ADVIL

Main information

  • Trade name:
  • ADVIL Tablets Effervescent 200 Milligram
  • Dosage:
  • 200 Milligram
  • Pharmaceutical form:
  • Tablets Effervescent
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADVIL Tablets Effervescent 200 Milligram
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/029/007
  • Authorization date:
  • 05-02-2010
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

IRISHMEDICINESBOARDACT1995,asamended

MedicinalProducts(ControlofPlacingontheMarket)Regulations,2007,asamended

PA0172/029/007

CaseNo:2084421

TheIrishMedicinesBoardinexerciseofthepowersconferredonitbytheabovementionedRegulationsherebygrantsto

PfizerConsumerHealthcareLtd

RamsgateRoad,Sandwich,Kent,CT139NJ,UnitedKingdom

anauthorisation,subjecttotheprovisionsofthesaidRegulations,inrespectoftheproduct

Advil200mgEffervescentTablets

theparticularsofwhicharesetoutintheattachedSchedule.Theauthorisationisalsosubjecttothegeneralconditionsasmaybespecifiedin

thesaidRegulationsaslistedonthereverseofthisdocument.

Thisauthorisation,unlesspreviouslyrevoked,shallcontinueinforcefrom23/07/2010until04/02/2015.

SignedonbehalfoftheIrishMedicinesBoardthis

________________

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Date Printed 23/07/2010 CRN 2084421 page number: 1

PartII

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

Advil200mgEffervescentTablets

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Eacheffervescenttabletcontains200mgibuprofen.

Excipients:

Eacheffervescenttabletcontains:

2.2mmol(85mg)potassium,aspotassiumcarbonate.

8.8mmol(204mg)sodium,assodiumhydrogencarbonate,monosodiumcitrate,sodiumcarbonateand

saccharinsodium.

upto0.2mgsucrose,presentinsaccharosepalmitate.

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

Effervescenttablet.

Round,whitetablet,flat-facedonbothsides.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Thismedicinalproductissuitableforadultsandadolescentsover12yearsofageandover30kginweightfortherelief

ofmildtomoderatepainsuchasheadache,backache,rheumaticormuscularpain,dysmenorrhoea,dentalpain,

feverishnessandforthereliefofsymptomsofcoldsandinfluenza.

4.2Posologyandmethodofadministration

Fororaluse.

Forshort-termuseonly.

Theminimumeffectivedoseshouldbeusedfortheshortesttimenecessarytorelievesymptoms.Ifthemedicinal

productisrequiredformorethan5daysforpainor3daysforfeverorifthesymptomsworsen,thepatientshould

consultadoctor.

Theeffervescenttabletsshouldbedissolvedinaglassofwaterandthesolutiondrunkimmediatelyafterdissolution.

Donotswalloweffervescenttabletswhole.

Suitableforadults,theelderlyandadolescentsover12yearsofageandover30kginweight:

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Adults,theelderlyandadolescentsover12yearsofageandover30kginweight:200to400mg(oneortwotablets)to

berepeated,ifnecessary,every4-6hours.Donottakemorethan1200mgibuprofen(6effervescenttablets)inany24

hourperiod.

Theproductisnotrecommendedforuseinchildrenbelow12yearsold.

Theelderlyandpatientswithrenalandhepaticimpairmentshouldalwaysbetreatedwiththelowesteffectivedose.

4.3Contraindications

Hypersensitivitytoibuprofenoranyoftheexcipients.

Patientswhohavepreviouslyshownhypersensitivityreactions(e.g.asthma,rhinitisorurticaria)inresponseto

acetylsalicylicacid/aspirinorotherNSAIDs.

Activeorpreviouspepticulcer.

Activeorhistoryofuppergastrointestinalbleedingorperforation(twoormoredifferentepisodesofulcerationor

bleeding),includingthatassociatedwithpreviousNSAIDtherapy.

Patientswithseverehepaticfailure,severerenalfailureorsevereheartfailure(seesection4.4).

UsewithconcomitantNSAIDsincludingcyclo-oxygenase-2specificinhibitors(seesection4.5).

