BUCCASTEM

Main information

  • Trade name:
  • BUCCASTEM Buccal Tablet 3 Milligram
  • Dosage:
  • 3 Milligram
  • Pharmaceutical form:
  • Buccal Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BUCCASTEM Buccal Tablet 3 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0943/016/001
  • Authorization date:
  • 18-12-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Buccastem3mgBuccalTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachbuccaltabletcontains3mgprochlorperazinemaleate.

Excipients:Eachbuccaltabletcontainsatleast47mgsucrose.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Buccaltablet

Paleyellow,round,biconvex,buccaltablet,with‘J1’ononeface.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofacutevertigo,suchasisassociatedwithMeniere’sSyndrome,nauseaandvomiting,and

migraine.

4.2Posologyandmethodofadministration

Tobeplacedinthebuccalcavity.

Adultsandchildrenover12years:Onetablettakentwiceaday.

Childrenunder12years:Notrecommended.

Thecourseoftreatmentshouldnotexceedtwoweeksinduration.

4.3Contraindications

Buccastemiscontraindicatedinpatientswithimpairedliverfunction,existingblooddyscrasiasandknown

hypersensitivitytotheactiveingredient.

4.4Specialwarningsandprecautionsforuse

Phenothiazinesshouldonlybeusedwithgreatcautioninpatientswithahistoryofjaundice.

Patientsreceivingphenothiazinesoveraprolongedperiodrequireregularandcarefulsurveillancewithparticular

attentiontopotentialforinducingeyechange,effectsonhaemopoiesis,liverdysfunction,myocardialconduction

effects,particularlyifotherconcurrentlyadministereddrugsalsohavepotentialeffectsonthesesymptoms.

Phenothiazinesmayinducedrowsiness.Personstakingthesedrugsshouldnotdriveoroperatemachineryunlessthe

drughasbeenshownnottointerferewithphysicalormentalability.

Useofphenothiazinesathigh(relativeorabsolute)dosesmayinduceextrapyramidalside-effects,dyskinesia,

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Prolongedadministrationofanyphenothiazinemayresultinpersistentortardivedyskinesias,particularlyinthe

elderly.

Phenothiazinesshouldonlybeusedwithgreatcautioninpatientswithcoronaryinsufficiencyorcardiacdisease.

Casesofvenousthromboembolism(VTE)havebeenreportedwithantipsychoticdrugs.Sincepatientstreatedwith

antipsychoticsoftenpresentwithacquiredriskfactorsforVTE,allpossibleriskfactorsforVTEshouldbeidentified

beforeandduringtreatmentwithBuccastemandpreventivemeasuresundertaken

IncreasedMortalityinElderlypeoplewithDementia

Datafromtwolargeobservationalstudiesshowedthatelderlypeoplewithdementiawhoaretreatedwith

antipsychoticsareatasmallincreasedriskofdeathcomparedwiththosewhoarenottreated.Thereareinsufficient

datatogiveafirmestimateoftheprecisemagnitudeoftheriskandthecauseoftheincreasedriskisnotknown.

Buccastemisnotlicensedforthetreatmentofdementia-relatedbehaviouraldisturbances.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministrationofthisproductwithmedicationssuchascentralnervoussystemdepressants(including

alcoholandanaesthetics),orantihypertensivesoranticholinergicswillresultinaccentuationoftheireffectwhile

potentiationofactionwillalsooccurwithmonoamineoxidaseinhibitors,antidepressantsandanalgesics.

4.6Pregnancyandlactation

Phenothiazinesshouldonlybeusedinpregnancyifconsideredessentialbythephysician.Thedrugisexcretedin

breastmilk,andbreastfeedingshouldceaseduringtherapy.

4.7Effectsonabilitytodriveandusemachines

Patientswhodriveoroperatemachineryshouldbewarnedofthepossibilityofdrowsiness.

4.8Undesirableeffects

Drowsiness,dizziness,drymouth,insomnia,agitationandmildskinreactionsmayoccur.Extrapyramidalreactionsare

veryunlikelyattherecommendeddosage.Othereffectswhichhaveoccurredrarelywithprochlorperazineandother

phenothiazineneurolepticsincludejaundice,blooddyscrasiasand,veryrarely,hyperprolactinaemiceffectssuchas

gynaecomastia.Neurolepticmalignantsyndrome(hyperthermia,rigidity,autonomicdysfunctionandaltered

consciousness)mayoccurwithanyneuroleptic.

Casesofvenousthromboembolism,includingcasesofpulmonaryembolismandcasesofdeepveinthrombosishave

beenreportedwithantipsychoticdrugs-frequencyunknown.

4.9Overdose

Thesignsandsymptomswillbepredominantlyextrapyramidalandmaybeaccompaniedeitherbyrestlessnessand

agitationorcentralnervousdepression.Hypotensionmayoccur.Treatmentisessentiallysymptomaticandsupportive.

RareOccurrenceofcasesofseriousarrhythmias,includingtachycardiaandfibrillation,havealsooccurredafter

overdosage.

Thereisnospecificantidote.Gastriclavageishelpful,particularlywhencarriedoutwithin6hoursofingestion.Donot

inducevomiting.Particularattentionmustbedirectedtomaintainingaclearairwaysincethismaybethreatenedby

extrapyramidalmuscledystonias.Severedystonicreactionsusuallyrespondtoprocyclidine(5-10mg)ororphenadrine

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Ifhypotensionispresent,strictattentiontoventilationandposturingofthepatientwilloftensecurethedesiredeffect,

butfailingthis,considerationshouldbegiventovolumeexpansionbyi.v.fluids.Ifthisisinsufficient,positive

inotropicagentssuchasdopaminemaybetried,butperipheralvasoconstrictoragentsarenotgenerallyrecommended.

AdrenalineshouldNOTbeused.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Prochlorperazineisamemberofthephenothiazinegroupofneurolepticswhich,indoseslowerthanthoseusedin

psychiatry,isusuallyemployedforitsanti-emeticproperties.

5.2Pharmacokineticproperties

Buccastemtabletscontainedinabuccalformulationwhicheliminatesfirstpasshepaticmetabolism.Theelimination

half-lifeofprochlorperazineinthisformulationis9.0hourssimilartothatobservedwiththeoralformulation.

5.3Preclinicalsafetydata

Nopreclinicalfindingsofrelevancehavebeenreported.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Compressiblesugar

PovidoneK30

Xanthangum

Locustbeangum

Talc

Magnesiumstearate

Riboflavinsodiumphosphate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Themedicinalproductdoesnotrequireanyspecialtemperaturestorageconditions.

Keeptheblistersintheoutercarton.

6.5Natureandcontentsofcontainer

PVC/PVDC/Aluminiumfoilblisterpackscontaining50tablets.

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AlliancePharamceuticalsLimited

AvonbridgeHouse

BathRoad

ChippenhamSN152BB

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA943/16/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:23September1987

Dateoflastrenewal:23September2007

10DATEOFREVISIONOFTHETEXT

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