CEPTON MEDICATED LOTION

Main information

  • Trade name:
  • CEPTON MEDICATED LOTION
  • Dosage:
  • 0.1 %w/v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEPTON MEDICATED LOTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0739/003/002
  • Authorization date:
  • 26-06-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

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