FML FORTE LIQUIFILM

Main information

  • Trade name:
  • FML FORTE LIQUIFILM
  • Dosage:
  • 2.5
  • Pharmaceutical form:
  • Eye Drops Suspension
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FML FORTE LIQUIFILM
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0148/007/002
  • Authorization date:
  • 16-06-1986
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACTS1995AND2006

MEDICINALPRODUCTS(CONTROLOFPLACINGONTHEMARKET)REGULATIONS,2007

(S.I.No.540of2007)

PA0148/007/002

CaseNo:2049159

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

AllerganPharmaceuticalsIreland

CastlebarRoad,Westport,Co.Mayo,Ireland

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

FMLForteLiquifilm2.5mg/mleyedrops,suspension

TheparticularsofwhicharesetoutinPartIandPartIIoftheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsas

maybespecifiedinthesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom15/04/2008.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

Irish Medicines Board

______________________________________________________________________________________________________________________

Date Printed 17/04/2008 CRN 2049159 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FMLForteLiquifilm2.5mg/mleyedrops,suspension

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Excipients:

Benzalkoniumchloride 0.05mg/ml

Forfulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Eyedrops,suspension

Sterile,white,microfinesuspension.

4CLINICALPARTICULARS

4.1TherapeuticIndications

FMLForteisindicatedforcorticosteroidresponsiveinflammationofthepalpebralandbulbarconjunctiva,corneaand

anteriorsegmentoftheglobe.

4.2Posologyandmethodofadministration

Adultsandchildrenovertheageof2yearsonly:Instillonedropintotheconjunctivalsactwotofourtimesdaily.In

theinitial24to48hours,thisdosemaybeincreasedtoonedropeveryhour.

Careshouldbetakennottodiscontinuetherapyprematurely.

4.3Contraindications

Useinpatientswhoarehypersensitivetocorticosteroidpreparations.

Useinthepresenceoffungal,tuberculous,orviraloruntreatedbacterialinfectionsoftheeye.

4.4Specialwarningsandprecautionsforuse

Prolongedusemayresultinglaucoma,cornealthinningandperforation,subcapsularcataractformation,ormay

facilitatethedevelopmentofsecondaryocularinfections.

Steroidmedicationinthetreatmentofherpessimplexkeratitis(involvingthestroma)requiresgreatcaution,frequent

slitlampmicroscopyismandatory,inseverecasesonceaday.

Eyedropscontainingcorticosteroids,shouldnotbeusedformorethanoneweekexceptunderstrictophthalmic

ActiveIngredient Percent(w/v) mg/ml

Irish Medicines Board

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Date Printed 17/04/2008 CRN 2049159 page number: 2

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Corticosteroidsmayincreasetheactivityof:

Barbiturates

Sedativesandhypnotics

Tricyclicantidepressants

Corticosteroidsmaydecreasetheactivityof:

Anticholinesterases

Antiviraleyepreparations

Salicylates

4.6Pregnancyandlactation

Therearenoadequateandwellcontrolledstudiesinpregnantwomen.FMLForteshouldbeusedduringpregnancy

onlyifthepotentialbenefitoutweighsthepotentialrisktothefoetus.Useinwomenbreastfeedinginfantsisnot

recommended.

4.7Effectsonabilitytodriveandusemachines

Noneknown.

4.8Undesirableeffects

Glaucomawithopticnervedamage,visualacuityorfielddefects,posteriorsubcapsularcataractformation,secondary

ocularinfectionfrompathogensliberatedfromoculartissues,perforationoftheglobeanddelayedwoundhealing.

Althoughsystemiceffectsareextremelyuncommon,therehavebeenrareoccurrencesofsystemichypercorticoidism

afteruseoftopicalsteroids.Corticosteroid-containingpreparationshavealsobeenreportedtocauseacuteanterior

uveitisandperforationoftheglobe.Keratitis,conjunctivitis,cornealulcers,mydriasis,conjunctivalhyperaemia,loss

ofaccommodationandptosishaveoccasionallybeenreportedfollowinglocaluseofcorticosteroids,however,acausal

relationshipwasnotdetermined.

4.9Overdose

Overdosagewillnotordinarilycauseacuteproblems.Ifaccidentaloverdosageoccursintheeye,flushtheeyewith

waterornormalsaline.Ifaccidentallyingested,drinkfluidstodilute.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Fluorometholone,asyntheticcorticosteroid,haspotentanti-inflammatoryactivitywithareducedtendencytocause

increasedintraocularpressureascomparedtoothertopicalcorticosteroids.Corticosteroidsinhibittheinflammatory

responsetoavarietyofincitingagents.Theyinhibittheedema,fibrindeposition,capillarydilation,leukocyte

migration,phagocyticactivity,capillaryproliferation,fibroblastproliferation,depositionofcollagenandscar

formationassociatedwithinflammation.Inhibitionofhistidinedecarboxylasebycorticosteroidsinhibitssynthesisof

histaminefromdegranulatedmastcells.Corticosteroidsalsodecreaseprostaglandinsynthesisandretardepithelial

regeneration.Themechanismofactionofcorticosteroidshasnotbeenentirelyestablished;however,itisbelievedthat

corticosteroidsblocktheprogressionofinflammationbyincreasingtheresistanceofcellstocytotoxicbreakdown

productsintheinflammatoryzone.

5.2Pharmacokineticproperties

Irish Medicines Board

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Date Printed 17/04/2008 CRN 2049159 page number: 3

5.3Preclinicalsafetydata

Notapplicable

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Polyvinylalcohol

Benzalkoniumchloride

Disodiumedetate

Sodiumchloride

Sodiumdihydrogenphosphatemonohydrate

Sodiumphosphate,dibasic,heptahydrate

Polysorbate80

Sodiumhydroxide(forpH-adjustment)

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3ShelfLife

Unopened:15months

Opened:4weeks

6.4Specialprecautionsforstorage

Donotstoreabove25 °

Donotfreeze.

6.5Natureandcontentsofcontainer

Theproductwillbemarketedina5mland10mlsize.Bottlewithdropperapplicator,containingawhite,microfine

sterileophthalmicsuspension.Allbottlesandtipsaremadefromlowdensitypolyethylene.Thecapsareof

polystyrene.Asafetysealisplacedaroundthebottlecaptoinsureintegrityoftheproduct.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

AllerganPharmaceuticalsIreland

CastlebarRoad

Westport

Irish Medicines Board

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Date Printed 17/04/2008 CRN 2049159 page number: 4

8MARKETINGAUTHORISATIONNUMBER

PA148/7/2

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16 th

June1986

Dateoflastrenewal:16 th

June2006

10DATEOFREVISIONOFTHETEXT

Irish Medicines Board

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Date Printed 17/04/2008 CRN 2049159 page number: 5