CODAFEN CONTINUS

Main information

  • Trade name:
  • CODAFEN CONTINUS
  • Dosage:
  • 300mg, 20m %v/ v
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CODAFEN CONTINUS
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0913/009/001
  • Authorization date:
  • 07-04-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Codafen ContinusTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Ibuprofen 300 mg (prolonged release)

CodeinePhosphate20 mg.

Forexcipientssee6.1.

3PHARMACEUTICALFORM

Prolonged releasetablets.

Biconvex capsule-shaped tablets, consisting ofadark pink layerand awhitelayerofapproximately equalthickness

with‘IBC3’marked on thewhitelayer.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Arthriticpain

Shorttomediumtermuseinacuteandchronicpainfularthrosesandrheumatoid'flare',includingrelieffromsevere

pain in osteoarthritis, rheumatoid arthritis,ankylosing spondylitisand sero-negativearthropathies.

Otherinflammatory disorders

Shorttermrelieffromseverepainassociated with inflammatory disorderssuch asbursitis, capsulitisoftheshoulder,

tendinitis, tenosynovitis.

Cancerpain

Forusein patientswherethepain may becontrolled by thiscombination priorto theadministration ofmorphine.

Dysmenorrhoea

Shorttermtreatmentofseverepain associated with dysmenorrhoea.

Severepain in otherclinicalconditions

Shorttermtreatmentofseverepaininclinicalconditionssuchasdentalextraction,post-operativepain(includingpost-

episiotomy), migraine, sprains, strainsand lowback pain.

4.2Posologyandmethodofadminstration

RouteofAdministration

Irish Medicines Board

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Date Issued 03/08/2005 CRN 2013152 page number: 1

Adults:

Thestartingdoseistwotabletstakentwelvehourly.Thismaybeincreasedtothreetabletstwelvehourly.The

maintenancedoseisoneto threetabletstwelvehourly.

Children under12 years:

Notrecommended.

Elderly:

No specialdosagemodificationsarerequired forelderly patientsunlessrenalorhepaticfunction isimpaired, in which

casedosageshould beassessed individually.

4.3Contraindications

Respiratory depression, hypersensitivity to ibuprofen, codeineorany otherconstituentsofthetablets, ahistory of

pepticulceration orchronicconstipation.

4.4Special warningsandspecialprecautionsforuse

CODAFENCONTINUStabletsshould beused with caution in patientswith gastro-intestinaldisease.Ifgiven to

patientsreceiving anti-coagulanttherapy, prothrombin timeshould bemonitored daily forthefirstfewdaysof

combined treatment.

CODAFENCONTINUStabletsshould beusedwithcaution inthosewith hypotension,hypothyroidism, hepaticand/or

renalimpairment(GFR<20 ml.min -1

CODAFENCONTINUStabletsshouldbegivenwithcaretopatientswithahistoryofheartfailureorhypertension

sinceoedemahasbeen reported in association with ibuprofen administration.

NSAIDshavebeenreportedtocausenephrotoxicityinvariousforms:interstitialnephritis,nephroticsyndromeand

renalfailure.Inpatientswithrenal,cardiacorhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmay

resultinthedeteriorationofrenalfunction.Thedoseshouldbekeptaslowaspossibleandrenalfunctionshouldbe

monitored in thesepatients.

Thetabletsshouldbeusedwithcautioninpatientswithraisedintracranialpressureorheadinjury.Bronchospasmmay

beprecipitatedinpatientssufferingfromorwithahistoryofbronchialasthmaorallergicdisease.Thepossibilityof

cross-sensitivity with aspirin and othernon-steroidalanti-inflammatory agentsshould beconsidered.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Careshouldbeexercisedinpatientstakingmonoamineoxidaseinhibitors,thiazidediuretics,oralanticoagulants,

antihypertensives,cardiacglycosides,lithium,methotrexate,cyclosporin,mifepristone,otherNSAIDs,corticosteroids,

quinoloneantibiotics.

4.6Pregnancyandlactation

Based on animalstudiesand clinicalexperiencethereisno evidenceto suggestfoetalabnormalitiesassociated with the

useofibuprofen orcodeine.However, aswith alldrugs, CODAFENCONTINUStabletsshould beavoidedduring

pregnancy, unlessessential.Ibuprofen and codeineareexcreted in breastmilk.

