DIFFERIN CUTANEOUS SOLUTION 0.1% W/W

Main information

  • Trade name:
  • DIFFERIN CUTANEOUS SOLUTION 0.1% W/W
  • Dosage:
  • 0.1%w/w %w/w
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • DIFFERIN CUTANEOUS SOLUTION 0.1% W/W
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0590/006/001
  • Authorization date:
  • 19-10-1993
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Differin CutaneousSolution 0.1 %w/w

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Adapalene0.1 %w/w.

Forexcipients, see6.1.

3PHARMACEUTICALFORM

Cutaneoussolution.

Clear, colourlesssolution.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetreatmentofacnevulgarisoftheface, chestand back wherecomedones, papulesand pustulespredominate.

4.2Posologyandmethodofadminstration

Fortopical(cutaneous)administration only.

Athin filmofthesolution should beapplied onceaday beforeretiring and afterwashing to theacne-affected areas.

Ensurethattheaffected areasaredry beforeapplication. Careshould betaken to avoid eyesand lips.

Itisrecommended thatthephysician assessthecontinuation ofimprovementofthepatientafterthreemonthsof

treatmentwith Differin CutaneousSolution.

4.3Contraindications

Usein patientshypersensitiveto any oftheingredients.

4.4Special warningsandspecialprecautionsforuse

Thisproductshould notcomeinto contactwiththeeyes, mouth, anglesofthenose, ormucousmembranes.

Differin CutaneousSolution should notbeapplied to eczematousskin, cutsand abrasions. Handsshould be

washed afteruse. Ifthesolution enterstheeye, itshouldbewashed immediately with warmwater.

Ifareaction suggesting sensitivity orsevereirritation occurs, useofthemedication should bediscontinued. Ifthe

degreeoflocalirritation warrants, patientsshould bedirected to usethemedication lessfrequently, to

discontinueusetemporarily orto discontinueusealtogether.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

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product. Adapaleneisessentially stableto oxidation and chemically nonreactive. Concomitantuseoftopicalantibiotics

orbenzoylperoxidearenotexpected to producemutualdegradativeeffects.

Percutaneousabsorption ofadapalenesolution islow, thereforeinteraction with systemicmedicamentsisunlikely.

Thereisno evidencethattheefficacy oforaldrugssuch ascontraceptivesteroidsand antibioticsisinfluenced by the

topicaluseofadapalene.

Becausethisproducthasthepotentialforlocalirritation, itispossiblethattheconcomitantuseofabrasivecleansers,

strong drying agentsorirritantproductswillproduceadditiveirritanteffects.

Thisproduct, used atnight, may also beadministered with othertopicalanti-acnetreatmentsapplied in themorning,

e.g. erythromycin (4%)orclindamycin (1%)lotions, and benzoylperoxidewaterbased productsup to 10%.

4.6Pregnancyandlactation

Studiesin animalshaveshown no realteratogeniceffectsofthisproductathigh doses. However, thereareno adequate

reproduction studiesin pregnantwomen and thereforethisproductshould notbeused during pregnancy unless

considered essentialby thephysician.

Itisnotknownwhetherthisdrug isexcreted in animalorhuman milk. Thereforethisproductshould notbegiven to

women breast-feeding infantsunlessconsidered essentialby thephysician. Itshould notbeused on thechestareain

thesewomen.

4.7Effectsonabilitytodriveandusemachines

Based on thepharmacodynamicprofileand clinicalexperience,performancerelated to driving and using machines

should notbeaffected.

4.8Undesirableeffects

Sideeffectsincludeskin irritation, (erythema, dryness, scaling, burning)and stinging atthesiteofapplication which is

reversiblewhen treatmentisreduced in frequency ordiscontinued. Eyelid oedemaaswellaseyeirritation when the

productcomesinto contactwith theeyeshavebeenreported rarely.

4.9Overdose

DifferinCutaneousSolution isintended fortopicaluseonly. Ifthemedication isapplied excessively, no morerapid or

betterresultswillbeobtained and marked redness, peeling ordiscomfortmayoccur.

Theacuteoraltoxicity valuein miceisgreaterthan10ml/kg. Unlesstheamountingested issmall, an appropriate

method ofgastricemptying should beconsidered.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Productwithretinoid likepharmacologicalprofile, poorly absorbed aftertopicalapplication.

5.2Pharmacokineticproperties

Metabolismismainly by 0-demethylation, hydroxylation and conjugation, and excretion isprimarily by thebiliary

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5.3Preclinical safetydata

In animalstudies, adapalenewaswelltolerated on cutaneousapplication forperiodsofup to six monthsin rabbitsand

forup to two yearsin mice. Themajorsymptomsoftoxicity found in allanimalspeciesby theoralroutewererelated

to an hypervitaminosisAsyndrome, and included bonedissolution, elevated alkalinephosphataseand slightanaemia.

Largeoraldosesofadapaleneproduced no adverseneurological, cardiovascularorrespiratory effectsin animals.

Adapaleneisnotmutagenic. Lifetimestudieswith adapalenehavebeen completed in miceatcutaneousdosesof0.6, 2

and 6 mg/kg/day and in ratsatoraldosesof0.15, 0.5 and1.5 mg/kg/day. Theonly significantfinding wasa

statistically significantincreaseofbenign phaeochromocytomasoftheadrenalmedullaamong maleratsreceiving

adapaleneat1.5mg/kg/day. Thechangesareconsidered to haveno relevanceto thecutaneoususeofadapalene.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Ethanol

Macrogol400

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:5 years

Afterfirstopening:30 days

6.4Special precautionsforstorage

Do notstoreabove25°C.

Becausetheproductcontainsethanol, avoid exposureto excessiveheat.

6.5Natureandcontentsofcontainer

TypeIIIPh. Eur. frosted glassbottlefitted with ascrewcap.Thebottleisaccompanied with aDab-O-Matic

applicator.

6.6Instructionsforuseandhandling

No specialrequirements.

7MARKETINGAUTHORISATIONHOLDER

Galderma(UK)Ltd.

GaldermaHouse

Church Lane

KingsLangley

HertsWD4 8JP

England

8MARKETINGAUTHORISATIONNUMBER

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation: 19 th

October1993

Dateoflastrenewal: 19 th

October2003

10DATEOFREVISIONOFTHETEXT

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