FLECTOR TISSUGEL

Main information

  • Trade name:
  • FLECTOR TISSUGEL
  • Dosage:
  • 1.293 g Grams
  • Pharmaceutical form:
  • Medicated Plaster
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FLECTOR TISSUGEL
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0030/058/001
  • Authorization date:
  • 31-03-2006
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FlectorTissugel140mgmedicatedplaster

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each140cm 2 (10cmx14cm)ofmedicatedplastercontainsatotalof180mgofdiclofenacepolaminecorresponding

to140mgofdiclofenacsodium(1%w/w).

Excipients:

methylparahydroxybenzoate(E218):14mg

propylparahydroxybenzoate(E216):7mg

propyleneglycol:420mg

Referredtoamountperplaster.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Medicatedplaster.

Whitetopaleyellowpastespreadasauniformlayerontounwovensupport.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Localsymptomatictreatmentofpaininepicondylitisandanklesprain.

4.2Posologyandmethodofadministration

Cutaneoususeonly

Posology

Adultsandadolescents16yearsandolder

Symptomatictreatmentofanklesprains:1applicationaday

Symptomatictreatmentofepicondylitis:1applicationmorningandevening.

Durationofadministration

FlectorTissugelistobeusedforasshortaspossibledependingontheindication:

-Symptomatictreatmentofanklesprains:3days

-Symptomatictreatmentofepicondylitis:max.14days.

Ifthereisnoimprovement,duringtherecommendeddurationoftreatmentorsymptomsworsen,adoctorshouldbe

consulted.

Elderly

Thismedicationshouldbeusedwithcautioninelderlypatientswhoaremorepronetoadverseevents.SeealsoSection

4.4.

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Thereareinsufficientdataonefficacyandsafetyavailableforchildrenandadolescentsbelow16yearsofage(seealso

contraindicationsection4.3).

Inchildrenaged16yearsandover,ifthisproductisrequiredformorethan7daysforpainrelieforifthesymptoms

worsen,thepatient/parentsoftheadolescentsis/areadvisedtoconsultadoctor.

Patientswithhepaticorrenalinsufficiency

FortheuseofFlectorTissugelinpatientswithhepaticorrenalinsufficiencyseesection4.4.

Methodofadministration

Cuttheenvelopecontainingthemedicatedplasterasindicated.Removeonemedicatedplaster,removetheplasticfilm

usedtoprotecttheadhesivesurfaceandapplyittopainfuljointorregion.Ifnecessaryitcanbeheldinplacewithan

elasticnet.Carefullyresealtheenvelopewiththeslidingclosure.

Theplastershouldbeusedwhole.

4.3Contraindications

Thismedicinalproductiscontraindicatedinthefollowingcases:

-Hypersensitivitytodiclofenac,acetylsalysilicacidorothernon-steroidalanti-inflammatorydrugs(NSAIDs)orany

excipientsofthefinishedmedicinalproduct.

-damagedskin,whateverthelesioninvolved:exudativedermatitis,eczema,infectedlesion,burnorwound.

-fromthebeginningofthe6 th

monthofpregnancy(see4.6Pregnancyandlactation).

-Patientswithactivepepticulceration.

-Childrenandadolescentsagedlessthan16years.

4.4Specialwarningsandprecautionsforuse

Themedicatedplastershouldnotcomeintocontactwithorbeappliedtothemucosaeortheeyes.

Notforusewithocclusivedressing.

Discontinuethetreatmentimmediatelyifaskinrashdevelopsafterapplyingthemedicatedplaster.

Donotadministerconcurrently,byeitherthetopicalorthesystemicroute,anymedicinalproductcontaining

diclofenacorotherNSAIDs.

Althoughsystemiceffectsshouldbelow,theplastershouldbeusedwithcautioninpatientswithrenal,cardiacor

hepaticimpairment,historyofpepticulcerationorinflammatoryboweldiseaseorbleedingdiathesis.Non-steroidal

anti-inflammatorydrugsshouldbeusedwithparticularcautioninelderlypatientswhoaremorepronetoadverse

events.

