GERINAP E.C.

Main information

  • Trade name:
  • GERINAP E.C.
  • Dosage:
  • 250 Milligram
  • Pharmaceutical form:
  • Tablets Gastro-Resistant
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GERINAP E.C.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0577/008/001
  • Authorization date:
  • 20-02-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

GerinapE.C.250mgGastro-resistantTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains250mgofNaproxen.

Excipients:Eachtabletcontains8mglactosemonohydrate.

Forafulllistofexcipientsseesection6.1.

3PHARMACEUTICALFORM

Gastro-resistanttablets.

White,circular,biconvextablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthemanagementofvariousarthritides,suchasrheumatoidarthritis,osteoarthrosis,spondylitis,gout,etc.,andof

musculoskeletaldisorders.Forthemanagementofrheumatoidarthritisinchildrenovertheageoffiveyears.

Inthemanagementofdysmenorrhoea.

4.2Posologyandmethodofadministration

Undesirableeffectsmaybeminimisedbyusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seesection4.4,Specialwarningsandprecautionsforuse).

GerinapECtabletsshouldbeswallowedwholeandnotbrokenorcrushed.

Adults

Theusualdoseis250mgdaily,withamaximumdailydoseof1000mg.

Inthecaseofgoutadoseof750mgmayberequiredasaninitialdosegivenonce,with250mgeveryeighthours

thereafterforamaximumof72hours.Subsequentlyusemaybemadeoftheusualregimenifnecessary.

Fordysmenorrhoeatheusualinitialdoseis500mgandthereafter250mgevery6to8hours.

Elderly

NSAIDsshouldbeusedwithparticularcautioninelderlypatientswhoaremorepronetoadverseevents.Thelowest

dosecompatiblewithadequatesafeclinicalcontrolshouldbeemployed.Seealso(seesection4.4,Specialwarnings

andprecautionsforuse)

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Childrenovertheageof5years

GerinapECiseffectiveinthetreatmentofjuvenilerheumatoidarthritisinchildrenover5yearsofageatadoseof

10mg/kg/daytakenintwodosesat12hourintervals.GerinapECtabletsarenotrecommendedforuseforanyother

indicationinchildrenunder16yearsofage.

Childrenundertheageof5years

ThesafetyofGerinapECtabletsinchildrenunder5yearsofagehasnotbeenestablishedandthereforeuseisnot

recommended.

4.3Contraindications

Useinpatientswithpepticulcerdisease,activepepticulcerationorintestinalinflammatorydisease.

Useinpatientshypersensitivetonaproxenorothernon-steroidalanti-inflammatoryagentsincludingaspirin.

Severeheartfailure

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.Active,orhistoryof

recurrentpepticulcer/haemorrhage(twoormoredistinctepisodesofprovenulcerationorbleeding).

4.4Specialwarningsandprecautionsforuse

TheuseofGerinapECwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshouldbeavoided.

Undesirableeffectsmaybereducedbyusingthelowesteffectivedosefortheshortestpossibledurationnecessaryto

controlsymptoms(seesection4.2,PosologyandmethodofadministrationandGIandcardiovascularrisksbelow).

Cardiovascularandcerebrovasculareffects.

Appropriatemonitoringandadvicearerequiredforpatientswithahistoryofhypertensionand/ormildtomoderate

congestiveheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

ClinicaltrialandepidemiologicaldatasuggestthatuseofcoxibsandsomeNSAIDs(particularlyathighdosesandin

longtermtreatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarctionorstroke).AlthoughdatasuggestthattheuseofNaproxen(1000mgdaily)maybeassociated

withalowerrisk,someriskcannotbeexcluded.

Patientswithuncontrolledhypertension,congestiveheartfailure,establishedischaemicheartdisease,peripheral

arterialdisease,and/orcerebrovasculardiseaseshouldonlybetreatedwithnaproxenaftercarefulconsideration.

Similarconsiderationshouldbemadebeforeinitiatinglonger-termtreatmentofpatientswithriskfactorsfor

cardiovascularevents(e.g.hypertension,hyperlipidaemia,diabetesmellitus,smoking).

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinalbleeding

andperforationwhichmaybefatal(seesection4.2,Posologyandmethodofadministration)

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationorperforation,whichcanbefatal,has

beenreportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevioushistoryof

seriousGIevents.

