DIPENTUM

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0365/082/002
  • Authorization date:
  • 18-05-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dipentum500mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains500mgolsalazinesodium.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet.

Ayellowcapsule-shapedtabletdebossedwith‘D500’ononesideandascorelineontheother.

Thescorelineisonlytofaciiltatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofmildtomoderateulcerationcolitiswithorwithoutcorticosteroids.Thedrugmayalsobeusedinthe

long-termmaintenanceofremissionofulcerativecolitis.Itisparticularlyusefulwherepatientscannottolerate

sulphasalazinebecauseofsulphaintolerance.

4.2Posologyandmethodofadministration

Oral

Recommendeddosageschedules

Tobetakenindivideddose,withmeals.

Acutemilddisease

Adultsincludingtheelderly:Commenceon1gramdailyindivideddosesdependingonpatientresponsestitrate

dosageupwardstothemaximumof3gdailyover1week.Concomitantoralorrectalsteroidsmaybeused.Inthe

eventofdrugrelateddiarrhoeaoccurring,itmaybetransient.Ifitisnot,thedosemaybereduced;wherediarrhoea

continuesdespitethisreductionthedrugshouldbestopped.

Asingledoseshouldnotexceed1g

Long-termmaintenance

Adultsincludingtheelderly:Onetabletmaybetakentwicedailywithfood.

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4.3Contraindications

Patientshypersensitivetoolsalazineorothersalicylatesoranyoftheexcipients.Severerenalimpairment.

4.4Specialwarningsandprecautionsforuse

Itisrecommendedtomonitorpatientswithimpairedkidneyorliverfunction.

Patientssufferingfromsevereallergyorasthmashouldbeobservedforsignsofworseningoftheseconditions.

Invitroandin-vivolaboratorystudiesdonotsuggestpharmacogeneticproblemsassociatedwiththedrug.

Itisrecommendedtomonitorrenalfunctioninpatientsreceivingolsalazine,byestimatingserumcreatininebefore

treatment,every3monthsforthefirstyear,every6monthsforthenext4years,andannuallyafter5yearsoftreatment.

Seriousblooddycrasiashavebeenreportedveryrarelywitholsalazine.Hematologicalinvestigationsshouldbe

performedifthepatientdevelopsunexplainedbleeding,bruising,purpura,anaemia,fever,sorethroatormouthulcers.

Treatmentshouldbestoppedifthereisasuspicionorevidenceofblooddycrasia.

Patientsortheircarersshouldbeinstructedhowtorecognisethesignsofhaematotoxicityandshouldbeadvisedto

contacttheirphysiciansimmediatelyifthesymptomssuchasfever,sorethroat,mouthulcers,bruising,orbleeding

develop.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thecoadministrationofsalicylatesandlowmolecularweightheparinsorheparinoidsmayresultinanincreasedriskof

bleeding,morespecificallyhematomasfollowingneuraxialanesthesia.Salicylatesshouldbediscontinuedpriortothe

initiationofalowmolecularweightheparinorheparinoid.Ifthisisnotpossible,itisrecommendedtomonitorpatients

closelyforbleeding.

Increasedprothrombintimeinpatientstakingconcomitantwarfarinhasbeenreported.

Thecoadministrationofolsalazineand6-mercaptopurineorthioguaninemayresultinanincreasedriskof

myelosuppression.Ifcoadministeredwith6-mercaptopurine,itisrecommendedtousethelowestpossibledosesof

eachdrugandtomonitorthepatient,especiallyforleukopenia.Incaseofcoadministrationwiththioguanine,careful

monitoringofbloodcountsisrecommended.

Itisrecommendednottogivesalicylatesforsixweeksafterthevaricellavaccinetoavoidapossibleincreasedriskof

developingReye’ssyndrome.

4.6Fertility,pregnancyandlactation

Pregnancy:

Olsalazinehasbeenshowntoproducefetaldevelopmentaltoxicityasindicatedbyreducedfetalweights,retarded

ossificationsandimmaturityofthefetalvisceralorganswhengivenduringorganogenesistopregnantratsindoses5to

20timesthehumandose(100to400mg/kg).