Useinthirdtrimesterofpregnancy(seesection4.6).

4.4Specialwarningsandprecautionsforuse

TheuseofAdvil200mgEffervescentTabletswithconcomitantNSAIDsincludingcyclo-oxygenase-2selective

inhibitorsshouldbeavoided.

Cautionisrequiredinpatientswithcertainconditions:

-systemiclupuserythematosusaswellasthosewithmixedconnectivetissuedisease,duetoincreasedriskof

asepticmeningitis(seesection4.8).

-gastrointestinaldisordersandchronicinflammatoryintestinaldiseaseastheseconditionsmaybeexacerbated

(ulcerativecolitis,Crohn’sdisease)(seesection4.8).

-oedema,hypertensionand/orcardiacimpairmentasrenalfunctionmaydeteriorateand/orfluidretentionoccur

(seesection4.5).

-renalimpairmentasrenalfunctionmaydeteriorate(seesection4.3and4.8).

-hepaticdysfunction(seesection4.3and4.8).

-bronchialasthma(seesection4.3and4.8).

Bronchospasm,urticariaorangioedemamaybeprecipitatedinpatientssufferingfromorwithaprevioushistoryof

bronchialasthmaorallergicdisease.

Undesirableeffectsmaybeminimisedbyusingtheminimumeffectivedosefortheshortestpossibleduration(see

gastro-intestinal(GI)andcardiovascularrisksbelow).

TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDs,especiallygastrointestinalbleedingand

perforationthatmaybefatal(seesection4.2).

Thereissomeevidencethatmedicinalproductswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycause

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Gastrointestinaleffects

GIbleeding,ulcerationorperforation,whichcanbefatal,hasbeenreportedwithallNSAIDsatanytimeduring

treatment,withorwithoutwarningsymptomsoraprevioushistoryofseriousGIevents.

TheriskofGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswithahistoryof

ulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3),andintheelderly.Thesepatients

shouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotectiveagents(e.g.misoprostol

orprotonpumpinhibitors)shouldbeconsideredforthesepatients,andalsoforpatientsrequiringconcomitantlowdose

acetylsalicylicacid/aspirin,orotherdrugslikelytoincreasegastrointestinalrisk(seebelowandsection4.5).

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskofulcerationor

bleeding,suchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptakeinhibitorsoranti-

plateletagentssuchasacetylsalicylicacid/aspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingibuprofen,thetreatmentshouldbewithdrawn.

Cardiovascularandcerebrovasculareffects

Caution(discussionwithdoctororpharmacist)isrequiredpriortostartingtreatmentinpatientswithahistoryof

hypertensionand/orheartfailureasfluidretention,hypertensionandoedemahavebeenreportedinassociationwith

NSAIDtherapy.

Clinicaltrialandepidemiologicaldatasuggestthatuseofibuprofen,particularlyathighdoses(2400mgdaily)andin

long-termtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarctionorstroke).Overall,epidemiologicalstudiesdonotsuggestthatlowdoseibuprofen(e.g. ≤

1200mgdaily)isassociatedwithanincreasedriskofmyocardialinfarction.

Dermatologicaleffects

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndrome,andtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(seesection4.8).Patients

appeartobeathighestriskforthesereactionsearlyinthecourseoftherapy:theonsetofthereactionoccurringinthe

majorityofcaseswithinthefirstmonthoftreatment.Advil200mgEffervescentTabletsshouldbediscontinuedatthe

firstappearanceofskinrash,mucosallesions,oranyothersignofhypersensitivity.

Thismedicinecontains2.2mmol(85mg)potassiumpereffervescenttablet.Tobetakenintoconsiderationbypatients

withreducedkidneyfunctionorpatientsonacontrolledpotassiumdiet.

Thismedicinealsocontains8.8mmol(204mg)sodiumpereffervescenttablet.Tobetakenintoconsiderationby

patientsonacontrolledsodiumdiet.

