BEECHAMS MAX STRENGTH COLD AND FLU

Main information

  • Trade name:
  • BEECHAMS MAX STRENGTH COLD AND FLU
  • Dosage:
  • 1000 Milligram
  • Pharmaceutical form:
  • Oral Powder
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BEECHAMS MAX STRENGTH COLD AND FLU
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0678/104/001
  • Authorization date:
  • 02-06-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0678/104/001

CaseNo:2054166

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKlineConsumerHealthcare(Ireland)Limited

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BeechamsMaxstrengthColdandFlu1000mgPowderfororalsolution.

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom11/09/2008until01/06/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 01/10/2008 CRN 2054166 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BeechamsMaxstrengthColdandFlu1000mgPowderfororalsolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsachetcontains1000mgofParacetamol.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

PowderforOralSolution

Paleyellowsolublepowderwithanodourandtasteoflemon.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Shorttermsymptomaticreliefofinfluenza,feverishness,chillsandcoldsincludingheadache,sorethroatpain,

sinusitis,achesandpains.

4.2Posologyandmethodofadministration

Fororaladministration,dissolvedinhotwater,asahotlemondrink.

Adults(includingtheelderly)andchildrenaged12yearsandover:

Onesachet,dissolvedinacupormugofhotwater,tobetakeneveryfourtosixhoursasnecessaryuptoamaximum

offoursachetsinany24hours.

Donotexceedthestateddose.

Theproductshouldnotbeusedcontinuouslyformorethansevendayswithoutseekingmedicaladvice.

Childrenunder12yearsofage.

Nottobegiventochildrenunder12yearsofage,exceptonmedicaladvice.

4.3Contraindications

Knownhypersensitivitytoparacetamoloranyoftheexcipients.

Useinchildrenunder12yearsofage.

4.4Specialwarningsandprecautionsforuse

Careisadvisedintheadministrationofparacetamoltopatientswithsevererenalorseverehepaticimpairment.The

hazardofoverdoseisgreaterinthosewithnon-cirrhoticalcoholicliverdisease.

Concomitantuseofother‘fluorcoldmedicines,orotherparacetamol-containingmedicinesshouldbeavoided.

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Donotexceedthestateddose.

Thisproductshouldonlybeusedwhenclearlynecessary.

Keepoutofreachofchildren.

PackLabelWarnings:

Immediatemedicaladviceshouldbesoughtintheeventofanoverdose,evenifyoufeelwell.

Donottakewithother‘flu’orcoldproducts.

Donottakewithanyotherparacetamol-containingproducts.

PatientInformationLeafletWarnings:

Immediatemedicaladviceshouldbesoughtintheeventofanoverdose,evenifyoufeelwell,becauseoftheriskof

delayed,seriousliverdamage.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thespeedofabsorptionofparacetamolmaybeincreasedbymetoclopramideordomperidoneandabsorptionreduced

bycholestyramine.

Theanticoagulanteffectofwarfarinandothercoumarinsmaybeenhancedbyprolongedregularuseofparacetamol

withincreasedriskofbleeding.Occasionaldoseshavenosignificanteffect.

4.6Pregnancyandlactation

Pregnancy

Epidemiologicalstudiesinhumanpregnancyhaveshownnoilleffectsduetoparacetamolusedintherecommended

dosage,butpatientsshouldfollowtheadviceoftheirdoctorregardingitsuse.

Lactation

Paracetamolisexcretedinbreastmilkbutnotinaclinicallysignificantamount.

4.7Effectsonabilitytodriveandusemachines

Normaluseoftheproductisnotknowntohaveanyaffectsonabilitytodriveorusemachines.

Thedrugsubstanceisnotknowntocausesedation.

4.8Undesirableeffects

Adverseeffectsofparacetamolarerare.

Skinrashesandotherallergiescanoccasionallyoccur.

Therehavebeenrarereportsofblooddyscrasiasincludingthrombocytopeniaandagranulocytosisbutthesewerenot

necessarilycausallyrelatedtoparacetamol.

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Frequencytable:

4.9Overdose

Acutesystemictoxicity

Symptomsofparacetamoloverdoseinthefirst24hoursarepallor,nausea,vomiting,anorexiaandabdominalpain.

Liverdamagemaybecomeapparent12to48hoursafteringestion.Abnormalitiesofglucosemetabolismandmetabolic

acidosismayoccur.Inseverepoisoning,hepaticfailuremayprogresstoencephalopathy,comaanddeath.Acuterenal

failurewithacutetubularnecrosismaydevelopevenintheabsenceofsevereliverdamage.Cardiacarrythmiasand

pancreatitishavebeenreported.

Liverdamageispossibleinadultswhohavetaken10gormoreofparacetamol.Itisconsideredthatexcessquantities

ofatoxicmetabolite(usuallyadequatelydetoxifiedbyglutathionewhennormaldosesofparacetamolareingested),

becomeirreversiblyboundtolivertissue.

Immediatetreatmentisessentialinthemanagementofparacetamoloverdose.

Despitealackofsignificantearlysymptoms,patientsshouldbereferredtohospitalurgentlyforimmediatemedical

attentionandanypatientwhohasingestedaround7.5gormoreofparacetamolinthepreceding4hoursshould

undergogastriclavage.Gastriclavageortheadministrationofactivatedcharcoalmaybebeneficialwhenperformed

withinonehouroftheoverdosebutcanbeconsideredforuptofourhoursaftertheoverdose.

