FUCIBET LIPID

Main information

  • Trade name:
  • FUCIBET LIPID
  • Dosage:
  • 20mg/ g + 1 mg/ g
  • Pharmaceutical form:
  • Cream
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • FUCIBET LIPID
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PPA1659/052/001
  • Authorization date:
  • 16-09-2011
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

FucibetLipid20mg/g+1mg/gcream

2QUALITATIVEANDQUANTITATIVECOMPOSITION

FucibetLipidcreamcontainsFusidicacid20mg/gandBetamethasone1mg/g(asthevalerateester).

Excipients:containscetostearylalcohol,methylparahydroxybenzoate(E218),propylparahydroxybenzoate(E216)and

potassiumsorbate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Cream.

ProductimportedfromtheUK:

Awhitehighlyviscousoil-in-wateremulsioncream.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Useininflammatorydermatoseswherebacterialinfectionispresentorlikelytooccur.

4.2Posologyandmethodofadministration

Applyasmallquantitytotheaffectedareatwicedailyuntilasatisfactoryresponseisobtained.Asingletreatment

courseshouldnotnormallyexceed2weeks.

4.3Contraindications

Knownhypersensitivitytofusidicacid/sodiumfusidate,betamethasonevalerateoranyoftheexcipients.

Duetothecontentofcorticosteroid,FucibetLipidiscontraindicatedinthefollowingconditions:skininfections

primarilycausedbybacteria,fungiorvirus(suchasherpesorvaricella),skinmanifestationsinrelationtotuberculosis

orsyphilis,perioraldermatitisandrosacea.

4.4Specialwarningsandprecautionsforuse

Long-termcontinuoustopicaltherapyshouldbeavoided,particularlyininfantsandchildren.Adrenalsuppressioncan

occurevenwithoutocclusion.Atrophicchangesmayoccurontheface,andtoalesserdegreeinotherpartsofthe

body,afterprolongedtreatmentwithpotenttopicalsteroids.CautionshouldbeexercisedifFucibetlipidcreamisused

neartheeye.Glaucomamightresultifthepreparationenterstheeye.Systemicchemotherapyisrequiredifbacterial

infectionpersists.

Bacterialresistancehasbeenreportedtooccurwiththeuseoffusidicacid.Aswithallantibiotics,extendedor

recurrentusemayincreasetheriskofdevelopingantibioticresistance.

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hypersensitivityreactions.

Duetothecontentofcorticosteroid,useofFucibetLipidshouldbeavoidedinthefollowingconditions:Atrophicskin,

cutaneousulcers,acnevulgarisandinflexures/genitalarea.

FucibetLipidmustbeusedwithcautioninthetreatmentoflargeareasofthebodyandface.Contactwithopenwounds

andmucousmembranesshouldbeavoided.

Duetothepresenceofcetostearylalcoholandpotassiumsorbate,thisproductmaycauselocalskinreactions.Dueto

thepresenceofpropylparahydroxybenzoate(E216)&methylparahydroxybenzoate(E218),thisproductmaycause

allergicreactions(possiblydelayed).

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Noneknown.

4.6Fertility,pregnancyandlactation

Pregnancy

SafetyforuseofFucibetLipidduringhumanpregnancyhasnotbeenestablished.Studiesinanimalshavenotshown

teratogeniceffectswithfusidicacidbutstudieswithcorticosteroidshaveshownteratogeniceffects.Thepotentialrisk

forhumansisunknown.FucibetLipidshouldnotbeusedduringpregnancyunlessclearlynecessary.

Lactation

Noeffectsonthesucklingchildareanticipatedsincethesystemicexposureofthebreast-feedingwomantofusidicacid

andbetamethasoneisnegligiblefollowingtopicalapplicationtoalimitedareaofskin.FucibetLipidcanbeused

duringbreast-feeding.

FucibetLipidshouldnotbeusedonthebreastbybreast-feedingwomen.

4.7Effectsonabilitytodriveandusemachines

FucibetLipidhasnoornegligibleinfluenceontheabilitytodriveandtousemachines.

4.8Undesirableeffects

Verycommon>1/10

Common >1/100and<1/10

Uncommon >1/1,000and<1/100

Rare >1/10,000and<1/1,000

Veryrare <1/10,000

Themostfrequentlyreportedundesirableeffectsarevarioussymptomsofapplicationsiteirritation.Allergicreactions

havebeenreported.

