Strumafeline 5 mg coated tablets for Cats

Main information

  • Trade name:
  • Strumafeline 5 mg coated tablets for Cats
  • Pharmaceutical form:
  • Coated tablet
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • Strumafeline 5 mg coated tablets for Cats
    France
  • Language:
  • English

Therapeutic information

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

Other information

Status

  • Source:
  • HMA - Europe
  • Authorization number:
  • UK/V/0466/002
  • Authorization date:
  • 29-05-2013
  • EU code:
  • UK/V/0466/002
  • Last update:
  • 09-08-2016

Summary of Product characteristics: dosage,interactions,side effects

Issued:August2013

AN:00232/2012

Page1of6

SUMMARYOFPRODUCTCHARACTERISTICS

1. NAMEOFTHEVETERINARYMEDICINALPRODUCT

Thiafeline5mgFilm-coatedTabletsforCats(AT,BE,CZ,DE,EE,EL,ES,FR,HU,

IE,IS,IT,LT,LU,LV,PL,PT,RO,SE,SK,UK)

Thiafelinevet5mgFilm-coatedTabletsforcats(FI)

ThiafelineVet(DK,NO)

2. QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains:

Activesubstance:

Thiamazole 5 mg

Excipient(s):

Titaniumdioxide(E171) 0.15mg

SunsetYellowFCF(E110) 0.09mg

QuinolineYellowWS(E104) 0.075mg

Forafulllistofexcipients,seesection6.1.

3. PHARMACEUTICALFORM

Film-coatedtablet.

Orangebiconvextablets5.5mmdiameter.

4. CLINICALPARTICULARS

4.1Targetspecies

Cats.

4.2Indicationsforuse,specifyingthetargetspecies

Forthestabilisationofhyperthyroidismincatspriortosurgicalthyroidectomy.

Forthelong-termtreatmentoffelinehyperthyroidism.

4.3Contraindications

Donotuseincatssufferingfromsystemicdiseasesuchasprimaryliverdiseaseor

diabetesmellitus.

Donotuseincatsshowingsignsofautoimmunedisease.

Donotuseinanimalswithdisordersofwhitebloodcells,suchasneutropeniaand

lymphopenia.

Donotuseinanimalswithplateletdisordersandcoagulopathies(particularly

thrombocytopenia).

Issued:August2013

AN:00232/2012

Page2of6

Donotuseinpregnantorlactatingfemales.Refertosection4.7.

Donotuseincatswithhypersensitivitytothiamazoleortheexcipient,polyethylene

glycol.

4.4Specialwarningsforeachtargetspecies

Asthiamazolecancausehaemoconcentration,catsshouldalwayshaveaccessto

drinkingwater.

4.5Specialprecautionsforuse

Specialprecautionsforuseinanimals

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularly

carefully.

Useoftheproductincatswithrenaldysfunctionshouldbesubjecttocarefulrisk:

benefitassessmentbytheclinician.Duetotheeffectthiamazolecanhaveon

reducingtheglomerularfiltrationrate,theeffectoftherapyonrenalfunctionshould

bemonitoredcloselyasdeteriorationofanunderlyingconditionmayoccur.

Haematologymustbemonitoredduetoriskofleucopeniaorhaemolyticanaemia.

Anyanimalthatsuddenlyappearsunwellduringtherapy,particularlyiftheyare

febrile,shouldhaveabloodsampletakenforroutinehaematologyandbiochemistry.

Neutropenicanimals(neutrophilcounts<2.5x10 9

/l)shouldbetreatedwith

prophylacticbactericidalantibacterialdrugsandsupportivetherapy.

Specialprecautionstobetakenbythepersonadministeringtheveterinary

medicinalproducttoanimals

Washhandsafteruse.

Inthecaseofaccidentalingestion,seekmedicaladviceimmediatelyandshowthe

packageleafletorthelabeltothephysician.

Thiamazolemaycausevomiting,epigastricdistress,headache,fever,arthralgia,

pruritusandpancytopaenia.Treatmentissymptomatic.

Washhandswithsoapandwaterafterhandlinglitterusedbytreatedanimals.

Donoteat,drinkorsmokewhilehandlingthetabletorusedlitter.

Donothandlethisproductifyouareallergictoanti-thyroidproducts.Ifallergic

symptomsdevelop,suchasaskinrash,swellingoftheface,lipsoreyesordifficulty

inbreathing,youshouldseekmedicalattentionimmediatelyandshowthepackage

leafletorlabeltothedoctor.