-Thismedicinalproductcontainsmethylparahydroxybenzoateandpropylparahydroxybenzoate.Itmaycauseallergic

reactions(possiblydelayed).Italsocontainspropyleneglycol,whichmaycauseskinirritation.

-Patientsshouldbewarnedagainstexposuretodirectandsolariumsunlightinordertoreducetheriskof

photosensitivity.

-Bronchospasmmaybeprecipitatedinpatientssufferingfromorwithaprevioushistoryofbronchialasthmaor

allergenicdiseaseorallergytoacetylsalicylicacidorotherNSAID.Themedicatedplastershouldbeusedwithcaution

inpatientswithorwithoutchronicasthmainwhomattacksofasthma,urticariaoracuterhinitisareprecipitatedby

acetylsalicylicacidorothernon-steroidalanti-inflammatoryagents(see4.3Contraindications).Inordertominimisethe

occurrenceofundesirableeffectsitisrecommendedtousethelowesteffectivedosefortheshortestdurationnecessary

tocontrolsymptoms,withoutexceedingtheapprovedmaximum14days.(Pleaseseesection4.2and4.8)

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Inviewofthelowrateofsystemictransferduringnormaluseofthemedicatedplasters,thedruginteractionsreported

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4.6Fertility,pregnancyandlactation

Byanalogywiththeotherroutesofadministration

Pregnancy

Thereisinsufficientexperiencefortheuseduringpregnancy.Animalstudieshaveshownreproductivetoxicity(see

section5.3).Thepotentialriskforhumansisunknown.ThereforeFlectorTissugelshouldnotbeusedduringfirstand

secondtrimester,andiscontra-indicatedfromthebeginningofthe6 th

monthofpregnancy.

Duringthelasttrimesterofpregnancy,theuseofprostaglandinesynthetaseinhibitorsmayresultin:

Inhibitionofuterinecontractions,prolongationofpregnancyanddelivery

Pulmonaryandcardiactoxicityinthefoetus(pulmonaryhypertensionwithpretermclosingoftheductus

arteriosus)

Renalinsufficiencyinthefoetuswitholigohydramnios

Increasepossibilityofbleedinginthemotherandchildandincreasedoedemaformationinthemother.

Lactation

Experimentaldataregardingexcretionofdiclofenacepolamineinhumanoranimalmilkarenotavailabletherefore,

FlectorTissugelisnotrecommendedinnursingmothers.

4.7Effectsonabilitytodriveandusemachines

PatientswhoexperienceddizzinessorothercentralnervousdisturbanceswhiletakingNSAID'sshouldrefrainfrom

drivingoroperatingmachinery,butthiswouldbeveryunlikelyusingtopicalpreparationssuchasFlectorTissugel.

4.8Undesirableeffects

Skindisordersarecommonlyreported.

Skin:pruritus,redness,erythema(inveryrarecaseserythemabullosum),rashes,applicationsitereactions,allergic

dermatitis.

1252patientsweretreatedwithFlectorTissugeland734withPlaceboinclinicaltrials.Thefollowingadversedrug

reactionswerereported:

SystemOrganClass Common (

1/100,<1/10) Uncommon

1/1000,

<1/100) Rare

(1/10'000,

<1/1000)

Skinandsubcutaneoustissue

disorders 2.95%

-Pruritus 2.3%

-Redness 0.3%

-Erythema 0.05%

-Dermatitisallergic 0.15%

-Petechiae 0.1%

-Dryskin 0.05%

General disorders and

administrationsiteconditions 1.05%

-Applicationsiterash 0.5%

-Applicationsitereaction 0.4%

-Feelinghot 0.1%

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Undesirableeffectsmaybereducedbyusingtheminimumeffectivedosefortheshortestpossibleduration.

