BENDROFLUAZIDE

Main information

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

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0408/030/001
  • Authorization date:
  • 24-02-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BendroflumethiazideTabletsBP5mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Bendroflumethiazide5.0 mg

Forexcipients, see6.1

3PHARMACEUTICALFORM

Whitecircularbiconvex tabletwith abreaklineon onesideand embossed“RIMA”on theotherside.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asadiureticin themanagementofoedemasuch asarisefromcardiac, renalorhepaticorigin, toxaemiaorpregnancy,

corticosteroid administration.

4.2Posologyandmethodofadminstration

Fororaladministration only.

Adults:

Theusualinitialdoseis5-10mg asasingledose, with amaintenancedosageof2.5-10mg daily, preferably in the

morning.

4.3Contraindications

Useofthisproductin thepresenceofhypokalaemia, pre-comaassociated with hepaticcirrhosisorAddison’sdisease.

4.4Special warningsandspecialprecautionsforuse

Patientswhoarebeing treated with thispreparation requireregularsupervision with monitoring offluid and electrolyte

stateto avoid inadequatepotassiumsupplementation orexcessivelossoffluid.Thepreparation should only beused

with particularcaution in elderlypatients, orthosewith potentialobstruction oftheurinary tract, orwith disorders

rendering theirelectrolytebalanceprecarious.Hyperuricaemiaand goutmay beinduced by thispreparation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Theconcomitantadministration ofthispreparation with cardiacglycosidesorhypotensiveagentsmay necessitate

adjustmentofthedosageofthesedrugs.

Thepreparation may inducehyperglycaemiaparticularly in patientswith latentdiabetes, and may necessitate

adjustmentofcontrolby hypoglycaemicagentsin casesofdiabetesmellitus.

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 07/11/2005 CRN 2016322 page number: 1

4.6Pregnancyandlactation

Thepreparation should only beused during pregnancy ifconsidered essentialby thephysician.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Sideeffectsmay includeskin rashes, gastricirritation, dizziness,headache.

4.9Overdose

Following overdose, empty thestomachby emesisorlavageand apply symptomatictreatment.Treatmentshould be

directed atfluid and electrolytereplacement.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Bendroflumethiazideisathiazidediureticwhich reducesthereabsorption ofelectrolytesfromtherenaltubules, thereby

increasing theexcretion ofsodiumand chlorideions, and consequently ofwater.Potassiumionsareexcreted to a

lesserextent.Itsinhibitory action on carbonicanhydraseisweak, butcarbonicanhydraseactivity isreduced so that

bicarbonateexcretion isincreased,butthiseffectisgenerally smallcompared with theeffecton chlorideexcretion and

doesnotappreciably altertheacid basebalanceon thepHoftheurine.Thethiazides, likeBendroflumethiazide, also

haveaslightly lowering effecton blood pressureand enhancetheeffectofotherantihypertensiveagents.

Paradoxically, they havean antidiureticeffectin patientswith diabetesinsipidus. Bendroflumethiazideinhibits

lactation and should beavoided in nursing mothers.When treatmentisprolonged, orin susceptiblepatients, lossof

potassiummay besufficientto producehypokalaemia(potassiumsupplementsshouldthen begiven).

5.2Pharmacokineticproperties

Bendroflumethiazideisathiazidediuretic, wellabsorbed fromthegastro-intestinaltract, excreted unchanged in the

urineusually within 24 hours.

5.3Preclinical safetydata

Clinicaltrialshavenotbeen carried outbecausethisproductisonewith an established usewhich hasbeen adequately

tested on human beingsso thatitseffects,includesideeffects, arealready known.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lactose

MagnesiumStearate

SodiumStarch Glycollate

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 07/11/2005 CRN 2016322 page number: 2

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.Keepcontainertightly closed.

6.5Natureandcontentsofcontainer

Whitepolypropylenecontainers

1000, 500, 250, 100 tablets.

6.6Instructionsforuseandhandling

Nonestated.

7MARKETINGAUTHORISATIONHOLDER

Ranbaxy Ireland Ltd.,

Spafield,

Cork Road,

Cashel,

Co. Tipperary,

Ireland.

8MARKETINGAUTHORISATIONNUMBER

PA408/30/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 24 th

February 1992

Dateoflastrenewal: 24 th

February 2002

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 07/11/2005 CRN 2016322 page number: 3