FUCITHALMIC

Main information

  • Trade name:
  • FUCITHALMIC Eye Drops Suspension 10 mg/ g
  • Dosage:
  • 10 mg/ g
  • Pharmaceutical form:
  • Eye Drops Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FUCITHALMIC Eye Drops Suspension 10 mg/g
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0046/056/001
  • Authorization date:
  • 06-04-1988
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Fucithalmic10mg/gViscousEyeDrops,suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Contains1%w/wfusidicacidanhydrous(asthehemihydrate).

Excipients:Contains0.011%w/wbenzalkoniumchloride.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,suspension(eyedrops)

Awhitetooff-whiteviscoussuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofocularinfectionduetosensitiveorganisms.

4.2Posologyandmethodofadministration

OnedropofFucithalmicshouldbeappliedtotheconjunctivalsacevery12hours.Treatmentshouldbecontinuedfor2

daysaftertheeyeappearsnormal.

4.3Contraindications

Knownhypersensitivitytofusidicacid/sodiumfusidateortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Contactlensesshouldnotbeworn/usedwhenFucithalmicisused.

Themicrocrystallinefusidicacidmaycausescratchesinthecontactlensorcornea.

Fucithalmiceyegel(intube)containsbenzalkoniumchloride,whichisknowntodiscoloursoftcontactlenses.

Bacterialresistancehasbeenreportedtooccurwiththeuseoffusidicacid.Aswithallantibiotics,extendedor

recurrentusemayincreasetheriskofdevelopingantibioticresistance.

Excipientswarning:

Fucithalmiceyegelcontainsbenzalkoniumchloride,whichmaycauseeyeirritation.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

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Limitedclinicaldataonexposedpregnanciesisavailable.Thisdataandanimalstudiesandmanyyearsofclinical

experiencewithsystemicandtopicalfusidicacidsuggestthatfusidicacidisdevoidofteratogeniceffect.Consequently

anyrisktothefoetusisunlikelyusingtheverylowdosesoffusidicacidappliedtopicallyinFucithalmic.Canbe

administeredduringpregnancyifconsiderednecessary.

Lactation

Noeffectsonthesucklingchildareanticipatedsincethesystemicexposureofthebreast-feedingwomantofusidicacid

isnegligible.Fucithalmic ®

eyegelcanbeusedduringbreast-feeding.

4.7Effectsonabilitytodriveandusemachines

Fucithalmicmaycauseatransientblurringofvisionfollowingapplication.Whenvisionisnotaffected,Fucithalmic

hasnoornegligibleinfluenceontheabilitytodriveortousemachines.

4.8Undesirableeffects

Pooleddatafromclinicalstudies,includingmorethan2,600patientswithacuteconjunctivitis,showedthatundesirable

effectsoccurredinapproximately10%ofthepatients;primarilyshortlastinglocaldiscomfortintheformofstinging

andburningsensation.

Themostfrequentlyreportedadversedrugreactionsarevarioussitereactionssuchastransientstingingandburning

sensationortransientblurringofvision.Urticaria,rashandallergicreactionshavebeenreported.

UndesirableeffectsarelistedbyMedDRASOCandtheindividualundesirableeffectsarelistedstartingwiththemost

frequentlyreported.

Immunesystemdisorders

Rare:( ≥1/10,000and<1/1,000)

Allergicreaction

EyeDisorders

Common:( ≥1/100and<1/10)

Eyeburning

Eyestinging

Transientblurringofvision

Uncommon:( ≥1/1,000and<1/100)

Wateryeyes

Rare:( ≥1/10,000and<1/1,000)

Conjunctivitisaggravated

Skinandsubcutaneoustissuedisorders

Notknown:

Pruritus

Periorbitaloedema

Rash

Urticaria

Angioedema

Generaldisordersandadministrationsiteconditions

Common:( ≥1/100and<1/10)

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4.9Overdose

Overdosageisunlikelytooccur.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

FucithalmicisactiveagainstawiderangeofGrampositiveorganisms,particularlystaphylococci.Crossallergy

betweenfusidicacidandotherantibioticshasnotbeenreported.

5.2Pharmacokineticproperties

TheformulationofFucithalmicensuresaprolongedcontactwiththeconjunctivalsac.Fusidicacidpenetratesinto

aqueoushumour.

5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Benzalkoniumchloride

Disodiumedetate

Mannitol

Carbomer

Sodiumhydroxide(forpHadjustment)

Waterforinjections

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Unopenedcontainer:3years

Afterfirstopeningcontainer:Discardanyremainingdropsonemonthafterfirstopening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Keepcaptightlyclosed.

6.5Natureandcontentsofcontainer

Polyethylenelaminatedaluminiumtube,withaHDPEcap,containing5gofeyedropssuspension.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

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medicinesnolongerrequired.Thesemeasureswillhelpprotecttheenvironment.

7MARKETINGAUTHORISATIONHOLDER

LEOLaboratoriesLimited

CashelRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA46/56/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:06April1988

Dateoflastrenewal:27November2007

10DATEOFREVISIONOFTHETEXT

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