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:
  • PPA1562/017/001
  • Authorization date:
  • 05-02-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Acupan30mgfilm-coatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains30mgnefopamhydrochloride.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Film-CoatedTablets

ProductimportedfromtheUK

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.

Acupanshouldbeusedcautiouslyinpatientswithhypertension,thyrotoxicosisandheartdisease,andwhennefopamis

administeredconcurrentlywithtricyclicantidepressants.Acupanshouldbeusedwithcautioninpatientswith,orat

Irish Medicines Board

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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

Irish Medicines Board

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5.2Pharmacokineticproperties

Metabolismofnefopamtakesplaceintheliverandexcretionisthroughtheurine.Theplasmahalf-lifeis

approximatelyfourhours.

5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardsforhumansbasedonconventionalstudiesofsafetypharmacology,repeated

dosetoxicity,carcinogenicpotential,andtoxicitytoreproduction.

Non-clinicaldataongenotoxicityarenotavailable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Tabletcore:

dicalciumphosphatedihydrate,

microcrystallinecellulose,

pregelantinisedmaizestarch,

magnesiumstearate,

hydrogenatedvegetableoil,

colloidalsiliconedioxide

Filmcoating:

hydroxypropylmethylcellulose

titaniumdioxide(E171)

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelflifeexpirydateforthisproductshallbethedateshownontheblisterstripandouterpackageoftheproduct

onthemarketinthecountryoforigin.

6.4Specialprecautionsforstorage

Donotstoreabove30ºC.

6.5Natureandcontentsofcontainer

AcupanaresuppliedinUPVC/aluminium/UPVCblisterstripsof30tablets.Eachpackcontains90tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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7PARALLELPRODUCTAUTHORISATIONHOLDER

LTTPharmaLimited

Unit18,OxleasowRoad

EastMoonMoat

Redditch

WorcestershireB980RE

UnitedKingdom

8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1562/017/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5 th

February2010

Irish Medicines Board

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