BARICOL

Main information

  • Trade name:
  • BARICOL Rectal Suspension 1.05 Grams
  • Dosage:
  • 1.05 Grams
  • Pharmaceutical form:
  • Rectal Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BARICOL Rectal Suspension 1.05 Grams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1037/001/001
  • Authorization date:
  • 17-12-2002
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Baricol1.05g/mlRectalSuspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

BariumSulphate1.05g/ml.

Forexcipients,see6.1.

3PHARMACEUTICALFORM

RectalSuspension

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thismedicinalproductisfordiagnosticuseonly.

‘Baricol’isaradiopaquediagnosticagentforuseinairdoublecontrastX-rayvisualisationofthelowergastro-

intestinaltract.

4.2Posologyandmethodofadministration

‘Baricol’isintendedforrectal(enema)administration.Thedosageadministeredwillbedependentuponthepatientand

thetechniqueinvolvedandwillbedeterminedfromexperiencebytheradiologist.

Adults:Thevolumeadministeredwillnormallybeabout600ml.

Children:Thequantityof‘Baricol’shouldbedetermined,fromexperience,bythephysicianandwillbedependenton

theageandweightofthechild.

Elderly:Radiologicalexaminationsintheelderlyshouldbecarriedoutwithextremecareandthedosagedetermined

bytheradiologist.

AtthetimeoftheexaminationthelargebowelshouldbefreeofanyresiduesthatmayinterferewiththeX-ray

examination.

4.3Contraindications

‘Baricol’shouldnotbeusedinpatientswithunclearabdomenwithirritatedperitoneumandknownorsuspected

perforation;postoperativesutureinsufficiency,intestinalfistulaewithapassagetothemediastinum,pleuralcavityor

peritonealcavity;freshinjuriesorchemicalburnsoftheoesophageal-gastro-intestinaltract,ischemiaoftheintestinal

wall,necrotisingenterocolitisandimmediatelybeforesurgeryofthegastro-intestinaltract.

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4.4Specialwarningsandprecautionsforuse

Theproductshouldbeusedundermedicalsupervision.‘Baricol’aswithotherbariumsulphateenemapreparations,

shouldbeusedcautiouslyininfantsandelderlypatientswithpre-existingorganinjuries(multimorbidity)mainlyofthe

cardiovascularsystemsincetheexaminationincludingmeasuresforpreparationmaybestressfultothesepatients.A

carefulbenefit/riskconsiderationisrequiredinpatientswithhigh-gradestenosesespeciallythosedistaltothestomach

andinconditionsandillnesseswithincreasedrisksofperforationsuchasknowngastro-intestinalfistulaeand

carcinomas,inflammatoryintestinaldisease,diverticulitisanddiverticulosisandamoebiasis.Dependingonthelocation

andextentoftheintervention‘Baricol’shouldnotbeusedforupto7daysafteranendoscopicexcisionnorduringand

upto4weeksafterconcomitantradiotherapy.

Topreventpotentiallyseriousadversereactionspenetrationofbariumsulphateintoparenteralareasliketissues,

vascularspaceandbodycavitiesortherespiratorytractmustbeavoided.Adequatehydrationaftertheprocedure

shouldbeensuredtopreventsevereconstipation.

Aswithanybariumsulphatepreparation,careshouldbetakenwhenadministering‘Baricol’byenematochildren,the

elderlyorthedebilitated.

‘Baricol’containssodiumbenzoate,whichisamildirritanttotheskin,eyesandmucousmembraneanditcontains

potassiumsorbate,whichisirritantandcancausedermatitis.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Apharmaceuticalorotherwiseinducedreductionofintestinalperistalsismayleadtoanobstructionviathickeningof

thebariumsulphatesuspension.

4.6Pregnancyandlactation

Inprincipletherearenoobjectionsagainstusingbariumsulphateduringpregnancy.Sinceradiationexposureduring

pregnancyshouldbeavoidedanyway,regardlesswhetheracontrastagentisusedornot,thebenefitofX-ray

examinationhastobeconsideredcarefully.

