DHC CONTINUS

Main information

  • Trade name:
  • DHC CONTINUS
  • Dosage:
  • 60 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0913/008/001
  • Authorization date:
  • 06-03-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DHCContinusProlonged-releaseTablets60mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

DihydrocodeineTartrate60mg

Forexcipients,see6.1.

3PHARMACEUTICALFORM

Prolonged-releasetablets.

Whitecapsule-shapedtabletswith'DHC60'ononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asananalgesicinthereliefofmoderatetoseverepain.

4.2Posologyandmethodofadminstration

Adultsonly

Onetablet12hourly.

Elderly

Reduceddosageorincreasedintervalsbetweendosesmayberequired.

RouteofAdministration

Oral.

4.3Contraindications

DHCCONTINUStabletsshouldnotbeusedinpatientshypersensitivetotheactiveingredientoranyoftheother

constituentsoftheproductorinpatientswithrespiratorydepressionorobstructiveairwaysdisease,paralyticileus,

headinjury,raisedintracranialpressureoracutealcoholism.Asdihydrocodeinemaycausethereleaseofhistamineit

shouldnotbegivenduringanattackofasthma.Patientswithrarehereditaryproblemsofgalactoseintolerance,the

Lapplactasedeficiencyorglucose-galactosemalabsorptionshouldnottakethismedicine.DHCCONTINUStablets

shouldnotbeusedinchildrenunder12yearsofage.

4.4Specialwarningsandprecautionsforuse

DHCCONTINUStabletsshouldbeusedwithgreatcautioninpatientswithahistoryofasthma.

Reduceddosageorincreasedintervalsbetweendosesmayberequiredinpatientswithhypothyroidismandinthose

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Dihydrocodeineshouldbeadministeredwithcautiontopatientswithahistoryofopioidabuse,biliarytractdisorders,

prostatichypertrophy,pancreatitis,constipation,obstructiveboweldisordersandseverecorpulmonale.

Dihydrocodeinehasarecognisedabuseandaddictionprofilesimilartootheropioids.Prolongeduseofhighdosage

mayinducedependencewithawithdrawalsyndromeondiscontinuation.Tolerancetoanalgesiceffectsmaydevelop

uponrepeatedadministration.

DHCContinustabletsmustbeswallowedwhole,andnotbroken,chewedorcrushed.Theadministrationofbroken,

chewedorcrushedtabletsmayleadtoarapidreleaseandabsorptionofapotentialoverdoseofdihydrocodeine(see

Section4.9)

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Dihydrocodeineshouldbeusedwithcautioninpatientswhoarecurrentlyreceiving,orhavewithintheprevioustwo

weeksreceived,monoamineoxidaseinhibitors.

Othercentralnervoussystemdepressants,includingsedativesorhypnotics,phenothiazines,othertranquillisersand

alcohol,mayresultinrespiratorydepressionorsedation.

4.6Pregnancyandlactation

Allthenarcoticanalgesicsareabletotraversetheplacentaandarealsoexcretedinmilk.Theyshouldnotbeused

duringpregnancyorlactationunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Thisproductmayinducedrowsiness.Patientsreceivingitshouldnotdriveoroperatemachineryunlessithasbeen

shownnottoaffectphysicalormentalability.

4.8Undesirableeffects

Commonadversedrugreactionsseenduringtherapyareconstipation,nausea,vomiting,headache,somnolence,

pruritusandrash.Uncommonadversereactionsareurinaryretention,uretericorbiliaryspasm,drymouth,mood

changes,blurredvision,sweating,decreasedlibido,flushing,abdominalpain,hypotension,paraesthesia,confusion,

dizziness,hallucinations,urticaria,paralyticileusandrespiratorydepression.Toleranceanddependencemayoccur.

4.9Overdose

Acuteoverdosagewithdihydrocodeinecanbemanifestedbysomnolenceprogressingtostupororcoma,mioticpupils,

bradycardia,hypotensionandrespiratorydepressionorapnoea.

Apatentairwaymustbeadministered.Administernaloxone0.8mgintravenously.Repeatat2-3minuteintervalsas

necessary,orbyaninfusionof2mgin500mlofnormalsalineor5%dextrose(0.004mg/ml).Theinfusionshouldbe

runataraterelatedtothepreviousbolusdosesadministeredandshouldbeinaccordancewiththepatient’sresponse.

Emptythestomach.Assistrespirationifnecessary.Maintainfluidandelectrolytelevels.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Naturalopiumalkaloids

ATCcode:N02AA08

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Itactsonopioidreceptorsinthebraintoreducethepatient’sperceptionofpainandimprovethepsychologicalreaction

topainbyreducingtheassociatedanxiety.

5.2Pharmacokineticproperties

DihydrocodeineiswellabsorbedfromthegastrointestinaltractfollowingadministrationofDHCCONTINUStablets

andplasmalevelsaremaintainedthroughoutthetwelvehourdosinginterval.

Likeotherphenanthrenederivatives,dihydrocodeineismainlymetabolisedintheliverwiththeresultantmetabolites

beingexcretedmainlyintheurine.Metabolismofdihydrocodeineincludes0-demethylation,N-demethylationand6-

ketoreduction.

5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactoseanhydrous

Hydroxyethylcellulose

Cetostearylalcohol

Magnesiumstearate

Purifiedtalc

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Polypropylenecontainerswithpolyethylenelids,containing8,56,or250tablets.

PVdCcoatedPVCblisterswithaluminiumbackingfoilcontaining8or56tablets.

Polyethylenecontainswithpolypropylenelids,containing56tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

NappPharmaceuticalsLimited

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MiltonRoad

Cambridge

CB40GW

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA913/8/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:06March1987

Dateoflastrenewal:19April2005

10DATEOFREVISIONOFTHETEXT

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