Patientswithrarehereditaryproblemsoffructoseintolerance,glucose-galactosemalabsorptionorsucrase-isomaltase

insufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

Ibuprofenshouldnotbeusedincombinationwith:

-Acetylsalicylicacid/aspirin:(above75mgdaily):asthismayincreasetheriskofadversereactions(seesection

4.3).

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Ibuprofenshouldbeusedwithcautionincombinationwith:

-Acetylsalicylicacid/aspirinwhenusedasananti-aggregrant,becausethismayincreasetheriskofgastrointestinal

bleedinganddecreasethebenefitoftakingacetylsalicylicacid/aspirin.

-SSRIs(selectiveserotonin-reuptakeinhibitors):mayincreasetheriskofgastrointestinalbleeding.

-Corticosteroids:mayincreasetheriskofadversereactions,especiallyofthegastrointestinaltract(seesection

4.4).

-Antihypertensivesanddiuretics:DiureticsandACE-inhibitorscanincreasethenephrotoxicityofNSAIDs.

NSAIDsmaydiminishtheeffectsofthesemedicinalproducts,includingACE-inhibitorsandbeta-blockers.In

particular,concomitantuseofpotassium-sparingdiureticsorACE-inhibitorscanresultinhyperkalaemia.

-Anticoagulants:NSAIDSmayenhancetheeffectsofanticoagulants,suchaswarfarinandticlopidine(seesection

4.4).

-Lithium,digoxin,phenytoin:thereisevidenceforpotentialincreaseinplasmalevelsofthesemedicinalproducts

whenco-administeredwithibuprofen.

-Methotrexate:thereisthepotentialforincreasedplasmalevelsofmethotrexate.

-Cyclosporin:inhibitionofrenalprostaglandinactivitybyNSAIDsmayincreasetheplasmaconcentrationof

cyclosporinandtheriskofcyclosporin-inducednephrotoxicity.

Zidovudine:thereisevidenceofanincreasedriskofhaemarthrosesandhaematomainHIVpositive

haemophiliacsreceivingconcurrenttreatmentwithzidovudineandibuprofen.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseacetylsalicylicacid/aspirinonplatelet

aggregationwhentheyaredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregarding

extrapolationofexvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofen

use,andnoclinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

4.6Pregnancyandlactation

Pregnancy:

Inhibitionofprostaglandinsynthesismayadverselyaffectthepregnancyand/ortheembryo/foetaldevelopment.Data

fromepidemiologicalstudiessuggestanincreasedriskofmiscarriageandofcardiacmalformationandgastroschisis

afteruseofaprostaglandinsynthesisinhibitorinearlypregnancy.Theabsoluteriskforcardiovascularmalformation

wasincreasedfromlessthan1%,uptoapproximately1.5%.Theriskisbelievedtoincreasewithdoseanddurationof

therapy.Inanimals,administrationofaprostaglandinsynthesisinhibitorhasbeenshowntoresultinincreasedpre-

andpost-implantationlossandembryo-foetallethality.Inaddition,increasedincidencesofvariousmalformations,

includingcardiovascular,havebeenreportedinanimalsgivenaprostaglandinsynthesisinhibitorduringthe

organogeneticperiod.Duringthefirstandsecondtrimestersofpregnancy,ibuprofenshouldnotbegivenunless

clearlynecessary.Ifibuprofenisusedbyawomanattemptingtoconceive,orduringthefirstandsecondtrimestersof

pregnancy,thedoseshouldbekeptaslowanddurationoftreatmentasshortaspossible.

Duringthethirdtrimesterofpregnancy,allprostaglandinsynthesisinhibitorsmayexposethefoetusto:

cardio-pulmonarytoxicity(withprematureclosureoftheductusarteriosusandpulmonaryhypertension);

renaldysfunction,whichmayprogresstorenalfailurewitholigo-hydroamniosis;

themotherandtheneonate,attheendofpregnancy,to:

possibleprolongationofbleedingtime,ananti-aggregatingeffectwhichmayoccurevenafterverylowdoses;

inhibitionofuterinecontractionsresultingindelayedorprolongedlabour.

Consequently,ibuprofeniscontraindicatedduringthethirdtrimesterofpregnancy.

