BETADINE EAR 5 %w/v Ear Drops Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
POVIDONE-IODINE
Available from:
Seton Healthcare Group PLC
INN (International Name):
POVIDONE-IODINE
Dosage:
5 %w/v
Pharmaceutical form:
Ear Drops Solution
Authorization status:
Withdrawn
Authorization number:
PA0696/002/009
Authorization date:
2006-05-23

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

BetadineEarDrops.

2QUALITATIVEANDQUANTITATIVECOMPOSITION

PovidoneIodine5 %w/v

Forexcipients, seesection 6.1

3PHARMACEUTICALFORM

Eardrops, solution.

Iodine-coloured, clear, aqueoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Asan antisepticforthemanagementofsuperficialearinfections.

4.2Posologyandmethodofadminstration

Fortopicaladministration.

Threetofourdropsinstilled by dropperfourtimesdaily, orasdirected by thephysician.

4.3Contraindications

1. Usein patientswho areiodine-sensitive.

2. Usein patientswith perforated eardrum.

4.4Special warningsandspecialprecautionsforuse

Caremustbetaken when applying theproductto areasofbroken skin, asexcessiveabsorption ofiodinemay occur.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Usein pregnancy and lactation should belimited and although no adverseeffectsareanticipated when used atthe

recommended dose, caution isrecommended andtherapeuticbenefitmustbebalanced againstpossibleeffectsofthe

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 24/10/2005 CRN 2016054 page number: 1

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Povidoneiodinemay producelocalskin reactionsalthough itisconsidered to belessirritantthaniodine.

4.9Overdose

In thecaseofaccidentalingestion oflargequantitiesofBetadine, symptomaticand supportivetreatmentshould be

provided with specialattention toelectrolytebalanceand renaland thyroid function.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Theactiveingredient, povidoneiodineslowly liberatesiodinewhen in contactwith skin and mucousmembranes.The

activityofiodineasamicrobicideisthen governed by aseriesofdissociations.

+I

I2 +HO HOI +I

I2 +I I3

ThemicrobicidalspeciesHOIpreferentially displacesOastheend electron acceptorin themicro organisms

respiratory cycle. HOIsimilarly interactswithin theelectron transportchain andreactswiththeamino acidsofthe

microbialcellmembrane.

5.2Pharmacokineticproperties

Notrelevantto topicalproducts.

5.3Preclinical safetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Glycerol

Dried disodiumphosphate

Citricacid (anhydrous)

Sodiumchloride

Polyoxyethylated nonylphenol

Sodiumhydroxidesolution

Purified water

6.2Incompatibilities

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 24/10/2005 CRN 2016054 page number: 2

6.3ShelfLife

Threeyears.

6.4Special precautionsforstorage

Do notstoreabove25°C.

Storecontainerin outercarton.

6.5Natureandcontentsofcontainer

12 mlround, amberglassbottle, fitted with dropperassembly.

6.6Instructionsforuseandhandling

None.

7MARKETINGAUTHORISATIONHOLDER

Seton HealthcareGroup plc

Tubiton House

Oldham

OL1 3HS

England

8MARKETINGAUTHORISATIONNUMBER

PA696/2/9

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 28 th

July 1975

Dateoflastrenewal: 27 th

July 2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 24/10/2005 CRN 2016054 page number: 3

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