DIPENTUM 250MG CAPSULES.

Main information

  • Trade name:
  • DIPENTUM 250MG CAPSULES.
  • Dosage:
  • 250 Milligram
  • Pharmaceutical form:
  • Capsule
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIPENTUM 250MG CAPSULES.
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0365/082/001
  • Authorization date:
  • 12-07-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Dipentum250mghardCapsules.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachcapsulecontains250mgolsalazinesodium.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Capsule,hard.

Beige,opaque,hardgelatinsize1capsuleradiallyprinted"DIPENTUM250mg"inblack.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofmildtomoderateacuteulcerativecolitiswithorwithoutcorticosteroids.Thedrugmayalsobeusedinthe

longtermmaintenanceorremissionofulcerativecolitis.Itisparticularlyusefulwherepatientscannottolerate

sulphazalazinebecauseofsulphaintolerance.

4.2Posologyandmethodofadministration

Tobetakenindivideddoseswithmeals

General

Olsalazinetakenonanemptystomachmaysometimesleadtoloosestoolsordiarrhoea.Bytakingthedrugattheendofa

meal,thismaybeavoided.

AcuteMildDisease

Adultsincludingtheelderly:Commenceon1gdailyindivideddosestakenattheendofmeals.Dependingonthe

patient’sresponse,thedosemaybetitratedupwardsoveraperiodofoneweektoamaximumof3gdaily.Concommitant

oralorrectalsteroidsmaybeused.Intheeventofdrugrelateddiarrhoeaoccurring,itmaybetransient.Ifitisnot,dose

maybereduced;wherediarrhoeacontinuesdespitethisreductionthedrugshouldbestopped.

Asingledoseshouldnotexceed1g.

Longtermmaintenanceofremission

Adultsincludingtheelderly:Twocapsulesmaybetakentwicedailywithfood.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/09/2011 CRN 2100353 page number: 1

4.3Contraindications

Patientshypersensitivetoolsalazineorothersalicylatesoranyoftheexcipients.Severerenalimpairment.

4.4Specialwarningsandprecautionsforuse

Itisrecommendedtomonitorpatientswithimpairedkidneyorliverfunction.

Patientssufferingfromsevereallergyorasthmashouldbeobservedforsignsofworseningoftheseconditions.

In-vitroandin-vivolaboratorystudiesdonotsuggestpharmacogeneticproblemsassociatedwiththedrug.

Itisrecommendedtomonitorrenalfunctioninpatientsreceivingolsalazine,byestimatingserumcreatininebefore

treatment,every3monthsforthefirstyear,every6monthsforthenext4years,andannuallyafter5yearsoftreatment.

Haematologicalinvestigationsshouldbeperformedifthepatientdevelopsunexplainedbleeding,bruising,purpura,

anaemia,fever,sorethroatormouthulcers.Treatmentshouldbestoppedifthereisasuspicionorevidenceofablood

dyscrasia.

Patientsortheircarersshouldbeinstructedhowtorecognisethesignsofhaematotoxicityandshouldbeadvisedtocontact

theirphysiciansimmediatelyifthesymptomssuchasfever,sorethroat,mouthulcers,bruising,orbleedingdevelop.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Thecoadministrationofsalicylatesandlowmolecularweightheparinsorheparinoidsmayresultinanincreasedriskof

bleeding,morespecificallyhematomasfollowingneuraxialanesthesia.Salicylatesshouldbediscontinuedpriortothe

initiationofalowmolecularweightheparinorheparinoid.Ifthisisnotpossible,itisrecommendedtomonitorpatients

closelyforbleeding.

Increasedprothrombintimeinpatientstakingconcomitantwarfarinhasbeenreported.

Thecoadministrationofolsalazineand6-mercaptopurineorthioguaninemayresultinanincreasedriskof

myelosuppression.Ifcoadministeredwith6-mercaptopurine,itisrecommendedtousethelowestpossibledosesofeach

drugandtomonitorthepatient,especiallyforleukopenia.Incaseofcoadministrationwiththioguanine,carefulmonitoring

ofbloodcountsisrecommended.

Itisrecommendednottogivesalicylatesforsixweeksafterthevaricellavaccinetoavoidapossibleincreasedriskof

developingReye’ssyndrome.

