BETADINE VAGINAL

Main information

  • Trade name:
  • BETADINE VAGINAL
  • Dosage:
  • 200mg Milligram
  • Pharmaceutical form:
  • Pessary
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

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

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0696/002/019
  • Authorization date:
  • 01-04-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetadineVaginalPessaries.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

PovidoneIodine200mg

Forexcipientsseesection 6.1

3PHARMACEUTICALFORM

Pessary

Smooth dark-brown in colourand tapered.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asan antisepticin themanagementofvaginitisdueto organismssensitiveto iodineand in pre-operativevaginal

preparation

4.2Posologyandmethodofadminstration

Forintravaginaladministration.

Usingtheapplicator, insertapessary morning and nightforup to 14 days.Each pessary should bewetted with water

immediately priorto insertion, thusensuring maximumdispersion oftheactiveconstituentand avoiding risk oflocal

irritation.

Ifmenstruation occursduring treatment, itisimportantto continuetreatmentduring thedaysoftheperiod.

4.3Contraindications

1. Known orsuspected iodinehypersensitivity.

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

endemicgoitreand Hashimoto’sthyroiditis).

3. Usein pre-pubertalchildren.

4.4Special warningsandspecialprecautionsforuse

1. Iflocalirritation, rednessorswelling developsdiscontinuetreatment.Iodineisabsorbed fromthevaginaand

followingprolonged use,thyroid dysfunction may develop.Theproductmay bespermicidaland should not

beused when conception isdesired.

2. Ifno improvementoccursthedoctorshould beconsulted.

3. Specialcaution isneeded when regularapplicationsto inflamed orbroken vaginalmucosaaremadeto patients

with pre-existing renalinsufficiency.

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016029 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1. Absorption ofiodinefrompovidoneiodinethrough eitherintactordamaged skin may interferewith thyroid

function tests.

2. Contamination with povidoneiodineofseveraltypesoftestsforthedetection ofoccultblood in faecesorblood

in urinemay producefalsepositiveresults.

4.6Pregnancyandlactation

Regularuseofpovidone-iodineshould beavoided in pregnantorlactating women asabsorbed iodinecan crossthe

placentalbarrierand can besecreted into breastmilk.Although noadverseeffectshavebeen reported fromlimited

use, caution should berecommended andtherapeuticbenefitmustbebalanced againstpossibleeffectsoftheabsorption

ofiodineon foetalthyroid function and development.

4.7Effectsonabilitytodriveandusemachines

Nonestated

4.8Undesirableeffects

Iflocalirritation, rednessorswelling developsdiscontinuetreatment.Iodineisabsorbed fromthevaginaand

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

when conception isdesired.

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

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016029 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

Stripsofaluminiumfoillaminated to polyethyleneorpre-formed PVCpackaging with apolyethylenelining containing

28 pessaries. Thestripsarepackaged in acarton.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Seton HealthcareGroup plc

Tubiton House

Oldham

OL1 3HS

England

8MARKETINGAUTHORISATIONNUMBER

PA696/2/19

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 1 st

April1983

Dateoflastrenewal: 1 st

April2003

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Issued 24/10/2005 CRN 2016029 page number: 3