4.7Effectsonabilitytodriveandusemachines

Irish Medicines Board

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4.8Undesirableeffects

Ibuprofen:

Themostcommonly-observedgastrointestinaleffectsarenausea,vomiting,diarrhoea,dyspepsia,abdominalpain,

melaena,haematemesis,ulcerativestomatitisandgastrointestinalhaemorrhage.Lessfrequently,gastritis,duodenal

ulcer, gastriculcerand gastrointestinalperforation havebeenobserved.

Oedemahasbeen reported in association with ibuprofen treatment.

Otheradverseeventsreportedlesscommonlyforwhichcausalityhasnotnecessarilybeenestablishedinclude:

nephrotoxicityincludinginterstitialnephritis,nephroticsyndromeandrenalfailure;abnormalliverfunction,hepatitis

andjaundice;visualdisturbances,opticneuritis,headaches,paraesthesia,depression,confusion,hallucinations,

tinnitus,vertigo,dizziness,malaise,fatigueanddrowsiness,thrombocytopenia,neutropenia,agranulocytosis,aplastic

anaemiaand haemolyticanaemia, photosensitivity.

Hypersensitivityreactionshavebeenreportedfollowingtreatmentwithibuprofen.Theseconsistof(a)non-specific

allergicreactionandanaphylaxis,(b)respiratorytractreactivitycomprisingasthma,aggravatedasthma,bronchospasm

ordyspnoea,or(c)assortedskindisordersincludingrashesofvarioustypes,pruritus,urticaria,purpura,angioedema

and, lesscommonly, bullousdermatoses(including epidermalnecrolysisand erythemamultiforme).

Codeine:

Adverseeventsoccurring with codeineincludeconstipation, respiratory depression, cough suppression, nauseaand

drowsiness.

4.9Overdose

Symptomsofoverdosewithibuprofencouldbeexpectedtoincludethefollowing;headache,vomiting,drowsiness,

lossofconsciousnessandhypotension.Nauseaandvomitingareprominentfeaturesofcodeineoverdosage.

Respiratory depression may also occurwith alargecodeineoverdose.

Thestomach should beemptied.

Symptomsshouldbetreatedonappearanceandanyimbalanceinelectrolytelevelsshouldbecorrected.Monitoringof

potassiumlevelsshould beconsidered.

IfsevereCNSdepression hasoccurred, artificialrespiration, oxygen andparenteralnaloxonemay beneeded.

Thephysician should bearin mind thatthetabletsin theintestinemay releaseibuprofen foraperiod ofhours.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ibuprofenisanon-steroidalanti-inflammatorydrugwithpotentanalgesicproperties.Itinhibitsprostaglandin

synthetaseandthereforethesynthesisofprostaglandinswhichareknowntobeinvolvedinthesensitisationofpain

receptorsand theinflammatory process.

Codeineisanarcoticanalgesicandactsatopioid/opiatereceptorsintheCNS,particularlymureceptorswhichmediate

analgesia.

Thecombinationofawelltoleratedperipheralanalgesicwithacentrallyactiveanalgesicprovidesoptimumpain

Irish Medicines Board

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Date Issued 03/08/2005 CRN 2013152 page number: 3

5.2Pharmacokineticproperties

CODAFENCONTINUStabletsprovideimmediatereleaseofcodeinetoachieverapidpainreliefwhilstallowing

controlled releaseofibuprofen to achievecontinuousrelieffrompain and inflammation.

Theplasmahalf-lifeforibuprofenis2hourswhilstthatforcodeineis2.5-3hours.Bothdrugsaremetabolisedbythe

liverand excreted mainly in theurine.

5.3Preclinical safetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MicrocrystallineCellulose

Lactose(anhydrous)

Hydroxyethylcellulose

Hypromellose

Ponceau 4 R(E124)

CetostearylAlcohol

Talc

Pregelatinised MaizeStarch

Povidone

6.2Incompatibilities

Noneknown.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.

6.5Natureandcontentsofcontainer

Polypropylenecontainerswith polyethylenelidscontaining 10, 28, 56 or112 tabletsand PVdCcoated PVCblister

packswith aluminiumbacking foilcontaining 28 or56 tablets.

6.6Instructionsforuseandhandling

Irish Medicines Board

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Date Issued 03/08/2005 CRN 2013152 page number: 4

7MARKETINGAUTHORISATIONHOLDER

Napp PharmaceuticalsLtd,

CambridgeSciencePark

Milton Road

CambridgeCB4 0GW

England

8MARKETINGAUTHORISATIONNUMBER

PA913/9/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 7 th

April1992

Dateoflastrenewal: 7 th

April2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 03/08/2005 CRN 2013152 page number: 5