BENYLIN WITH CODEINE

Main information

  • Trade name:
  • BENYLIN WITH CODEINE
  • Dosage:
  • 14/ 5.7/ 1.1 %v/ v
  • Pharmaceutical form:
  • Syrup
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENYLIN WITH CODEINE
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0823/011/001
  • Authorization date:
  • 04-03-1995
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0823/011/001

CaseNo:2043984

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

McNeilHealthcare(Ireland)Ltd

AirtonRoad,Tallaght,Dublin24,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BenylinwithCodeineSyrup

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom31/10/2008until03/03/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 31/10/2008 CRN 2043984 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BENYLINwithCodeineSyrup

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BenylinwithCodeinecontainsDiphenhydramineHydrochloride14mg,CodeinePhosphateHemihydrate5.7mgand

Levomenthol1.1mgineach5ml.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Syrup

Clearredsyrupwithatasteofmenthol.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BenylinwithCodeineisindicatedforthereliefofpersistent,dry,irritatingcough.

4.2Posologyandmethodofadministration

Fororaluse.

Adultsandchildrenover12years:

10mlthreetofourtimesdaily.

Childrenaged6to12years:

Oneteaspoonful(5ml)threetofourtimesdaily.

BenylinwithCodeineisnotrecommendedforchildrenunder6years.

TheElderly:

Experiencesuggeststhatnormaladultdosageisappropriate(seePharmacokinetics–TheElderly).

Renaldysfunction:

Itmaybeprudenttoincreasethedosageintervalinsubjectswithmoderatetosevererenalfailure

(seePharmacokinetics–Renaldysfunction).

4.3Contraindications

BenylinwithCodeineiscontra-indicatedinindividualswithknownhypersensitivitytotheproductoranyofits

constituents.

BenylinwithCodeineiscontra-indicatedinindividualswithhepaticorrespiratoryfailure.

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4.4Specialwarningsandprecautionsforuse

Thisproductmaycausedrowsiness.Ifaffected,individualsshouldnotdriveoroperatemachinery.

Subjectswithmoderatetosevererenaldysfunctionshouldexercisecautionwhenusingthisproduct

(seePharmacokinetics–Renaldysfunction).

Thisproductshouldnotbetakenbyindividualswithnarrow-angleglaucomaorsymptomaticprostatichypertrophy.

Thisproductcontainscodeinewhichisanarcoticanalgesic.Tolerance,psychologicaldependenceandconstipation

mayoccurathighdoses.Thisshouldbeborneinmindwhenprescribingforpatientswithapropensityforaddictionto

drugs,includingalcohol.

BenylinwithCodeineshouldnotbeadministeredtopatientswithchronicorpersistentcough,suchasoccurswith

asthma,orwherecoughisaccompaniedbyexcessivesecretions,unlessdirectedbyaphysician.

Thisproductmayactasacerebralstimulantinchildrenandoccasionallyinadults.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.

Prolongedregularuse,exceptundermedicalsupervision,mayleadtophysicalandpsychologicaldependence

(addiction)andresultinwithdrawalsymptoms,suchasrestlessnessandirritabilityoncethedrugisstopped.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ThisproductcontainsdiphenhydramineandthereforemaypotentiatetheeffectofalcoholandotherCNSdepressants.

Asdiphenhydraminepossessessomeanticholinergicactivity,theeffectsofanticholinergics(e.g.somepsychotrophic

drugsandatropine)maybepotentiatedbythisproduct.Thismayresultintachycardia,drymouth,gastrointestinal

disturbances(e.g.colic)urinaryretentionandheadache.

4.6Pregnancyandlactation

Althoughdiphenhydramineandcodeinehavebeeninwidespreaduseformanyyearswithoutillconsequence,bothare

knowntocrosstheplacentaandhavealsobeendetectedinbreastmilk.BenylinwithCodeineshouldthereforeonlybe

usedwhenthepotentialbenefitoftreatmenttothemotherexceedsanypossiblehazardstothedevelopingfoetusor

sucklinginfant.