Bariumsulphateisnotabsorbedsystemicallyandis,therefore,notcontra-indicatedduringlactation.

4.7Effectsonabilitytodriveandusemachines

‘Baricol’hasnoinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Constipationmayoccurfollowingabariumsulphateenema(1in500,000),rarelyimpaction,obstructionand

appendicitishaveoccurred.Bariumsulphateenemasmayexacerbateulcerativecolitis.Rarecasesofallergicreactions

(urticaria,anaphylacticshock,rashes)havebeenmentionedintheliterature(1in250,000).

Duringabariumprocedure,intestinalperforationmayrarelyoccurandmaybefollowedbyperitonitisandgranuloma.

Intravasationandembolisationofbariummayalsooccurrarely.

4.9Overdose

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

PharmacotherapeuticGroup:ContrastMedia,BariumSulphate.

ATCcode:VO8B.

Bariumsulphateitselfhasnopharmacologicaleffects.ItsuseisbasedontheabsorptionofX-raysduringvisualisation

ofthegastro-intestinaltract.

Purebariumsulphateafterenteralapplicationischemicallyinertandunderphysiologicalconditionspractically

insolubleandnon-toxic.Nosystemiceffectofbariumsulphatewasrevealedbytoxicologicalexaminations.Nolocal

changestothemucousmembraneofthegastro-intestinaltractwereobserved.

5.2Pharmacokineticproperties

Notapplicable.Bariumsulphate,theactiveconstituentof‘Baricol’isnotabsorbedfromthegastro-intestinaltract.

5.3Preclinicalsafetydata

Thetoxicologicalevaluationofbariumsulphatedidnotrevealanysystemiceffect.Reproductiontoxicity,mutagenicity

andcarcinogenicityhavenotbeeninvestigatedwhichare,however,nottobeexpectedbecauseoftheinsolubilityofthe

substance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Simethiconeemulsion(includingmethylcelluloseandsorbicacid)

Xanthangum(E415)

Spray-driedacacia

Sodiumcarrageenan(E407)

Potassiumsorbate(E202)

Sodiumbenzoate(E211)

Potassiumchloride

Vanillaflavouredliquid(includingpropyleneglycol,naturalandartificialflavouring,caramelcolourandwater)

Anhydrouscitricacid

Sorbitol(E420)

Sodiumcitratedihydrate(E331)

Polyoxyethyleneglycerylmono-oleate

Sodiumsaccharin

Concentratedhydrochloricacid

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

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6.4Specialprecautionsforstorage

Donotfreeze.

Iftheproducthasbeendilutedpriortouse,thenthedilutedsuspensionshouldbeusesimmediatelyandanyunused

suspensiondiscardedimmediatelyafterinitialuse.

6.5Natureandcontentsofcontainer

Highdensitypolyethylenebottlewithpolypropylenescrew-onclosurecontaining600ml‘Baricol’.

Highdensitypolyethylenebottlewithpolypropylenescrew-onclosurecontaining1900ml‘Baricol’.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

‘Baricol’isintendedforrectal(enema)administrationonly.Shakewellbeforeusing.

‘Baricol’shouldbeusedundilutedtoperformdoublecontrastbariumenemastudies.Shouldaclinicianwishtousea

suspensionoflowerdensity,‘Baricol’maybedilutedwithwatertoachievethedesireddensityrequiredbythe

radiologist.Iftheproducthasbeendilutedpriortouse,thenthedilutedsuspensionshouldbediscardedimmediately

afterinitialuse.

7MARKETINGAUTHORISATIONHOLDER

E-Z-EMNederlandb.v.

Planckstraat69

3316GSDordrecht

TheNetherlands

8MARKETINGAUTHORISATIONNUMBER

PA1037/1/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:17December2002

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