FULL MARKS LOTION

Main information

  • Trade name:
  • FULL MARKS LOTION
  • Dosage:
  • 0.2 %w/v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FULL MARKS LOTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA1138/005/001
  • Authorization date:
  • 25-06-2009
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FullMarksLotion0.2%w/vCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Phenothrin0.2%w/v

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cutaneoussolution.

Clear,colourlesssolutionhavingapleasantherbal,alcoholicaroma.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofheadandpubichairliceinfestations

4.2Posologyandmethodofadministration

Fortopicalexternaluseonly

Adults,theelderlyandchildrenaged6monthsandabove:

Thesourceoftheinfestationshouldbesoughtandtreated.

Familymembersandclosecontactsshouldbeinspected,andiffoundtobeinfected,treatedsimultaneously.

Forheadlice

1.Sprinklethelotiononthehairandrubgentlyontotheheaduntiltheentirescalpismoistened.Payspecialattention

tothebackoftheneckandtheareabehindtheears.

2.Allowtodrynaturally.Usenoheat.

3.Thehairmaybewashedwithnormalshampoo2hoursafterapplication.

4.Whilethehairisstillwet,combwithanordinarycomb.Thefine-toothedSetoncombcanthenbeusedtoremove

thedeadordyingliceandeggs.

Treatmentshouldberepeatedafter7days.

Forpubiclice

Applicationanddosageetcareasforthehead.Applythelotiontothepubichairandhairbetweenthelegsandaround

theanus.Allowtodrynaturally,usingnoheat.

Treatmentshouldberepeatedafter7days.

Childrenunder6months:

Irish Medicines Board

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4.3Contraindications

Ahistoryofsensitivitytopyrethroidinsecticides

4.4Specialwarningsandprecautionsforuse

Containsflammablealcohol.Applyanddrywithcare.Avoidnakedflamesandlightedobjects.Donotexposeto

artificialheat(egelectrichairdryers).Dryinawellventilatedroom.Donotcovertheheadbeforethelotionhasdried

completely.Ensurethatthehairhasdriedbeforeretiringtobed.

Childrenunder6monthsshouldonlybetreatedundermedicalsupervision.

Avoidcontactwiththeeyes.Theeyesshouldbewellprotectedduringtheapplicationandwashingofthehair.

WhenFullMarksLotionisusedbyaschoolnurseorotherhealthofficerinthemasstreatmentoflargenumbersof

children,itisadvisablethatprotectiveplasticorrubberglovesbeworn.

FullMarksLotioncontainsisopropanol,whichmaycausewheezinginasthmaticpatientsorcauseinflammationofthe

skininpatientswithsevereeczema.Ifsucheffectsareapparent,patientsshoulduseashampooformulation.

Donotuseonbrokenorsecondarilyinfectedskin.

Continuedprolongedtreatmentwiththisproductshouldbeavoided.Itshouldnotbeusedmorethanonceaweek,and

fornotmorethanthreeconsecutiveweeks.

Thistreatmentmayaffectpermed,pre-rinsed,colouredorbleachedhair.Ifyourhairhasbeenpermed,pre-rinsed,

colouredorbleached,itisadvisabletocarryoutastrandtest,testingasmallsectionofhair,beforeusingthisproduct

onthewholehead.

Thelotionshouldnotbeappliedtodamagedskinexceptaftermedicalconsultation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nonestated.

4.6Pregnancyandlactation

Therearenoknowneffectsinhumanpregnancyandlactation.However,aswithalldrugs,FullMarksLotionshould

beusedwithcautioninpregnantorlactatingwomen.

4.7Effectsonabilitytodriveandusemachines

Nonestated.

4.8Undesirableeffects

Somepatientsmayexperiencestingingorinflammationoftheskinduetothealcoholcontentofthelotion.

UseofFullMarksLotionmayexacerbateasthmaoreczema.

4.9Overdose

Intheeventofdeliberateoraccidentalingestion,asforethylalcohol,emptythestomachcontentsbygastriclavageand

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Phenothrin

ATCcode:P03AC03

Phenothrinisasyntheticpyrethroidinsecticide,highlyeffectiveagainsthumanlicebutwithanexceptionallylow

mammaliantoxicity.

5.2Pharmacokineticproperties

FullMarksLotionisappliedtopicallytotheaffectedarea.Apharmacokineticstudyhasshownabsorptionofthe

activeconstituentisnegligible.

5.3Preclinicalsafetydata

Nonestated.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Isopropylalcohol

Purifiedwater

HerbalgreenbouquetP15312

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

3years.

6.4Specialprecautionsforstorage

Donotstoreabove30ºC.Keepthebottleintheoutercarton.

6.5Natureandcontentsofcontainer

50ml,55ml,100ml,110ml,160ml,200ml:cartoned,clearorambertypeIIIglassbottlewithpolyethylenecapsand

polyethylenesprinklerinserts.

Notallpacksizesmaybemarketed

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Avoidnakedflamesorlightedobjects.Donotuseartificialheat(e.g.electrichairdryers).Whenemptydisposeof

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7MARKETINGAUTHORISATIONHOLDER

SSLInternationalPlc

Venus1OldParkLane

TraffordPark

Manchester

M417HA

8MARKETINGAUTHORISATIONNUMBER

PA1138/005/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 15April1996

Dateoflastrenewal: 15April2006

10DATEOFREVISIONOFTHETEXT

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