BENYLIN FOUR FLU

Main information

  • Trade name:
  • BENYLIN FOUR FLU
  • Dosage:
  • 25/1000/45 %v/v
  • Pharmaceutical form:
  • Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BENYLIN FOUR FLU
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0823/034/001
  • Authorization date:
  • 02-06-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BenylinFourFluOralSolution

Paracetamol1000mg/20ml

Diphenhydraminehydrochloride25mg/20ml

Pseudoephedrinehydrochloride45mg/20ml

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each20mlcontains:

Diphenhydraminehydrochloride25mg

Paracetamol1000mg

Pseudoephedrinehydrochloride45mg

Alsocontains:

Ethanol

Ponceau4R(E124)

Sodium

Fructose

E306Naturaltocopherolsextract(fromsoyaoil)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralsolution.

Aclearorangetobrownoralsolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofsymptomsassociatedwithcoldsandflu;includingreliefofnasalcongestionandcongestionofmucous

membranesoftheupperrespiratorytract,sneezing,runnynose,coughing,fever,headache,muscularachesandpains.

4.2Posologyandmethodofadministration

Fororaluse

Adults,theelderlyandchildrenaged12yearsandover:

One20mldoseuptofourtimesdaily,asrequired.Donottakemorefrequentlythaneveryfourhours.

Childrenunder12years:

BenylinFourFluOralSolutionisnotrecommendedforuseinchildrenundertheageof12years(seesection4.4).

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4.3Contraindications

Knownhypersensitivitytodiphenhydramine,paracetamol,pseudoephedrineortoanyoftheexcipients.

Concomitantuseofothersympathomimeticagentsincludingthosegivenbyotherroutes,beta-blockers(seesection

4.5)andmonoamineoxidaseinhibitors(MAOIs),orwithin14daysofstoppingMAOItreatment(seesection4.5).

Cardiovasculardiseaseincludinghypertension

Diabetesmellitus

Phaeochromocytoma

Hyperthyroidism

Closedangleglaucoma

Severerenalimpairment

4.4Specialwarningsandprecautionsforuse

Asbothdiphenhydramineandpseudoephedrinehavebeenassociatedwithcentralnervoussystemadverseevents(see

section4.8),thereisapossibilitythattheriskofexperiencingsuchadverseeventsmaybeincreasedbyuseofthe

combination.

Ifanyofthefollowingoccur,BenylinFourFluOralSolutionshouldbestopped

Hallucinations

Restlessness

Sleepdisturbances

Usewithcautioninprostatichypertrophy,urinaryretention,susceptibilitytoangle-closureglaucoma,moderaterenal

impairment,hepaticdiseaseorocclusivevasculardisease.

Thehazardofoverdoseisgreaterinthosewithnon-cirrhoticalcoholicliverdisease.

BenylinFourFluOralSolutionisnotrecommendedforuseinchildrenundertheageof12years(seesection4.2).

Theproductlabellingwillcontainthefollowingadvice:-

Immediatemedicaladviceshouldbesoughtintheeventofanoverdose,evenifyoufeelwell,becauseoftheriskof

delayed,seriousliverdamage.

Donottakewithanyotherparacetamol-containingproducts.

Ifsymptomspersist,consultyourdoctororpharmacist.

Keepoutofthereachandsightofchildren.

Askadoctorbeforeuseifyousufferfromachronicorpersistentcough,ifyouhaveasthma,aresufferingfroman

acuteasthmaattackorwherecoughisaccompaniedbyexcessivesecretions.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

CNSdepressants:mayenhancethesedativeeffectsofCNSdepressantsincludingbarbiturates,hypnotics,opioid

analgesics,anxiolyticsedatives,antipsychoticsandalcohol.

Antimuscarinicdrugs:mayhaveanadditivemuscarinicactionwithotherdrugs,suchasatropineandsome

antidepressants.

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stoppingtreatmentasthereisariskofserotoninsyndrome(diphenhydramine)orhypertensivecrisis

(pseudoephedrine).

Moclobemide:riskofhypertensivecrisis.

Antihypertensives(includingadrenergicneuroneblockers&beta-blockers-seesection4.3):BenylinFour

FluOralSolutionmayblockthehypotensiveeffects.

Cardiacglycosides:increasedriskofdysrhythmias

Ergotalkaloids(ergotamine&methysergide):increasedriskofergotism

Appetitesuppressantsandamphetamine-likepsychostimulants:riskofhypertension

Oxytocin–riskofhypertension

Enhanceseffectsofanticholinergicdrugs(suchasTCAs)

Thespeedofabsorptionofparacetamolmaybeincreasedbymetoclopramideordomperidone,andabsorptionreduced

bycolestyramine.

