ARTHRIMEL 750 Milligram Film Coated Tablet

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
GLUCOSAMINE SULFATE GLUCOSAMINE SULPHATE SODIUM CHLORIDE
Available from:
FMC Pharma Ltd
INN (International Name):
GLUCOSAMINE SULFATE GLUCOSAMINE SULPHATE SODIUM CHLORIDE
Dosage:
750 Milligram
Pharmaceutical form:
Film Coated Tablet
Prescription type:
Product not subject to medical prescription
Authorization status:
Authorised
Authorization number:
PA1521/004/002
Authorization date:
0000-00-00

PackageLeaflet:InformationfortheUser

Arthrimel®750mgFilm-CoatedTablets

GlucosamineSulfate

Readallofthisleafletcarefullybeforeyoustarttakingthismedicinebecauseitcontains

importantinformationforyou.

Alwaystakethismedicineexactlyasdescribedinthisleafletorasyourdoctororpharmacist

havetoldyou.

Keepthisleaflet.Youmayneedtoreaditagain.

Askyourpharmacistifyouneedmoreinformationoradvice.

Ifyougetanysideeffects,talktoyourdoctororpharmacist.Thisincludesanypossible

sideeffectsnotlistedinthisleaflet.

Youmusttalktoadoctorifyoudonotfeelbetterorifyoufeelworseafter1month.

Inthis leaflet:

WhatArthrimel® is and whatitis used for

Beforeyou takeArthrimel®

Howto takeArthrimel®

Possiblesideeffects

Howto storeArthrimel®

Furtherinformation

1. WhatArthrimel®is andwhatitis usedfor

Arthrimel® belongs to agroup ofmedicines called otheranti-inflammatoryandanti-

rheumaticagents, non steroids.

Arthrimel®is used forthereliefofsymptoms ofmild to moderateosteoarthritisoftheknee

thathas previouslybeendiagnosed byyourdoctor.

Osteoarthritis is atypeofjointdegeneration thatgenerates symptoms suchas stiffness(after

sleep orlongrest)and pain atmotion(e.g. when climbingthestairs orwalkingalonguneven

surfaces).

2. BeforeyoutakeArthrimel®

DONOTTAKEArthrimel®

-Ifyou areallergic(hypersensitive)to:

-GlucosamineortoanyoftheotheringredientsofArthrimel®(seeSection6“Further

Information”)

-Shellfish, sinceArthrimel® is manufacturedfromshellfish.

TAKESPECIALCAREwithArthrimel®ifyou

- Sufferfromimpairedglucosetolerance.Morefrequentcontrolsofyourbloodglucose

levels maybenecessarywhenstartingtreatmentwithArthrimel®

- Havekidneyorliverdysfunction,sincenostudieshavebeenperformedinsuchpatients

doserecommendations cannotbegiven.

- Haveaknownriskfactorforheart(cardiovascular)disease,sincehighcholesterol

(hypercholesterolemia)hasbeenobservedinafewcasesinpatientstreatedwith

Arthrimel®.

- Sufferwithasthma.WhenstartingonArthrimel®,youshouldbeawareofpotential

worseningofsymptoms.

- Ifyouhavejointswelling,warmthandredness,jointpainfulness,persistentjoint

stiffness,painatrest,paininmorethanonejoint,increasedbodytemperatureand

decreaseinbodyweightbecausetheycanbesymptomsofmoreseriousdiseasessuchas

rheumatoid arthritis, systemiclupus, gout, tumours.

Consulta doctorbeforeusingArthrimel®.ifany oftheabovementionedapplies to you.

Takingothermedicines

Pleasetellyourdoctororpharmacistifyou aretakingorhaverecentlytaken anyother

medicines, includingmedicines obtained withoutaprescription.

Caution should beexercised ifArthrimel® has tobecombined with othermedicines,

especiallywith:

-Warfarin(amedicineused to thin theblood)orsimilartypeofproducts(anticoagulents

used to preventblood-clotting). Theeffectoftheanticoagulantmaybeintensified in

association with glucosamine. Patients treated with such combinations should thereforebe

monitored extracarefullywhen initiatingorendingglucosaminetherapy.

-Medicines fordiabetes,yourdoctormaywish tomonitoryourblood sugarlevels closely

whileyouaretakingArthrimel®

-Tetracycline(anantibioticeffectiveagainstawiderangeofbacterialinfections).

PleasecontactyourdoctororpharmacistformedicaladvicebeforeusingArthrimel®ifyou

useanyoftheabovementioned medicines.

Taking Arthrimel®withfoodanddrink

You can takeArthrimel®with orwithoutfood.