BasedonclinicalstudydataforFucibet ®

approximately3%ofpatientscanbeexpectedtoexperienceanundesirable

effect.Transientskinirritation,stingingorburningsensation,pruritus,rashandworseningofeczemawere

uncommon.

Immunesystemdisorders

Veryrare:

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Skinandsubcutaneoustissuedisorders

Uncommon:

Eczemaaggravation

Urticaria

Contactdermatitis

Dryskin

Rash

Skinirritation

Skinburningsensation

Skinstingingsensation

Pruritus

Erythema

Veryrare:

Skinatrophy

Telangiectasia

Undesirableeffectsobservedforcorticosteroidsinclude:

Skinatrophy,telangiectasiaandskinstriae,especiallyduringprolongedapplication,folliculitis,hypertrichosis,perioral

dermatitis,allergiccontactdermatitis,depigmentation,systemicactivitysuchasglaucomaandadrenocortical

suppression.

4.9Overdose

Excessiveprolongeduseoftopicalcorticosteroidsmaysuppressthepituitary-adrenalfunctionsresultinginsecondary

adrenalinsufficiencywhichisusuallyreversible.Insuchcasessymptomatictreatmentisindicated.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

ATCcode:D07CC01

FucibetLipidcombinesthepotenttopicalantibacterialactionoffusidicacidwiththeanti-inflammatoryandantipruritic

effectsofbetamethasonevalerate.

Fusidicacidanditssaltsexhibitfatandwatersolubilitypropertieswithstrongsurfaceactivity,andshowunusual

abilitytopenetrateintactskin.Concentrationsof0.03-0.12mcg/mlinhibitnearlyallstrainsofStaphylococcus

aureus.TopicalFucidinisalsoactiveagainstStreptococci,Corynebacteria,NeisseriaandcertainClostridia.

Betamethasonevalerateisapotenttopicalcorticosteroidrapidlyeffectiveinthoseinflammatorydermatoseswhich

normallyrespondtothisformoftherapy.

5.2Pharmacokineticproperties

TherearenodatawhichdefinethepharmacokineticsofFucibetLipid,followingtopicaladministrationinman.

However,invitrostudiesshowthatfusidicacidcanpenetrateintacthumanskin.Thedegreeofpenetrationdependson

factorssuchasthedurationofexposuretofusidicacidandtheconditionoftheskin.Fusidicacidisexcretedmainlyin

thebilewithlittleexcretedintheurine.

Betamethasoneisabsorbedfollowingtopicaladministration.Thedegreeofabsorptionisdependentonvariousfactors

includingskinconditionandsiteofapplication.Betamethasoneismetabolisedlargelyintheliverbutalsotoalimited

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5.3Preclinicalsafetydata

Therearenopreclinicaldataofrelevancetotheprescriberwhichareadditionaltothatalreadyincludedinother

sectionsoftheSPC.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Steareth-21

Cetostearylalcohol

Whitesoftparaffin

Liquidparaffin

Hypromellose

Citricacidmonohydrate

Methylparahydroxybenzoate(E218)

Propylparahydroxybenzoate(E216)

Potassiumsorbate

Purifiedwater

6.2Incompatibilities

Notapplicable.

6.3Shelflife

Theshelf-lifeexpirydateofthisproductshallbethedateshownonthetubeandouterpackageoftheproductonthe

marketinthecountryoforigin.

Discardanyremainingcream3monthsafterfirstopening.

6.4Specialprecautionsforstorage

Donotstoreabove25°C.Storeintheoriginalcontainer.

6.5Natureandcontentsofcontainer

Aluminiumtubefittedwithawhitepolyethylenescrewcap.Contents:30ginanoverlabelledcarton

6.6Specialprecautionsfordisposalofausedmedicinalproductorwastematerialsderivedfrom

suchmedicinalproductandotherhandlingoftheproduct

Nospecialrequirements.

7PARALLELPRODUCTAUTHORISATIONHOLDER

IPSHealthcareLimited

SterlingHouse

501MiddletonRoad

Chadderton

Oldham

Lancashire

OL99LY

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8PARALLELPRODUCTAUTHORISATIONNUMBER

PPA1659/052/001

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:16 th

September2011

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