Theanticoagulanteffectofwarfarinandothercoumarinsmaybeenhancedbyprolongedregularuseofparacetamol

withincreasedriskofbleeding;occasionaldoseshavenosignificanteffect.

Theuseofdrugswhichinducehepaticmicrosomalenzymes,suchasanticonvulsantsandoralcontraceptivesteroids,

mayincreasetheextentofmetabolismofparacetamol,resultinginreducedplasmaconcentrationsofthedruganda

fastereliminationrate.

4.6Fertility,pregnancyandlactation

TheactiveingredientsinBenylinFourFluhavenotbeenconclusivelyassociatedwithadverseeffectsonthe

developingfoetus;butaswithalldrugs,careshouldbeexercisedinuseoftheproduct,particularlyduringthefirst

trimester.

Epidemiologicalstudiesinhumanpregnancyhaveshownnoilleffectsduetoparacetamolusedintherecommended

dosage,butpatientsshouldfollowtheadviceoftheirdoctorregardingitsuse.

Alloftheactivesareexcretedintobreastmilk,althoughfewadverseeffectshavebeenreportedasaresultofingestion,

cautioususeofBenylinFourFluisadvisedduringlactation.

Paracetamolisexcretedinbreastmilkbutnotinaclinicallysignificantamount.Availablepublisheddatadonot

contraindicatebreastfeeding.

4.7Effectsonabilitytodriveandusemachines

BenylinFourFlumaycausedrowsiness.Ifpatientsareaffectedtheyshouldnotdriveorusemachinery.

4.8Undesirableeffects

SystemOrganClass AdverseEvent

Bloodandthelymphatic

systemdisorders Blooddisorders;blooddyscrasiassuchas

thrombocytopeniaandagranulocytosishave

beenreportedfollowingparacetamoluse,but

werenotnecessarilycausallyrelatedtothe

drug

Immunesystemdisorders Hypersensitivityreactions,includingskinrash

andcross-sensitivitywithother

sympathomimetics

Psychiatricdisorders Confusion;depression;sleepdisturbances;

irritability;anxiety;restlessness;excitability;

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4.9Overdose

Paracetamol

Liverdamageispossibleinadultswhohavetaken10gormoreofparacetamol.Ingestionof5gormoreofparacetamol

mayleadtoliverdamageifthepatienthasriskfactors(seebelow).

RiskFactors:

Ifthepatient

Isonlongtermtreatmentwithcarbamazepine,phenobarbital,phenytoin,primidone,rifampicin,St

John’sWortorotherdrugsthatinduceliverenzymes.

Regularlyconsumesethanolinexcessofrecommendedamounts.

Islikelytobeglutathionedepletee.g.eatingdisorders,cysticfibrosis,HIVinfection,starvation,

cachexia.

Symptoms

Symptomsofparacetamoloverdoseinthefirst24hoursarepallor,nausea,vomiting,anorexiaandabdominalpain.

Liverdamagemaybecomeapparent12to48hoursafteringestion.Abnormalitiesofglucosemetabolismand

delusions

Nervoussystemdisorders Drowsiness(usuallydiminisheswithinafew

days);paradoxicalstimulation;headache;

psychomotorimpairment;extrapyramidal

effects;dizziness;tremor;convulsions

Eyedisorders Blurredvision

Cardiacdisorders Palpitations;tachycardia;arrhythmia;other

cardiacdysrhythmias

Vasculardisorders Hypotension;hypertension

Respiratory,thoracicand

mediastinaldisorders Thickenedrespiratorytractsecretions

Gastrointestinaldisorders Gastrointestinaldisturbances;drymouth;

nauseaand/orvomiting

Hepato-biliarydisorders Liverdysfunction

Skinandsubcutaneous

tissuedisorders Rash

Renalandurinary

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hypoglycaemia,cerebraloedema,comaanddeath.Acuterenalfailurewithacutetubularnecrosis,stronglysuggested

byloinpain,haematuriaandproteinuria,maydevelopevenintheabsenceofsevereliverdamage.Cardiacarrhythmias

andpancreatitishavebeenreported.

Management

Immediatetreatmentisessentialinthemanagementofparacetamoloverdose.Despitealackofsignificantearly

symptoms,patientsshouldbereferredtohospitalurgentlyforimmediatemedicalattention.Symptomsmaybelimited

tonauseaorvomitingandmaynotreflecttheseverityofoverdoseortheriskoforgandamage.Managementshouldbe

inaccordancewithestablishedtreatmentguidelines.

Treatmentwithactivatedcharcoalshouldbeconsiderediftheoverdosehasbeentakenwithin1hour.Plasma

paracetamolconcentrationshouldbemeasuredat4hoursorlaterafteringestion(earlierconcentrationsareunreliable).

