BELLRAN

Main information

  • Trade name:
  • BELLRAN Tablets 75 Milligram
  • Dosage:
  • 75 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BELLRAN Tablets 75 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0967/001/001
  • Authorization date:
  • 21-07-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Bellran75mgTablets.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachfilm-coatedtabletcontains83.75mgofRanitidineHydrochlorideequivalentto75mgofRanitidine.

Forexcipientssee6.1

3PHARMACEUTICALFORM

Film-coatedtablet.

4CLINICALPARTICULARS

4.1TherapeuticIndications

BellranTabletsareindicatedfortheshort-termsymptomaticreliefofacidindigestionandheartburn.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andadolescentsof16yearsofageandolder.

OneBellran75mgtabletshouldbetakenwhensymptomsoccur,dayornight.Donottakemorethantwotabletsin24

hours.

Patientswillbeinstructednottotakethetabletsformorethan2weekscontinuously.Theymustconsulttheirdoctorif

symptomsdeteriorateorpersistafter2weekstreatment.

Childrenunder16years.

Thetabletsarenotrecommendedforchildrenunder16yearsofage.

4.3Contraindications

Hypersensitivitytotheactivesubstanceranitidineortoanyoftheexcipientsofthemedicinalproduct.

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4.4Specialwarningsandprecautionsforuse

Theproductisnotindicatedifthepatientpresentswithanyofthefollowingwithoutfirstseekingtheirdoctor’sadvice:

Treatmentwithhistamine(H

)antagonistsmaymasksymptomsassociatedwithcarcinomaofthestomachand

maythereforedelaydiagnosisofthecondition.Ifthepatienthasbeendiagnosedashavingagastriculcerorin

middleagedorolderpatientswhohaveexperiencedneworrecentlychangeddyspepticsymptomsthe

possibilityofmalignancymustbeexcludedbeforecommencingranitidine.

Patientswhohaveunintendedweightlossassociatedwiththeirindigestionsymptoms.

Patientswithrenaland/orhepaticimpairmentorpatientsunderregularmedicalsupervisionforanyreason.

Patientssufferingfromanyotherillnessortakingself-prescribedorphysician-prescribedmedicines.

PatientstakingNSAID’s,especiallytheelderly,shouldseektheirdoctor’sadvicebeforetakingranitidine.

BellranTabletsshouldbeavoidedinpatientswithahistoryofacuteintermittentporphyria.

Patientswithahistoryofpepticulceroratriskofdevelopingpepticulcershouldseektheirdoctor’sadvice

beforetakingtabletscontaining75mgranitidine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

RanitidinemayinhibitthehepaticcytochromeP450-linkedmixedfunctionoxygenesesystemtoalowdegree.

Athigherdosesofranitidine,theremaybeareductioninexcretionofprocainamideandN-acetylprocainamidedueto

inhibitionoftubularsecretion.

Asranitidineabsorptionfromthegastro-intestinaltractmaybereducedbytheconcurrentuseofantacidsorsucralfate,

ranitidineshouldbetakenabout2hoursbeforesuchagents.

Inclinicaltrials,animpairmentofthemetabolismoftheophyllineand/oranelevationofthetheophyllineplasma

concentrationsbyranitidinehasnotbeenshown.However,thereareisolatedreportsofpatients,inwhomelevationsof

theophyllineplasmalevelsandsignsandsymptomsoftheophyllineoverdosagewereobservedunderconcurrent

treatmentwithranitidineandtheophylline.Therefore,duringconcurrenttreatmentwithranitidine,thetheophylline

plasmaconcentrationsshouldbecontrolledandthetheophyllinedosageadjustedifnecessary.

Incaseofconcurrentuseofdrugs,theabsorptionofwhichispH-dependent-suchasketoconazole,thealtered

absorptionofthesesubstancesshouldbeborneinmind.

Concomitanttreatmentwithranitidineandglipizidemightresultinincreasedplasmaconcentrationsofglipizide.

Theeffectsofalcoholmaybeincreasedbytakingranitidine.

4.6Pregnancyandlactation

Therearenoadequateorwellcontrolledstudiesinman.Adoseequivalentto160timesthenormalhumandose

showednoadverseeffectsonthefoetuswhengiventopregnantratsandrabbits.

Ranitidineisexcretedinbreast-milk,andwomenwhoarebreast-feedingmustbeadvisedtotaketheadviceoftheir

doctorbeforecommencingranitidine.Italsocrossestheplacenta;buttherapeuticdosesgiventoobstetricpatientsin

labourorundergoingcaesareansectionhavenotbeenobservedtocauseadverseeffectsonlabour,deliveryor

subsequentneonatalprogress.Ranitidine,asotherselfprescribeddrugs,shouldnotbetakenduringpregnancywithout

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4.7Effectsonabilitytodriveandusemachines

Nostudiesontheeffectsofranitidineonabilitytodriveandusemachineshavebeenperformed.

Accordingtothepharmacodynamicpropertiesofranitidine,noinfluenceontheabilitytodriveorusemachinesis

expected.However,raresideeffects(seesection4.8Undesirableeffects)affectingtheCNSandtheeye,andan

increaseintheeffectsofalcoholwiththeintakeofranitidine(seesection4.5Interactionswithothermedicinalproducts

andotherformsofinteraction)mightadverselyaffecttheseabilities.

4.8Undesirableeffects

Thefollowingadverseeffectshavebeenreportedinclinicaltrialsorinroutinemanagementofpatientstreatedwith

ranitidine

Bloodandthelymphaticsystemdisorders:

Rare(>1/10000,<1/1000):agranulocytosis,andpancytopenia,sometimeswithbonemarrowhypoplasiaoraplasia.