Innursingmothers,whoareultra-rapidmetabolisersofcodeine,higherthanexpectedserumandbreastmilkmorphine

levelscanoccur.Morphinetoxicityinbabiescancauseexcessivesomnolence,hypotonia,miosisanddifficulty

breastfeedingorbreathing.Inseverecasesrespiratorydepressionanddeathcanoccur.Inseverecases,naloxonemay

beappropriatetoreversetheeffects.Thelowesteffectivedoseshouldbeused,fortheshortestpossibletime.

Nursingmothersshouldbeinformedaboutcarefullymonitoringtheinfantduringtreatmentsforanysignsand/or

symptomsofmorphinetoxicitysuchasincreaseddrowsinessorsedation,difficultybreastfeeding,breathing

difficulties,miosisanddecreasedtone,andseekingimmediatemedicalcareifsuchsymptomsorsignsarenoticed.The

nursingmothershouldbeinformedaboutmonitoringforsignsandsymptomsofmaternalopoidtoxicityaswell.

Shouldsuchsignsbenotedinmothersorbaby,themothershouldimmediatelystoptakingallcodeine-containing

medicinesandseekmedicaladvice.

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4.7Effectsonabilitytodriveandusemachines

Thisproductmaycausedrowsiness.Ifaffected,individualsshouldnotdriveoroperatemachinery.

4.8Undesirableeffects

SideeffectsassociatedwiththeuseofBenylinwithCodeineareuncommon.

Diphenhydraminemaycausedrowsiness,dizziness,gastrointestinaldisturbance,drymouth,noseandthroat,difficulty

inurinationorblurredvision,skinrash.

Codeinemaycauseconstipation,nausea,dizzinessanddrowsiness.

AdversereactionstomentholatthelowconcentrationpresentinBenylinwithCodeinearenotanticipated.

4.9Overdose

Symptomsandsigns

ThesymptomsandsignsofBenylinwithCodeineoverdosemayincludedrowsiness,hyperpyrexiaandanticholinergic

effects.

Withhigherdoses,andparticularlyinchildren,symptomsofCNSexcitationincludinghallucinationsandconvulsions

mayappear.Withmassivedoses,comaorcardiovascularcollapsemayfollow.Codeinemaycauserespiratory

depression.

Treatment

Treatmentofoverdoseshouldbesymptomaticandsupportive.Measurestopromoterapidgastricemptying(withsyrup

ofipecac-inducedemesisorgastriclavage)andincasesofacutepoisoning,theuseofactivatedcharcoal,maybe

useful.Theintravenoususeofphysostigminemaybeefficaciousinantagonisingsevereanticholinergic

symptoms.Administrationofnaloxoneisrecommendedifadverseeffectsduetocodeineoverdoseareevident.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Diphenhydraminepossessesantitussive,antihistaminicandanticholinergicproperties.Experimentshaveshownthatthe

antitussiveeffect(resultingfromanactiononthebrainstem)isdiscretefromitsantihistaminiceffect.Thedurationof

activityisbetween4and8hours.

Codeineisanopiateagonist,havingnarcoticantitussiveandanalgesicproperties.

Mentholhasmildlocalanaestheticanddecongestantproperties.

5.2Pharmacokineticproperties

Absorption

Diphenhydramine,codeineandmentholarewellabsorbedfromthegutfollowingoraladministration.Peakserum

levelsofdiphenhydraminefollowinga50mgoraldosearereachedatbetween2and2.5hours.Peakplasmalevelsof

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Distribution

Diphenhydramineiswidelydistributedthroughoutthebody,includingtheCNS.Followinga50mgoraldoseof

diphenhydramine,thevolumeofdistributionisintherange3.3-6.8L/kganditissome78%boundtoplasmaproteins.

Codeineiswidelydistributedthroughoutthebodyandissome25%boundtoplasmaproteins.

Metabolismandelimination

Diphenhydramineundergoesextensivefirstpassmetabolism.TwosuccessiveN-demethylationsoccur,withthe

resultantaminebeingoxidisedtoacarboxylicacid.Valuesforplasmaclearanceofa50mgoraldoseof

diphenhydraminelieintherange600-1300ml/minandtheterminaleliminationhalf-lifeliesintherange3.4-9.3hours.

