ANUSOL HC N/A Ointment

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
HYDROCORTISONE ACETATE, BENZYL BENZOATE, BISMUTH SUBGALLATE, BISMUTH OXIDE, BALSAM PERU, ZINC OXIDE
Available from:
McNeil Healthcare (Ireland) Ltd
ATC code:
D07BA
INN (International Name):
HYDROCORTISONE ACETATE, BENZYL BENZOATE, BISMUTH SUBGALLATE, BISMUTH OXIDE, BALSAM PERU, ZINC OXIDE
Dosage:
N/A
Pharmaceutical form:
Ointment
Prescription type:
Product not subject to medical prescription
Therapeutic area:
CORTICOSTEROIDS, WEAK, COMB WITH ANTISEPTICS
Authorization status:
Transfer Pending
Authorization number:
PA0823/040/003
Authorization date:
2000-03-30

hydrocortisone acetate, zinc oxide, bismuth oxide,

bismuth subgallate, balsam peru, benzyl benzoate

Thismedicineisusedforthereliefofinternaland

externalpiles,analitching,analinflammationand

analfissures.Itcanalsobeusedfollowingano-rectal

surgery.

Thismedicineisforuseinadultsovertheageof

18years.

Donotusethismedicine:

IfyouhavehadabadreactiontoAnusoloranyof

theingredientsinit.Seesection6 c

Ifyouhavefungal,viralorbacterialskinsores.

Seesection2 c

Speaktoyourdoctor:

Ifyouhaverectalbleedingwhichhasnotbeen

diagnosedaspiles.Seesection2

Ifyoursymptomshaveworsenedornotimproved

within7daysofusingthisproduct.Seesection2 c

Followtheinstructionsonhowtousethisproduct

carefully.Seesection3 c

Thismedicinehasbeenprescribedforyoubyyour

doctor.Donotpassitontoothers.Itmayharmthem

eveniftheirsymptomsarethesameasyours.

Nowreadthiswholeleafletcarefullybeforeyouuse

thismedicine.Keeptheleaflet:youmightneeditagain.

1 Whatthemedicineisfor

Anusol HC Ointment helps to relieve the pain, swelling,

itch and irritation of internal and external piles, it

helps relieves anal inflammation, anal fissures and

anal itching. It can also be used following ano-rectal

surgery. It contains the following ingredients:

Hydrocortisone acetateis a mild steroid which helps

reduce inflammation.

Zinc oxideandBismuth saltsare mildly astringent and

antiseptic.They soothe and protect raw areas.

action on sore areas and may help healing.

Benzyl benzoatehas mild antiseptic properties.

This product is for use by adults over the age of 18 years.

2 Before using this medicine

This medicine is suitable for most people but a few

people should not use it. If you are in any doubt, talk to

your doctor or pharmacist.

Donotusethismedicine…

IfyouareallergictoAnusoloranyoftheother

ingredientsofthismedicine(listedinsection6.1).

Ifyouhavefungal,viralorbacterialskinsores.

Iftheabovebulletpointsapplytoyou,getadvicefrom

adoctororpharmacistwithoutusingAnusol.

Talktoyourdoctororpharmacist…

Ifyouhaverectalbleedingorbloodinthestool

orifyouareindoubtwhetheranybleedingyou

haveexperiencediscausedbypiles.

Ifsymptomsworsenordonotimproveafteryou

haveusedthemedicinefor7days.

■ Usewithothermedicinescontainingcorticosteroids

mayincreasetheriskofsystemicsideeffects.

Iftheabovebulletpointsapplytoyou,talktoadoctor

orpharmacist.

Ifyouarepregnantorbreast-feeding

Ifyouarepregnantorbreastfeedingonlyuse

ontheadviceofyourdoctor.

Someoftheingredientscancauseproblems

Castoroilmaycauseskinreactions.

Lanolinanhydrousmaycauselocalskin

reactionse.g.contactdermatitiswhichis

alocalirritationatthesiteofuse.

3 Howtousethismedicine

Anusol HC Ointment is for topical use only, which

means it is applied directly to the affected area.

