CEPTON MEDICATED CLEAR GEL

Main information

  • Trade name:
  • CEPTON MEDICATED CLEAR GEL
  • Dosage:
  • 0.5 %w/w
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CEPTON MEDICATED CLEAR GEL
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0739/003/001
  • Authorization date:
  • 20-08-1996
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

CeptonMedicatedClearGel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Activeingredient:ChlorhexidineGluconate0.5%w/w(incorporatedasChlorhexidineGluconateSolutionBP2.5%

v/w)

Forexcipients,seeSection6.1

3PHARMACEUTICALFORM

Gel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Anaidinthetreatmentofspotsandacne.

4.2Posologyandmethodofadministration

Fortopicaluseonly

Applymorningandnightasfollows:

Washhandsandface,applyathincoatingofthegeltotheaffectedareaandworkinthoroughly.

4.3Contraindications

Noneknown.

4.4Specialwarningsandprecautionsforuse

Forexternaluseonly

Keepallmedicinesawayfromchildren

Ifnoimprovementoccursorskinsirritationfollows,stopusingandtalktoyourdoctor

Keepoutoftheeyes.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Irish Medicines Board

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

4.6Pregnancyandlactation

Nouseinpregnancywarningisrequired.

4.7Effectsonabilitytodriveandusemachines

Theabilitytodriveorusemachinesisnotaffected.

4.8Undesirableeffects

Noneknown.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Chlorhexidineisaneffectiveantisepticwithawiderangeofactivityagainstmicro-organisms,includinggrampositive

andgramnegativebacteria,fungiandviruses.

5.2Pharmacokineticproperties

Notapplicable.

5.3Preclinicalsafetydata

Notapplicable.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol

Polyoxyethylatedcastoroilhydrogenated

Hydroxyethylcellulose

Sodiumacetate

Perfume

Water

6.2Incompatibilities

None.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Irish Medicines Board

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

6.5Natureandcontentsofcontainer

InternallylacqueredcollapsiblealuminiumtubewithHDPEscrewcapclosure.

Packsizes30g.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

EasternPharmaceuticalsLimited,

CoombHouse,7St.John’sRoad,

Isleworth,

MiddlesexTW76NA,

UnitedKingdom.

8MARKETINGAUTHORISATIONNUMBER

PA0739/003/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20August1991

Dateoflastrenewal: 20August2001

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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