BETAHECON

Main information

  • Trade name:
  • BETAHECON Tablets 16 Milligram
  • Dosage:
  • 16 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETAHECON Tablets 16 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0108/032/002
  • Authorization date:
  • 12-12-2008
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Betahecon16mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains16mgbetahistinedihydrochloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

Around,biconvex,scored,whitetablet,imprinted‘267'ononeface.Thescorelineisonlytofacilitatebreakingfor

easeofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthemanagementofvertigo,tinnitusandhearinglossassociatedwithMénière'ssyndrome.

4.2Posologyandmethodofadministration

Adults(includingtheelderly):Initially16mgthreetimesdailytakenpreferablywithmeals.Maintenancedosesare

generallyintherange24-48mgdaily.

Children:Notapplicable.

4.3Contraindications

Useconcurrentlywithantihistamines.

Useinchildren.

Useinphaeochromocytoma.

4.4Specialwarningsandprecautionsforuse

Cautionisadvisedinthetreatmentofpatientswithahistoryofpepticulcer.Clinicalintolerancetobetahistinein

bronchialasthmapatientshasbeenshowninarelativelyfewpatientsandthereforecautionshouldbeexercisedwhen

administeringbetahistinetopatientswithbronchialasthma.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Althoughanantagonismbetweenbetahistineandantihistaminescouldbeexpectedonatheoreticalbasis,nosuch

Irish Medicines Board

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4.6Fertility,pregnancyandlactation

Highdosageanimaltestshaveshownnoteratogenicproperties,buttheusualprecautionsshouldbeobservedwhen

administeringbetahistinetopatientsduringpregnancy.

Betahistinedoesnotaccumulateinfatandhasaverylowsideeffectprofilethereforenoadverseeffectswouldbe

anticipatedfromlactation.

4.7Effectsonabilitytodriveandusemachines

Ithasbeenshownthatatover4timestherecommendeddailydose,betahistinedoesnotaffectdrivingorpsychomotor

ability.

4.8Undesirableeffects

Relativelyfewsideeffectshavebeenreported.Theyincludegastro-intestinalupset,(includingdyspepsia),headache,

skinrashandpruritus.

4.9Overdose

Symptoms:Nausea.

Treatment:Nospecificantidote.Gastriclavageandsymptomatictreatmentisrecommended.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Themechanismofactionofbetahistineisnotknown.Pharmacologicaltestinginanimalshasshownthattheblood

circulationinthestriaevascularisoftheinnerearimproves,probablybymeansofarelaxationoftheprecapillary

sphinctersofthemicrocirculationoftheinnerear.

Inpharmacologicalstudies,betahistinewasfoundtohaveweakH

receptoragonisticandconsiderableH

antagonistic

propertiesintheCNSandautonomicnervoussystem.Betahistinewasalsofoundtohaveadose-dependentinhibiting

effectonspikegenerationofneuronsinlateralandmedialvestibularnuclei.Theimportanceofthisobservationinthe

actionagainstMénière'ssyndromeorvestibularvertigo,however,remainsunclear.

5.2Pharmacokineticproperties

Betahistinedihydrochlorideiscompletelyabsorbedafteroraladministration.Onlyonemetabolite,2-pyridylaceticacid,

whichisexcretedintheurine,isknown.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinothersections

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

Mannitol(E421)

Citricacidmonohydrate

Colloidalanhydroussilica

Talc

6.2Incompatibilities

Notapplicable.

6.3Shelflife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Storeintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

Cartonscontaining84tabletsinPVC/PVDC-Alblisterstrips.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AbbottHealthcareProductsLimited

MansbridgeRoad

WestEnd

Southampton

SO183JD

UnitedKingdom

Tradingas:

EconHealthcare

MagnaBusinessPark

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:29September2000

Dateoflastrenewal:29September2010

10DATEOFREVISIONOFTHETEXT

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