Pregnancy andbreast-feeding

Arthrimel®shouldnotbeusedduringpregnancy.TheuseofArthrimel®duringbreast-

feedingisnotrecommended.Askyourdoctororpharmacistforadvicebeforetakingany

medicine.

Driving andusing machines

Nostudiesontheeffectsontheabilitytodriveandusemachineshavebeenperformed.If

youexperiencedizzinessordrowsinessfromArthrimel®,youshouldnotdriveoroperate

machinery.

Importantinformationaboutsomeoftheingredients ofArthrimel®

Thismedicinalproductcontains76mgsodiumpertablet.Thisshouldbetakeninto

considerationbypatientsonacontrolledsodiumdiet.Arthrimel®containslactose.Ifyouhave

beentoldbyyourdoctorthatyouhaveanintolerancetosomesugars,contactyourdoctorbefore

takingthismedicinalproduct.Arthrimel®containssoyalecithin.Donotusethisproductifyou

areallergictosoyaorpeanuts.

3. Howto takeArthrimel®

Always takeArthrimel®exactlyasyourdoctorhas toldyou. You should check withyour

doctororpharmacistifyou arenotsure.

OneArthrimel® tabletshould betakentwicedailyorTwo Arthrimeltabletsto betaken once

daily.Thetablets should beswallowed wholewith water.

Arthrimel® is notindicated forthetreatmentofacutepainfulsymptoms(rapid onsetofbrief

severepain). Reliefofsymptoms(especiallypain relief)maynotbeexperienced untilafter

severalweeks oftreatmentand in somecases even longer.Ifno reliefofsymptoms is

experienced after2-3 months, continued treatmentwith Arthrimel® should bere-evaluatedby

yourhealthcarepractitioner. You should stop takingArthrimel® and seeyourdoctorifyou

experienceanydeterioration in symptoms afterstartingArthrimel®.

Childrenandadolescents

Arthrimel®isnotrecommendedforuseinchildrenandadolescentsbelowtheageof18,due

to lack ofdataon safetyand efficacy.

Elderly

No dosageadjustmentis requiredwhen treatingotherwisehealthyelderlypatients, however

yourdoctorwilldecideyourdose.

Patients withimpairedrenaland/orliverfunction

No doserecommendations can begiven, sincenostudies havebeen performed.

IfyoutakemoreArthrimel®thanyoushould

Ifyou havetaken largequantitiesyou mustconsultyourdoctororahospital.

Incaseofan overdoseyou mayexperiencesymptoms such as:

headache

dizziness

disorientation

jointpain

feelingsick(nausea)orbeingsick(vomiting)

diarrhoeaorconstipation.

Ifyouforgetto takeArthrimel®

Do nottakeadoubledoseto makeup foraforgotten dose.

Ifyoustopusing Arthrimel®

Yoursymptomsmayreoccur.Ifyouhaveanyfurtherquestionsontheuseofthisproduct,

askyourdoctororpharmacist.

4. Possiblesideeffects

Likeallmedicines,Arthrimel®can causesideeffects, although noteveryonegets them.

You should stop takingArthrimel® and seeyourdoctorimmediatelyifyou experience

symptoms such as:swollen face, tongueand/orpharynxand/ordifficultytoswalloworhives

togetherwith difficultiesto breathe(angioedema).

Thefollowingsideeffects havebeenreported:

Commonside-effects(inless than1 in10patients butinmorethan1 outof100 patients

treated)

Headache

Tiredness

Nausea

Abdominalpain

Indigestion

Diarrhoea

Constipation

Wind(flatulence)

Uncommonside-effects(inless than1 in100patients butmorethan1 in1000 patients

treated)

Rash

Itching

Flushing

Unknownfrequency

Allergicreaction

Visualdisturbance

Hairloss(alopecia)

Dizziness

Swellingofthefeetorankles

Vomiting

Diabetes mellitus inadequatecontrol

Asthmaoraggravation ofpre-existingasthma

Increased liverenzymes(hepaticenzymeelevation)

Yellowdiscoloration oftheskin(jaundice)

Elevated cholesterollevels havebeenalso reported.Itis notpossibleto determinewhether

theseevents weredirectlyrelated toArthrimel®

Ifanyofthesideeffectsgets serious, orifyou noticeanysideeffects notlisted in this leaflet,

pleasetellyourdoctororpharmacist.

Reportingofsideeffects

Ifyougetanysideeffects, talk toyourdoctororpharmacist. This includesanypossibleside

effects notlisted in this leaflet. Youcanalso reportsideeffects directly(seedetails below).

