ACUPAN

Main information

  • Trade name:
  • ACUPAN Film Coated Tablet 30 Milligram
  • Dosage:
  • 30 Milligram
  • Pharmaceutical form:
  • Film Coated Tablet
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACUPAN Film Coated Tablet 30 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1332/019/001
  • Authorization date:
  • 06-07-2007
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Acupan30mgFilm-CoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains30mgnefopamhydrochloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-CoatedTablet(Tablet)

White,circular,biconvextablet,7mmindiameterandmarkedAPNononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Acupanisindicatedforthereliefofpainincluding:post-operativepain;dentalpain;musculoskeletalpain;acute

traumaticpainandcancerpain.Eachcourseoftreatmentshouldbelimitedto7daysexceptinthecaseofcancer

therapy.

4.2Posologyandmethodofadministration

Adults:Dosagemayrangefromonetothreetabletsthreetimesdailydependingonresponse.Therecommended

startingdoseistwotabletsthreetimesdaily.

Elderly:Patientsmayrequirereduceddosageduetoslowermetabolism.Itisstronglyrecommendedthatthestarting

dosedoesnotexceedonetabletthreetimesdailyastheelderlyappearmoresusceptibletoinparticular,theCNSside

effectsofAcupanandsomecasesofhallucinationsandconfusionhavebeenreportedinthisagegroup.

Children:SinceAcupanhasnotbeenevaluatedinchildrennodosagerecommendationcanbegivenforpatientsunder

12years.

4.3Contraindications

Acupaniscontra-indicatedinpatientswithhepaticandrenalfailureandthosehypersensitivetotheactiveingredient.

SinceitpossessesCNSstimulanteffectsitsuseiscontra-indicatedinpatientswithconvulsivedisorders.Itshouldnot

begiventopatientstakingmonoamine-oxidase(MAO)inhibitorsorwithin14daysoftheiringestion.

4.4Specialwarningsandprecautionsforuse

ThesideeffectsofAcupanmaybeadditivetothoseofotheragentswithanticholinergicorsympathomimeticactivity.

Itshouldnotbeusedinthetreatmentofmyocardialinfarctionsincethereisnoclinicalexperienceinthisindication.

Hepaticandrenalinsufficiencymayinterferewiththemetabolismandexcretionofnefopam.Acupanshouldbeused

cautiouslyinpatientswithhypertension,thyrotoxicosisandheartdisease,andwhennefopamisadministered

concurrentlywithtricyclicantidepressants.Acupanshouldbeusedwithcautioninpatientswith,oratriskof,urinary

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Acupanshouldbeusedcautiouslyinconjunctionwithaspirinsincebloodlevelsofnefopammaybesignificantlyraised

insomepatients.Whileexcessivelyhighdosesofparacetamolandnurofenusedconcurrentlyhavegivenriseto

hepatotoxicityindogs,clinicaldoseshavenotdoneso.Cautionshouldneverthelessbeexercisedwhenbothagentsare

consideredforsimultaneoususe.

4.6Fertility,pregnancyandlactation

Thereisnoevidenceofsafetyofuseduringpregnancynoristhereevidencefromanimalworkthatitisfreefrom

hazard.Theproductshouldnotbeusedunlessconsideredabsolutelyessentialbythephysician.

Nefopamisexcretedinhumanmilk.Concentrationsareapproximatelythesameasthoseinmaternalplasma.Riskof

adverseeffectsinthenursinginfantisverysmall.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

Nausea,drymouth,fatigue,flushing,urinaryretention,hypotension,syncope,palpitations,gastrointestinal

disturbances(includingabdominalpainanddiarrhoea),dizziness,paraesthesia,convulsions,tremor,confusion,

hallucination,angioedema,andallergicreactionsmayoccur.Lessfrequently,vomiting,blurredvision,drowsiness,

sweating,insomnia,headacheandtachycardiahavebeenreported.

4.9Overdose

Theclinicalpatternofnefopamtoxicityinoverdoseisontheneurological(convulsions,hallucinationsandagitation)

andcardiovascularsystems(tachycardiawithahyperdynamiccirculation).Routinesupportivemeasuresshouldbe

takenandpromptremovalofingesteddrugbygastriclavageorinducedvomitingwithSyrupofIpecacuanhashouldbe

carriedout.Inductionofvomitingusingsaltwateriscontra-indicated.Oraladministrationofactivatedcharcoalmay

helppreventabsorption.

Convulsionsandhallucinationsshouldbecontrolled(egwithintra-venouslyorrectallyadministereddiazepam).Beta-

adrenergicblockersmayhelpcontrolthecardiovascularcomplications.

Ifamixedoverdoseincludingnefopamandparacetamolistaken,thereisatheoreticalpossibilityofinterferenceby

nefopaminthemetabolismofparacetamol.Measurestocounterparacetamoltoxicityshouldthereforebeimplemented

atlowerplasmaconcentrationsofparacetamolthanusual.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Nefopamisanon-narcoticanalgesicwithcentralstimulantandsympathomimeticproperties.

5.2Pharmacokineticproperties

Metabolismofnefopamtakesplaceintheliverandexcretionisthroughtheurine.Theplasmahalf-lifeis

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5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardsforhumansbasedonconventionalstudiesofsafetypharmacology,repeated

dosetoxicity,carcinogenicpotential,andtoxicitytoreproduction.

Non-clinicaldataongenotoxicityarenotavailable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

Calciumhydrogenphosphatedihydrate

Microcrystallinecellulose

Pregelatinisedmaizestarch

Magnesiumstearate

Hydrogenatedvegetableoil

Colloidalanhydroussilica

Filmcoating:

Hypromellose

Titaniumdioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove30ºC.

6.5Natureandcontentsofcontainer

Acupantabletsaresuppliedinamberglassbottleswithscrew-onmetalcapsorUPVC/aluminium/UPVCblisterpacks

containing90tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MedaHealthSalesIrelandLtd

Office10

DunboyneBusinessPark

Dunboyne

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8MARKETINGAUTHORISATIONNUMBER

PA1332/19/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:19February1981

Dateoflastrenewal:01October2009

10DATEOFREVISIONOFTHETEXT

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