CODEINE PHOSPHATE TABLETS BP 30 MG

Main information

  • Trade name:
  • CODEINE PHOSPHATE TABLETS BP 30 MG
  • Dosage:
  • 30 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CODEINE PHOSPHATE TABLETS BP 30 MG
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0408/042/002
  • Authorization date:
  • 24-02-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0408/042/002

CaseNo:2046546

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

RanbaxyIrelandLimited

Spafield,CorkRoad,Cashel,Co.Tipperary,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

CodeinePhosphateTabletsBP30mg

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom10/03/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 11/03/2008 CRN 2046546 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CodeinePhosphateTabletsBP30mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains30mgcodeinephosphate.

Excipient:Alsocontains36.5mglactose(asmonohydrate)

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Tablet

White,circular,biconvextabletabout5.5mmindiameterembossedwith‘R115’.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Adults:

Asananalgesicinmildtomoderatepain,asananti-tussive,andforthetreatmentofchronicdiarrhoea.

Children:

Asananalgesicinmildtomoderatepainandforoccasionaluseinthecontrolofintractablediarrhoeaunderspecialist

supervision.

4.2Posologyandmethodofadministration

Fororaladministration.

Inmildtomoderatepain:

Adults:30-60mgeveryfourhourswhennecessarytoamaximumof200mgdaily.

Children(6-12years):3mgperkiloofbodyweightdailyindivideddoses.

Asananti-tussive:

Adults:15-30mgthreeorfourtimesdaily.Notrecommendedforchildren.

Forthetreatmentofchronicdiarrhoea:

Adults:15-60mgeveryfourtosixhours.

Irish Medicines Board

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4.3Contraindications

Useinpatientshypersensitivetocodeine,orhypersensitivitytoanyoftheotherconstituents.

Useinpatientswithactueasthma,respiratorydepression,acutealcoholism,headinjuries,raisedintra-cranialpressure

andfollowingbiliarytractsurgery.

Useinpatientscurrentlyreceivingorwithin14daysofstoppingmonoamineoxidaseinhibitorytherapy.Seealso

Section4.6PregnancyandLactation.

Useofcodeinecontainingproductsiscontraindicatedinmotherswhoarebreastfeedingunlessprescribedbyadoctor.

4.4Specialwarningsandprecautionsforuse

Thisproductshouldonlybeusedwithgreatcareinanypatientwhoseconditionmaybeexacerbatedbyopioids,

particularlytheelderly,whomaybesensitivetoitscentralandgastro-intestinaleffects,thosewhoareonconcurrent

CNSdrugs,thosewithprostatichypertrophyorthosewithinflammatoryorobstructiveboweldisorders.

Caseshouldalsobeobsergvedifprolongedtherapyiscontemplated.

Toleranceanddependencecanoccur,especiallywithprolongedhighdosageofcodeine.

Prolongedregularuse,exceptundermedicalsupervision,mayleadtophysicalandpsychologicaldependence

(addiction)andresultinwithdrawalsymptomssuchasrestlessnessandirritabillity,oncethedrugisstopped.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsoroptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Formscodeinephenobarbitonecomplexwithphenobarbitonesodiumandcrystalofcodeineperiodidewithpotassium

iodide.

TheeffectsofCNSdepressants(includingalcohol)maybepotentiatedbycodeine.

4.6Pregnancyandlactation

Notrecommendedduringpregnancyduetoneonatalwithdrawalsymptomsandimpairedeffectonfoetus.

Innursingmothers,whoareultra-rapidmetabolisersofcodeine,higherthanexpectedserumandbreastmilkmorphine

levelscanoccur.Morphinetoxicityinbabiescancauseexcessivesomnolence,hypotonia,miosisanddifficulty

breastfeedingorbreathing.Inseverecasesrespiratorydepressionanddeathcanoccur.Inseverecases,naloxonemay

beappropriatetoreversetheeffects.Thelowesteffectivedoseshouldbeused,fortheshortestpossibletime.

Nursingmothersshouldbeinformedaboutcarefullymonitoringtheinfantduringtreatmentforanysignsand/or

symptomsofmorphinetoxicitysuchasincreaseddrowsinessorsedation,difficultybreastfeeding,breathing

difficulties,miosisanddecreasedtone,andseekingimmediatemedicalcareifsuchsymptomsorsignsarenoticed.The

nursingmothershouldbeinformedaboutmonitoringforsignsandsymptomsofmaternalopioidtoxicityaswell.

Shouldsuchsigns/symptomsbenotedinmotherorbaby,themothershouldimmediatelystoptakingallcodeine-

containingmedicinesandseekmedicaladvice.

Irish Medicines Board

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4.7Effectsonabilitytodriveandusemachines

Incombinationwithalcohol,CodeinePhosphatehasadeleteriouseffectondriving.

Patientsreviewingthismedicationshouldbeadvisednottodriveoroperatemachineryifaffectedbydizzinessor

sedation.

4.8Undesirableeffects

Codeinecanproducetypicalopioideffectsincludingconstipation,nausea,vomiting,dizziness,light-headedness,

confusion,drowsinessandurinaryretention.Thefrequencyandseverityaredeterminedbydosage,durationof

treatmentandindividualsensitivity.

4.9Overdose

Nauseandvomitingareprominenetsymptomsofcodeinetoxicityandifthereisevidenceofcirculatoryandrespiratory

depression,suggestedtreatmentisgastriclavageandcatharsis.IfCNSdepressionissevere,assistedventilation,

oxygenandparenteralnaloxonemaybeneeded.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

TheactionofcodeineislargelythatofMorphinefromwhichitisderivedi.e.itisaCNSdepressant.

5.2Pharmacokineticproperties

Codeineismetabolisedintheliverandisexcretedintheurine,largelyininactiveforms.Asmallfraction

(approximately10%)ofadministeredcodeineisdemethylatedtoformmorphine;tracesoffreemorphinecanbefound

intheurineaftertherapeuticdosesofcodeine.

5.3Preclinicalsafetydata

AnimalworksuggestedthattheanalgesicactivityofCodeinewasnotaffectedbyAcetylation.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

LactoseMonohydrate

MaizeStarch

MagnesiumStearate

SodiumStarchGlycolate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Irish Medicines Board

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6.4Specialprecautionsforstorage

Donotstoreabove25°C.Keepthecontainertightlyclosed.

6.5Natureandcontentsofcontainer

Opaqueplasticsecuritainers1000,500,250and100tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

RanbaxyIrelandLtd.

Spafield

CorkRoad

Cashel

Co.Tipperary

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA408/42/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24 th

February1992

Dateoflastrenewal:24 th

February2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 11/03/2008 CRN 2046546 page number: 5