DF 118

Main information

  • Trade name:
  • DF 118
  • Dosage:
  • 30 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DF 118
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1329/007/001
  • Authorization date:
  • 22-05-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA1329/007/001

CaseNo:2069929

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

GalenLimited

SeagoeIndustrialEstate,Craigavon,BT635UA,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

DF118Tablets30mg

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom15/02/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/05/2010 CRN 2069929 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DF118Tablets30mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Excipients:alsocontainslactosemonohydrate,127.2mgpertablet

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

Biconvexroundwhiteuncoatedtabletmarkedwith‘DF’runninghorizontallyand‘118’runningverticallyinacross

formationononeside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asananalgesicinthereliefofmoderatetoseverepain.

4.2Posologyandmethodofadministration

Fororaladministration.

AdultDosage:

Theusualdoseisonetableteveryfourtosixhoursorasdirectedbythephysician.

DF118isnotrecommendedforadministrationtochildren.

DF118isbestadministeredwithorafterfood.

4.3Contraindications

Useinpatientswithhypersensitivityoridiosyncraticresponsetotheactiveingredient.

Respiratorydepression;obstructiveairwaysdisease.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.4Specialwarningsandprecautionsforuse

ActiveSubstance PerTablet

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/05/2010 CRN 2069929 page number: 2

cautioninpatientswithaprevioushistoryofopioidabuse.

Repeatedusemayresultinthedevelopmentoftolerance.

Asdihydrocodeinemaybringabouthistaminerelease,DF118shouldnotbegivenduringanattackofasthmaandit

shouldbeadministeredwithduecaretopersonsliabletosuchattacks.

Dosageshouldbereducedintheelderly,inhypothyroidism,chronichepaticdiseaseandrenalinsufficiency.

AlcoholshouldbeavoidedwhilstundertreatmentwithDF118.UsewithcautioninpatientstakingconcomitantCNS

depressivemedications.

Usewithcautioninpatientswithbiliarytractdisorders,pancreatitis,severecorpulmonale,obstructiveinflammatory

bowelconditionsorprostatichypertrophy.

Observecautioninpatientswithdepressedconsciousness,headinjuryorraisedintracranialpressure.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Dihydrocodeineshouldonlybeusedwithcautioninpatientswhoarecurrentlyreceiving,orhavewithintheprevious

twoweeksreceivedmonoamineoxidaseinhibitors.

Potentialinteractionwithsildenafil(prolongedpriapismreported).

4.6Pregnancyandlactation

Allthenarcoticanalgesicsareabletotraversetheplacentaandarealsoexcretedinthemilk.Theyshouldnotbeused

duringpregnancyorlactationunlessconsideredessentialbythephysician.

4.7Effectsonabilitytodriveandusemachines

Thisproductmayinducedrowsiness.Patientsreceivingitshouldnotdriveoroperatemachineryunlessithasbeen

shownnottoaffectphysicalormentalability.

4.8Undesirableeffects

Sideeffectsincludeconstipation,nausea,vomiting,headacheandvertigo.Drowsiness,urinaryretention,abdominal

pain,paralyticileus,dizziness,confusion,hallucinations,paraesthesia,tolerance,dependence,respiratorydepression

andurticariamayoccur.

4.9Overdose

Symptomsofdihydrocodeineoverdosearetypicalofallopioidswithvaryingdegreesofcoma,respiratorydepression

andpinpointpupils.Thespecificopioidantagonistnaloxonehydrochlorideshouldbeusedtotreatsevererespiratory

depressionatadosageof0.4-2.0mgsubcutaneouslyorintravenously,repeatedasrequiredat2-3minuteintervalsor

itmaybegivenasacontinuousi.v.infusion.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Analgesics-Naturalopiumalkaloids

ATCcode:NO2AAO8

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/05/2010 CRN 2069929 page number: 3

severepain.

5.2Pharmacokineticproperties

Thepharmacokineticsofdihydrocodeinearesimilartothoseofcodeine.Absorptionafteroraladministrationmayvary

becauseofsubstantialfirstpassmetabolismintheliver.Peakplasmaconcentrationsareachievedinapproximately2

hours.Theeliminationhalf-lifevariesbetween3and5hours.Excretionoccursalmostentirelyviathekidneyas

conjugateswithglucuronicacid.

5.3Preclinicalsafetydata

Dihydrocodeinehydrogentartratehasbeenusedformanyyearsandthusitisnotconsiderednecessarytoprovide

informationunderthissection.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

LactoseMonohydrate

MicrocrystallineCellulose

MagnesiumStearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Storeintheoriginalpackageinordertoprotectfromlight.

6.5Natureandcontentsofcontainer

DF118tabletsarepackedinpolypropylenesecuritainersandareavailableinpacksof100and500.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

GalenLimited

SeagoeIndustrialEstate

Craigavon

BT635UA

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/05/2010 CRN 2069929 page number: 4

8MARKETINGAUTHORISATIONNUMBER

PA1329/007/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:4April1984

Dateoflastrenewal:15February2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 04/05/2010 CRN 2069929 page number: 5