DICLOFENAC SODIUM

Main information

  • Trade name:
  • DICLOFENAC SODIUM
  • Dosage:
  • 25 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DICLOFENAC SODIUM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0436/009/001
  • Authorization date:
  • 27-11-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

DiclofenacSodium25 mg TabletsEntericCoated

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each tabletcontains25 mg ofdiclofenacsodium.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Gastro-resistanttablets.

4CLINICALPARTICULARS

4.1TherapeuticIndications

4.1.1In thesymptomaticmanagementofrheumatoid arthritisincluding juvenilechronicarthritis, osteoarthritis,

ankylosing spondylitis, psoriaticarthropathy, lowback pain and acutemusculoskeletaldisordersincluding

periarthritis, tendinitis,tenosynovitis, bursitis, sprain, strains, dislocationsand inacutegout.

4.1.2In themanagementofpostoperativepain and inflammation in orthopaedicdislocationsand in acutegout.

4.1.3In themanagementofdysmenorrhoeaand associated menorrhagia.

4.2Posologyandmethodofadminstration

Adults:Theusualdaily dosageis100mg in divided doses. Thismay beincreased to 150mg daily.

Children:Theusualtotaldaily doseis1–3mg/kg daily in divided doses.

Elderly:NSAIDsshould beused with particularcaution in elderly patientswho aremoreproneto adverseevents. The

lowestdosecompatiblewith adequatesafeclinicalcontrolshould beemployed. Seealso section 4.4.

Treatmentshould bereviewed atregularintervalsand discontinued ifno benefitisseen.

4.3Contraindications

Usein asthmaticpatientshypersensitive(e.g. bronchospasm, rhinitis, urticaria)to aspirin orothernon-steroidalanti-

inflammatory agents, including diclofenac.

Usein patientswith activeorsuspected pepticulceration orpepticulcerdisease, orwith gastrointestinalbleeding.

4.4Special warningsandspecialprecautionsforuse

Theproductshould only beused with greatcaution in patientswith ahistory ofpepticulcer, gastrointestinalbleeding,

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Patientswith significanthepatic, renalorcardiacinsufficiency should bekeptunderclosesurveillanceastheuseof

non-steroidalanti-inflammatory drugsmay resultin adeterioration in renalfunction. Assessmentofrenalfunction

should occurpriorto theinitiation oftherapy and regularly thereafter.

Allpatientsonlong termnon-steroidalanti-inflammatory treatmentshould bekeptunderregularsurveillancewith

monitoring ofrenalhepaticfunction,and ofhaematologicalparameters. Thisisparticularlyimportantin theelderly.

Any evidenceofprogressivedeterioration in function should beregarded asareason fordiscontinuing therapy.

Undesirableeffectsmay bereduced by using theminimumeffectivedosefortheshortestpossibleduration. Patients

treated with NSAIDslongtermshould undergo regularmedicalsupervision to monitorforadverseevents.

AsNSAIDscan interferewith plateletfunction, they should beused with caution in patientswith intracranial

haemorrhageand bleeding diathesis.

Elderly patientsareparticularly susceptibleto theadverseeffectsofNSAIDs. Prolonged useofNSAIDsin theelderly

isnotrecommended. Whereprolonged therapy isrequired, patientsshould bereviewed regularly.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Itisconsidered unsafeto takeNSAIDsin combinationwith warfarin orheparin unlessunderdirectmedical

supervision.

Thisproductisstrongly protein bound. Studiesto dateshowno potentiation oforalhypoglycaemicsoranticoagulant

drugs.

Concurrentusewith aspirin resultsin reduced serumlevelsofdiclofenacsodiumand ofaspirin and salicylates,

although theclinicalrelevanceisunknown.

Co-administration ofdiclofenacsodiumwith othersystemicnon-steroidalanti-inflammatory drugsmay increasethe

risk ofunwanted adverseeffects.

Diclofenacsodiummay increaseplasmalevelsofconcurrently administered digoxin orlithium.

Theactivity ofsomediuretics(loop type)may beinhibited. Thepotassiumretaining diureticsshould beavoided since

non-steroidalanti-inflammatory drugsmay increasetherisk ofgastrointestinalhaemorrhage. Diureticscan increasethe

risk ofnephrotoxicity ofNSAIDs.

Methotrexate:decreased elimination ofmethotrexate.

Cyclosporin:increased risk ofnephrotoxicity with NSAIDs.

Corticosteroids:increased risk ofgastrointestinalbleeding.

Aminoglycosides:reduction in renalfunction in susceptibleindividualsdecreased elimination ofaminoglycosideand

increased plasmaconcentrations.

Probenecid:reduction in metabolismand elimination ofNSAIDand metabolites.

Anti-hypertensives:reduced anti-hypertensiveeffect.

Oralhypoglycemicagents:inhibition ofmetabolismofsulfonylureadrugsprolonged half-lifeand increased risk of

hypoglycaemia.

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4.6Pregnancyandlactation

Theproductshould notbeused in pregnancy orlactation unlessconsidered essentialby thephysician. UseofPG

synthetaseinhibitorsinthethird trimestermay resultin prematureclosureoftheductusarteriosus. Tracesofdrug are

detectablein breastmilk butarenotclinically significant.

4.7Effectsonabilitytodriveandusemachines

NoneKnown.

4.8Undesirableeffects

Sideeffectsincludegastrointestinaldisturbances, headache, dizzinessand skin rashes, and lessfrequently gastric

bleeding, fluid retention, hepatitis, renaldysfunction, anaphylaxis, irritability andrarely blood dyscrasias,

bronchospasmand erythemamultiforme.

4.9Overdose

Asthereisno known antidoteto diclofenacsodiumtreatmentissymptomatic. Forced emesisshould beapplied

immediately to recoverundigestedtablets.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Anon-steroidalanti-inflammatory agentand inhibitorofPGsynthetase.

5.2Pharmacokineticproperties

Thedrug iswellabsorbed with peak plasmalevelsin 1–4 hours. Itisextensively metabolised in theliverand excreted

through bileand urine. Thedrug isstrongly protein bound. Ithasahalf-lifeof2–4 hours.

5.3Preclinical safetydata

NotApplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactose

SodiumStarch Glycollate

PolyvidoneBP

MaizeStarch

Isopropanol

MagnesiumStearate

Sealant:

Hydroxypropylmethyl-cellulose

StearicAcid

Isopropanol

Irish Medicines Board

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EntericCoating:

EudragitL

Diethylphthalate

Isopropanol

Purified Water

Purified Talc

K-1-3678:

TitaniumDioxide–E171

QuinolineYellowAluminiumLake–E104

Iron OxideYellow–E172

HydroxypropylCellulose

Iron OxideRed–E172

Iron OxideBlack–E172

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyearsfromthedateofitsmanufacture.

6.4Special precautionsforstorage

Do notstoreabove25°C.Storein theoriginalcontainer.

6.5Natureandcontentsofcontainer

Polypropylenetubularcontainerwith an open end equipped to acceptapolyethyleneclosure, with atamper-evident

tearstrip.Pack sizesare50,100, 250, 500 or1000.

Blisterpacksof250µopaqueUPVC-PVDC20µhard temperaluminiumfoil-5-6 gsmvinylheatseal.Thepack sizes

arefiveblisterstrips, each containing twenty tablets.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Norton Waterford

Unit301

Waterford IndustrialEstate

Waterford

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 27 th

November1992

Dateoflastrenewal: 27 th

November2002

10DATEOFREVISIONOFTHETEXT

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