Washtheanalareaanddrygentlywithasofttowel

Thereisanozzlesuppliedwiththeproductwhich

canbeusedtoapplytheointmentintotheback

passage(anus).

Forexternalpiles–afterwashinganddryingthe

affectedarea,theointmentshouldbeappliedusing

agauzedressing.

Forinternalpiles–afterwashinganddryingthe

affectedarea,screwthenozzleprovidedontothe

tube,removethenozzlecap;insertthenozzleinto

thebackpassageandsqueezegently.Cleanthe

nozzleaftereachuse.

WashyourhandsbeforeandafterusingAnusol.

Children(under18years):

Thismedicineisnotrecommendedforchildren

under18yearsold.

Adultsandtheelderly:

■ Excessiveuseoruseforlongperiodsoftimecanbe

harmful,causingtheskintothin,developastripy

appearanceoraffectthebloodvesselsjustbelowthe

skin.Itcanalsocauseadrenalsuppression(atypeof

hormoneimbalancethatcausesgeneralisedeffects

onthebody).Ifaffectedstoptreatmentandspeakto

yourdoctororpharmacistimmediately.

Ifanyonehasswallovedthisproduct

IfanyoneaccidentallyswallowsAnusolHC

Ointment,contactadoctororyournearestAccident

andEmergencydepartment,takingthisleafletand

X

!

i

i

DoNOTtakeorally

Donotusemorethan4timesadayunless

prescribedotherwisebyyourdoctor

Donotuseformorethan7consecutivedays Age Dose

Adultsand

theelderly Applysparinglytotheaffected

area.Youshoulduseasoftenas

prescribedbyyourdoctor,however

AnusolHCOintmentisusuallyused

atnight,inthemorningandafter

eachbowelmovement.

!

F310637 - Leaflet Anusol HC Ointment IEv8.0.indd 1 18/01/16 16:50

Ifyouforgettousethismedicine

AnusolHCOintmentshouldbeusedonanas

requiredbasis.However,ifyouwereunabletouse

thisproductwhenneeded,donotuseadoubledose.

4 Possibleside-effects

Likeallmedicines,thismedicinecancauseside

effects,althoughnoteverybodygetsthem.

Ifyouexperiencethefollowing,stopusingthe

medicineandtalktoyourdoctor:

Rare:mayaffectupto1in1,000people

Hypersensitivityreactions(suchasrash).

Othereffectswhichmayoccurbutitisunknown

howoften:

Burning,redness,irritation,itching,orpainmay

occurwhenapplyingtheointment.Thisdoesnot

usuallylastalongtime,soifthislastslongerthana

fewdays,tellyourdoctor.

Reportingofside-effects

If you get any side-effects, talk to your doctor,

pharmacist or nurse.This includes any possible side-

effects not listed in this leaflet.You can also report side-

effects directly via HPRA Pharmacovigilance, Earlsfort

Terrace, IRL-Dublin 2;Tel: +35316764971;

Fax: +35316762517Website: www.hpra.ie;

Email: medsafety@hpra.ie.

By reporting side-effects you can help provide more

information on the safety of the medicine.

5 Storingthismedicine

Keepoutofthesightandreachofchildren.

Donotstoreabove25°C.

Donotuseyourmedicineafterthedateshownas

expirydateafter“EXP”onthecartonandtube.

Donotthrowawayanymedicinesviawastewateror

householdwaste.Askyourpharmacisthowtothrow

awaymedicinesyounolongeruse.Thesemeasures

6 Furtherinformation

What’sinthismedicine?

Theactivesubstancesareper100g:Hydrocortisone

acetate0.25g,Zincoxide10.75g,Bismuthsubgallate

2.25g,BalsamPeru1.875g,Bismuthoxide0.875g

andBenzylbenzoate1.25g.

Otheringredientsare:Magnesiumstearate,theobroma

oil,woolfat(lanolinanhydrous),castoroil,kaolinlight,

calciumhydrogenphosphateandwhitesoftparaffin.

Whatthemedicinelookslike

Anusol HC Ointment is a buff coloured ointment

available in 15 g tubes.