TheriskofGIbleeding,ulcerationorperforationsishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(Seesection4.3,Contraindications),andinthe

elderly.Thesepatientsshouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotective

agents(e.g.misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatients

requiringconcomitantlowdoseaspirin,orotherdrugslikelytoincreasegastrointestinalrisk(seebelowandsection

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PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleedingsuchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsoranti-

plateletagentssuchasaspirin(Seesection4.5,Interactionwithothermedicinalproductsandotherformsof

interactions).

WhenGIbleedingorulcerationoccursinpatientsreceivingGerinapEC,thetreatmentshouldbewithdrawn.

GerinapE.C.tabletsshouldbeusedwithcautioninpatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,

Crohn’sdisease)astheirconditionmaybeexacerbated(Seesection4.8,Undesirableeffects).

Cautionisrequiredinpatientswithahistoryofhypertensionand/orheartfailureasfluidretentionandoedemahave

beenreportedinassociationwithNSAIDtherapy.

Theuseofnaproxenmayimpairfemalefertilityandisnotrecommendedinwomenattemptingtoconceive.Inwomen

whohavedifficultiesconceivingorwhoareundergoinginvestigationofinfertility,withdrawalofnaproxenshouldbe

considered.

Seriousskinreactions,someofthemfatal,includingexfolativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(Seesection4.8,

Undesirableeffects).Patientsappeartobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetof

thereactionoccurringinthemajorityofcaseswiththefirstmonthoftreatment.GerinapECshouldbediscontinuedat

thefirstappearanceofskinrash,mucosallesions,oranyothersignofhypersensitivity.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactasedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported:

Anti-coagulants:NSAIDsmayenhancetheeffectsofanti-coagulants,suchaswarfarin(seesection4.4,Special

warningsandprecautionsforuse)

Anti-hypertensives:reducedanti-hypertensiveeffect.

Diuretics:reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

Cardiacglycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

levels.

Lithium:decreasedeliminationoflithium.

Methotrexate:decreasedeliminationofmethotrexate.

Cyclosporin:increasedriskofnephrotoxicitywithNSAIDs.

OtherNSAIDs:avoidconcomitantuseoftwoormoreNSAIDs.

Corticosteroids:increasedriskofgastrointestinalulcerationorbleeding(seesection4.4,Specialwarningsand

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Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):Increasedriskofgastrointestinalbleeding(see

section4.4,Specialwarningsandprecautionsforuse)

Aminoglycosides:reductioninrenalfunctioninsusceptibleindividualsdecreasedeliminationofaminoglycosideand

increasedplasmaconcentrations.

Probenecid:reductioninmetabolismandeliminationofNSAIDandmetabolites.

Oralhypoglycemicagents:inhibitionofmetabolismofsulfonylureadrugs,prolongedhalf-lifeandincreasedriskof

hypoglycaemia.

Theproductishighlyboundtoplasmaproteinsothatcautionshouldbeexercisedinuseinpatientsconcomitantly

receivingotherdrugsstronglyproteinboundsuchasanticoagulants,sulphonamidesandhydratoins.

Patientswithestablishedaspirinhypersensitivitymayreactsimilarlytonaproxen.Thisisparticularlyofconcern

inthosewithasthmainwhombronchospasmmaybeprecipitated.

Naproxenmayinterferewithsometestsof17-ketogenicsteroidsandassaysofurinary5-hydroxyindoleacetic

acid,itisadvisedthatnaproxentherapybetemporarilydiscontinuedfor48hoursbeforeadrenalfunctionand

otheraffectedtests.

Thenatriureticeffectoffrusemidehasbeenreportedtobeinhibitedbysomedrugsofthisclass.Alsotheanti-

hypersensitiveeffectofpropranololandotherbeta-blockersmaybereduced.

4.6Pregnancyandlactation

Thereisinadequateevidenceofsafetyofthedruginhumanpregnancy.Aswithotherdrugsofthistypenaproxen

delaysparturitioninanimalsbuttherelevanceofthisfindingtohumanpatientsisnotknown.Italsoeffectsthehuman

foetalcardiovascularsystembycausingclosureoftheductusarteriosus.

