ARTHRIMEL ONCE DAILY

Main information

  • Trade name:
  • ARTHRIMEL ONCE DAILY
  • Dosage:
  • 1500 Base Milligrams
  • Pharmaceutical form:
  • Powder for Oral Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ARTHRIMEL ONCE DAILY
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0126/149/004
  • Authorization date:
  • 13-11-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0126/149/004

CaseNo:2078176

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

ClonmelHealthcareLimited

WaterfordRoad,Clonmel,Co.Tipperary,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ArthrimelOnceDaily1500mgPowderforOralSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom25/05/2010until12/11/2014.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 25/05/2010 CRN 2078176 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ArthrimelOnceDaily1500mgPowderforOralSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachsachetcontains1884mgofglucosaminesulfateandsodiumchlorideequivalentto1500mgofglucosamine

sulfateand384mgofsodiumchlorideorto1178mgglucosamine.

Excipients:

Eachsachetcontains2.5mgaspartame,2,023.5mgsorbitoland6.57mmol(or151mg)sodium.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Powderfororalsolution.

Off-whitetoyellowishhomogeneouspowder.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Reliefofsymptomsinmildtomoderateosteoarthritisoftheknee.

4.2Posologyandmethodofadministration

Onesachet,dissolvedinaglassofwater,oncedailyforreliefofsymptoms.

Glucosamineisnotindicatedforthetreatmentofacutepainfulsymptoms.Reliefofsymptoms(especiallypainrelief)

maynotbeexperienceduntilafterseveralweeksoftreatmentandinsomecasesevenlonger.Ifnoreliefofsymptoms

isexperiencedafter2-3months,continuedtreatmentwithglucosamineshouldbere-evaluated.

Sachetscanbetakenwithorwithoutfood.

Additionalinformationonspecialpopulations.

ChildrenandAdolescents

Arthrimelisnotrecommendedforuseinchildrenandadolescentsbelowtheageof18years(seesection4.4).

Elderly

Nospecificstudieshavebeenperformedintheelderly,butaccordingtoclinicalexperiencedosageadjustmentisnot

requiredwhentreatingotherwisehealthy,elderlypatients.

Impairedrenaland/orliverfunction

Inpatientswithimpairedrenaland/orliverfunctionnodoserecommendationscanbegiven,sincenostudieshavebeen

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4.3Contraindications

Knownhypersensitivitytoglucosamineortoanyoftheexcipients.

Arthrimelmustnotbegiventopatientswhoareallergictoshellfishastheactivesubstanceisobtainedfromshellfish.

4.4Specialwarningsandprecautionsforuse

Thepresenceofjointdiseasesforwhichothertreatmentshouldbeconsideredmustberuledout.

Inpatientswithimpairedglucosetolerance,monitoringofthebloodglucoselevelsand,whererelevant,insulin

requirementsisrecommendedbeforestartoftreatmentandperiodicallyduringtreatment.

Inpatientswithaknownriskfactorforcardiovasculardisease,monitoringofthebloodlipidlevelsisrecommended,

sincehypercholesterolemiahasbeenobservedinafewcasesinpatientstreatedwithglucosamine.

Areportonexacerbatedasthmasymptomstriggeredafterinitiationofglucosaminetherapyhasbeendescribed

(symptomsresolvedafterwithdrawalofglucosamine).Asthmaticpatientsstartingonglucosamineshouldthereforebe

awareofpotentialworseningofsymptoms.

Glucosamineshouldnotbeusedinchildrenandadolescentsundertheageof18yearssafetyandefficacyhavenot

beenestablished.

Thismedicinalproductcontains6.57mmol(or151mg)sodiumpersachet.Tobetakenintoconsiderationbypatients

onacontrolledsodiumdiet.

Themedicinalproductcontainsaspartame,whichisasourceofphenylalanine.Itmaybeharmfulforpeoplewith

phenylketonuria.

Themedicinalproductcontainssorbitol:patientswithrarehereditaryproblemsoffructoseintolerance,shouldnottake

thismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Dataonpossibledruginteractionswithglucosamineislimited,butincreasedINRwithcoumarinanticoagulants

(warfarinandacenocoumarol)hasbeenreported.Patientstreatedwithcoumarinanticoagulantsshouldthereforebe

monitoredcloselywheninitiatingorendingglucosaminetherapy.

Concurrenttreatmentwithglucosaminemayincreasetheabsorptionandserumconcentrationoftetracyclines,butthe

clinicalrelevanceofthisinteractionisprobablylimited.

ConcurrenttreatmentwithglucosaminemaydecreasetheabsorptionofpenicillineVandchloramphenicol.

Duetolimiteddocumentationonpotentialdruginteractionswithglucosamine,oneshouldgenerallybeawareof

alteredresponseorconcentrationofconcurrentlyusedmedicinalproducts.

