CLINICIDE LOTION

Main information

  • Trade name:
  • CLINICIDE LOTION
  • Dosage:
  • 0.5 %w/ w
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CLINICIDE LOTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0299/010/001
  • Authorization date:
  • 20-10-1987
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0299/010/001

CaseNo:2036411

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

E.C.DeWitt&CompanyLimited

AegonHouse,DaresburyPark,Daresbury,Warrington,CheshireWA44HS,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

ClinicideLotion0.5%w/wCutaneousSolution

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom20/10/2007.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 23/10/2007 CRN 2036411 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

ClinicideLotion,0.5%w/wCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Carbaryl0.5%w/w.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneoussolution

Aclear,paleyellow,strawcolouredmobileliquid.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofhairinfestationsspecificallyheadliceandpubiclice.Fortreatmentonlyandnotfortheprevention

ofheadlice.

Fortopicaladministrationonly.

Whenamemberofyourfamilyneedtreatment,otherfamilymembersshouldbecheckedforliveliceandtreatedonly

ifinfestationisfound.

4.2Posologyandmethodofadministration

Adultsandchildren

Shakewellbeforeuse.

ForHeadLice

Applyfreelytorootsofdryhairandscalp,payingspecialattentiontopartings,backofneckandbehind

ears.

Allowhairtodrynaturally.

Washhairwithordinaryshampoonextday.

Whilethehairisstillwetuseametalcombtoremovedeadliceandeggs(nits).

ForPubicLice

Applyfreelytoallpartsofthehairinaffectedareaspayingspecialattentiontoroots.

Allowtodrynaturallyanduseablandshampoonextday.

4.3Contraindications

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 23/10/2007 CRN 2036411 page number: 2

4.4Specialwarningsandprecautionsforuse

Shakethebottlebeforeuse.

Forexternaluseonly.

Allowhairtodrynaturally.Donotuseahairdryer.Takecaretoavoideyes.

Childrenundertheageof6monthsshouldbetreatedundermedicalsupervision.

Healthworkersinmasstreatmentcampaignsareadvisedtowearplasticorrubbergloves.

Keepallmedicinesoutofthereachandsightofchildren.

Localhealthauthoritieshaveapolicyofusinginsecticidesinsequencetodiscourageresistance.Itisadvisabletocheck

onlocalcurrentpolicy.

Continuedprolongedtreatmentwithcarbarylcontainingproductsshouldbeavoided.Theyshouldnotbeusedmore

thanonceaweekandfornolongerthanthreeconsecutiveweeks.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Notapplicable.

4.6Pregnancyandlactation

Notapplicable.

4.7Effectsonabilitytodriveandusemachines

Notapplicable.

4.8Undesirableeffects

Thefeedingofcarbaryltoratsandmicethroughoutlifeledtoanincreasedincidenceofbenignandmalignanttumours

onlyatveryhighdoses.However,arangeofin-vivoandin-vitromutagenicitytestshaveindicatedthatCarbarylisnot

genotoxic.

ThesefindingssuggestthatuseofCarbaryltotreatlouseinfestationsisunlikelytoposeasignificantcancerriskin

humans.

4.9Overdose

ItisunlikelythatatoxicdoseofCarbarylwillbeingested.Treatmentconsistsofgastriclavage,assistedrespirationand

ifnecessaryadministrationofatropine.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

P03AX-Otherectoparasiticides,incl.scabicides.

Carbarylisacarbamatepesticide,whichisalsousedforthetreatmentofpediculosiscapitis.

5.2Pharmacokineticproperties

Irish Medicines Board

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Date Printed 23/10/2007 CRN 2036411 page number: 3

5.3Preclinicalsafetydata

Thefeedingofcarbaryltoratsandmicethroughoutlifeledtoanincreasedincidenceofbenignandmalignanttumours

onlyatveryhighdoses.However,arangeofinvivoandinvitromutagenicitytestshaveindicatedthatcarbarylisnot

genotoxic.

ThesefindingssuggestthatuseofCarbaryltotreatlouseinfestationsisunlikelytoposeasignificantcancerriskin

humans.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Macrogol7glycerolcocoate

Denaturedethanol

Citricacidmonohydrate

Sodiumcitrate

Deionisedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

30months.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

Keepcontainerintheoutercarton.

6.5Natureandcontentsofcontainer

50mlHDPEbottlewithscrewcap.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ECDeWitt&CompanyLtd

TudorRoad

ManorPark

RuncornWA71SZ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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Date Printed 23/10/2007 CRN 2036411 page number: 4

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:20October1987

Dateoflastrenewal:20October2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 23/10/2007 CRN 2036411 page number: 5