DIMOTANE CO

Main information

  • Trade name:
  • DIMOTANE CO
  • Dosage:
  • 2/30/10 MG/5ml
  • Pharmaceutical form:
  • Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIMOTANE CO
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/032/001
  • Authorization date:
  • 14-03-2001
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DimotaneCo.Oralsolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each5mlofliquidcontains:

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Oralsolution

Aclear,darkpinksolutionwiththeodourofraspberry.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofcoughassociatedwithcoldsandothersimilarconditionsfortheupperrespiratorytract.

4.2Posologyandmethodofadministration

Takenorally.

Adults:

1x10mlmeasures3timesdaily.

Children:

6-12years: 1x5-7.5mlmeasures3timesdaily.

4-6years: 1x5mlmeasure3timesdaily.

2-4years: 1x2.5mlmeasures3timesdaily.

Under2years: Nottobeused.

4.3Contraindications

Useinpatientshypersensitivetotheactiveingredients.

BrompheniramineMaleate 2.0mg

PseudoephedrineHydrochloride 30.0mg

CodeinePhosphate(ashemihydrate) 10.0mg

Excipients:

Sorbitol(E420) 1187.2mg

Ethanol 95.6mg

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Useinpatientswhoarecurrentlyreceivingothersympathomimeticdrugs.

Useinpatientswhoarereceivingorhavereceivedwithin14daystricyclicanti-depressantsormonoamineoxidase

inhibitors.

4.4Specialwarningsandprecautionsforuse

Thisproductmaycausedrowsinessandpatientsreceivingitshouldnotdriveoroperatemachineryunlessithasbeen

shownthattheirphysicalandmentalcapacityremainsunaffected.

Thisproductmaypotentiatetheeffectsofalcoholandothercentralnervoussystemdepressants.

Thisproductmayactasacerebralstimulantinchildrenandoccasionallyinadultsgivingrisetoinsomnia,nervousness,

hyperpyrexia,tremorsandepileptiformconvulsions.

Childrenontherapyshouldnotbeleftunattended.

Ifthepatientisreceivingmedicationorisunderadoctor'scare,consultthedoctorbeforeusing.

Donotexceedthestateddose.

Usewithcautioninpatientswithpersistentorchroniccoughsuchasoccurswithsmoking,asthmaoremphysemaorif

coughisaccompaniedbyphlegm.

Ifsymptomspersistorworsenconsultyourdoctor.

Thephysicianorpharmacistshouldreassurehimselfthatsympathomimeticcontainingpreparationsarenot

simultaneouslyadministeredbyseveralroutese.g.orallyandtopically.

Prolongedregularuse,exceptundermedicalsupervision,mayleadtophysicalandpsychologicaldependence

(addiction)andresultinwithdrawalsymptoms,suchasrestlessnessandirritabilityoncethedrugisstopped.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theeffectsofanti-cholinergicse.g.somepsychotropicdrugsandatropine,maybepotentiatedbythisproductgiving

risetotachycardia,mouthdryness,gastrointestinaldisturbances,e.g.colic,urinaryretentionandheadache.

Thisproductshouldbeusedwithcautioninpatientsreceivingdigitalis,beta-adrenergicblockers,guanethidine,

reserpine,methyldopaorotheranti-hypertensiveagents.

ThisproductmayenhancethesedativeeffectsofCNSdepressantsincludingalcohol,barbiturates,hypnotics,opioid

analgesicsanxiolyticsedativesandantipsychotics.

4.6Pregnancyandlactation

Thisproductshouldnotbeusedduringpregnancyunlessconsideredessentialbythephysician.Breastfeedingshould

beavoided.

4.7Effectsonabilitytodriveandusemachines

Thisproductmaycausedrowsinessandpatientsreceivingitshouldnotdriveoroperatemachineryunlessithasshown

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4.8Undesirableeffects

Incommonwithmanyantihistamines,Brompheniraminehasanatropine-likeactionandthereforeshouldbeusedwith

cautioninpatientswithbronchialasthma,especiallychildren.

