BETADINE VAGINAL

Main information

  • Trade name:
  • BETADINE VAGINAL
  • Dosage:
  • 10 %w/ v
  • Pharmaceutical form:
  • Vaginal Gel
  • 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:
  • PA1175/002/009
  • Authorization date:
  • 11-02-2005
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetadineVaginalGel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

PovidoneIodine10%w/w.

Forexcipients,seesection6.1.

3PHARMACEUTICALFORM

Vaginalgel

Darkred-brownincolourwithasmoothconsistency.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asanantisepticforuseinthemanagementofvaginitisduetoorganismssensitivetoiodineandinpre-operative

vaginalpreparation.

4.2Posologyandmethodofadministration

Forintravaginaladministration.

Oneapplicatorfullnightly.

Removecapfromtubeandscrewtubeintothreadedopenendofapplicator.Pullplungerbacktolimit.Fillapplicator

withvaginalgelanddetachfromtube.Inarecliningposition,gentlyinsertapplicatorhighinvaginaanddepress

plungertodepositvaginalgel.

Insertanapplicatorfullofgel(5g)everynightforupto14days.Ifmenstruationoccursduringtreatmentitisimportant

tocontinuetreatmentduringthedaysoftheperiod.

4.3Contraindications

1.Knownorsuspectediodinehypersensitivity.

2.Regularuseiscontraindicatedinpatientsanduserswiththyroiddisorders(inparticularnodularcolloidgoitre,

endemicgoitreandHashimoto’sthyroiditis).

3.Useinpre-pubertalchildren.

4.4Specialwarningsandprecautionsforuse

1.Iflocalirritation,rednessorswellingdevelopsdiscontinuetreatment.Iodineisabsorbedfromthevaginaand

followingprolongeduse,thyroiddysfunctionmaydevelop.Theproductmaybespermicidalandshouldnotbe

usedwhenconceptionisdesired.

2.Ifnoimprovementoccursthedoctorshouldbeconsulted.

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withpreexistingrenalinsufficiency.

4.Regularuseshouldbeavoidedinpatientsonconcurrentlithiumtherapy.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

1.Absorptionofiodinefrompovidoneiodinethrougheitherintactordamagedskinmayinterferewiththyroid

functiontests.

2.Contaminationwithpovidoneiodineofseveraltypesoftestsforthedetectionofoccultbloodinfaecesorbloodin

urinemayproducefalsepositiveresults.

4.6Pregnancyandlactation

Regularuseofpovidone-iodineshouldbeavoidedinpregnantorlactatingwomenasabsorbediodinecancrossthe

placentalbarrierandcanbesecretedintobreastmilk.Althoughnoadverseeffectshavebeenreportedfromlimiteduse,

cautionshouldberecommendedandtherapeuticbenefitmustbebalancedagainstpossibleeffectsoftheabsorptionof

iodineonfoetalthyroidfunctionanddevelopment.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Iflocalirritation,rednessorswellingdevelopsdiscontinuetreatment.Iodineisabsorbedfromthevaginaandfollowing

prolongeduse,thyroiddysfunctionmaydevelop.Theproductmaybespermicidalandshouldnotbeusedwhen

conceptionisdesired.

Anaphylacticreactions,anaphylactoidreactionsandanaphylacticshockhavebeenreporteduncommonlywithproducts

containingpovidone-iodineorpovidine.

4.9Overdose

Excessiodinecanproducegoitreandhypothyroidismorhyperthyroidism.Inthecaseofaccidentalingestionoflarge

quantitiesofBetadine,symptomaticandsupportivetreatmentshouldbeprovidedwithspecialattentiontoelectrolyte

balanceandrenalandthyroidfunction.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Povidone-iodineisacomplexofiodinewhichshowsallthebroadspectrumgermicidalactivityofelementaliodine.

Thegermicidalactivityismaintainedinthepresenceofblood,pus,serumandnecrotictissue.Itiseffectiveinthe

treatmentofinfectionscausedbybacteria,fungi,yeastsandviruses(e.g.HerpesVirusTypesIandII).

5.2Pharmacokineticproperties

Nonestated.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol1000

Macrogol1500

Macrogol4000

Purifiedwater

Sodiumhydrogencarbonate

Macrogol400

6.2Incompatibilities

Compatibilitywithbarriercontraceptiveshasnotbeenestablished.Therefore,thisproductshouldnotbeusedwith

suchmethodsofcontraceptionastheirreliabilitymaybeaffected.

6.3ShelfLife

Threeyears.

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

Non-lacquered,wax-lined,aluminiumtubesfittedwithwhitepolyethylenecapscontaining80gofgel.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

MedlockMedicalLtd.

TubitonHouse

MedlockSt.

Oldham

Lancashire

OL13HS

England.

8MARKETINGAUTHORISATIONNUMBER

PA1175/2/9

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:01April1983

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10DATEOFREVISIONOFTHETEXT

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