GELTEARS 0.2% W/ W CARBOMER EYE GEL

Main information

  • Trade name:
  • GELTEARS 0.2% W/ W CARBOMER EYE GEL
  • Dosage:
  • 0.2 %w/ w
  • Pharmaceutical form:
  • Eyegel
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • GELTEARS 0.2% W/W CARBOMER EYE GEL
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0118/045/001
  • Authorization date:
  • 07-02-1997
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Geltears0.2%w/wCarbomerEyeGel

2QUALITATIVEANDQUANTITATIVECOMPOSITION

0.2%w/wcarbomer.

Excipientscontains0.01%w/wBenzalkoniumchloride.

Forafulllistofexcipients,seesection6.1

3PHARMACEUTICALFORM

Eyegel.

Homogeneous,colourless,gel.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Substitutionoftearfluidinthemanagementofdryeyeconditions,includingkeratoconjunctivitissiccaandunstable

tearfilm.

4.2Posologyandmethodofadministration

Adults(includingtheelderly)andchildren:

Onedroptobeinstilledintotheconjunctivalfoldofeachaffectedeye3-4timesdailyorasrequired,dependingonthe

degreeofdiscomfort.

4.3Contraindications

Useinpatientswithaknownhypersensitivitytoanycomponentofthepreparation.

4.4Specialwarningsandprecautionsforuse

Blurredvisioncanoccuriftoomuchgelisinstilledatonetime,orifthegelisusedtoofrequently.Thiseffectcanlast

foruptoanhour.Recoverycanbeaidedbyblinkingvigorouslyforafewseconds.Ifthisfails,thelowereyelidshould

bemanipulateduntilthegelreturnstothelowerfornixandnormalvisionisrestored.

ContactlensesshouldberemovedduringtreatmentwithGelTears.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Nosignificantinteractionshavebeenreported.

4.6Fertility,pregnancyandlactation

Safetyforuseinpregnancyandlactationhasnotbeenestablished,therefore,GelTearsshouldnotbeusedinthese

Irish Medicines Board

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Date Printed 27/04/2011 CRN 2072600 page number: 1

4.7Effectsonabilitytodriveandusemachines

Aswithotherophthalmicpreparations,transientblurringofvisionmayoccuroninstillation.Ifaffected,thepatient

shouldbeadvisednottodriveoroperatehazardousmachineryuntilnormalvisionisrestored.

4.8Undesirableeffects

Cornealirritationduetobenzalkoniumchloridecouldpossiblyoccurwithprolongeduse.

Furtherundesirableeffectsmightbeeyeerythema,eyerednessandvisualdisturbance.

4.9Overdose

Notapplicable.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

GelTearscontainsCarbomer980,ahydrophilic,highmolecularweightpolymerofcarboxyvinylicacid.Thegelforms

atransparentlubricatingandmoisteningfilmonthesurfaceoftheeye.ThepreparationhasapHsimilartothosefound

inthenormaltearfilmandisslightlyhypotonicwithrespecttotears.GelTearsrelievesthesymptomsofirritation

linkedwithdryeyesyndromesandprotectsthecorneaagainstdryingout.

Theuseofvitalstainshasprovidedobjectiveevidencethatthecornealandconjunctivalepitheliallesionsassociated

withdryeyesyndromesshowimprovementontreatmentwithGelTears.Thegelremainsonthesurfaceoftheeyefor

longerthanlowviscosityartificialtearsandhence,lessfrequentapplicationisrequired.

5.2Pharmacokineticproperties

Nohumanpharmacokineticstudiesareavailable;however,absorptionoraccumulationintissuesislikelytobe

negligibleduetothehighmolecularweightoftheactiveingredient.

5.3Preclinicalsafetydata

Noadversesafetyissuesweredetectedduringthedevelopmentofthisformulation.Theingredientsarewellestablished

inclinicalophthalmology.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride

Purifiedwater

Sorbitol

Sodiumhydroxide

6.2Incompatibilities

Notapplicable

6.3Shelflife

Unopened:3years

Irish Medicines Board

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Date Printed 27/04/2011 CRN 2072600 page number: 2

6.4Specialprecautionsforstorage

Storebelow25°C.

6.5Natureandcontentsofcontainer

Sterileophthalmicgelpresentedin10gplasticised,lacqueredaluminiumtubes,closedwithatamperevidenthigh

densitypolyethylenecap.Eachtubeisindividuallypackagedwithapatientinformationleaflet.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

ChauvinPharmaceuticalsLtd.

106LondonRoad

Kingston-upon-Thames

Surrey

KT26TN

UnitedKingdom

Tel:01748-828864

Email: bl@professionalinformation.co.uk

8MARKETINGAUTHORISATIONNUMBER

PA118/45/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:07February1997

Dateoflastrenewal:07February2007

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 27/04/2011 CRN 2072600 page number: 3