Byreportingsideeffectsyou can help providemoreinformation on thesafetyofthis

medicine. Reports maybemadebyfollowingthelinks to theonlinereportingoption

accessiblefromtheIMBhomepage, orbycompletingthedownloadablereportformalso

accessiblefromtheIMBwebsite, which maybecompleted manuallyand submitted to the

IMBviafreepost, to thefollowingaddress:

FREEPOST

PharmacovigilanceSection

Irish MedicinesBoard

Kevin O’MalleyHouse

EarlsfortCentre

EarlsfortTerrace

Dublin 2

Tel:+353 1 6764971

Fax:+353 1 6762517

Website:www.imb.ie

e-mail:imbpharmacovigilance@imb.ie

5. Howto storeArthrimel®

Keepoutofthereachandsightofchildren.

Donotstoreabove25 C.Storein theoriginalpackagein orderto protectfrommoisture.

Do notuseArthrimel®aftertheexpirydatestatedon thelabeland cartonafterEXP:.The

expirydatereferstothelastdayofthatmonth.

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyour

pharmacisthowtodisposeofmedicinesnolongerrequired.Thesemeasureswillhelpto

protecttheenvironment.

6. Furtherinformation

WhatArthrimel®contains

Theactivesubstanceisglucosaminesulfate.Eachtabletcontains942 mgofglucosamine

sulfatesodiumchloride(equivalentto750 mgofglucosaminesulfate).

Theotheringredients are

Tablet:Microcrystallinecellulose101,Microcrystallinecellulose102,lactosemonohydrate,

pregelatinised maizestarch, crospovidone, stearicacid.

Coating:titaniumdioxide(E171),talc(E553b),Lecithinsoya(E322),macrogol3350,

poly(vinyl)alcoholhydrolysed.

WhatArthrimel®lookslikeandcontents ofthepack

Arthrimel®750mgtablets areoff-white, oblong, film-coated tablets.

Thetablets areavailablein two types ofpackaging:

Cartons containingPVdCcoated PVC/Alblisters.

Pack Size:8, 10, 12, 14,20, 28, 30, 56, 60, 112, 120, 168, 180, 336, 360 film-coated tablets.

Cartons containingHDPE containers fitted with atamper-evidentHDPE screwcap.

Pack Size:8, 10, 12, 14,20, 28, 30, 56, 60, 112, 120, 168, 180, 336, 360 film-coated tablets.

Notallpack sizes maybemarketed.

Marketing authorisationholder

FMCPharmaLtd.

Unit622, Northern extension, Co. Waterford

Ireland

Manufacturers

ClonmelHealthcareLtd.,Waterford Road, Clonme1, Co. Tipperary,Ireland.

ChanelleMedical,Loughrea, Co.Galway,Ireland.

Walmark a.s, Polni/73961 Trinec1, Czech Republic.

This leafletwas lastapprovedinAugust2013.

Arthrimel®.is aregistered Trademark.

Document Outline

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Arthrimel750mgFilmCoatedTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains942mgglucosaminesulfatesodiumchlorideequivalentto750mgglucosamine

sulfate.

Excipients:

Eachtabletcontains75.9mg(3.3mmol)ofsodium.

Lactosemonohydrate3.0mg

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Film-coatedtablets

Off-white,oblongshapedfilm-coatedtablet

4CLINICALPARTICULARS

4.1TherapeuticIndications

Arthrimeltabletsareindicatedforreliefofsymptomsinmildtomoderateosteoarthritisofthekneeasdiagnosedbya

doctor.

4.2Posologyandmethodofadministration

Administration:

Arthrimeltabletsshouldbeswallowedwhole.

Tabletscanbetakenwithorwithoutfood.

Adultsandtheelderly:

OneArthrimeltabletshouldbetakentwicedaily.

TwoArthrimeltabletstobetakenoncedaily.

Glucosamineisnotindicatedforthetreatmentofacutepainfulsymptoms.Reliefofsymptoms(especiallypainrelief)

maynotbeexperienceduntilafterseveralweeksoftreatmentandinsomecasesevenlonger.Ifnoreliefofsymptoms

isexperiencedafter2-3months,continuedtreatmentwithglucosamineshouldbereevaluatedbyyourhealthcare

practitioner.

Patientsshouldseekmedicaladviceiftheirsymptomsdeteriorateaftercommencingtreatmentwithglucosamine.

Additionalinformationonspecialpopulations:

Children/adolescents:

Safetyandefficacyhasnotbeenestablishedinchildrenandadolescents,therefore,Arthrimeltabletsshouldnotbeused

inpersonsundertheageof18years.

