BY-VERTIN

Main information

  • Trade name:
  • BY-VERTIN Tablets 8 Milligram
  • Dosage:
  • 8 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BY-VERTIN Tablets 8 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0966/004/001
  • Authorization date:
  • 26-01-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

By-Vertin8mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains8mgbetahistinedihydrochloride.

Eachtabletcontains70mglactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

Cylindrical,biplanewhitetabletwithbevel-edgesonbothsides,diameter7mm.

Embossed'B8'ononeside,plainreverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Betahistineisindicatedforthetreatmentofvertigo,tinnitus,hearinglossandnauseaassociatedwithMénière´s

syndrome.

4.2Posologyandmethodofadministration

Dosage

Adults(includingtheelderly):

Initialoraltreatmentis8to16mgthreetimesdaily,takenwithfood.Maintenancedosesaregenerallyintherange24-

48mgdaily.Dosagecanbeadjustedtosuitindividualpatientneeds.

Children:

Betahistinetabletsarenotrecommendedforuseinchildren.Betahistineefficacyandsafetyhavenotbeenstudiedin

childrenandadolescentsbelowtheageof18years.

4.3Contraindications

Betahistineiscontraindicatedinpatientswithphaeochromocytoma.Asbetahistineisasyntheticanalogueofhistamine

itmayinducethereleaseofcatecholaminesfromthetumorresultinginseverehypertension.

Alsocontraindicatedarethefollowing:

Knownhypersensitivitytobetahistinehydrochlorideand/oranyotherexcipient.

Concurrentusewithantihistamines.

4.4Specialwarningsandprecautionsforuse

Cautionisadvisedinthetreatmentofpatientswithpepticulcerorahistoryofpepticulceration,becauseofthe

occasionaldyspepsiaencounteredinpatientsonbetahistine.

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Cautionisadvisedinprescribingbetahistinetopatientswitheitherurticaria,rashesofallergicrhinitis,becauseofthe

possibilityofaggravatingthesesymptoms.

Cautionisadvisedinpatientswithseverehypotension.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Therearenoprovencasesofhazardousinteractions.

Thereisacasereportofaninteractionwithethanolandacompoundcontainingpyrimethaminewithdapsoneand

anotherofpotentiationofbetahistinewithsalbutamol.

Bethahistineisahistaminanalogue,concurrentadministrationofH1antagonistmaycauseamutualattenuationof

effectoftheactiveagents.

4.6Fertility,pregnancyandlactation

Pregnancy

Thereisaverylimitedamountofdatafromtheuseofbetahistineinpregnantwomen.Animalstudies,though

insuffcientdonotindicatedirectorindirectharmfuleffectswithrespecttoreproductivetoxicity(seesection5.3).Asa

precautionarymeasure,itispreferabletoavoidtheuseofbetahistineduringpregnancy.

Lactation

Thereisinsufficientinformationontheexcretionofbetahistineinhumanmilk.Betahistineshouldnotbeusedduring

breast-feeding.

4.7Effectsonabilitytodriveandusemachines

Rarereportsofdrowsinessassociatedwithbetahistinehavebeenmade.Patientsshouldbeadvisedthatiftheyare

affectedinthiswaytheyshouldavoidactivitiesrequiringconcentration,suchasdrivingandoperatingmachinery.

4.8Undesirableeffects

Skinandsubcutaneoustissuedisorders:

Rare(>1/10,000,<1/1,000):urticaria

Veryrare:skinrashesandpruritus

Hepatobiliarydisorders:

Veryrare:liverinjuryafterlongexposure

Nervoussystemdisorders:

Notknown(cannotbeestimatedfromtheavailabledata):headaches,andoccasionaldrowsiness

Gastrointestinaldisorders:

Rare:gastro-intestinalupset,nausea,dyspepsia

Cardiacdisorders

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4.9Overdose

Thesymptomofbetahistineoverdosearenausea,vomiting,dyspepsia,ataxiaandseizuresathigherdoses.Nospecific

antidote.Gastriclavageandsymptomatictreatmentarerecommended.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

TheATCcodeofbetahistineisN07CA01.Betahistineisanantivertigopreparation,whichbelongstothegroupof

miscellaneousdrugsthatactonthenervoussystem.

BetahistinesH

-agonistactivityathistaminereceptorsinperipheralbloodvesselshasbeendemonstratedinmanbythe

abrogationofbetahistine-inducedvasodilationwiththehistamineantagonistdiphenhydramine.Betahistinehas

minimaleffectsongastricacidsecretion(anH

-receptormediatedresponse).

Theefficacyofbetahistineinthetreatmentofvertigomaybeduetoitsabilitytomodifythecirculationoftheinnerear

orduetoadirecteffectonneuronsofthevestibularnucleus.

Singleoraldosesofbetahistineofupto32mginnormalsubjectsproducedmaximalsuppressionofinducedvestibular

nystagmus3to4hourspost-dose,withlargerdosesbeingmoreeffectiveinreducingthenystagmusduration.

Pulmonaryepithelialpermeabilityinmanisincreasedbybetahistine.Thisisderivedfromareductioninthetimeof

clearancefromthelungtobloodofaradioactivemarker.Thisactionispreventedbyoralpre-treatmentwith

terfenadine,aknownH

-receptorblocker.

Whilsthistaminehaspositiveinotropiceffectsontheheart,betahistineisnotknowntoincreasecardiacoutputandits

vasodilatoreffectmayproduceasmallfallinbloodpressureinsomepatients.Inman,betahistinehaslittleeffecton

exocrineglands.

5.2Pharmacokineticproperties

Absorption

Betahistineiscompletelyabsorbedafteroraladministration,andpeakplasmaconcentrationsof 14

Clabelledbetahistine

areattainedafterapproximatelyonehouroforaladministrationforfastingsubjects.

Distribution

Littleornobindingoccurswithhumanplasmaproteins.

Metabolism&elimination

Eliminationofbetahistinetakesplacemainlybymetabolismandthemetabolitesaresubsequentlyeliminatedmainlyby

renalexcretion.85-90%oftheradioactivityofan8mgdoseappearsintheurineover56hours,withmaximum

excretionratesreachedwithin2hoursofadministration.Afteroraladministrationofbetahistine,itsplasmalevelsare

verylow.Therefore,theassessmentofthepharmacokineticsofbetahistineisbasedontheplasmaconcentrationdataof

theonlymetabolite2-pyridylaceticacid.Thereisnoevidenceofpresystemicmetabolismandbiliaryexcretionisnot

thoughttobeanimportantrouteofeliminationforthedrugoranyofitsmetabolites,howeverbetahistineissubjectto

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5.3Preclinicalsafetydata

Repeateddosetoxicitystudiesofsixmonthsdurationindogsand18monthsdurationinalbinoratsrevealedno

clinicallyrelevantharmfuleffectsatdoselevelsintherange2.5to120mg.kg –1

.Betahistineisdevoidofmutagenic

potentialandtherewasnoevidenceofcarcinogenicityinrats.Testsconductedonpregnantrabbitsshowednoevidence

ofteratologicaleffects.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Povidone

Microcrystallinecellulose

Lactosemonohydrate

Colloidalanhydroussilica

Crospovidone

Stearicacid

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Alu/PVC/PVDCblisterstrips.Availableinpacksof50,100and120tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ErghaHealthcareLtd.

Damastown

Mulhuddart

Dublin15

Ireland

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26January2001

Dateoflastrenewal:23October2010

10DATEOFREVISIONOFTHETEXT

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