Therearenoadequateandwell-controlledstudiesinpregnantwomen.Olsalazineshouldbeusedduringpregnancy

onlyifthepotentialbenefitjustifiesthepotentialrisktothefoetus.

Lactation:

Smallamountsoftheactivemetaboliteofolsalazine(5-ASA)maypassintobreastmilk.Harmfulinfanteffects

(diarrhea)havebeenreportedwhen5-ASAwasusedduringbreastfeeding.Unlessthebenefitofthetreatment

outweighstherisks,olsalazineshouldnotbetakenbybreast-feedingwomen,orpatientsshouldbeadvisedto

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4.7Effectsonabilitytodriveandusemachines

Onthebasisofthepharmacodynamicprofileandreportedadverseevents,olsalazinedoesnotappeartoproduceany

effectsonabilitytodriveandusemachines.

4.8Undesirableeffects

Frequencyestimate:verycommon(1/10);common(1/100to<1/10);uncommon(1/1,000to<1/100);rare

(1/10,000to<1/1,000);veryrare(<1/10,000),notknown(cannotbeestimatedfromtheavailabledata).

Themostcommonsideeffectisdiarrhoeawhichisusuallytransient.

Inaddition,thefollowingundesirableeffectshavebeenreported:

Generaldisordersandadministrationsiteconditions:

Common:headache

Uncommon:pyrexia

Bloodandlymphaticsystemdisorders:

Uncommon:thrombocytopenia

Notknown:aplasticanaemia,eosinophilia,haemolyticanemia,leukopenia,neutropenia,pancytopenia

Gastrointestinaldisorders:

Common:diarrhoea,nausea

Uncommon:vomiting,dyspepsia

Notknown:abdominalpainupper,pancreatitis

Hepatobiliarydisorders:

Uncommon:hepaticenzymeincreased

Notknown:hepatitis,increasedbilirubin,

Skinandsubcutaneoustissuedisorders:

Common:rash

Uncommon:pruritus,alopecia,photosensitivityreaction,urticaria

Notknown:,angioneuroticoedema,

Cardiacdisorders:

Uncommon:tachycardia

Notknown:myocarditis,palpitations,pericarditis

Renalandurinarydisorders:

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Respiratory,thoracicandmediastinaldisorders:

Uncommon:dyspnoea

Notknown:interstitiallungdisease

Musculoskeletalandconnectivetissuedisorders:

Common:arthralgia,

Uncommon:myalgia

Nervoussystemdisorders:

Uncommon:dizziness,paraesthesia,

Notknown:peripheralneuropathy

Psychiatricdisorders:

Uncommon:depression

Eyedisorders:

Notknown:visionblurred

4.9Overdose

Theknowledgeofoverdosageislimited.Possibleoverdosesymptomsincludenausea,vomitinganddiarrhoea.Itis

recommendedtocheckhematology,acid-base,electrolyte,liverandkidneystatus,andtoprovidesupportive

treatment.ThereisnospecificantidotetoDipentum.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Aminosalicylicacidandsimilaragents

ATCCode:A07EC03

5.2Pharmacokineticproperties

Olsalazinesodiumwasdevelopedasapro-drugforthereleaseof5-aminosalicylicacidinthecolonbybacterialazo

reduction.Neithersubstanceissignificantlyabsorbed,butthe5ASAwhichistakenupislargelyacetylatedinthegut

wall,andurinaryexcretionisprincipallyastheacetylatedform.Olsalazineundergoesenterohepaticcirculationwith

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5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardsforhumansbasedonconventionalstudiesofsafetypharmacology,repeated

dosetoxicity,genotoxicity,carcinogenicpotentialandtoxicitytoreproduction.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

MagnesiumStearate(E572)

ColloidalAnhydrousSilica

Povidone(E1201)

Crospovidone

6.2Incompatibilities

Notapplicable.

6.3Shelflife

4years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Keepthecontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

WhiteHDPEbottlewithwhitepolypropylenecapandfoilinnerseal.

Packsize:60tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirementsfordisposal.

7MARKETINGAUTHORISATIONHOLDER

UCBPharmaLimited

208BathRoad

Slough

BerkshireSL13WE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA365/82/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 18May1995

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10DATEOFREVISIONOFTHETEXT

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