Irish Medicines Board

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Date Printed 13/01/2014 CRN 2131241 page number: 1

Nospecificstudieshavebeenperformedintheelderly,butaccordingtoclinicalexperiencedosageadjustmentisnot

requiredwhentreatingotherwisehealthy,elderlypatients.

Impairedrenaland/orliverfunction

Inpatientswithimpairedrenaland/orliverfunctionnodoserecommendationscanbegiven,sincenostudieshavebeen

performed.

4.3Contraindications

Knownsensitivitytoglucosamine(oranyofitsderivatives),sulfatesoranyoftheotheringredientsinArthrimeltablets

(listedinsection6.1).

Arthrimeltabletsmustnotbeusedinpatientswhoareallergictoshellfishastheactiveingredientisobtainedfrom

shellfish.

Arthrimeltabletscontainsoyalecithin.Personsallergictosoyaorpeanutshouldthereforenotusethismedicinal

product.

4.4Specialwarningsandprecautionsforuse

Warnings

Arthrimeltabletscontainlactosemonohydrate,patientswithrarehereditaryproblemsofgalactoseintolerance,the

Lapplactasedeficiencyorglucose-galactosemalabsorptionshouldnottakethismedicine.

Thismedicinalproductcontains75.9mgsodiumperdose.Thedailysodiumintakeis151.7mg(equivalentto6.6

mmol).Tobetakenintoconsiderationbypatientsonacontrolledsodiumdiet.

Thepresenceofotherjointdisease,whichwouldrequirealternativetreatment,shouldbeexcluded.

Inpatientswithimpairedglucosetolerance,monitoringofthebloodglucoselevelsand,whererelevant,insulin

requirementsisrecommendedbeforestartoftreatmentandperiodicallyduringtreatment.

Inpatientswithaknownriskfactorforcardiovasculardisease,monitoringofthebloodlipidlevelsisrecommended

sincehypercholesterolemiahasbeenobservedinafewpatientstreatedwithglucosamine.

Areportonexacerbatedasthmasymptomstriggeredafterinitiationofglucosaminetherapyhasbeendescribed

(symptomsresolvedafterwithdrawalofglucosamine).Asthmaticpatientsstartingonglucosamineshouldthereforebe

awareofpotentialworseningofasthmasymptoms.

Ifunusualsignsorsymptomsappear,orifanychangesinthecourseofusualsymptomsoccur,thepatientis

recommendedtoconsultthephysicianimmediately.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Increasedeffectofcoumarinanticoagulants(e.g.warfarin)duringconcomitanttreatmentwithglucosaminehasbeen

reported.Patientstreatedwithcoumarinanticoagulantsshouldthereforebemonitoredcloselywheninitiatingorending

glucosaminetherapy.

Closemonitoringofbloodsugarlevelsisrecommendedfordiabeticsonhypoglycaemicagents.

Concurrenttreatmentwithglucosaminemayincreasetheabsorptionandserumconcentrationsoftetracyclines,butthe

clinicalrelevanceofthisinteractionisprobablylimited.

Duetolimiteddocumentationonpotentialdruginteractionswithglucosamine,oneshouldgenerallybeawareof

Irish Medicines Board

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Date Printed 13/01/2014 CRN 2131241 page number: 2

4.6Fertility,pregnancyandlactation

Pregnancy:

Thereareinadequatedataconcerningtheuseofglucosamineinpregnantwomen.Fromanimalstudiesonlyinsufficient

dataareavailable.Glucosamineshouldnotbeusedduringpregnancy.

Breastfeeding:

Thereisnodataavailableontheexcretionofglucosamineinbreastmilk.Theuseofglucosamineduringbreastfeeding

isthereforenotrecommendedasthereisnodataonthesafetyofthechild.

4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsontheabilitytodriveorusemachineshavebeenperformed.Ifdizzinessordrowsinessis

experienced,cardrivingandtheoperatingofmachineryisnotrecommended.

4.8Undesirableeffects

Themostcommonadversereactionsassociatedwithtreatmentwithglucosaminearenausea,abdominalpain,

indigestion,constipationanddiarrhoea.Inaddition,headache,tiredness,rashitching,andflushinghavebeenreported.

Thereportedadversereactionsareusuallymildandtransitory.

