GERINAP

Main information

  • Trade name:
  • GERINAP Tablets 500 Milligram
  • Dosage:
  • 500 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GERINAP Tablets 500 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0405/011/002
  • Authorization date:
  • 22-11-1985
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Gerinap 500mgTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains500mg naproxen.

Forexcipients, seesection 6.1.

3PHARMACEUTICALFORM

Tablet.

Ayellowcapsuleshaped tablet, approximately 17 mmx 9 mmand approximately 5.4 mmin thickness, with‘NP500’

on onesideand‘G’on thereverse.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthemanagementofvariousarthritides, such asrheumatoid arthritis, osteoarthrosis, spondylitis, gout, etc., and of

musculoskeletaldisorders.Forthemanagementofrheumatoidarthritisin children overtheageoffiveyears.

4.2Posologyandmethodofadminstration

Adults

Theusualdoseis250 mg twicedaily, with amaximumdaily doseof1000mg.

In thecaseofgoutadoseof750mg may berequired asan initialdosegiven once, with 250 mg every eighthours

thereafterforamaximumof72hours.Subsequently usemay bemadeoftheusualregimen ifnecessary.

Elderly

Thelowesteffectivedoseshould beadministered to theelderly.

Children overtheageof5 years

Naproxen iseffectivein thetreatmentofjuvenilerheumatoid arthritisin children over5 yearsofageatadoseof

10mg/kg/day taken in two dosesat12hourintervals.Naproxen tabletsarenotrecommended foruseforany other

indication in children under16 yearsofage.

Children under5 years

Thesafety ofNaproxentabletsin children under5 yearsofagehasnotbeen established and thereforeisnot

recommended.

4.3Contraindications

Usein patientswith pepticulcerdisease, activepepticulceration orintestinalinflammatory disease.

Usein patientshypersensitiveto Naproxen orothernon-steroidalanti-inflammatory agentsincluding

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4.4Special warningsandprecautionsforuse

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

4.6Pregnancyandlactation

Thereisinadequateevidenceofsafety ofthedrug in human pregnancy.Aswithotherdrugsofthistypenaproxen

delaysparturition in animalsbuttherelevanceofthisfinding to human patientsisnotknown.Italso affectsthehuman

foetalcardiovascularsystemby causing closureoftheductusarteriosus.

Episodesofgastrointestinalbleeding havebeen reported in patientswith naproxen therapy.Greatcaution

should beexercised and closesupervision should begiven to patientswith ahistory orexistentgastro-

intestinaldisease.

Theproductshould only beused with greatcaution in patientswith ahistory of, orin thosewith impaired

liverfunction.

AswithotherNSAIDsbronchospasmmay beprecipitated in patientssuffering from, orwith ahistory of,

bronchialasthmaorallergicdisease.

Theproductwillprolong bleeding timeand decreaseplateletaggregation.

Becauseofitsoccasionaltendency to increasefluid retention, useofthedrug requirescarefulobservation

forthisfeaturein personswithincipientorexistentcongestivefailure.

Naproxen ismainly excreted through thekidney by glomerularfiltration.Itshould only beused with

caution in patientswith renaldysfunction particularly iflong termdosageisunderconsideration.Such

patientswith pre-existentrenaldysfunction should haveregularmonitoring ofserumcreatinineclearance.

Useisnotrecommended in patientswith acreatinineclearanceoflessthan 20 ml/min.

Certain patientsin whomrenalblood flowiscompromised such asin extracellularfluidvolumedepletion,

cirrhosisoftheliver, sodiumretention, congestiveheartfailureand renaldiseaseshould haverenalfunction

assessed beforeand during therapy.Elderly patientsin whomrenalfunction isoften impaired would also be

included in thisgroup.Consideration should begiven to areduction in daily dosage.

Patientswith rarehereditary problemsofgalactoseintolerance, theLapp lactasedeficiency orglucose-

galactosemalabsorption should nottakethismedicine.

Theexcretion ofmethotrexateand lithiumisreduced by co-administration ofnaproxen.Probenecid given

with naproxen dueto decreased excretion.

