BETADINE VAGINAL CLEANSING KIT

Main information

  • Trade name:
  • BETADINE VAGINAL CLEANSING KIT
  • Dosage:
  • 10%w/v %w/v
  • Pharmaceutical form:
  • Vaginal Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • BETADINE VAGINAL CLEANSING KIT
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0696/002/020
  • Authorization date:
  • 01-04-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetadineVaginalCleansing Kit.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

PovidoneIodine10%w/v

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Concentrateforvaginalsolution

Adark brown coloured solution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asan antisepticforusein themanagementofpre-operativedisinfection ofvaginitisdueto organismssensitiveto the

iodineand in pre-operativepreparation ofthevagina.

4.2Posologyandmethodofadminstration

Forintravaginaladministration.

BetadineVaginalCleansing concentrateshould bediluted 1:10 and used according to thepatientinstruction leaflet

provided.

Useonceaday (preferably in themorning)for14 consecutivedays.Ifmenstruation occursduring thetreatmentitis

importantto continuetreatmentduring thedaysoftheperiod.

4.3Contraindications

1. Usein patientshypersensitiveto iodine.

2. Usein pregnancy.

3. Regularuseiscontraindicated in patientsand userswith thyroid disorders(in particularnodularcolloid goitre,

endemicgoitreand Hashimoto’sthyroiditis).

4. Usein pre-pubertalchildren

4.4Special warningsandspecialprecautionsforuse

Iflocalirritation, rednessorswelling developsdiscontinuetreatment.Iodineisabsorbed fromthevaginaand

followingprolonged use, thyroid dysfunction may develop.Theproductmay bespermicidaland should notbe

used when conception isdesired.

Ifno improvementoccursthedoctorshould beconsulted.

Specialcaution isneeded when regularapplicationsto inflamed orbroken vaginalmucosaaremadeto patients

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016032 page number: 1

Regularuseshould beavoided in patientson concurrentlithiumtherapy.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1. Absorption ofiodinefrompovidoneiodinethrough eitherintactordamaged skin may interferewith thyroid

function tests.

2. Contamination with povidoneiodineofseveraltypesoftestsforthedetection ofoccultblood in faecesorblood

in urinemay producefalsepositiveresults.

4.6Pregnancyandlactation

Aswithotherdouches, thisproductisnotrecommended during pregnancy.

4.7Effectsonabilitytodriveandusemachines

Nonestated

4.8Undesirableeffects

Localirritation, rednessorswelling may occur.

Anaphylacticreactions, anaphylactoid reactionsand anaphylacticshock havebeen reported uncommonly with products

containing povidone-iodineorpovidone.

4.9Overdose

Excessiodinecan producegoitreand hypothyroidismorhyperthyroidism.In thecaseofaccidentalingestion oflarge

quantitiesofBetadine, symptomaticandsupportivetreatmentshould beprovided with specialattention to electrolyte

balanceand renaland 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

Nonoxinol9

FleuromaBouquet477

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016032 page number: 2

6.2Incompatibilities

Compatibility with barriercontraceptiveshasnotbeen established. Therefore, thisproductshould notbeused with

such methodsofcontraceptionastheirreliability may beaffected.

6.3ShelfLife

Threeyears.

6.4Special precautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

250mlhigh density polyethylenebottleappropriately sealed with ameasuring cup, andaccompanied by an empty

turquoiselowdensity polyethylenesqueezebottlewith vaginalapplicator.

6.6Instructionsforuseandhandling

TheBetadineVaginalCleansing concentrateshould bediluted 1:10 and used according to thepatientinstruction leaflet

provided.

Oncediluted, thecolourofthesolution isclearyellow-brown.

7MARKETINGAUTHORISATIONHOLDER

Seton HealthcareGroup plc

Tubiton House

Oldham

OL1 3HS

England

8MARKETINGAUTHORISATIONNUMBER

PA696/2/20

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 1 st

April1993

Dateoflastrenewal: 1 st

April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016032 page number: 3