MedraSystem

OrganClass Common(1/100

to<1/10) Uncommon

(1/1,000to

<1/100) Rare(1/10,000

to<1/1000) Notknown

(cannotbe

estimatedfrom

theavailable

data)

Nervoussystem

disorders Headache

Tiredness Dizziness

Respiratory,

thoracicand

mediastinal

disorders Asthma/Asthma

aggravated

Gastrointestinal

disorders Nausea

Abdominalpain

Indigestion

Diarrhoea

Constipation Vomiting

Skinand

subcutaneous

tissuedisorders Rash

Itching

Flushing Angiodema

Urticaria

Metabolismand

nutrition

disorders Diabetesmellitus

inadequatecontrol

Hypercholesterolaemia

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/01/2014 CRN 2131241 page number: 3

CasesofHypercholesterolemia,Asthma,aggravatedandDiabetesmellitusinadequatecontrolhavebeenreported,but

causalityhasnotbeenestablished.

ArthrimeltabletsmaycauseHepaticenzymeelevationandrarelyjaundice.

Reportingofsuspectedadversereactions

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportany

suspectedadversereactionspreferablythroughtheonlinereportingoptionaccessiblefromtheIMBhomepage.A

downloadablereportformisalsoaccessiblefromtheIMBwebsite,whichmaybecompletedmanuallyandsubmitted

totheIMBvia‘freepost’,inadditiontothetraditionalpost-paid‘yellowcard’option.

FREEPOST

PharmacovigilanceSection

IrishMedicinesBoard

KevinO’MalleyHouse

EarlsfortCentre

EarlsfortTerrace

Dublin2

Tel:+35316764971

Fax:+35316762517

Website: www.imb.ie

e-mail: imbpharmacovigilance@imb.ie

4.9Overdose

Signsandsymptomsofaccidentalorintentionaloverdosewithglucosaminemightincludeheadache,dizziness,

disorientation,arthralgia,nausea,vomiting,diarrhoeaorconstipation.

Incasesofoverdose,treatmentwithglucosamineshouldbediscontinuedandstandardsupportivemeasuresshouldbe

adoptedasrequired.

Inclinicaltrialsoneoffivehealthyyoungsubjectsexperiencedheadachefollowinginfusionofglucosaminupto30g.

Inaddition,onecaseofoverdosehasbeenreportedina12-yearoldfemalewhotookorally28gofglucosamine

hydrochloride.Shedevelopedarthralgia,vomitinganddisorientation.Thepatientfullyrecovered.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Otheranti-inflammatoryandanti-rheumaticagents,non-steroidalanti-inflammatorydrugs.

ATCcode:M01AX05

Glucosamineisanendogenoussubstance,anormalconstituentofthepolysaccharidechainsofcartilagematrixand

synovialfluidglucosaminoglycans.Invitroandinvivostudieshaveshownglucosaminestimulatesthesynthesisof

physiologicalglycosaminoglycansandproteoglycansbychondrocytesandofhyaluronicacidbysynoviocytes.The

mechanismofactionofglucosamineinhumansisunknown.Theperiodtoonsetofresponsecannotbeassessed.

5.2Pharmacokineticproperties

Glucosamineisarelativelysmallmolecule(molecularmass179),whichiseasilydissolvedinwaterandsolublein

and

administration

siteconditions oedema Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/01/2014 CRN 2131241 page number: 4

absolutebioavailabilityisunknown.Thedistributionvolumeisapproximately5litresandthehalf-lifeafterintravenous

administrationisapproximately2hours.Approximately38%ofanintravenousdoseisexcretedintheurineas

unchangedsubstance.

5.3Preclinicalsafetydata

D-glucosaminehaslowacutetoxicity.Animalexperimentaldatarelatingtotoxicityduringrepeatedadministration,

reproductiontoxicity,mutagenicityandcarcinogenicityislackingforglucosamine.

Resultsfrominvitrostudiesandinvivostudiesinanimalshaveshownthatglucosaminereducesinsulinsecretionand

inducesinsulinresistance,probablyviaglucokinaseinhibitioninthebetacells.Theclinicalrelevanceisunknown.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose

Lactosemonohydrate

Pregelatinisedmaizestarch

Crospovidone

Stearicacid

Polyvinyl-alcoholparthydrolyzed

Titaniumdioxide(E171)

TalcE553b

LecithinsoyaE322

Macrogol3350

6.2Incompatibilities

Notapplicable.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Storeintheoriginalpackageinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

CartonscontainingPVdCcoatedPVC/Alblisterstrips,orHDPEcontainersfittedwithatamper-evidentHDPEscrew

cap.

PackSize:8,10,12,14,20,28,30,56,60,112,120,168,180,336,360film-coatedtablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/01/2014 CRN 2131241 page number: 5

7MARKETINGAUTHORISATIONHOLDER

FMCPharmaLtd

Unit622

NorthernExtension

Co.Waterford

8MARKETINGAUTHORISATIONNUMBER

PA1521/004/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:15 th

July2011

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 13/01/2014 CRN 2131241 page number: 6

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