BRUSH-OFF COLD SORE TREATMENT

Main information

  • Trade name:
  • BRUSH-OFF COLD SORE TREATMENT
  • Dosage:
  • 10%w/v %w/v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BRUSH-OFF COLD SORE TREATMENT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0696/005/001
  • Authorization date:
  • 02-06-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Brush-OffCold SoreTreatment

2QUALITATIVEANDQUANTITATIVECOMPOSITION

PovidoneIodine10%w/v

Forexcipients, seesection 6.1

3PHARMACEUTICALFORM

Cutaneoussolution

Aclear, reddish brown, alcoholic/aqueoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asatopicalantisepticin theprevention and treatmentoftopicalcutaneousinfections.

4.2Posologyandmethodofadminstration

Fortopicaladministration.

Useonceortwicedaily orasdirected.

Apply directly to theaffected areaand allowto dry.Coverwith adressing ifdesired.

4.3Contraindications

1. Usein patientswith aknown orsuspected hypersensitivity to iodine.

2. Regularusein patientsand userswith thyroid disorders(in particularnodularcolloid goitre, endemicgoitreand

Hashimoto’sthyroiditis).

3. Do notuseon children under2 yearsofage.

4.4Special warningsandspecialprecautionsforuse

1. Ifsymptomspersist, consultyourdoctor.

2. Sideeffectsincludelocalirritation and hypersensitivity.

3. Theproductshould notbeused neartheeyes.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1. Absorption ofiodinefrompovidoneiodinethrough eitherintactordamaged skin may interferewith thyroid

function tests.

2. Contamination with povidoneiodineofseveraltypesoftestsforthedetection ofoccultblood in faecesorblood

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016059 page number: 1

4.6Pregnancyandlactation

Regularuseofpovidoneiodineshould beavoided in pregnantorlactating women asabsorbediodinecan crossthe

placentalbarrierand besecreted into breastmilk.Although noadverseeffectshavebeen reported fromlimited use,

caution should berecommended and therapeuticbenefitmustbebalanced againstpossibleeffectsoftheabsorption of

iodineon foetalthyroid function and development.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Rarely, localirritationmay occur.

Anaphylacticreactions, anaphylactoid reactionsand anaphylacticshock havebeen reported uncommonly with products

containing povidone-iodineorpovidone.

4.9Overdose

Overdoseisunlikely with thisproduct.However, in thecasesofaccidentalingestion oflargequantitiesofBrush-Off

Cold SoreTreatment, symptomaticand supportivetreatmentshould beprovided with specialattention to electrolyte

balanceand thyroid function.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Povidone-iodineisacomplex ofiodinewhich showsallthebroad spectrumgermicidalactivity ofelementaliodine.

Thegermicidalactivity ismaintained in thepresenceofblood, pus, serumand necrotictissue.Itiseffectivein the

treatmentofinfectionscaused by bacteria, fungi, yeastsand viruses(e.g. HerpesVirusTypesIandII).

5.2Pharmacokineticproperties

Nonestated.

5.3Preclinical safetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Nonoxynol9

DibasicSodiumPhosphate(anhydrous)

CitricAcid monohydrate(E330)

IndustrialMethylated Spirit

SodiumHydroxide(10%Solution)

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016059 page number: 2

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Threeyears.

6.4Special precautionsforstorage

Storebelow25°C.Storein theoriginalcontainer.

6.5Natureandcontentsofcontainer

Glassbottle(TypeIII)with applicatorbrush containing 8 mlofproduct.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Seton HealthcareGroup plc

Tubiton House

Oldham

OL1 3HS

England

8MARKETINGAUTHORISATIONNUMBER

PA696/5/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 2 nd

June1988

Dateoflastrenewal: 2 nd

June2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016059 page number: 3