DAY COLD COMFORT

Main information

  • Trade name:
  • DAY COLD COMFORT
  • Dosage:
  • 600/ 10/ 40 mg/ 30ml
  • Pharmaceutical form:
  • Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DAY COLD COMFORT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0004/026/001
  • Authorization date:
  • 13-04-1983
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995

MEDICINALPRODUCTS(LICENSINGANDSALE)REGULATIONS,1998

(S.I.No.142of1998)

PA0004/026/001

CaseNo:2032173

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

TheBootsCompanyPlc

1ThaneRoad,NottinghamNG23AA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DayColdComfort

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom07/02/2007until12/04/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 10/02/2007 CRN 2032173 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DayColdComfort

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Oralsolution

Aclear,orangeslightlyviscoussolutionwithamentholandmixedfruitflavour.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthereliefofthesymptomsofcoldsandinfluenza.

4.2Posologyandmethodofadministration

Fororaladministration.

Adultsandchildrenover12years:30ml

Children6to12years:15ml

Dosesmayberepeatedevery4hours,uptoamaximumof4dosesin24hoursifneeded.

Childrenunder6years:Nottobegiventochildrenunder6yearsofage.

4.3Contraindications

1.Useinpatientswithaknownhypersensitivitytoanyoftheingredients.

2.Useinpatientswhoarereceivingmonoamineoxidaseinhibitors,orwithinfourteendaysofstoppingsuch

treatment.

3.Useinpatientswhoarecurrentlyreceivingothersympathomimeticdrugs.

4.4Specialwarningsandprecautionsforuse

1.Theproductshouldbeusedwithgreatcareinpatientssufferingfromcardiovasculardiseaseorhyperthyroidism.

Paracetamol 600mg/30ml

Pseudoephedrinehydrochloride 40mg/30ml

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4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1.Cautionshouldbeexercisedinitsusewithanaestheticagentssuchaschloroform,cyclopropane,halothaneand

otherhalogenatedagentsastheymayprovokeorworsenventriculararrhythmias.

2.Thisproductshouldbeusedwithcautioninpatientsreceivingdigitalis,-adrenergicblockers,methyldopaor

otherantihypertensiveagents,andtricyclicantidepressants.

4.6Pregnancyandlactation

Thisproductshouldnotbeusedinpregnancyunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Noadverseeffectsknown.

4.8Undesirableeffects

Maycausenausea,vomiting,diarrhoeaorconstipation,epigastricpain,headache,blurredvision,tinnitus,irritability,

nightmares,anorexia,difficultyinmicturition,tachycardia,tremors,skinrashes,sputumretentionandsweating.

4.9Overdose

Symptomsofoverdosagemayincludedrowsiness,headache,nausea,vomiting,tachycardia,urinaryretention,

hallucinations,coma,hyperreflexia,tremor,excitement,hypertensionandarrhythmias.Hepaticandrenalimpairment

mayoccurafter3-5days,togetherwithhypoprothrombinaemia,metabolicacidosis,hypoglycaemiaorhyperglycaemia.

Treatmentconsistsofemesisorgastriclavage,ifindicated.Plasmaparacetamollevelsshouldbechecked.Ifpatient

presentslessthan16hoursafteringestion,2.5gmethionineshouldbegivenorallyeveryfourhoursforfourdoses.

Alternatively,orifthepatientisvomitingorunconscious,acetylcysteineshouldbegivenintravenously,150mg/kg

over15minutes,followedbyaninfusionof50mg/kgin500mlof5%dextroseover4hoursandthen100mg/kgina

litreof5%dextroseoverthenext16hours.Inaddition,symptomaticandsupportivetherapymaybenecessary

includingtheadministrationofabeta-blockerifsupraventriculartachycardiasupervenesandtheadministrationofthe

specificnarcoticantagonistnaloxone.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Paracetamolhasanalgesicandantipyreticactions.Pseudoephedrineisasympathomimeticagentwithbothdirectand

indirecteffectsonadrenergicreceptors.Pholcodineisacoughsuppressant.

5.2Pharmacokineticproperties

Paracetamolisreadilyabsorbedfromthegastrointestinaltractwithpeakplasmaconcentrationsoccurringabout10-60

minutesafteroraladministration.Paracetamolisdistributedintomostbodytissues.Itcrossestheplacentaandis

presentinbreastmilk.Plasmaproteinbindingisnegligibleatusualtherapeuticconcentrations.Paracetamolis

metabolisedpredominantlyintheliverandexcretedintheurinemainlyastheglucuronideandsulphateconjugates.

Lessthan5%isexcretedasunchangedparacetamol.Theeliminationhalflifevariesfromabout1to3hours.

Pseudoephedrineisabsorbedfromthegastrointestinaltract.Itisresistanttometabolismandisexcretedlargely

unchangedintheurine.Ithasahalflifeofseveralhoursbuteliminationisenhancedandhalflifeshortenedinacid

urine.

Pholcodineisrapidlyabsorbedafteroraladministrationandmaximumplasmaconcentrationsareattainedinabout4-8

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23.5%proteinbound.

Pholcodineismetabolisedintheliverbutundergoeslittleconjugationwithglucuronideandsulphate.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincluded.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol

Propyleneglycol

Glycerol

Citricacid

Sodiumcitrate

Sodiumbenzoate(E211)

Peachflavour

Peardropflavour

Limeflavour

Levomenthol

Riboflavine5phosphatesodium

LiquidsugardeminorSucrose

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Keepthecontainertightlyclosed.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

EitheraclearglassbottlewithpilferproofaluminiumscrewcaporaclearPETbottlewithchildresistantcap.

Eachcontains210mlofliquid.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

TheBootsCompanyPlc.

1ThaneRoadWest

NottinghamNG23AA

Irish Medicines Board

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8MARKETINGAUTHORISATIONNUMBER

PA4/26/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13April1983

Dateoflastrenewal:13April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 10/02/2007 CRN 2032173 page number: 5