ANUGESIC HC

Main information

  • Trade name:
  • ANUGESIC HC
  • Pharmaceutical form:
  • Suppositories
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ANUGESIC HC
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0822/009/002
  • Authorization date:
  • 15-03-2000
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AnugesicHCSuppositories

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Suppository

Theproductisabuffcolouredsuppository.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AnugesicHCSuppositoriesareindicatedforthecomprehensivesymptomatictreatmentofsevereandacute

discomfortorpainassociatedwithinternalandexternalhaemorrhoids,proctitis,cryptitis,analfissures,

pruritusaniandperianalsinuses.Alsoindicatedpost-operativelyinano-rectalsurgicalprocedures.

4.2Posologyandmethodofadministration

Intrarectal.

Adults:Removeplasticcoverandinsertonesuppositoryintotheanusatnight,inthemorningandafter

eachevacuation.

Nottobetakenorally.

Elderly(over65years):Asforadults.

Children:Notrecommended.

4.3Contraindications

Tubercular,fungalandvirallesionsincludingherpessimplex,vacciniaandvaricella.

Each2.8gsuppositorycontains:

PramocaineHydrochloride 27 mg

HydrocortisoneAcetate 5 mg

BenzylBenzoate 33 mg

Bismuthoxide 24 mg

BalsamPeru 49 mg

ZincOxide 296 mg

Irish Medicines Board

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Date Printed 31/01/2012 CRN 2110627 page number: 1

4.4Specialwarningsandprecautionsforuse

Aswithallproductscontainingtopicalsteroidsthepossibilityofsystemicabsorptionshouldbebornein

mind.

Prolongedorexcessiveusemayproducesystemiccorticosteroideffects,anduseforperiodslongerthan

sevendaysisnotrecommended.

Followingsymptomaticreliefdefinitivediagnosisshouldbeestablished.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Shouldnotbeusedduringpregnancyorlactationunlessconsideredessentialbythephysician.

Thereisinadequateevidenceofsafetyinhumanpregnancyandtheremaybeaverysmallriskofcleft

palateandintra-uterinegrowthretardationaswellassuppressionoftheneonatalhypothalamicpituitary-

adrenal(HPA)axis.Thereisevidenceofharmfuleffectsinanimals.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Rarely,sensitivityreactions.Patientsmayoccasionallyexperiencetransientburningonapplication,

especiallyiftheanodermisnotintact.

4.9Overdose

Ifswallowed,fever,nausea,vomiting,stomachcrampsanddiarrhoeamaydevelop3-12hoursafter

ingestion.

Pramocaineisrelativelynon-toxicandlesssensitisingthanotherlocalanaesthetics.

Hydrocortisonedoesnotnormallyproducetoxiceffectsinanacutesingleoverdose.

Treatmentofalargeacuteoverdosageshouldincludegastriclavage,purgationwithmagnesiumsulphate

andcompletebedrest.Ifnecessary,giveoxygenandgeneralsupportivemeasures.

Methaemoglobinaemiashouldbetreatedbyintravenousmethylthioniniumchloride.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pramocainehydrochlorideisasurfaceanaestheticusedontheskinandmucousmembranestorelieve

surfacepainandpruritus.

Hydrocortisoneacetatehasthegeneralpropertiesofhydrocortisoneandtheanti-inflammatoryactionisof

Irish Medicines Board

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Date Printed 31/01/2012 CRN 2110627 page number: 2

Benzylbenzoateisusedasasolubilisingagentandhasmildantisepticandpreservativeproperties.

Bismuthoxideexertsaprotectiveactiononmucousmembranesandrawsurfaces.Itisweaklyastringent

andisreportedtohaveantisepticproperties.

BalsamPeruhasprotectivepropertiesandaverymildantisepticactionbyvirtueofitscontentofcinnamic

andbenzoicacids.Itisbelievedtopromotethegrowthofepithelialcells,zincoxideactsasanastringent

andmildantiseptic.

5.2Pharmacokineticproperties

Itiswellknownthattopicallyappliedcorticosteroidscanbeabsorbedpercutaneously.Thisappearstobe

morelikelyuponrepeatedorprolongeduse.TheremainingactiveingredientsinAnugesicHC

Suppositoriesexerttheirtherapeuticeffectwithoutbeingabsorbedintothesystemiccirculation.These

observationsaresupportedbyevidencefromvariousstudiesandreviews.

5.3Preclinicalsafetydata

Preclinicaldatadoesnotaddanythingoffurthersignificancetotheprescriber.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

CalciumHydrogenPhosphate

HardFatA

HardFatC

TheobromaOil

6.2Incompatibilities

Noneknown.

6.3Shelflife

2years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

C.Storeintheoriginalpackage.

6.5Natureandcontentsofcontainer

Printedstrippackconsistingofwhiteopaquepvc/polythenelaminatedfilm.Therearesixsuppositoriesina

stripandtwostrips(12suppositories)inabox.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Irish Medicines Board

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Date Printed 31/01/2012 CRN 2110627 page number: 3

7MARKETINGAUTHORISATIONHOLDER

PfizerHealthcareIreland

9Riverwalk

NationalDigitalPark

CitywestBusinessCampus

Dublin24

8MARKETINGAUTHORISATIONNUMBER

PA822/9/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1978

Dateoflastrenewal:15March2010

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 31/01/2012 CRN 2110627 page number: 4