TreatmentwithN-acetylcysteinemaybeusedupto24hoursafteringestionofparacetamol,howeverthemaximum

protectiveeffectisobtainedupto8hourspost-ingestion.Theeffectivenessoftheantidotedeclinessharplyafterthis

time.IfrequiredthepatientshouldbegivenintravenousN-acetylcysteine,inlinewiththeestablisheddosage

schedule.Ifvomitingisnotaproblem,oralmethioninemaybeasuitablealternativeforremoteareas,outsidehospital.

Managementofpatientswhopresentwithserioushepaticdysfunctionbeyond24hfromingestionshouldbediscussed

withthelocalcentresand/orexpertsthatprovideadviceonpoisonsandoverdosesoraliverunit.

Diphenhydramine

Symptomsofoverdosemayincludedrowsiness,hyperpyrexiaandanticholinergiceffects.Withhigherdoses,and

particularlyinchildren,symptomsofCNSexcitationincludeinsomnia,nervousness,tremorsandepileptiform

convulsions.Withmassiveoverdose,comaorcardiovascularcollapsemayfollow.

Treatmentofoverdoseshouldbesymptomaticandsupportive.Measurestopromotegastricemptying(suchasinduced

emesisorgastriclavage),andincasesofacutepoisoningactivatedcharcoal,maybeuseful.

Pseudoephedrine

Aswithothersympathomimeticagents,symptomsofoverdoseincludeirritability,restlessness,tremor,convulsions,

palpitations,hypertensionanddifficultyinmicturition.

Necessarymeasuresshouldbetakentomaintainandsupportrespirationandcontrolconvulsions.Gastriclavage

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pseudoephedrinecanbeacceleratedbyaciddiuresisorbydialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:N02BE51.

Diphenhydraminehasapotentantihistaminicactionalthoughtheactionsmostbeneficialininfluenzaareitsantitussive

andtoalesserextentanticholinergicproperties,whichmayalleviatemucushypersecretion.

Paracetamolhascentralanalgesicandantipyreticactionsandpseudoephedrineisanindirectlyactingsympathomimetic

whichhasvasoconstrictor,bronchodilatoranddecongestanteffects.

5.2Pharmacokineticproperties

Diphenhydramineiswellabsorbedafteroraladministrationwithpeakplasmalevelsat2.5hoursandissubjectto

extensivefirstpassmetabolism.Thedrugis75%boundtoplasmaproteins,butbindingdecreaseswithchronicliver

disease.Metabolismisby2successiveN-demethylationsfollowedbyoxidationtoacarboxylicacid.Theterminalhalf

lifeliesbetween3.4and9.3hours.

Paracetamolisrapidlyandcompletelyabsorbedwithpeakplasmalevelsseenwithin30to60minutes.Lessthan50%

isproteinboundandthedrugisuniformlydistributedthroughoutthebodyfluids.Paracetamoliseliminatedby

metabolismtoinactiveconjugatesfollowedbyurinaryexcretion.Thehalflifeis2.75-3.25hours.

Pseudoephedrineisrapidlyabsorbed,withpeakserumlevelsafterapproximately2.6hoursandonsetofeffectwithin

about30minutes.Itiswelldistributedthroughoutbodyfluidsandtissues.Approximately50%ofthedrugisexcreted

unchanged,theremainderundergoesmetabolismtoinactivemetabolites.About6%isconvertedtotheactive

metabolitenorpseudoephedrine.

5.3Preclinicalsafetydata

TheactiveingredientsofBenylinFourFluOralSolutionarewellknownconstituentsofmedicinalproductsandtheir

safetyprofileiswelldocumented.Theresultsofpreclinicalstudiesdonotthereforeaddanythingofrelevancefor

therapeuticpurposes.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyethyleneglycol

Glycerol

Propyleneglycol

Saccharinsodium

Citricacidmonohydrate

Sodiumbenzoate

Eucalyptol

Menthol

Carmellosesodium

Sodiumcitrate

Ethanol96%v/v

Colourings:

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Ponceau4R(E124)

PatentBlueV(E131)

Flavourings:

Honey

Lemonandcream

Water

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30 o

C.Keepcontainerintheoutercarton.

6.5Natureandcontentsofcontainer

30mland200mlroundamberglassbottleswithaluminiumscrewcap.

30mland200mlroundamberglassbottleswithaplasticchildresistant,tamperevidentclosurefittedwithapolyester

facedwadorpolyethylene/expandedpolyethylenelaminatedwad.

Apolypropylenemeasuringcupissuppliedwitheach200mlbottle.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Keepbottletightlyclosed.

7MARKETINGAUTHORISATIONHOLDER

McNeilHealthcare(Ireland)Limited

AirtonRoad

Tallaght

Dublin24

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA823/34/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:2June1998

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10DATEOFREVISIONOFTHETEXT

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