BY-MADOL

Main information

  • Trade name:
  • BY-MADOL Capsule 50 Milligram
  • Dosage:
  • 50 Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BY-MADOL Capsule 50 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0915/026/001
  • Authorization date:
  • 27-03-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0915/026/001

CaseNo:2080524

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

HelsinnBirexTherapeuticsLtd

Damastown,Mulhuddart,Dublin15,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

By-Madol50mgCapsules

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom11/05/2010.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 11/05/2010 CRN 2080524 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

By-Madol50mgCapsules

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains50mgtramadolhydrochloride.

Excipients:Lactosemonohydrate 103.0mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard.

Capsuleshaveahard,yellowcapandagreenbody.Eachcapsuleisprinted'TRA50'onthecapandbody.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Management(treatmentandprevention)ofseverepain.

4.2Posologyandmethodofadministration

Aswithallanalgesics,thedoseofBy-Madolshouldbeadjustedaccordingtotheseverityofthepainandtheclinical

responseoftheindividualpatient.Treatmentperiodsshouldbeshortandintermittentasdependencecanoccurwith

tramadol.Thebenefitsofcontinueduseshouldbereviewedinordertoensurethattheyoutweightherisksof

dependence(seeSpecialWarnings&PrecautionsforUseandUndesirableEffectsSections).

Adultsandadolescentsovertheageof12years:

Dependingupontheseverityofthepain,theinitialdoseis50to100mgtramadol,then50mgto100mg4-6hourly.If

tramadolisusedforthetreatmentofacutepain,itshouldbetakenintoaccountthattheeffectstartsslightlylaterthan

thatofotheranalgesics.Foracutepainaninitialdoseof100mgisusuallyrequired.Forpainassociatedwithchronic

conditions,aninitialdoseof50mgisrecommended.Atotaldailydoseofmorethan400mgisnotusuallyrequired.

Elderly:

Theusualdosagesmaybeusedsincenosignificantchangeofthepharmacokineticparametersappears.

Renalandhepaticimpairment:

Inpatientswithrenalorhepaticimpairmenttheusualinitialdosemaybeused,howevertheintervalbetween

subsequentdosesshouldbetwiceaslong.Inpatientswithbothrenalandhepaticimpairment,theuseoftramadol

shouldbeavoided.

RenalDialysis:

Tramadolisremovedveryslowlybyhaemodialysisorhaemofiltration,thereforepostdialysisadministrationto

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Childrenunder12years:

OnaccountoftheirhighdosagestrengthBy-Madol50mgcapsulesarenotrecommendedforuseinchildrenunder12

years.

Routeofadministration:Oral.

4.3Contraindications

Hypersensitivitytotramadoloranyoftheexcipientsorotheropioids.

Acuteintoxicationwithalcohol,hypnotics,centrallyactinganalgesicsorothercentrallyactingdrugs.Tramadolshould

notbeadministeredtopatientsconcomitantlywithmonoamineoxidaseinhibitorsorwithintwoweeksoftheir

withdrawal.

4.4Specialwarningsandprecautionsforuse

Tramadolhasthepotentialtocausephysicaldependenceattherapeuticdoses(SeeUndesirableEffects).

By-Madolshouldbeusedwithcautioninpatientswithheadinjury,increasedintracranialpressure,severeimpairment

ofhepaticandrenalfunctionandinpatientspronetoconvulsivedisordersorinshock.

Careshouldbetakenwhentreatingpatientswithsevererespiratorydepression,ifconcomitantlyCNSdepressantdrugs

arebeingadministeredoriftherecommendeddoseisexceededconsiderably,sincethepossibilityofrespiratory

depressioncannotbeexcludedinthesesituations.

Tramadolisnotsuitableasasubstituteinopioid-dependentpatients.Althoughitisanopioidagonist,itcannot

suppressmorphinewithdrawalsymptoms.

Forphysicaldependency,addictionandhabituation:seeUndesirableEffects.