Littleunchangeddrugisexcretedintheurine.

Theplasmahalf-lifeofcodeinehasbeenreportedtobebetween3and4hours.Metabolismtakesplaceintheliverby

O-demethylationtoformmorphine(approx10%),N-demethylationtoformnorcodeineandconjugationtoform

glucuronidesandsulphatesofbothunchangeddruganditsmetabolites.Codeineanditsmetabolitesareexcretedalmost

entirelybythekidney,mainlyasconjugateswithglucuronicacid.Mentholisconjugatedintheliverandexcretedboth

inurineandbileastheglucuronide.

Mentholishydroxylatedintheliverbymicrosomalenzymestop-methane-3,8diol.Thisisthenconjugatedwith

glucuronideandexcretedbothinurineandbileastheglucuronide.

TheElderly

Pharmacokineticstudiesindicatenomajordifferencesindistributionoreliminationofdiphenhydraminecomparedto

youngeradults.Thereisinsufficientinformationtodeterminetheeffectsofoldageonthepharmacokineticsofcodeine

(seePharmacokinetics–Hepaticdysfunction).

RenalDysfunction

Theresultsofareviewontheuseofavarietyofdrugsinrenalfailuresuggestthat,fordiphenhydramine,inmoderate

tosevererenalfailure,thedoseintervalshouldbeextendedbyaperioddependentonglomerularfiltrationrate(GFR).

Nodosageadjustmentsaresuggestedwhenadministeringcodeine.

HepaticDysfunction

Afterintravenousadministrationof0.8mg/kgdiphenhydramine,aprolongedhalf-lifewasnotedinpatientswith

chronicliverdiseasewhichcorrelatedwiththeseverityofthedisease.However,themeanplasmaclearanceand

apparentvolumeofdistributionwerenotsignificantlyaffected.Ascodeineismetabolisedintheliver,hepatic

dysfunctionmayaffectthepharmacokineticsofcodeine.

5.3Preclinicalsafetydata

Mutagenicity

Theresultsofarangeoftestssuggestthatneitherdiphenhydraminenormentholhavemutagenicpotential.Thereis

insufficientinformationavailabletodetermineifcodeinehasmutagenicpotential.

Carcinogenicity

Thereisinsufficientinformationtodeterminethecarcinogenicpotentialofdiphenhydramine,menthol,orcodeine,

althoughsucheffectshavenotbeenassociatedwiththesedrugsinanimalstudies.

Teratogenicity

Theresultsofanumberofstudiessuggestthattheadministrationofeitherdiphenhydramineormentholdoesnot

produceanystatisticallysignificantteratogeniceffectsinrats,rabbitsandmice.Thereisinsufficientinformationto

determinewhethercodeinehasteratogenicpotential.

Fertility

Thereisinsufficientinformationtodeterminewhetherdiphenhydramine,codeineormentholhavethepotentialto

impairfertility,althoughadiminishedfertilityratehasbeenobservedinmiceadministereddiphenhydramineinone

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glucosesyrup

Sucrose

Sodiumcitrate

Ethanol(96%)

Citricacidmonohydrate

Glycerol

Saccharinsodium

Sodiumbenzoate(E211)

Ponceau4R(E124)

CaramelT12(E150)

Raspberryessence

Purifiedwater

6.2Incompatibilities

Noneknown.

6.3ShelfLife

3yearsunopened.

6.4Specialprecautionsforstorage

Donotstoreabove30 °

C.Keepthebottletightlyclosed.

6.5Natureandcontentsofcontainer

125mlamberglassbottlewithaROPPaluminiumcapora3pieceplasticchildresistant,tamperevidentclosurefitted

withaPE-Alu-PETorpolyethylene/expandedpolyethylenelaminatedwadorwithaHDPEplasticcapfittedwitha

PE-Alu-PETwad.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

McNeilHealthcare(Ireland)Ltd.

AirtonRoad

Tallaght

Dublin24

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:04March1975

Dateoflastrenewal:04March2005

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 31/10/2008 CRN 2043984 page number: 7