CENTYL

Main information

  • Trade name:
  • CENTYL Tablets 5 Milligram
  • Dosage:
  • 5 Milligram
  • Pharmaceutical form:
  • Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CENTYL Tablets 5 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0046/018/002
  • Authorization date:
  • 01-04-1978
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0046/018/002

CaseNo:2052909

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

LeoLaboratoriesLimited

CashelRoad,Dublin12,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Centyl5mgTablets

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom18/07/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

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Date Printed 23/07/2008 CRN 2052909 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Centyl5mgTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eachtabletcontains5mgofbendroflumethiazide

Excipients:Lactosemonohydrate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Tablet

White,circular,flat,slightlybevelledtabletwithasinglescorelineengravedononefaceandacentralcirculargroove

engravedontheother.

Thescorelineisonlytofacilitatebreakingforeaseofswallowingandnottodivideintoequaldoses.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asadiureticinthemanagementofoedemasuchasthatwhicharisesfromcardiac,renalandhepaticorigin.

Inthemanagementofhypertensionaloneorincombinationwithotherantihypertensives.

4.2Posologyandmethodofadministration

Adults:

Oedema

Theusualinitialdoseis2.5to10mgasasingledose,withamaintenancedosageof2.5to5mgdaily,preferablyinthe

morning.

Hypertension

2.5to5mgoncedaily.

4.3Contraindications

Hypersensitivitytotheactivesubstanceortoanyoftheexcipients.

Severeelectrolyteimbalanceincludinghypercalcaemia,hyperchloraemiaorhypokalaemia.

Severerenalimpairment.

Severehepaticimpairment.

Addison’sdisease.

Establishedgout.

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4.4Specialwarningsandprecautionsforuse

Considerationsshouldbegiventofluidandelectrolytestatustoavoidinadequatepotassiumsupplementationor

excessivelossoffluidespeciallyinelderlypatients.Concomitantmedicationshouldalsobeconsidered.

Bendroflumethiazidemayprovokehyperglycaemiaandglycosuriaindiabeticandothersusceptiblepatients.Incaseof

reducedglucosetolerance,adjustmentsofanti-diabeticmedicinesmaybenecessary.

Thiazidediureticsshouldbeusedwithcautioninpatientswithrenalorhepaticimpairmentandinpatientswith

potentialobstructionoftheurinarytractorwithdisordersrenderingtheirelectrolytebalanceprecarious.

Thiazidesmaycausehyperuricaemiaandprecipitateoraggravateattacksofgout.

Bendroflumethiazidemaycauseexacerbationoractivatingofsystemiclupuserythematous.

Bendroflumethiazidefoundinurinebydopingtestiscausefordisqualificationofathletes.

Patientswithrarehereditaryproblemsofgalactoseintolerance,theLapplactosedeficiencyorglucose-galactose

malabsorptionshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministrationofthispreparationwithcardiacglycosidesorhypotensiveagentsmaynecessitate

adjustmentofthedosageofthosedrugs.

Bendroflumethiazidemaypotentiatetheeffectofantihypertensiveagentsanddrugsinducingposturalhypotensione.g.

tricyclicantidepressants.

Bendroflumethiazidemayimpaircontrolbyhypoglycaemicagentsincasesofdiabetesmellitus(c.f.section4.4).

Non-steroidalanti-inflammatorydrugs(NSAID)inhibittheeffectofbendroflumethiazide.

Bendroflumethiazidereduceslithiumclearanceresultinginhighserumlevelsoflithium,thereforeconcurrentuseis

contraindicated(c.f.section4.3).

Probenecidinhibitstherenaltubularsecretionofbendroflumethiazideleadingtoadiminishednatriuresis.

Cholestyramineandsimilardrugsreducestheabsorptionofthiazides.

Co-administrationofbendroflumethiazideandotherdrugsknowntocausephotosensitivityreactionsmayincrease

theseverityofthesereactions.

Hypokalaemia(whichmaybeinducedbybendroflumethiazide)increasesthesensitivitytodigitalisglycosidesand

non-depolarisingneuromuscularblockingagents.

Theurinaryexcretionofcalciumisreduced.

4.6Pregnancyandlactation

Animalstudiesareinsufficientwithrespecttoeffectsonpregnancy.Thepotentialriskforhumansisunknown.