4.6Fertility,pregnancyandlactation

Pregnancy:

Olsalazinehasbeenshowntoproducefetaldevelopmentaltoxicityasindicatedbyreducedfetalweights,retarded

ossificationsandimmaturityofthefetalvisceralorganswhengivenduringorganogenesistopregnantratsindoses5to20

timesthehumandose(100to400mg/kg).

Therearenoadequateandwell-controlledstudiesinpregnantwomen.Olsalazineshouldbeusedduringpregnancyonlyif

thepotentialbenefitjustifiesthepotentialrisktothefoetus.

Lactation:

Smallamountsoftheactivemetaboliteofolsalazine(5-ASA)maypassintobreastmilk.Harmfulinfanteffects(diarrhea)

havebeenreportedwhen5-ASAwasusedduringbreastfeeding.Unlessthebenefitofthetreatmentoutweighstherisks,

olsalazineshouldnotbetakenbybreast-feedingwomen,orpatientsshouldbeadvisedtodiscontinuebreastfeedingifusing

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/09/2011 CRN 2100353 page number: 2

4.7Effectsonabilitytodriveandusemachines

Onthebasisofthepharmacodynamicprofileandreportedadverseevents,olsalazinedoesnotappeartoproduceany

effectsonabilitytodriveandusemachines.

4.8Undesirableeffects

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

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

Themostcommonsideeffectisdiarrhoeawhichisusuallytransient.

Inaddition,thefollowingundesirableeffectshavebeenreported:

Generaldisordersandadministrationsiteconditions:

Common:headache

Uncommon:pyrexia

Bloodandlymphaticsystemdisorders:

Uncommon:thrombocytopenia

Notknown:aplasticanaemia,eosinophilia,haemolyticanaemia,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:

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/09/2011 CRN 2100353 page number: 3

Respiratory,thoracicandmediastinaldisorders:

Uncommon:dyspnoea

Notknown:interstitiallungdisease

Musculoskeletalandconnectivetissuedisorders:

Common:arthralgia

Uncommon:myalgia

Nervoussystemdisorders:

Uncommon:dizzinessparaesthesia

Notknown:peripheralneuropathy

Psychiatricdisorders:

Uncommon:depression

Eyedisorders:

Notknown:visionblurred

4.9Overdose

Theknowledgeofoverdosageislimited.Possibleoverdosesymptomsincludenausea,vomitinganddiarrhoea.Itis

recommendedtocheckhematology,acid-base,electrolyte,liverandkidneystatus,andtoprovidesupportivetreatment.

ThereisnospecificantidotetoDipentum.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Aminosalicylicacidandsimilaragents.

ATCCode:A07EC03

5.2Pharmacokineticproperties

Olsalazinesodiumwasdevelopedasapro-drugforthereleaseof5-amonosalicylicacidinthecolonbybacterialazo

reduction.Neithersubstanceisissignficantlyabsorbed,butthe5ASAwhichistakenupislargelyacetylatedinthegut

wall,andurinaryexcretionisprincipallyastheacetylatedform.OlsalazineundergoesenterohepaticcirculationwithaT1/2

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/09/2011 CRN 2100353 page number: 4

5.3Preclinicalsafetydata

Non-clinicaldatarevealnospecialhazardsforhumansbasedonconventionalstudiesofsafetypharmacology,repeated

dosetoxicity,genotoxicity,carcinogenicpotentialandtoxicitytoreproduction.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Magnesiumstearate(E572)

PrintingInk

Shellac

Blackironoxide(E172)

Propyleneglycol

Postassiumhydroxide(onlyininksourcedfromTek)

CapsuleShell

Caramel(E150)

Titaniumdioxide(E171)

Gelatin

6.2Incompatibilities

Notapplicable.

6.3Shelflife

5years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Keepthecontainertightlyclosedinordertoprotectfrommoisture.

6.5Natureandcontentsofcontainer

White,HDPEbottlesealedbyafoilinner-sealandtamper-evidentLDPEcap,containing112capsules.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfromsuch

medicinalproductandotherhandlingoftheproduct

Nospecialrequirementsfordisposal.

7MARKETINGAUTHORISATIONHOLDER

UCBPharmaLimited

208BathRoad

Slough

BerkshireSL13WE

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/09/2011 CRN 2100353 page number: 5

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:12July1995

Dateoflastrenewal: 12July2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 08/09/2011 CRN 2100353 page number: 6