CEPTON MEDICATED LOTION 0.1 %w/v Cutaneous Solution

Ireland - English - HPRA (Health Products Regulatory Authority)

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Active ingredient:
CHLORHEXIDINE GLUCONATE
Available from:
Eastern Pharmaceuticals Limited
INN (International Name):
CHLORHEXIDINE GLUCONATE
Dosage:
0.1 %w/v
Pharmaceutical form:
Cutaneous Solution
Prescription type:
Product not subject to medical prescription
Authorization status:
Authorised
Authorization number:
PA0739/003/002
Authorization date:
0000-00-00

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CeptonMedicatedLotion

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activeingredient:ChlorhexidineGluconate0.1%w/v(incorporatedasChlorhexidineGluconateSolutionBP0.5%

v/v)

Forexcipients,seeSection6.1

3PHARMACEUTICALFORM

Cutaneoussolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Anaidinthetreatmentofspotsandacne.

4.2Posologyandmethodofadministration

Applymorningandnightasfollows:

Afterwashing-MoistenacottonwoolpadwithMedicatedLotionandapplytotheface,particularlyaroundthe

nose,foreheadandchin.Donotrinseoff.

Aftershaving-PourMedicatedLotionintothehandsandsplashontotheface

Duringtheday-MoistenapadortissuewithMedicatedLotionandapplytooilyareastocleanse,tonandremove

greasypatchesastheyappear.

4.3Contraindications

Noneknown.

4.4Specialwarningsandprecautionsforuse

Forexternaluseonly

Keepallmedicinesawayfromchildren

Keepoutoftheeyes

Flammable

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/05/2010 CRN 2083457 page number: 1

4.6Pregnancyandlactation

Noknownrestrictions.

4.7Effectsonabilitytodriveandusemachines

Theabilitytodriveorusemachinesisnotaffected.

4.8Undesirableeffects

Noneknown.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Chlorhexidineisaneffectiveantisepticwithawiderangeofactivitiesagainstmicro-organisms,includinggram

positiveandgramnegativebacteria,fungiandviruses.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

BrilliantBlue(E133)

Ethanol

Macrogol

Perfumecompound8411

Purifiedwater

6.2Incompatibilities

Noneknown.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/05/2010 CRN 2083457 page number: 2

6.5Natureandcontentsofcontainer

Opaquehighdensitypolyethylenebottlewithpiercedpolyethyleneshiveandureaformaldehydecap.

Packsizes:25,150ml

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

EasternPharmaceuticalsLimited,

CoombHouse,7St.John’sRoad,

Isleworth,

MiddlesexTW76NA,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA0739/003/002

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:26June1991

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 28/05/2010 CRN 2083457 page number: 3

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