FUCITHALMIC

Main information

  • Trade name:
  • FUCITHALMIC Eye Drops Suspension 2mg/ 0.2 Grams
  • Dosage:
  • 2mg/ 0.2 Grams
  • Pharmaceutical form:
  • Eye Drops Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FUCITHALMIC Eye Drops Suspension 2mg/0.2 Grams
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0046/056/002
  • Authorization date:
  • 27-11-1992
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Fucithalmic2mg/0.2gUnitDose,eyedrops,suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Each0.2gunitcontains2mgoffusidicacidanhydrous(asthehemihydrate).

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,suspension(eyedrops)

Asterile,white,opalescent,viscoussuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Treatmentofocularinfectionduetosensitiveorganisms.

4.2Posologyandmethodofadministration

OnedropofFucithalmicshouldbeappliedtotheconjunctivalsacevery12hours.Treatmentshouldbecontinuedfor2

daysaftertheeyeappearsnormal.

ThecontentsofeachFucithalmic2mg/0.2gUnitDosecontaineraresufficientforthetreatmentofbotheyesif

necessary.

4.3Contraindications

Knownhypersensitivitytofusidicacid/sodiumfusidateortoanyoftheexcipients.

4.4Specialwarningsandprecautionsforuse

Contactlensesshouldnotbeworn/usedwhenFucithalmicisused.

Themicrocrystallinefusidicacidmaycausescratchesinthecontactlensorcornea.

Bacterialresistancehasbeenreportedtooccurwiththeuseoffusidicacid.Aswithallantibiotics,extendedor

recurrentusemayincreasetheriskofdevelopingantibioticresistance.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Pregnancy

Limitedclinicaldataonexposedpregnanciesisavailable.Thisdataandanimalstudiesandmanyyearsofclinical

experiencewithsystemicandtopicalfusidicacidsuggestthatfusidicacidisdevoidofteratogenciceffect.

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Canbeadministeredduringpregnancyifconsiderednecessary.

Lactation

Noeffectsonthesucklingchildareanticipatedsincethesystemicexposureofthebreast-feedingwomantofusidicacid

isnegligible.

Fucithalmiccanbeusedduringbreastfeeding.

4.7Effectsonabilitytodriveandusemachines

Fucithalmicmaycauseatransientblurringofvisionfollowingapplication.Whenvisionisnotaffected,Fucithalmic

hasnoornegligibleinfluenceontheabilitytodriveortousemachines.

4.8Undesirableeffects

Pooleddatafromclinicalstudies,includingmorethan2,600patientswithacuteconjunctivitis,showedthatundesirable

effectsoccurredinapproximately10%ofthepatients,primarilyshortlastinglocaldiscomfortintheformofstinging

andburningsensation.

Themostfrequentlyreportedadversedrugreactionsarevariousapplicationsitereactionssuchastransientstingingand

burningsensationortransientblurringofvision.

Urticaria,rashandallergicreactionshavebeenreported.

UndesirableeffectsarelistedbyMedDRASOCandtheindividualundesirableeffectsarelistedstartingwiththemost

frequentlyreported.

Immunesystemdisorders

Rare( ≥1/10,000and<1/1000):

Allergicreaction

EyeDisorders

Common( ≥1/100and<1/10):

EyeBurning

EyeStinging

Transientblurringofvision

Rare( ≥1/10,000and<1/1000):

Conjunctivitisaggravated

Uncommon( ≥1/1,000and<1/100):

Wateryeyes

Skinandsubcutaneoustissuedisorders

Frequencyunknown:

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

Carbomer

Mannitol

Sodiumacetate

Sodiumhydroxide(forpHadjustment)

WaterforInjections

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Unopenedcontainer:2years

Afterfirstopeningcontainer:Anyremainingcontentsinasingleusecontainershouldbediscardedafteroneuse.

Discardanyremainingsingleusecontainersonemonthafteropeningfoilpack.

6.4Specialprecautionsforstorage

Nospecialprecautionsforstorage.

6.5Natureandcontentsofcontainer

Stripof12singleuseLDPEcontainerspackedinapouchoflaminatedaluminiumfoil,polyethyleneandpaper.Each

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6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Medicinesshouldnotbedisposedofviawastewaterorhouseholdwaste.Askyourpharmacisthowtodisposeof

medicinesnolongerrequired.Thesemeasureswillhelptoprotecttheenvironment.

7MARKETINGAUTHORISATIONHOLDER

LEOLaboratoriesLimited

CashelRoad

Dublin12

8MARKETINGAUTHORISATIONNUMBER

PA46/56/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:27November1992

Dateoflastrenewal:27November2007

10DATEOFREVISIONOFTHETEXT

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