Tolerance,psychologicalandphysicaldependenceandconstipationmayoccur.

Mayactascerebralstimulantinchildrenandoccasionallyinadults.Ifthisoccursitispossiblethattachycardia,

anxiety,insomnia,nervousness,hyperpyrexiaortremormayoccurandveryrarelyepileptiformconvulsions.Therefore,

childrentakingthisproductshouldnotbeleftunattendedforlongperiods.

4.9Overdose

Insevereoverdosagewithantihistaminesthestomachshouldbeemptiedbyaspirationandlavage.Othertreatmentis

supportiveandsymptomaticandmayincludeartificialrespirationandexternalcoolingforhyperpyrexia.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

BrompheniramineMaleate

BrompheniramineisanalkylaminederivativewiththeactionsandusesoftheHistamineH

receptorantagonists,

includingantimuscarinicandcentralsedativeproperties.

PseudoephedrineHydrochloride

Pseudoephedrineisastereoisomerofephedrineandhasasimilaractionbuthasbeenstatedtohavelesspressoractivity

andcentralnervouseffects.

Itisasympathomimeticagentwithindirectanddirecteffectsonadrenergicreceptors.Ithasalphaandbeta-adrenergic

activityandhaspronouncedstimulatingeffectsonthecentralnervoussystem.Intherapeuticdosesitraisestheblood

pressurebyincreasingcardiacoutputandalsobyinducingperipheralvasoconstriction.

CodeinePhosphate

Codeineisanopiumalkaloidwithactivitysimilartobutweakerthanthatofmorphine.Itisgivenmainlybymouthin

thetreatmentofmildtomoderatepainandasanantitussive.

5.2Pharmacokineticproperties

BrompheniramineMaleate

AfteroraladministrationBrompheniraminemaleateappearstobewellabsorbedfromthegastrointestinaltract.Peak

plasmaconcentrationsareachievedwithinaboutfivehours.Theeliminationhalf-lifeisabout25hoursandthe

metabolitesareprimarilyexcretedintheurine.

PseudoephedrineHydrochloride

Pseudoephedrineisabsorbedfromthegastrointestinaltract.Itisresistanttometabolismbymonoamineoxidaseandis

excretedlargelyunchangedintheurinetogetherwithsmallamountsofitshepaticmetabolite.Ithasahalf-lifeof

severalhours;eliminationisenhancedandthehalf-lifeisaccordinglyshorterinacidicurine.

CodeinePhosphate

Codeineanditssaltsareabsorbedfromthegastrointestinaltract.Ingestionofcodeinephosphateproducespeakplasma

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norcodeineandothermetabolitesincludingnormorphineandhydrocodone.Codeineanditsmetabolitesareexcreted

almostentirelybythekidney,mainlyasaconjugatewithglucuronicacid.Theplasmahalf-lifehasbeenreportedtobe

betweenthreeandfourhoursafteradministrationbymouthorintramuscularinjection.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

DisodiumEdetate

SodiumBenzoate

Levomenthol

Amaranth(E123)

Caramel(E150)

AnhydrousCitricAcid

LiquidSorbitol(non-crystallising)(E420)

Ethanol(96%)

Glycerol

Cherry/GrenadineFlavour

XanthanGum

SodiumCyclamate

AcesulfamePotassium

PurifiedWater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

TypeIIIamberglassbottlescontaining100ml,200mland250ml.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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7MARKETINGAUTHORISATIONHOLDER

WhitehallLaboratoriesLtd

Tradingas:WyethConsumerHealthcare

HuntercombeLaneSouth

Taplow

Maidenhead

Berkshire

SL60PH

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA172/32/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:14March1986

Dateoflastrenewal:14March2006

10DATEOFREVISIONOFTHETEXT

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