Bendroflumethiazideshouldnotbeusedduringpregnancyunlessclearlynecessary.

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4.7Effectsonabilitytodriveandusemachines

Bendroflumethiazidehasnoornegligibleinfluenceontheabilitytodriveandusemachines.

4.8Undesirableeffects

Themostfrequentundesirableeffectsareheadache,dizziness,fatigue,posturalhypotensionandgastrointestinal

symptoms.Electrolytedisturbancescanoccurespeciallyduringlongtermtreatment.

Thiazidediureticsmaycauseanumberofmetabolicdisturbancesincludingreducedglucosetoleranceand

hyperuricaemia.Musclecramps,variousskinreactions,photosensitivityreactionsanderectiledysfunctionareless

frequent.Vasculitis,blooddyscrasias,mainlyaffectingtheplateletsandacutepancreatitis,havealsobeenreported.

BasedontheclinicaltrialdataforCentyl®Kundesirableeffectsoccurredinapproximately15%andaredose

dependant.

Basedonpost-marketingdataforbothCentyl®andCentyl®K,thetotal“reportingrate”ofundesirableeffectsisvery

rarebeingapproximately2:100,000treatmentmonths.

TheundesirableeffectsarelistedbyMedDRASOCandtheindividualundesirableeffectsarelistedstartingwiththe

mostfrequentlyreported.

Nervoussystemdisorders

Headache

Dizziness

Vertigo

Syncope

Posturalhypotension

Generaldisordersandapplicationsiteconditions

Fatigue

Asthenia

Drymouth

Thirst

Paraesthesia

Gastrointestinaldisorders

Nausea

Gastricirritation

Vomiting

Diarrhoea

Constipation

Metabolismandnutritiondisorder

Dehydration

Hyponatraemia

Hypokalaemia

Gout

Hyperuricaemia

Hyperglycaemia

DiabetesMellitus

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Hypochloraemia

Hypocalcaemia

Hypomagnesaemia

Musculoskeletalandconnectivetissuedisorders

Myalgia

Musclecramp

Skinandsubcutaneoustissuereactions

Rash

Photosensitivityreactions

Pruritus

Reproductiveandbreastdisorder

Erectiledysfunction

VascularDisorders

Hypotension

Vasculitis

Bloodandlymphaticsystemdisorder

Thrombocytopenia

Granulocytopenia

4.9Overdose

Inhighdosesthiazidediureticsmaycauseelectrolyteimbalance,dehydrationandpolyuria.

Symptomsofelectrolyteimbalanceincludedrymouth,thirst,weakness,lethargy,drowsiness,gastrointestinal

disturbances,restlessness,musclepainandcramps,andseizures.

Treatmentisadjustmentofthefluidandelectrolyteimbalance.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:C03AA01

Bendroflumethiazideisathiazidediureticwhichactsonbothdeterminantsofhypertension,i.e.cardiacoutputand

peripheralresistance.Cardiacoutputisreducedduetothedecreaseinbloodvolumeresultingfromthediureticeffect.

Centylreducesperipheralresistancebyavasodilatingeffect,themechanismofwhichisnotcompletelyunderstood.In

oedematousconditionsthediureticactionreducesextravascularfluidvolume.

5.2Pharmacokineticproperties

Bendroflumethiazidehasbeenreportedtobecompletelyabsorbedfromthegastrointestinaltractandtohaveahalf-life

ofabout3or4hours.Plasmaproteinbinding,aswithmostthiazides,ishigh.Thereisevidencethat

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5.3Preclinicalsafetydata

Therearenopre-clinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Colloidalanhydroussilica

Gelatin

Maizestarch

Lactosemonohydrate

Talc

Magnesiumstearate

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

6.5Natureandcontentsofcontainer

Amberglassbottlesof100and500tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourpharmacisthowtodisposeof

medicinesnolongerrequired.Thesemeasureswillhelptoprotecttheenvironment.

7MARKETINGAUTHORISATIONHOLDER

LEOLaboratoriesLimited

285CashelRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Printed 23/07/2008 CRN 2052909 page number: 6

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1978

Dateoflastrenewal:14November2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 23/07/2008 CRN 2052909 page number: 7