ProductAuthorisationholder:McNeilHealthcare

(Ireland)Ltd.,AirtonRoad,Tallaght,Dublin24,Ireland.

Manufacturer:FamarOrléans,

5avenuedeConcyr,45071Orleans,Cedex2,France.

ThisleafletwasrevisedDecember2015.

Anusolisaregisteredtrademark.

AHealthyLivingPlanforPilesSufferers

Whatarepiles?

Piles(haemorrhoids)areswollenbloodvesselswhich

occurinsideoroutsidethebackpassage(anus).

Symptoms

Somepeoplehavepileswithoutexperiencingany

symptoms,butsufferersmaynoticethefollowing:

Bleeding:Althoughstreaksofbrightredbloodonthe

toiletpaperarenotuncommoninpeoplewithpiles,

itmaybeasignofamoreseriousconditionandyou

shouldseeyourdoctortocheckthis.

Swelling:Theswollenbloodvesselsmaybefeltasa

lumporblockageintheanus.

Pain,itchingandirritationintheanalregion.

Atleast40%ofpeoplesufferfrompilesatsome

timeintheirlives.However,manypeoplearetoo

embarrassedtoseekadviceortreatmentand,asa

result,sufferunnecessarydiscomfort.

situationandrelievethesymptoms.

Whatcausespiles?

Anumberoffactorscancontributetothedevelopment

ofpiles:

Themostcommoncauseisstrainingduringbowel

movement,usuallyasaresultofconstipation.

Duringpregnancy,thegrowingbabyexertsincreased

pressureontheanalvessels,whichcanleadtopiles.

Heredity:youmaybemorelikelytodeveloppilesif

yourfamilyhasahistoryofsuffering.

AHealthyLivingPlanforPilesSufferers

Youcanreducetheriskofpilesbyfollowingahealthy

dietandlifestylethathelpstokeepyourbowels

workingregularlyandpreventsconstipation.Thiscan

alsohelptospeedrecoveryfrompiles.

Eatahighfibredietincludingfoodslikebrownrice,

wholemealbread,wholewheatpastaetc.

Eatplentyoffreshfruit,vegetablesandsalads.

Drinkplentyofwater.

Don’teattoomuchsalty,fattyorsugaryfoodssuch

ascrisps,burgersandcakes.

Cutbackontheamountofalcohol,teaandcoffee

youdrink.

Exerciseregularly.

Ahealthydietandlifestylewillreducethelikelihood

ofconstipationandencouragearegularbowelhabit.

Gotothetoiletregularlyandtrytoavoidstraining.

Leaningforwardfromthehipsmayhelp.

Forexternalandinternalpiles,Ointmentcanbeused.

Ifinternalhaemorrhoidsaretheproblem,Suppositories

deliverameasureddosetotheaffectedarea.

Forfurtherinformation,pleasecontact:

McNeilHealthcare(Ireland)Ltd.,AirtonRoad,Tallaght,

Dublin24,Ireland.

F310637-41

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F310637 - Leaflet Anusol HC Ointment IEv8.0.indd 2 18/01/16 16:50

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AnusolHCOintment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each100gofointmentcontains:

Excipient:

WoolFat 8.00g

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Ointment

Asmooth,homogeneousbuffcolouredointmentwiththecharacteristicodourofBalsamPeru.

4CLINICALPARTICULARS

4.1TherapeuticIndications

AnusolHCOintmentisindicatedforthesymptomaticreliefofexternalandinternalhaemorrhoids,proctitis,cryptitis,

analfissures,pruritusaniandperianalsinuses.Alsoindicatedpost-operativelyinano-rectalsurgicalprocedures.

4.2Posologyandmethodofadministration

Topical.

Adults:Thoroughlycleansetheaffectedarea,dryandapplyointmentonagauzedressing.Applyointmenttothe

affectedareaatnight,inthemorningandaftereachevacuation.Forinternalconditionsuserectalnozzleprovidedand

cleanitaftereachuse.Donotuseforlongerthan7days,unlessontheadviceofadoctor.Nottobetakenorally.