Donotbreakorcrushtablets.

Asthiamazoleisasuspectedhumanteratogen,womenofchild-bearingageand

pregnantwomenshouldweargloveswhenhandlinglitteroftreatedcats.

Pregnantwomenshouldweargloveswhenhandlingthisproduct.

4.6Adversereactions(frequencyandseriousness)

Adversereactionshavebeenreportedfollowinglongtermcontrolofhyperthyroidism.

Inmanycasessignsmaybemildandtransitoryandnotareasonforwithdrawalof

treatment.Themoreseriouseffectsaremainlyreversiblewhenmedicationis

stopped.Adversereactionsareuncommon.Themostcommonclinicalsideeffects

reportedincludevomiting,inappetance/anorexia,lethargy,severepruritusand

excoriationsoftheheadandneck,bleedingdiathesisandicterusassociatedwith

hepatopathy, andhaematologicalabnormalities(eosinophilia,lymphocytosis,

neutropenia,lymphopenia,slightleucopenia,agranulocytosis,thrombocytopeniaor

haemolyticanaemia).Thesesideeffectsresolvedwithin7-45daysaftercessationof

thiamazoletherapy.

Issued:August2013

AN:00232/2012

Page3of6

Possibleimmunologicalsideeffectsincludeanaemiawithraresideeffectsincluding

thrombocytopenia and serum anti-nuclear antibodies, and, very rarely,

lymphadenopathycanoccur.Treatmentshouldbestoppedimmediatelyand

alternativetherapyconsideredfollowingasuitableperiodforrecovery.

Followinglong-termtreatmentwiththiamazoleinrodents,anincreasedriskof

neoplasiainthethyroidglandhasbeenshowntooccur,butnoevidenceisavailable

incats.

4.7Useduringpregnancy,lactationorlay

Laboratorystudiesinratsandmicehaveshownevidenceofteratogenicand

embryotoxiceffectsofthiamazole.Thesafetyoftheproductwasnotassessedin

pregnantorlactatingcats.Donotuseinpregnantorlactatingfemales.

4.8Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrenttreatmentwithphenobarbitalmayreducetheclinicalefficacyof

thiamazole.

Thiamazoleisknowntoreducethehepaticoxidationofbenzimidazolewormersand

mayleadtoincreasesintheirplasmaconcentrationswhengivenconcurrently.

Thiamazoleisimmunomodulatory,thereforethisshouldbetakenintoaccountwhen

consideringvaccinationprogrammes.

4.9Amountstobeadministeredandadministrationroute

Fororaladministrationonly.

Forthestabilisationoffelinehyperthyroidismpriortosurgicalthyroidectomyandfor

thelongtermtreatmentoffelinehyperthyroidism,therecommendedstartingdoseis

5mgperday.

Whereverpossible,thetotaldailydoseshouldbedividedintotwoandadministered

morningandevening.Tabletsshouldnotbesplit.

If,forreasonsofcompliance,oncedailydosingwitha5mgtabletispreferable,then

thisisacceptablealthoughthe2.5mgtabletgiventwicedailymaybemore

efficaciousintheshortterm.The5mgtabletisalsosuitableforcatsrequiringhigher

doserates.

Haematology,biochemistryandserumtotalT4shouldbeassessedbeforeinitiating

treatmentandafter3weeks,6weeks,10weeks,20weeks,andthereafterevery3

months.Ateachoftherecommendedmonitoringintervals,thedoseshouldbe

titratedtoeffectaccordingtothetotalT4andtoclinicalresponsetotreatment.Dose

adjustmentsshouldbemadeinincrementsof2.5mgandtheaimshouldbeto

achievethelowestpossibledoserate.

Ifmorethan10mgperdayisrequiredanimalsshouldbemonitoredparticularly

carefully.

Thedoseadministeredshouldnotexceed20mg/day.

Forlongtermtreatmentofhyperthyroidismtheanimalshouldbetreatedforlife.