Inonestudyuseoftramadolduringgeneralanaesthesiawithenfluraneandnitrousoxidewasreportedtoenhance

intraoperativerecall.UntilfurtherinformationisavailableuseofBy-Madolwithsuchanaesthesiashouldbeavoided.

Convulsionshavebeenreportedinpatientsreceivingtramadolattherecommendeddoselevels.Theriskmaybe

increasedwhendosesoftramadolexceedtherecommendedupperdailylimit(400mg).Inaddition,tramadolmay

increasetheseizureriskinpatientstakingothermedicationthataffectstheseizurethreshold(seeInteractions).

Patientswithepilepsyorthosesusceptibletoseizuresshouldbeonlytreatedwithtramadoliftherearecompelling

circumstances.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concomitantadministrationoftramadolwithmonoamineoxidaseinhibitorsorwithintwoweeksoftheirwithdrawalis

contraindicated.Concomitantadministrationoftramadolwithothercentrallyactingdrugsincludingalcoholmay

potentiateCNSdepressanteffects.

Therehavebeenisolatedspontaneousreportsofepileptiformconvulsionswhichinmostinstancesoccurredafter

intravenousadministrationofahighsingledoseoftramadolorduringconcomitantusewithantipsychoticsknownto

induceconvulsions.

Simultaneousadministrationwithcimetidineisassociatedwithclinicallyinsignificantchangesinserumconcentrations

oftramadol.Theeliminationhalf-lifeoftramadolmaybeslightlyprolongedbysome1-2hours.Undernormal

circumstancesthisshouldbeinsufficienttohaveclinicalrelevance.However,becauseofinter-individualvariation,it

isrecommendedthatcareshouldbetakenifprolongedco-administrationwithagentssuchascimetidineisneeded.

Simultaneousadministrationofcarbamazepinemarkedlydecreasesserumconcentrationsoftramadoltotheextentthat

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Tramadolcaninduceconvulsionsandincreasethepotentialforbothselectiveserotoninreuptakeinhibitors(SSRIs)

andtricyclicantidepressants(TCAs)tocauseconvulsions.

4.6Pregnancyandlactation

Thereisinadequateevidenceavailableonsafetyoftramadolinhumanpregnancy,butithasbeeninwideuseformany

yearswithoutapparentillconsequences.Animalstudieshavenotrevealedharmfuleffects.Astramadolcrossesthe

placenta,useduringpregnancyshouldonlybeconsideredifthereisnosaferalternative.

Tramadolmaybeusedduringdelivery.

Tramadolanditsmetabolitesarefoundinsmallamountsinhumanbreastmilk.Aninfantcouldingestabout0.1%ofa

dosegiventothemother.Tramadolshouldnotbeadministeredduringlactation.

4.7Effectsonabilitytodriveandusemachines

TramadolmaycausedrowsinessanddizzinessandthiseffectcanbepotentiatedbyalcoholandotherCNSdepressants.

Ambulantpatientsshouldbewarnednottodriveoroperatemachineryifaffected.

4.8Undesirableeffects

Aswithotheropioidsthefollowingadverseeffectshavebeenreported:dyspnoea,wheeze,bronchospasmand

worseningofexistingasthma,nausea,vomiting,drymouth,tiredness,fatigue,drowsiness,dizziness,headache,

pruritus,urticaria,sweating,flushing.

Orthostaticeffectse.g.posturalhypotensionandtachycardia,particularlyafterrapidintravenousadministrationhave

beenreportedrarely.Otherrareadverseeffectsincludegastrointestinalirritation,constipation,rashandCNS

excitation.

PhysicalDependence:

Dependence,abuseandwithdrawalreactionshavebeenreported.Themajorityofwithdrawalreactionsymptomsare

similartothoseoccurringduringopiatewithdrawalandincludeagitation,anxiety,nervousness,insomnia,

hypertension,tremorandgastrointestinalsymptoms(SeePosologyandAdministrationandSpecialWarnings).