Elderly(over65years):Asforadults.

Children:Notrecommended.

4.3Contraindications

Hypersensitivitytotheactivesubstance(s)ortoanyoftheexcipientslistedinsection6.1

Tubercular,fungal,bacterialandvirallesionsincludingherpessimplex,vacciniaandvaricella.

4.4Specialwarningsandprecautionsforuse

Patientswithrectalbleedingorbloodinthestoolshouldtalktotheirdoctorbeforeusingthisproductasthese

HydrocortisoneAcetate 0.25g

BenzylBenzoate 1.25g

BismuthSubgallate 2.25g

Bismuthoxide 0.875g

BalsamPeru 1.875g

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Aswithallproductscontainingtopicalsteroidsthepossibilityofsystemicabsorptionshouldbeborneinmind.

Prolongedorexcessiveusemayproducesystemiccorticosteroideffectswithsuppressionofadrenocorticalfunction

andtoxicity.Useforperiodslongerthansevendaysisnotrecommendedunlessunderthedirectionofadoctor.

Theproductshouldbediscontinuedandthepatientadvisedtoconsultamedicalpractitionerifsymptomsdonot

improve,worsen,orifrectalbleedingoccurs.

Continuousapplicationwithoutinterruptionwillresultinlocalatrophyoftheskin,striaeandsuperficialvascular

dilatation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Concurrentusewithothercorticosteroidpreparations,eithertopicallyororallymayincreasethelikelihoodofsystemic

effects.

4.6Fertility,pregnancyandlactation

Shouldnotbeusedduringpregnancyorlactationunlessthepotentialbenefitoftreatmenttothemotheroutweighsthe

possiblerisktothedevelopingfoetusornursinginfant.

Therearenoadequateandwell-controlledclinicalstudiesoffixedcombinationsofbalsamperu,benzylbenzoate,

bismuthoxide,bismuthsubgallate,zincoxideandhydrocortisoneacetateinpregnantorbreast-feedingwomen.There

maybeaverysmallriskofcleftpalateandintrauterinegrowthretardationaswellassuppressionoftheneonatal

hypothalamic-pituitary-adrenalaxis.Thereisevidenceofharmfuleffectsinanimals.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

NoAdverseDrugReactions(ADRs)havebeenidentifiedfromtheanalysisofpost-marketingdataforfixedcombinations

ofBalsamPeru,bismuthoxideandzincoxide.

ADRsidentifiedduringPost-MarketingexperiencewithZincOxide(topicaluse)arelistedbelowbySystemOrganClass

(SOC).

Thefrequenciesaredefinedinaccordancewithcurrentguidance,as:

Verycommon 1/10

Common 1/100and<1/10

Uncommon 1/1,000and<1/100

Rare 1/10,000and<1/1,000

Veryrare <1/10,000

Notknown (cannotbeestimatedfromtheavailabledata)

ADRsarepresentedbyfrequencycategorybasedon1)incidenceinadequatelydesignedclinicaltrialsorepidemiology

studies,ifavailable,or2)whenincidencecannotbeestimated,frequencycategoryislistedas'Notknown'

*TransientADRespeciallyiftheanodermisnotintact. SystemOrganClass(SOC) Frequency AdverseDrugReaction(PreferredTerm)

ImmuneSystemDisorders Rare Hypersensitivity

GeneralDisordersand

Administrationsiteconditions Notknown Applicationsitereactions(includingBurn*,Erythema,

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Otheradversereactionsinclude:Skinsensitisationreactionsandsystemiccontactdermatitis,attributeddirectlytoBalsam

Peruhavebeenreportedinpublishedliterature.

ReportingofSuspectedAdverseReactions.

Reportingsuspectedadversereactionsafterauthorisationofthemedicinalproductisimportant.Itallowscontinued

monitoringofthebenefit/riskbalanceofthemedicinalproduct.Healthcareprofessionalsareaskedtoreportanysuspected

adversereactionsviaHPRAPharmacovigilance,EarlsfortTerrace,IRL-Dublin2;Tel:+35316764971;Fax:+3531

6762517.Website: www.hpra.ie ;e-mail: medsafety@hpra.ie .