GerinapECshouldnotbeusedinpregnancyunlessconsideredessentialbythephysician.Naproxenhasbeenfoundin

themilkoflactatingmothers.Theuseofnaproxenshouldthereforebeavoidedinpatientswhoarebreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gastro-intestinal:Themostcommonlyobservedadverseeventsaregastrointestinalinnature.Peticulcers,perforation

orGIbleeding,sometimesfatal,particularlyintheelderly,mayoccur(seesection4.4,Specialwarningsand

precautionsforuse).Nausea,vomiting,diarrhoea,flatulence,constipation,dyspepsia,abdominalpain,melaena,

heamatemesis,ulcerativestomatitis,exacerbationofcolitisandCrohn’sdisease(seesection4.4–specialwarningsand

precautionsforuse)havebeenreportedfollowingadministration.Lessfrequently,gastritishasbeenobserved.

Hypersensitivity/skinreactions:Rashes,urticaria,anaphylaxis,angio-oedemaandeosinophilicpneumonitis.Erythema

multiforme,photosensitivityreactionsandalopecia.Rarelyepidermolysisbullosaandporphyriacutaneatardahave

beenreported.

BullousreactionsincludingStevens-Johnsonsyndromeandtoxicepidermalnecrolysis(veryrare).

CNS:Headache,insomnia,lackofconcentrationandcognitivedysfunction.

Haematological:Agranulocytosis,thrombocytopenia,aplasticandhaemolyticanaemiamayoccurrarely.

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Othersideeffectsreportedrarelyincludevertigo,hearingimpairment,tinnitusandvisualdisturbances.Jaundice,

hepatitis,mildperipheraloedema,nephropathy,haematuria,vasculitis,asepticmeningitisandulcerativestomatitis.

ClinicaltrialandepidermiologicaldatasuggestthatuseofsomeNSAIDs(particularlyathighdosesandinlongterm

treatment)maybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexamplemyocardial

infarctionorstroke)(seesection4.4,Specialwarningsandprecautionsforuse).

4.9Overdose

Overdosagecanbecharacterisedbydrowsiness,heartburn,indigestion,nauseaorvomiting.Thestomachmaybe

emptiedandusualsupportivemeasuresemployed.Itisnotknownwhatdoseislife-threatening.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Naproxenisanonsteroidalanti-inflammatoryagentandalsohasanalgesicandantipyreticactivityinman.Naproxen

reducesthesynthesisofprostaglandinsbyinhibitingthecyclo-oxygenaseenzyme.Theexactmechanismofitsanti-

inflammatoryactionisnotknown.

5.2Pharmacokineticproperties

Naproxeniscompletelyabsorbedfollowingoraladministration.Peakplasmaconcentrationsareseenafterabout2

hours.Absorptionrate,butnotextent,isdiminishedbyconcomitantadministrationwithfoodorantacids.

Naproxenishighlyproteinbound(>99%)resultinginavolumeofdistributionof0.91kg -1

Naproxenisextensivelymetabolisedbytheliver,andexcretionisprimarilybythekidneys.Lessthan10%ofadoseis

excretedunchanged.

Plasmahalflifeis12-15hours.

5.3Preclinicalsafetydata

Naproxendoesnothavemutagenicpotential.Thereisnoevidenceofcarcinogenicityintwoyearstudiesinrats.There

isnoevidenceofteratogenicityinmice,ratsorrabbits.Naproxenhasbeenshowntodelayparturitioninanimalsandto

affecttheclosureoftheductusarteriosusinthehumanfoetalcardiovascularsystem.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

MaizeStarch

Povidone

Crospovidone

Talc

ColloidalAnhydrousSilica

MagnesiumStearate

Cellacefate

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Polyvinylchloride(PVC)/aluminiumfoilblisterpackscontaining100or250tablets.

Polypropylenetabletcontainerwithpolyethylenecapcontaining100or250tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

McDermottLaboratoriesLimited

tradingasGerardLaboratories

35/36BaldoyleIndustrialEstate

GrangeRoad

Dublin13

8MARKETINGAUTHORISATIONNUMBER

PA0577/008/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20February1998

Dateoflastrenewal:20February2008

10DATEOFREVISIONOFTHETEXT

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