4.10Overdose(symptoms,emergencyprocedures,antidotes),ifnecessary

Intolerancestudiesinyounghealthycats,thefollowingdose-relatedclinicalsigns

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

and haematologicalandbiochemicalabnormalitiessuchas neutropenia,

lymphopenia,reducedserumpotassiumandphosphoruslevels,increased

magnesiumandcreatininelevelsandtheoccurrenceofanti-nuclearantibodies.Ata

doseof30mg/daysomecatsshowedsignsofhaemolyticanaemiaandsevere

Issued:August2013

AN:00232/2012

Page4of6

clinicaldeterioration.Someofthesesignsmayalsooccurinhyperthyroidcatstreated

atdosesofupto20mgperday.

Excessivedosesinhyperthyroidcatsmayresultinsignsofhypothyroidism.Thisis

howeverunlikely,ashypothyroidismisusuallycorrectedbynegativefeedback

mechanisms.PleaserefertoSection4.6:Adversereactions.

Ifoverdosageoccurs,stoptreatmentandgivesymptomaticandsupportivecare.

4.11Withdrawalperiod(s)

Notapplicable.

5. PHARMACOLOGICALPROPERTIES

Pharmacotherapeuticgroup:antithyroidpreparations,sulphur-containingimidazole

derivates.

ATCVetCode:QH03BB02.

5.1Pharmacodynamicproperties

Thiamazoleactsbyblockingthebiosynthesisofthyroidhormoneinvivo.Theprimary

actionistoinhibitbindingofiodidetotheenzymethyroidperoxidase,thereby

preventingthecatalysediodinationofthyroglobulinandT

andT

synthesis.

5.2Pharmacokineticparticulars

Absorption

Followingoraldosinginhealthycats,thiamazoleisrapidlyandcompletelyabsorbed

withabioavailabilityof>75%.However,thereisaconsiderablevariationbetween

animals.

Peakplasmalevelsoccurapproximately0.5-1hourafterdosing(t

=0.69h).C

isbetween1.1and2.7µg/ml(1.78µg/ml)andhalf-lifeis3.3h.

Distribution

Frommanandratsitisknownthatthedrugcancrosstheplacentaandconcentrates

inthefoetalthyroidgland.Thereisalsoahighrateoftransferintobreastmilk.

Thedrugresidencetimeinthethyroidglandisassumedtobelongerthaninthe

plasma.

Metabolismandelimination

Themetabolismofthiamazoleincatshasnotbeeninvestigated,however,inrats

thiamazoleisrapidlymetabolisedinthethyroidgland.About64%ofthe

administereddosebeingeliminatedintheurineandonly7.8%excretedinfaeces.

Thisisincontrastwithmanwheretheliverisimportantforthemetabolicdegradation

ofthecompound.

Issued:August2013

AN:00232/2012

Page5of6

6. PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

Lactosemonohydrate

Povidone

SodiumstarchglycolateTypeA

Silica,colloidalanhydrous

Magnesiumstearate

Coating:

Hypromellose

Cellulose,microcrystalline

Lactosemonohydrate

Macrogol

Titaniumdioxide(E171)

SunsetYellowFCF(E110)

QuinolineYellowWS(E104)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Shelf-lifeoftheveterinarymedicinalproductaspackagedforsale:30months.

6.4.Specialprecautionsforstorage

Keeptheblisterintheouterpackageinordertoprotectfromlight.

6.5Natureandcompositionofimmediatepackaging

30tabletsinacardboardcartoncontaining1aluminium/pvcstripseachstripwith30

tablets.

60tabletsinacardboardcartoncontaining2aluminium/pvcstripseachstripwith30

tablets.

120tabletsinacardboardcartoncontaining4aluminium/pvcstripseachstripwith30

tablets.

150tabletsinacardboardcartoncontaining5aluminium/pvcstripseachstripwith30

tablets.

300tabletsinacardboardcartoncontaining10aluminium/pvcstripseachstripwith30

tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsforthedisposalofunusedveterinarymedicinal

productorwastematerialsderivedfromtheuseofsuchproducts

Anyunusedveterinarymedicinalproductorwastematerialsderivedfromsuch

veterinarymedicinalproductsshouldbedisposedofinaccordancewithlocal

requirements.

Issued:August2013

AN:00232/2012

Page6of6

7. MARKETINGAUTHORISATIONHOLDER

LeVetBeheerB.V.

Wilgenweg7

3421TVOudewater

TheNetherlands

8. MARKETINGAUTHORISATIONNUMBER

Vm41821/4006

9. DATEOFFIRSTAUTHORISATION

22August2013

10 DATEOFREVISIONOFTHETEXT

August2013

Approved: 22/08/2013

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

There are no news related to this product.