4.9Overdose

Nooverdoserelatedadversedrugreactionshavebeenidentifiedfromthepost-marketingdataanalysisofBalsamPeru,

benzylbenzoate,bismuthoxide,bismuthsubgallate,hydrocortisoneacetateandzincoxide.

Theingestionoftopicalzincoxidecanpotentiategastrointestinalsymptoms.

Symptomsofacuteoraloverdoseofbismuth-containingpreparationsmayincludenausea,vomiting,renalfailureand

rarelyliverdamage.Encephalopathyanddiscolourationofmucousmembranesmayoccurwithchronicoverdose.

NocasesofBalsamPeruoverdosehavebeenidentifiedinthemedicalliterature.

Ifswallowed,fever,nausea,vomiting,stomachcrampsanddiarrhoeamaydevelop3-12hoursafteringestion.

Hydrocortisonedoesnotnormallyproducetoxiceffectsinanacutesingleoverdose.Prolonged,useoftopical

corticosteroidsmayincreasepotentialforlocaladverseeffects,includingsteroidatrophy(thinningoftheskin),striae

(stretchmarks),andTelangiectasia(visiblebloodvessels).Systemicavailabilityafterrectaladministrationisverylow;

however,excessiveadministrationofcorticosteroidsmayincreasethepotentialforsystemiceffects,suchas

hypothalamic-pituitaryaxissuppression.

Treatmentofalargeacuteoverdosageshouldincludegastriclavage,purgationwithmagnesiumsulphateandcomplete

bedrest.Ifnecessary,giveoxygenandgeneralsupportivemeasures.Methaemoglobinaemiashouldbetreatedby

intravenousmethylthioniniumchloride.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

AnusolHCOintmentprovidesantisepticastringent,emollientandvasculardecongestantproperties.Inaddition,

hydrocortisoneexertsananti-inflammatoryeffect.

Bismuthoxide,zincoxideandbismuthsubgallateexertaprotectiveactiononmucousmembranesandrawsurfaces.

Theyaremildlyastringentandarereportedtohaveantisepticproperties.

BalsamPeruhasprotectivepropertiesandaverymildantisepticactionbyvirtueofitscontentofcinnamicandbenzoic

acids.Itisbelievedtopromotethegrowthofepithelialcells.Benzylbenzoateisusedasasolubilisingagentandhas

mildantisepticandpreservativeproperties.

Hydrocortisoneacetatehasthegeneralpropertiesofhydrocortisoneandtheanti-inflammatoryactionisofprimary

interestinthisproduct.

5.2Pharmacokineticproperties

Itiswellknownthattopicallyappliedcorticosteroidscanbeabsorbedpercutaneously.Thisappearstobemorelikely

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TheotheractiveingredientsinAnusolHCOintmentexerttheirtherapeuticeffectwithoutbeingabsorbedintothe

systemiccirculation.Theseobservationsaresupportedbyevidencefromvariousstudiesandreviews.

5.3Preclinicalsafetydata

Pre-clinicalsafetydatadonotaddanythingoffurthersignificance.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Magnesiumstearate

TheobromaOil

Woolfat(Lanolinanhydrous)

Castoroil,virgin

Kaolinlight

WhiteSoftParaffin

Calciumhydrogenphosphate

6.2Incompatibilities

Noneapplicable.

6.3Shelflife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

Externalprintedaluminiumtube,withplasticscrewcap,accompaniedbyaplasticapplicatornozzle.

Packsize:15g,25g,30g

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements.

Anyunusedmedicinalproductorwastematerialshouldbedisposedofinaccordancewithlocalrequirements

7MARKETINGAUTHORISATIONHOLDER

McNeilHealthcare(Ireland)Ltd.

AirtonRoad

Tallaght

Dublin24

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8MARKETINGAUTHORISATIONNUMBER

PA0823/040/003

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:30March1990

Dateoflastrenewal:30March2010

10DATEOFREVISIONOFTHETEXT

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Date Printed 13/06/2016 CRN 2171627 page number: 5

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