BEECHAMS COLD & FLU BLACKCURRANT POWDER

Main information

  • Trade name:
  • BEECHAMS COLD & FLU BLACKCURRANT POWDER
  • Dosage:
  • 600/ 40 Milligram
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BEECHAMS COLD & FLU BLACKCURRANT POWDER
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0678/106/002
  • Authorization date:
  • 20-10-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0678/106/002

CaseNo:2056332

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GlaxoSmithKlineConsumerHealthcare(Ireland)Limited

StonemasonsWay,Rathfarnham,Dublin16,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

BeechamsCold&FluHotBlackcurrant600mg/40mgPowderfororalsolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom07/10/2008until19/10/2011.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 07/10/2008 CRN 2056332 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BeechamsCold&FluHotBlackcurrant600mg/40mgPowderfororalSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

ActiveConstituentsmg/6gpowdersachet

Paracetamol600.00

AscorbicAcid40.00

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Powderfororalsolution.

Apink/mauvecolouredfreeflowingpowderwithanodourofblackcurrant.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thereliefofsymptomsofinfluenzaandfeverishcoldsincludingheadache,andachesandpains.Alsoeffectiveinthe

reliefofmenstrualpain,toothacheandmusculoskeletaldisorders.

4.2Posologyandmethodofadministration

Directionsforuse

Emptycontentsofsachetintomug.Halffillwithveryhotwater.Stirwell.Addcoldwaterasnecessaryandsugarif

desired.

RecommendedDoseandDosageSchedule

Adults(includingelderly)andchildrenaged12yearsandover:

Onesachettobetakeneveryfourhours,ifnecessary,uptoamaximumofsixsachetsinany24hours.

Nottobegiventochildrenunder12yearsofageexceptonmedicaladvice

4.3Contraindications

Hypersensitivitytoanyoftheingredients.Hepaticorrenalimpairment.

4.4Specialwarningsandprecautionsforuse

Cautionisadvisedintheadministrationofparacetamoltopatientswithimpairedrenalandhepaticfunctionorifthey

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Keepoutofthereachofchildren.

Ifsymptomspersistconsultyourdoctor.Prolongeduseexceptundermedicalsupervisionmaybeharmful.

Donottakewithotherproductscontainingparacetamol.

Containsparacetamol.

Donotexceedthestateddose.

Thisproductshouldonlybeusedwhenclearlynecessary.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucoseintolerance,glucose-galactosemalabsorptionor

sucrase-isomaltaseinsufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Paracetamolisreportedtoincreasethehalf-lifeofchloramphenicol.Largedosesofparacetamolmaypotentiatethe

effectofcoumarinanticoagulants.Thehepatotoxicityofparacetamolmaybepotentiatedbyotherdrugsthataffectthe

liver.

4.6Pregnancyandlactation

Useduringpregnancyandlactationisnotcontraindicated.Howevercautionshouldbeexercisedanduseduring

pregnancyshouldbeontheadviceofadoctor.

4.7Effectsonabilitytodriveandusemachines

None

4.8Undesirableeffects

Skinrashesandotherallergicreactionsoccuroccasionallywithparacetamol.

4.9Overdose

Immediatemedicalattention(in-hospital,ifpossible)isrequiredintheeventofoverdose,evenifthereareno

significantearlysymptoms.Theremaybenoearlysymptomsfollowingalife-threateningoverdose.Ingestionofmore

than12gparacetamol(24standard500mgtablets)ormorethan150mgparacetamolperkgbodyweight(9g

paracetamolina60kgindividual),whicheveristhesmaller,cancausesevereliverdamage.Liverdamage(as

demonstratedbyariseinplasmatransaminaselevels)maybeapparentbetween8and36hoursfollowingoverdose.

Biochemicalevidenceofmaximaldamage,however,maynotbeattaineduntil72-96hoursafteringestionofthe

overdose.

IntravenousN-acetylcysteine(NAC)iseffectivewheninitiatedwithin8hoursoftheoverdose.Efficacydeclines

progressivelyafterthistime,butNACmayprovidesomebenefituptoandpossiblybeyond24hours.Oralmethionine

isalsoeffectiveprovidedthatitisgivenwithin10to12hoursoftheoverdose.Activatedcharcoalshouldbe

consideredifthedoseofparacetamolingestedexceeds12gor150mg/kg,whicheveristhesmaller,andtheprocedure

canbeundertakenwithin1houroftheoverdose.Thereislittleevidencethatundertakinggastriclavagewillbeof

benefittoapatientinwhomparacetamolisknowntohavebeentheonlysubstanceingested.

Symptomsofparacetamoloverdoseinthefirst24hoursmayincludepallor,nausea,vomiting,anorexia,andabdominal

pain.Abnormalitiesofglucosemetabolismandmetabolicacidosismayoccur.Inseverepoisoning,hepaticfailure

mayprogresstoencephalopathy,comaanddeath.Liverdamageresultswhenexcessquantitiesofatoxicmetabolite

(usuallyadequatelydetoxifiedbyglutathionewhennormaldosesofparacetamolareingested)becomeirreversibly

boundtolivertissue.Acuterenalfailurewithacutetubularnecrosismaydevelopevenintheabsenceofsevereliver

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Paracetamol:Providestheanalgesicandantipyreticactions.

Ascorbicacid:iscommonlyincludedincombinationcoldproductstocompensateforvitaminClossesthatmayoccur

intheinitialstagesofacuteviralinfections,includingthecommoncold.

5.2Pharmacokineticproperties

Paracetamol-isreadilyabsorbedfromthegastrointestinaltract.Itismetabolisedintheliverandexcretedinthe

urine,mainlyasglucuronideandsulphateconjugates.

Ascorbicacid-isreadilyabsorbedfromtheGItractandiswidelydistributedinthebodytissues,25%boundto

plasmaproteins.Ascorbicacidinexcessofthebody’sneedsiseliminatedintheurineasmetabolites.

5.3Preclinicalsafetydata

Thereisnopreclinicaldataofrelevancetotheprescriberwhichisadditionaltothatalreadyincludedinothersections

oftheSmPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Sucrose

Sodiumcitrate

Citricacid(anhydrous)

Sodiumcyclamate

Saccharinsodium

Blackcurrantjuice(spraydried)

Blackcurrantpolyaromas

Blackcurrantflavour

Naturalgrapeskincolour(E163)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Theproductisfilledintoflexiblelaminatesachetscomprisingpaper/polythene/aluminiumfoil/polythene.The

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialprecautionsrequired.

7MARKETINGAUTHORISATIONHOLDER

GlaxoSmithKlineConsumerHealthcare(Ireland)Limited

Stonemason’sWay

Rathfarnham

Dublin16

8MARKETINGAUTHORISATIONNUMBER

PA678/106/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

DateofFirstAuthorisation:20thOctober2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 07/10/2008 CRN 2056332 page number: 5