Felimazole 2.5mg Coated Tablet

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
    France
  • 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

3-8-2018

Scientific guideline:  Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Scientific guideline: Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance, adopted

Ledipasvir/sofosbuvir film-coated tablet 90 mg/400 mg product-specific bioequivalence guidance

Europe - EFSA - European Food Safety Authority EFSA Journal

21-2-2017

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls batch of Pamol® in packs of 300 film-coated tablets

Takeda Pharma A/S recalls a batch of Pamol® in packs of 300 film-coated tablets after the discovery of Ibumetin 600 mg containing ibuprofen in some packs. Both types of medicine are used for the treatment of mild pain, but they work in different ways and may cause different adverse reactions.

Danish Medicines Agency