AntidotessuchasintravenousN-acetylcysteine(NAC)ororalmethionineprotecttheliverifadministeredwithin

12hoursofoverdose.NACiseffectiveuptoandpossiblybeyond24hours.Generalsupportivemeasuresmustbe

Frequency System Symptoms

Common

(>1/100-<1/10)

Uncommon

(>1/1,000-<1/100)

Rare

(>1/10,000-<1/1,000) Cardiovascular

disorders Oedema.

Disordersofthe

Abnormalvision.

Disordersofthe

immunesystem Allergies(excludingangioedema).

Gastrointestinal

disorders HaemorrhageNOS,abdominalpainNOS,

diarrhoeaNOS,nausea,vomiting.

Generaldisorders Dizziness(excludingvertigo),malaise,

pyrexia,sedation,druginteractionNOS.

Haemopoietic Plateletdisorders,stemcelldisorders.

Hepato-biliary

disorders Hepaticfunctionabnormal,hepatic

failure,hepaticnecrosis,jaundice.

Injuryand

poisoning Overdoseandpoisoning

Neurological

disorders TremorNOS,headacheNOS.

Psychiatric

disorders DepressionNOS,confusion,

hallucinations.

Dermatological Pruritus,rash,sweating,purpura,

angioedema,urticaria

VeryRare

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otheranalgesicsandantipyretics.

ATCCode:N02BE01.

Paracetamolisananalgesic,antipyreticdrugsubstance.

Theantipyreticactivityofparacetamolisthoughttobemediatedbyitsabilitytoselectivelyinhibitprostaglandin

synthesisinthecentralnervoussystem.

Theprecisemechanismfortheanalgesicpropertiesofparacetamolremainstobeestablished.Datasuggestthatcentral

prostaglandinsynthetaseinhibitionislikelytobeofprimaryimportance.ParacetamolisaweakinhibitorofCOX-1

andCOX-2leadingtothesuggestionthattheremaybeanotherformofCOX,whichismoresensitivetoinhibitionby

paracetamol.

Paracetamoldoesnotappeartoinhibittheperipheralgenerationofprostaglandins,e.g.,itdoesnotalterthegastric

mucosalgenerationofprostaglandinsandseriousgastro-intestinaladverseeventsassociatedwithparacetamolarerare.

Paracetamolis,therefore,particularlysuitableforpatientswithahistoryofdiseaseoronconcomitantmedication

whereperipheralprostaglandininhibitionwouldbeundesirable,e.g.,withgastro-intestinalbleeding,cardiovascular

diseaseorintheelderly.

5.2Pharmacokineticproperties

AbsorptionandDistribution

Oralparacetamolisreadilyabsorbedfromtheuppersmallintestinetogivepeakplasmaconcentrationsof

15-20mcg/mlin30to120minutesafteroraladministrationofa1000mgdoseinadults.Thespeedofgastricemptying

modifiestherateofabsorption.Plasmaproteinbindingisminimalandthereisdistributiontoalltissues.

MetabolismandExcretion

Thereislimitedfirst-passmetabolismofparacetamolafteroraladministrationandabout80%ofa1000mgdoseis

bioavailable.Paracetamolismetabolisedprimarilyintheliver.

Aftera1000mgoraldoseinadults,50-60%isrecoveredintheurineastheglucuronideconjugate,25-35%asthe

sulphateconjugate,upto5%asunchangedparacetamoland2-5%asthecysteineormercapturatemetabolites.The

latterareformedfromthecombinationofglutathionewiththeoxidationmetaboliteofparacetamol,N-acetyl-p-

benzoquinoneimine(NAPQI).Excretionviatheurineisrapidandtheplasmahalf-lifeafteroraladministrationis

1-4hours.

5.3Preclinicalsafetydata

Thetoxicityofparacetamoliswelldocumented.

Effectsofchronictoxicityinratsandmiceincludegastrointestinallesions,bloodcountchanges,degenerationand

necroticchangesintesticularandlymphoidtissueinadditiontohepaticandrenalnecrosis.

Long-termstudiesinratsandmicegivenoconclusiveevidenceofcarcinogeniceffects.Thereisnoevidenceof

embryo-orfoeto-toxicityfromparacetamolinanimalstudies.

Paracetamolhepatotoxicityisdirectlydependentontheplasmaconcentrationinrelationtotime.Inman,plasma

concentrationsabove1.2mmol/lat4hours,0.6mmol/lat8hours,and0.3mmol/lat12hoursarecriteriafor

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Listofexcipients

Sucrose

CitricAcid,Anhydrous

SodiumCitrate

MaizeStarch(dried)

LemonFlavour

SodiumCyclamate

SaccharainSodium

AscorbicAcid

Colour–Curcumin(E100)

Silica,ColloidalAnhydrous

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Theproductispackedinlaminatesachetsandeachpackcontains5sachets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKlineConsumerHealthcare(Ireland)Limited

StonemasonsWay

Rathfarnham

Dublin16

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA678/104/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Irish Medicines Board

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10DATEOFREVISIONOFTHETEXT Irish Medicines Board

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