPARTICULARS

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AN:00700/2012

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6.1Listofexcipients

Tabletcore:

Lactosemonohydrate

Povidone

Sodiumstarchglycolate

Magnesiumstearate

Coating:

Sucrose

Povidone

DispersedPonceau4RLake(E124)

Macrogol

TalcWhitebeeswax

Carnaubawax

Shellac

Titaniumdioxide(E171)

Sodiummethylhydroxybenzoate(E219)

6.2Incompatibilities

Noneknown.

6.3Shelflife

Shelflifeoftheveterinarymedicinalproductaspackagedforsale:18months.

6.4.Specialprecautionsforstorage

Keepthecontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcompositionofimmediatepackaging

Whitepolypropylenetubwithwhitelowdensitypolyethylenetamperevidentlid

containing100tablets.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialderivedfromsuchveterinary

medicinalproductsshouldbedisposedofinaccordancewithlocalrequirements.

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7. MARKETINGAUTHORISATIONHOLDER

DechraLimited

DechraHouse

JamageIndustrialEstate

TalkePits

Stoke-on-Trent

Staffordshire

ST71XW

UK

8. MARKETINGAUTHORISATIONNUMBER

Vm10434/4082

9. DATEOFFIRSTAUTHORISATION

17September2013

10.DATEOFREVISIONOFTHETEXT

September2013

APPROVED 17/09/13

21-2-2017

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