InpatientsusingtopicalNSAIDpreparations,inveryrarecases,generalisedskinrash,hypersensitivityreactionssuch

asangioedemaandreactionsofanaphylactictypeandphotosensitivityreactionshavebeenreported.

Systemicabsorptionofdiclofenacisverylowcomparedwithplasmalevelsobtainedfollowingadministrationoforal

formsofdiclofenacandthelikelihoodofsystemicside-effectsreactions(likegastric,hepaticandrenaldisorders)

occurringwithtopicaldiclofenacisverysmallcomparedwiththefrequencyofside-effectsassociatedwithoral

diclofenac.However,whereFlectorTissugelisappliedtoarelativelylargeareaofskinandoveraprolongedperiod,

thepossibilityofsystemicside-effectscannotbeexcluded.

4.9Overdose

Notapplicable

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Antiinflammatorypreparations,non-steroidsfortopicaluse.

ATCCode:M02AA15

Diclofenachydroxyethylpyrrolidineordiclofenacepolamineisawatersolublesaltofdiclofenac.

Diclofenacisanonsteroidalanti-inflammatorydrugderivedfromphenylaceticacidwhichbelongstothearyl

carboxylicacidgroupofcompounds.

Intheformofamedicatedplaster,ithastopicalanti-inflammatoryandanalgesicactivity.

5.2Pharmacokineticproperties

Followingcutaneousapplicationofthemedicatedplaster,diclofenacepolamineisabsorbedthroughtheskin.

Theabsorptionkineticsatsteadystateshowaprolongedreleaseoftheactiveingredientwithamaximumdiclofenac

plasmalevel(Cmax)of17.4±13.5ng/ml,whichisreachedafterabout5hours(Tmax5.4±3.7hours).

Diclofenacisextensivelyboundtoplasmaprotein(about99%).

Systemictransferinhealthyvolunteerswhenusingthemedicatedplaster,comparedwithoralformsofdiclofenac,isof

theorderof2%,asestimatedfromtheurinaryexcretionofthedruganditsmetabolitesandfromabetweenstudy

comparison.

5.3Preclinicalsafetydata

Preclinicaldatarevealnospecialhazardforhumans,beyondtheinformationincludedinothersectionsoftheSPC.In

theratandrabbit,diclofenacepolamineandepolaminemonosubstanceandN-oxideepolamine(mainmetaboliteof

epolamineinhumans)havecausedeinbryotoxicityandincreasedembryolethalityafteroraluse.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Supportinglayer:

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Adhesivelayer(activegel):

Gelatin

Povidone(K90)

Liquidsorbitol(noncrystallising)

Heavykaolin

Titaniumdioxide(E171)

Propyleneglycol

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Disodiumedetate(E385)

Tartaricacid

Aluminiumglycinate

Carmellosesodium

Sodiumpolyacrylate

1,3-butyleneglycol

Polysorbate80

DalinPHperfume(propyleneglycol,benzylsalicylate,phenylethylalcohol,alphaamylcinnamicaldehyde,

hydroxycitronellal,phenyethylphenylacetate,cinnamylacetate,benzylacetate,terpineol,cinnamicalcohol,

cyclamenaldehyde)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

3years.

Afterfirstopeningthesealedenvelope:3months.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Sealedenvelopesmadeofpaper/PE/aluminium/ethyleneandmethacrylicacidcopolymer.

Contains2or5medicatedplasters.

Packsize:2,5,10and14medicatedplastersperbox.

Notallpacksizemaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Remainingactiveingredientoftheplastermayposearisktotheaquaticenvironment.Donotflushusedplastersdown

thetoilet.Theplastersshouldbedisposedofaccordingtolocalrequirements.

7MARKETINGAUTHORISATIONHOLDER

NovartisConsumerHealthUKLimited

WimblehurstRoad

Horsham

WestSussexRH125AB

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8MARKETINGAUTHORISATIONNUMBER

PA30/58/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:04November2003

Dateoflastauthorisation:22August2009

10DATEOFREVISIONOFTHETEXT

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