4.6Pregnancyandlactation

Pregnancy

Thereisnoadequatedatafromtheuseofglucosamineinpregnantwomen.Fromanimalstudies

onlyinsufficientdataareavailable,Glucosamineshouldthereforenotbeusedduringpregnancy.

BreastFeeding

Thereisnodataavailableontheexcretionofglucosamineinhumanmilk.Theuseofglucosamineduring

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4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.Ifdizzinessordrowsinessis

experienced,cardrivingandtheoperatingofmachineryisnotrecommended.

4.8Undesirableeffects

Themostcommonadversereactionsassociatedwithtreatmentwithglucosaminearenausea,abdominalpain,

indigestion,constipation,anddiarrhoea.Inaddition,headache,tiredness,rash,itching,andflushinghavebeen

reported.Thereportedadversereactionsareusuallymildandtransitory.

Inthetablebelow,allcausalityadverseeventsarelistedbysystemorganclassandfrequency(verycommon ≥1/10;

common ≥1/100to<1/10;uncommon≥1/1,000to<1/100;rare≥1/10,000to<1/1,000;veryrare<1/10,000;notknown

(frequencycannotbeestimatedfromtheavailabledata)).

SystemOrganClass Common Uncommon Notknown

Metabolismand

nutritiondisorders Hypercholesterolaemia,

bloodglucosecontrol

worsenedespeciallyin

patientswithdiabetes

mellitus/diabetes

mellitusinadequate

control

Nervoussystem

disorders Headache,

tiredness Dizziness-

Respiratory,thoracic

andmediastinal

disorder Asthma/asthmaaggravated

Gastrointestinal

disorders Nausea,

abdominalpain,

indigestion,

diarrhoea,

constipation Vomiting

Hepatobiliary

disorders Hepaticenzymeelevationand

jaundice

Skinand

subcutaneous

tissuedisorders Rash,

itching,

flushing Angioedema,

uriticaria

General

disordersand

administration

siteconditions Oedema/

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4.9Overdose

Signsandsymptomsofaccidentalorintentionaloverdosewithglucosaminemightincludeheadache,dizziness,

disorientation,arthralgia,nausea,vomiting,diarrhoeaorconstipation.

Incasesofoverdose,treatmentwithglucosamineshouldbediscontinuedandstandardsupportivemeasuresshouldbe

adoptedasrequired.

Inclinicaltrialsoneoffivehealthyyoungsubjectsexperiencedheadachefollowinginfusionofglucosamineupto30

g.Inaddition,onecaseofoverdosehasbeenreportedina12-yearoldfemalewhotookorally28gofglucosamine

hydrochloride.Shedevelopedarthralgia,vomitinganddisorientation.Thepatientfullyrecovered.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otheranti-inflammatoryandanti-rheumaticagents,non-steroidsATCcode:M01AX05

Glucosamineisanendogenoussubstance,anormalconstituentofthepolysaccharidechainsofcartilagematrixand

synovialfluidglucosaminoglycans.Invitroandinvivostudieshaveshownglucosaminestimulatesthesynthesisof

physiologicalglycosaminoglycansandproteoglycansbychondrocytesandofhyaluronicacidbysynoviocytes.

Themechanismofactionofglucosamineinhumansisunknown.

Theperiodtoonsetofresponsecannotbeassessed.

5.2Pharmacokineticproperties

Glucosamineisarelativelysmallmolecule(molecularmass179),whichiseasilydissolvedinwaterandsolublein

hydrophilicorganicsolvents.

Theavailableinformationonthepharmacokineticsofglucosamineislimited.Theabsolutebioavailabilityisunknown.

Thedistributionvolumeisapproximately5litresandthehalf-lifeafterintravenousadministrationisapproximately2

hours.Approximately38%ofanintravenousdoseisexcretedintheurineasunchangedsubstance.

5.3Preclinicalsafetydata

D-glucosaminehaslowacutetoxicity.

Animalexperimentaldatarelatingtotoxicityduringrepeatedadministration,reproductiontoxicity,mutagenicityand

carcinogenicityislackingforglucosamine.

Resultsfrominvitrostudiesandinvivostudiesinanimalshaveshownthatglucosaminereducesinsulinsecretionand

inducesinsulinresistance,probablyviaglucokinaseinhibitioninthebetacells.Theclinicalrelevanceisunknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Aspartame(E951)

Sorbitol(E420)

Citricacid,anhydrous

Macrogol4000

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years

6.4Specialprecautionsforstorage

Thismedicinalproductdoesnotrequireanyspecialstorageconditions.

6.5Natureandcontentsofcontainer

Paper/Aluminium/PEsachets.

Packsizesof10,20,30,40,60,90and180sachets.

Notallpack-sizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Anyunusedproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

ClonmelHealthcareLimited

WaterfordRoad

Clonmel

Co.Tipperary

Ireland

8MARKETINGAUTHORISATIONNUMBER

PA126/149/4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:13thNovember2009

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 25/05/2010 CRN 2078176 page number: 6