CONDYLINE 0.5 % W/V CUTANEOUS SOLUTION

Main information

  • Trade name:
  • CONDYLINE 0.5 % W/V CUTANEOUS SOLUTION
  • Dosage:
  • 0.5% %w/v
  • Pharmaceutical form:
  • Cutaneous Solution
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • CONDYLINE 0.5 % W/V CUTANEOUS SOLUTION
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0838/004/001
  • Authorization date:
  • 11-04-1998
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Condyline0.5%w/vCutaneousSolution

2QUALITATIVEANDQUANTITATIVECOMPOSITION

CondylineSolutioncontains0.5%w/vpodophyllotoxininbottlesof3.5ml.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

CutaneousSolution

EachpackofCondylineSolutionconsistsof3.5mlofaclear,colourless,alcoholiccutaneoussolutionof0.5%w/v

podophyllotoxin.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Forthetopicaltreatmentofcondylomata(warts)affectingthepenisorthefemaleexternalgenitalia.

4.2Posologyandmethodofadministration

Bytopicaladministration.

Adultsandtheelderly

Applytwicedailyforthreedaysdirectlytothewarts.Allowtodryaftertreatment.

Usetheapplicatorprovided,applyingnotmorethan50applicators-fullforeachtreatment.

Thisthreedaytreatmentmayberepeated,ifnecessary,atweeklyintervalsforamaximumoffiveweeksoftreatment.

Children

Notrecommended.

4.3Contraindications

Podophyllotoxiniscontraindicatedinpatientswiththefollowingconditions/diseases:

-knownorsuspectedhypersensitivitytopodophyllotoxinoranycomponentofthe

formulation;

-inflamedorbleedinglesions;

-openwoundsfollowingsurgicalprocedures;

-incombinationwithotherpodophyllincontainingpreparations;

-pregnantorbreast-feedingwomen;

Irish Medicines Board

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Date Printed 09/03/2011 CRN 2095632 page number: 1

4.4Specialwarningsandprecautionsforuse

Avoidcontactwithhealthyskinaswellastheeyesandfacebecauseofsevereirritation.

Lesionsinthefemaleandlesionsgreaterthan4cm 2

inthemaleshouldbetreatedunderdirectmedicalsupervision.

Theriskoftoxicityisincreasedduringsimultaneoustreatmentwithotherpodophyllincontainingpreparationssince

thesealsocontainpodophyllotoxinandshouldthereforebeavoided.

Theriskofsystemictoxicityaftertopicalapplicationisincreasedbythetreatmentoflargeareaswithexcessive

amountsforprolongedperiods,bythetreatmentoffriable,bleedingorrecentlyremovedwarts,andbyinadvertent

applicationtonormalskinormucousmembranes.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

CondylineSolutionshouldnotbeusedduringpregnancyorduringbreastfeeding.

4.7Effectsonabilitytodriveandusemachines

CondylineSolutiondoesnotinterferewiththeabilitytodriveorusemachines.

4.8Undesirableeffects

Disordersofthereproductivesystemandbreast:

Podophyllotoxinmayinducebalanoposthitis.

Skinandsubcutaneoustissuedisorders:

Podophyllotoxinmayprovokelocalirritations(ofthemucousmembranes)usuallymildandincludeitching,burning,

pain,erythemaorepithelialulceration.

4.9Overdose

Intopicaloverdosage,washwellwithsoapandwater;iftheeyesareinvolved,bathethoroughlywithwaterorif

available,withanappropriateeye-cleaningsolution.Ifaccidentallyingested,givestomachwashoutandmonitor

electrolytebalance,bloodgases,liverfunctionandbloodpicture.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Podophyllotoxinisananti-mitoticagent,withatopicalactionagainstwarts.

5.2Pharmacokineticproperties

Irish Medicines Board

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Date Printed 09/03/2011 CRN 2095632 page number: 2

5.3Preclinicalsafetydata

Norelevantstudieshavebeenperformed.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Lacticacid

Sodiumlactate60%solution

Ethanol96%

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years.

Shelf-lifeafteropeningtheimmediatecontainer:6weeks

6.4Specialprecautionsforstorage

Donotstoreabove25°C.

6.5Natureandcontentsofcontainer

EachpackofCondylineSolutionconsistsofanamberglassbottlefittedwithachildresistantpolypropyleneclosure,

containing3.5ml.Thepackissuppliedwith30disposableplasticapplicatorswhichhaveasmallholeinoneendthat

holdsthesolution.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

CondylineSolutionisflammableandshouldbekeptawayfromnakedflames.Apatientinformationleafletis

providedwiththeproductgivingdetailsontheuseandhandlingoftheproduct.

7MARKETINGAUTHORISATIONHOLDER

NycomedDanmarkA/S

Langebjerg1

P.O.Box88

DK-4000Roskilde

Denmark

8MARKETINGAUTHORISATIONNUMBER

Irish Medicines Board

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9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:11 th

April1988

Dateoflastrenewal:11 th

April2008

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 09/03/2011 CRN 2095632 page number: 4