4.9Overdose

Thesymptomsofoverdosearetypicalforopioid-analgesicsandincludemiosis,vomiting,cardiovascularcollapse,

sedationandcoma,seizuresandrespiratorydepression.Supportivemeasuressuchasmaintainingrespiratoryand

cardiovascularfunctionsshouldbeinstituted;naloxoneshouldbeusedtoreverserespiratorydepression;fitscanbe

controlledwithdiazepam.Astramadolisminimallyeliminatedfromtheserumbyhaemodialysisorhaemofiltration,

treatmentofacuteintoxicationwithBy-Madolwithhaemodialysisorhaemofiltrationaloneisnotsuitablefor

detoxification.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Tramadolisacentrallyactinganalgesic,effectiveformoderatetosevereacuteandchronicpains.Tramadolconsistsof

twoenantiomers.The(+)-isomerispredominantlyactiveasanopiatewithahigheraffinityfortheµ-opiatereceptor

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The(+)-desmethylmetabolitewillcertainlycontributetoitsactionasanopiateaswell.Themetabolitehasasixtimes

strongeraffinityfortheµ-receptorinvivothantramadol.Invitrothisaffinityis170timesstronger.The(-)-isomeracts

asaninhibitorofthere-uptakeofnoradrenalineandpotentiatestheanalgeticactionofthe(+)-isomer.Thecontribution

ofthestimulationoftheserotoninreleaseisconsideredlow.

Tramadolhasananalgesicandanti-tussiveeffect.Unlikemorphinerespiratorysuppressionishardlyobservedat

therapeuticdoses.Theinfluenceongastro-intestinalmotilityandonthecardiovascularsystemislowatthesedoses.

5.2Pharmacokineticproperties

Tramadolisabsorbedrapidlyandcompletelyafteroraladministration.Theabsolutebiologicalavailabilityis60-95%,

(onaverage72%).Maximumserumconcentrationsarereachedafterapprox.1hour.

Plasmaproteinbindingamountsto20%.Tramadolpassestheblood-brainbarrierandtheplacenta.Theexcretionof

tramadoloritsmetabolitesinhumanbreastmilkissmall(±0.1%).Tramadolisespeciallymetabolisedby

demethylationfollowedbyglucuronidationofthe0-desmethyl-metabolite.Only0-desmethyl-tramadolis

pharmacologicallyactive.Tramadolanditsmetabolitesarealmostcompletelyexcretedrenally,ofwhich

approximately10%isunchangedtramadol.Thehalflifeoftheterminaleliminationphaseofbothtramadolandits

metabolitesisapproximately6hours,bothinyoungvolunteersandinelderlypatients.Sincetramadoliseliminated

bothmetabolicallyandrenally,thehalflifeoftheterminaleliminationphasemaybeprolongedinimpairedhepatic

andrenalfunction.Inthosecasesthehalflifeoftheterminaleliminationphaseistwiceaslong.Inpatientswithboth

renalandhepaticimpairment,theuseoftramadolshouldbeavoided.

5.3Preclinicalsafetydata

Noparticulars.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

PolyvidoneK30

Lactosemonohydrate

Magnesiumstearate

Sodiumstarchglycolate(TypeA)

Hardgelatincapsuleshell:

Body:

YellowL520

Gelatin

Water

Erythrosine(E127)

TitaniumDioxide(E171)

Yellowironoxide(E172)

Cap:

GreenL730

Gelatin

Water

Indigocarmine(E132)

Titaniumdioxide(E171)

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PrintingInkColorconS-1-27794:

Shellac

Industrialmethylatedspirit740P

n-butylalcohol

Blackironoxide(E172)

Purifiedwater

Propyleneglycol

Isopropylalcohol

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

By-Madol50mgcapsulesarepackedinaPVC/PVDCblisterstripwithaluminiumfoil,packedinacardboardcarton.

Availableinpacksizesof10,30,60or100.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequiremnets.

7MARKETINGAUTHORISATIONHOLDER

HelsinnBirexTherapeuticsLtd

Damastown

Mulhuddart

Dublin15

8MARKETINGAUTHORISATIONNUMBER

PA915/26/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:24 th

August2001

10DATEOFREVISIONOFTHETEXT

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