ACNEGEL

Main information

  • Trade name:
  • ACNEGEL Gel 5.3 Per Cent
  • Dosage:
  • 5.3 Per Cent
  • Pharmaceutical form:
  • Gel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ACNEGEL Gel 5.3 Per Cent
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0144/028/001
  • Authorization date:
  • 25-05-1989
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Acnegel5%w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

HydrousBenzoylPeroxideequivalentto anhydrousbenzoylperoxide5%w/w.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Awhitecreamy homogeneousgel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Acnegelisindicated forthetreatmentofmild to moderateacnevulgaris.

4.2Posologyandmethodofadminstration

Adults

Apply to thewholeoftheaffected areaonceortwicedaily.Wash with soap and waterpriorto application.

Paediatricuse

Thesafety and efficacy ofAcnegelhasnotbeen established in children sinceacnevulgarisrarely presentsin thisage

group.

Elderly patients

Thereareno specificrecommendations.Acnevulgarisdoesnotpresentin theelderly.

4.3Contraindications

Patientswith known hypersensitivity to any oftheingredientsshould notusetheproduct.

4.4Special warningsandspecialprecautionsforuse

Avoid contactwith theeyes, mouth and othermucousmembranes.Careshould betaken when applying theproductto

theneck and othersensitiveareas.

Theproductmay bleach coloured ordyed fabrics.

Theproductshould only beused with caution in areasofthin orsensitiveskin. Fairskinned individualsarelikely to be

particularly sensitiveto irritation.

Benzoylperoxideshould notbeused in patientswith fairorsensitiveskin ifthereisconcurrentextensiveexposureto

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 21/10/2005 CRN 2015884 page number: 1

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Pregnancyandlactation

Thereareno restrictionson theuseofAcnegelduring pregnancy and lactation.

4.7Effectsonabilitytodriveandusemachines

None.

4.8Undesirableeffects

In normaluse,amild burningsensation willprobably befelton firstapplication and amoderatereddening and peeling

oftheskin willoccurwithin afewdays.During thefirstfewweeksoftreatment, asudden increasein peeling will

occurin mostpatients;thisisnotharmfuland willnormally subsidein aday ortwo iftreatmentistemporarily

discontinued.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Benzoylperoxidehasantibacterialactivity againstPropionibacteriumacnes, theorganismimplicated in acnevulgaris.

Ithaskeratolyticactivity and issebostatic, counteracting thehyperkeratinisation andexcessivesebumproduction

associated with acne.

5.2Pharmacokineticproperties

Aftertopicalapplication, benzoylperoxideisabsorbed in varying quantitiesthrough theskin ofman and animals.

Radio-labelled studieshaveshown thatabsorption ofbenzoylperoxidethrough theskin can only occurfollowing its

conversion to benzoicacid.Benzoicacid ismostly conjugated to formhippuricacid which isexcreted viathekidneys.

5.3Preclinical safetydata

Animaltoxicity studiesofbenzoylperoxidehaveshown thatthecompound isnon-toxicwhen applied topically

Benzoicacid, to which benzoylperoxideisconverted priorto absorption, hasawidemargin ofsafety.Benzoicacidis

Irish Medicines Board

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Date Issued 21/10/2005 CRN 2015884 page number: 2

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

ColloidalMagnesiumAluminiumSilicate

Hypromellose

MacrogolLaurilEther

Denatured Ethanol

CitricAcid

AlpineEssence6565A

Purified Water

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3 years.

6.4Special precautionsforstorage

Do notstoreabove25°C.

6.5Natureandcontentsofcontainer

Lacquered aluminiumtubeswith whitepolypropylenescrewcapscontaining 50 g.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

StiefelLaboratories(UK)Ltd,

HoltspurLane,

Wooburn Green,

High Wycombe,

BucksHP100AU,

8MARKETINGAUTHORISATIONNUMBER

PA144/28/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:25 th

May 1989

Dateoflastrenewal:25 th

Irish Medicines Board

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Date Issued 21/10/2005 CRN 2015884 page number: 3

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Issued 21/10/2005 CRN 2015884 page number: 4