Veryrare(<1/10000):leucopeniaandthrombocytopenia(whichareusuallyreversible).

Psychiatricdisorders:

Rare(>1/10000,<1/1000):mentalconfusion(reversible),agitation,depressionandhallucinations.Thesehavebeen

observed,mainlyinpatientswithsevereillnessandtheelderly.

Nervoussystemdisorders:

Common(>1/100,<1/10):headache(sometimessevere)anddizziness.

Rare(>1/10000,<1/1000):involuntarymovementdisorders.

Eyedisorders:

Rare(>1/10000,<1/1000):reversibleblurredvision(possiblyduetoimpairedaccommodation).

Cardiacdisorders:

Rare(>1/10000,<1/1000):bradycardia,tachycardiaandA-Vblock.

Vasculardisorders:

Veryrare(<1/10000),includingisolatedreports:vasculitis

Gastrointestinaldisorders:

Common(>1/100,<1/10):nausea,constipationanddiarrhoea.

Hepato-biliarydisorders:

Uncommon(>1/1000,<1/100):transientchangesintheresultsofliverfunctiontests.

Rare(>1/10000,<1/1000):hepatitis(hepatocellular,hepatocanalicularormixed)withorwithoutjaundice(usually

reversible),acutepancreatitis.

Skinandsubcutaneoustissuedisorders:

Rare(>1/10000,<1/1000):erythemamultiforme,alopeciaandpruritus.

Musculoskeletal,connectivetissueandbonedisorders:

Rare(>1/10000,<1/1000):arthralgiaandmyalgia.

Renalandurinarydisorders:

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Reproductivesystemandbreastdisorders:

Rare(>1/10000,<1/1000):impotenceandlossoflibidoinmalepatients.

Veryrare(<1/10000),includingisolatedreports:breastswellingand/ordiscomfortinmales(someofwhichhave

resolvedwithcontinuedranitidineuse).

Generaldisordersandadministrationsiteconditions:

Common(>1/100,<1/10):fatigue.

Veryrare(<1/10000):hypersensitivityreactions(urticaria,angioneuroticoedema,fever,bronchospasm,laryngeal

spasm,hypotension,anaphylacticshock,eosinophilia,chestpain),occasionallyafterasingledose.

4.9Overdose

Treatmentshouldbesupportiveandsymptomatic.Gastriclavageshouldbecarriedoutand/oremesisinduced.

Seizuresmaybemanagedwithdiazepam,bradycardiawithatropineandventriculararrhythmiaswithlidocaine

(lignocaine).Ranitidinemayberemovedfromplasmabyhaemodialysis.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:H

–receptorantagonists

ATCCode:A02BA02

Modeofaction:

Ranitidineisaspecific,histamineH

–antagonistwitharapidonsetofaction.Bothbasalandstimulatedgastricacid

secretionareinhibited,reducingboththeacidcontentandalsotoasmallerextentthepepsincontentandvolumeofthe

gastricjuice.

Ranitidinehasarelativelylongdurationofaction,a75mgdoseofranitidineeffectivelysuppressinggastricacid

secretionforupto12hours.

5.2Pharmacokineticproperties

Ranitidinehasabioavailabilityofapproximately50%.Afteroraladministration,rapidabsorptionisfollowedbythe

attainmentofpeakplasmaconcentrations2-3hourslater.

Thepharmacokineticsofranitidinearedoseproportionalinthedoserangebetween75mgand300mg.

RanitidineismetabolisedinthelivertoRanitidine-N-oxide,N-Desmethylranitidine,Ranitidine-S-oxideandthefurane

acidanalogue.Afteroraladministration,ranitidineisexcretedwithin24hoursviathekidneystoapprox.30%as

unchangedranitidine,upto6%asN-oxide,toasmalldegreeindemethylisedandinS-oxidisedform,andasfurane

acidanalogue.Inpatientswithnormalkidneys,renalexcretioniseffectedpredominantlybytubularsecretionwitha

renalclearanceofabout490-520ml/min.

Additionally,ranitidineisexcretedviathebile.

Afteroralintake,meaneliminationhalf-lifeinpatientswithnormalkidneysis2.3-3hours.Inpatientswithrenal

insufficiency,thehalf-lifeisprolongedtwo-tothreefold.

5.3Preclinicalsafetydata

Thepharmacologicalandtoxicologicalpropertiesofranitidinearewellestablished.Therearenoadditionaldatafrom

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Microcrystallinecellulose,croscarmellosesodium,colloidalanhydroussilica,magnesiumstearate,talc

Filmcoatingmaterial:CasteroilandOpadryOY-S-54902Pinkcontaininghypromellose,talc,titaniumdioxide(E171),

redferricoxide(E172).

PrintingInk:Opacode-S-1-27794BlackcontainingShellac,Ironoxideblack(E172),N-ButylalcoholandPropylene

Glycol.

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

Bellrantabletsarepackedincold-formblistersheets(structurefromoutertoinnerside:orientedpolyamide/aluminium

foil/hardPVCfilmwithabackingofaluminiumfoilcoatedwithheatseallacquer),eachcontaining6or7or10tablets.

Packsof6or7or10or12or14or20or28tablets.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Ranbaxy(UK)Limited,

95ParkLane,

Mayfair,

LondonWIY3TA

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA0967/001/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:21July2000

Irish Medicines Board

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10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 13/12/2007 CRN 2044513 page number: 6