Theproductishighly bound to plasmaprotein so thatcaution should beexercised in usein patients

concomitantly receiving otherdrugsstrongly protein bound such asanticoagulants, sulphonamidesand

hydantoins.

Patientswith established aspirin hypersensitivity may reactsimilarly to naproxen. Thisisparticularly of

concern in thosewith asthmain whombronchospasmmay beprecipitated.

Naproxen may interferewith sometestof17-ketogenicsteroidsand assaysofurinary 5-hydroxyindoleacetic

acid, itisadvised thatnaproxen therapy betemporarily discontinued for48 hoursbeforeadrenalfunction

and otheraffected tests.

Thenatriureticeffectoffrusemidehasbeen reported to beinhibited by somedrugsofthisclass.Also the

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themilk oflactating mothers.Theuseofnaproxen should thereforebeavoided inpatientswho arebreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Gastro-intestinal:Mostcommonly nausea, vomiting, epigastricdistressand abdominaldiscomfort.Occasionally, but

moreserious, gastro-intestinalbleeding, colitisand pepticulceration.

Hypersensitivity/skin reactions:Rashes, urticaria, anaphylaxis,angio-oedemaand eosinophilicpneumonitis. Erythema

multiforme, Stevens-Johnson syndrome, epidermalnecrolysis, photosensitivity reactionsand alopecia.Rarely

epidermolysisbullosaand porphyriacutaneatardahavebeen reported.

CNS:Headache, insomnia, lack ofconcentration and cognitivedysfunction.

Haematological:Agranulocytosis, thrombocytopenia, aplasticand haemolyticanaemiamay occurrarely.

Othersideeffectsreported rarely includevertigo, hearing impairment, tinnitusand visualdisturbances.Jaundice,

hepatitis, mild peripheraloedema, nephropathy, haematuria, vasculitis, asepticmeningitisand ulcerativestomatitis.

4.9Overdose

Overdosagecan becharacterised by drowsiness,heartburn, indigestion, nauseaorvomiting.Thestomach may be

emptied and usualsupportivemeasuresemployed.Itisnotknownwhatdoseislife-threatening.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Naproxen isanon steroidalanti-inflammatory agentand also hasanalgesicand antipyreticactivity in man.Naproxen

reducesthesynthesisofprostaglandinsby inhibiting thecyclo-oxygenaseenzyme.Theexactmechanismofitsanti-

inflammatory action isnotknown.

5.2Pharmacokineticproperties

Naproxen iscompletely absorbed following oraladministration.Peak plasmaconcentrationsareseen afterabout2

hours.Absorption rate, butnotextent, isdiminished by concomitantadministration with food orantacids.

Naproxen ishighly protein bound (>99%)resulting in avolumeofdistribution of0.91kg -1

Naproxen isextensively metabolised by theliver, and excretion isprimarily by thekidneys.Lessthan 10%ofadoseis

excreted unchanged.

Plasmahalf-lifeis12-15 hours.

5.3Preclinical safetydata

Thereisno potentialmutagenicity ofnaproxen.Thereisno evidenceofcarcinogenicity in two yearstudiesin rats.

Thereisno evidenceofteratogenicity in mice, ratsorrabbits.Naproxen hasbeen shown to delay parturition in

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactosemonohydrate

Maizestarch

Povidone

Sodiumstarch glycolate(typeA)

Talc

Magnesiumstearate

Polysorbate80

Quinolineyellow(aluminiumlake)(E104)

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

4 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.

Storein theoriginalpackage.

6.5Natureandcontentsofcontainer

Availablein packsof30 and 100 tabletsin:

Polypropylenetabletcontainerwith tamper-evidentpolyethylenecap.

Polyvinylchloride(PVC)/aluminiumfoilblisterpacks.

iii. High density polyethylenetabletcontainerwith polypropylenecap.

Notallpack sizesmay bemarketed.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Generics[UK]Limited

Station Close

PottersBar

HertfordshireEN6 1TL

United Kingdom

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 22 nd

November1985

Dateoflastrenewal: 22 nd

November2005

10DATEOFREVISIONOFTHETEXT

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