Lactation:

Inlimitedstudiesibuprofenappearsinbreastmilkinverylowconcentrations.

Fertility:

Thereissomeevidencethatmedicinalproductswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycause

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4.7Effectsonabilitytodriveandusemachines

Patientswhoexperiencedizziness,drowsiness,vertigoorvisualdisturbanceswhiletheyaretakingibuprofen,should

avoiddrivingorusingmachinery.Singleadministrationorshort-termuseofibuprofendoesnotusuallywarrantthe

adoptionofanyspecialprecautions.

4.8Undesirableeffects

Undesirableeffectsaremostlydose-dependent.Inparticulartheriskofoccurrenceofgastrointestinalbleedingwhichis

dependantonthedosagerangeanddurationoftreatment.Theundesirableeffectsarelessfrequentwhenthemaximum

dailydoseis1200mg.

Hypersensitivityreactionshavebeenreportedandthesemayconsistof:

Anaphylaxisandnon-specificallergicreactions.

Respiratorytractreactivitycomprisingbronchospasm,asthma,aggravatedasthmaordyspnoea.

Variousskinreactions,e.g.rarely,exfoliativeandbullousdermatoses(includingtoxicepidermalnecrolysisand

erythemamultiforme),angioedema,pruritusandurticaria.

ThefollowinglistofadversereactionsrelatestothoseexperiencedwithibuprofenatOTCdoses(maximum1200mg

perday),fromshort-termuse.Inchronicconditions,underlong-termtreatment,additionaladversereactionsmay

occur.

Adversereactionshavebeenrankedunderheadingsoffrequencyusingthefollowingconvention:verycommon(

1/10);common( 1/100to<1/10);uncommon( 1/1,000to<1/100);rare( 1/10,000to<1/1,000);veryrare(<

1/10,000).

Withineachfrequencygrouping,undesirableeffectsarepresentedinorderofdecreasingseriousness.

Bloodandlymphatic

disorders Veryrare: Haematopoieticdisorders:pancytopenia,

agranulocytosis,aplasticanaemia,hemolyticanaemia,

leucopenia,thrombocytopenia,anaemia.Firstsignsare:

fever,sorethroat,superficialmouthulcers,flu-like

symptoms,severeexhaustion,noseandskinbleeding.

Immunesystem

disorders Uncommon: Hypersensitivityreactionswithurticariaandpruritus.

Veryrare: Inpatientswithexistingauto-immunedisorders(suchas

systemiclupuserythematosus,mixedconnectivetissue

disease)duringtreatmentwithibuprofen,singlecasesof

symptomsofasepticmeningitis,suchasstiffneck,

headache,nausea,vomiting,feverordisorientationhave

beenobserved.

Severehypersensitivityreactions.Symptomscouldbe:

facial,tongueandlarynxswelling,dyspnoea,

tachycardia,hypotension(anaphylaxis,angioedemaor

severeshock).

Exacerbationofasthmaandbronchospasm.

Psychiatricdisorders Veryrare: Nervousness

Nervoussystem

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Oedema,hypertensionandcardiacfailurehavebeenreportedinassociationwithNSAIDtreatment.

Clinicaltrialandepidemiologicaldatasuggestthatuseofibuprofen(particularlyathighdoses,2400mgdaily)andin

long-termtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(forexample

myocardialinfarctionorstroke)(seesection4.4).

4.9Overdose

Inchildreningestionofmorethan400mg/kgmaycausesymptoms.Inadultsthedoseresponseeffectislessclearcut.

Veryrare: Asepticmeningitis

Cerebrovascularaccident

Eyedisorders Veryrare: Visualdisturbance

Earandlabyrinth

disorders Veryrare: Tinnitusandvertigo

Cardiacdisorders Veryrare: Cardiacfailure

Vasculardisorders Veryrare: Hypertension

Respiratory,thoracicand

mediastinaldisorders Veryrare: Asthma,bronchospasm,dyspnoeaandwheezing

Gastrointestinal

disorders Uncommon: Abdominalpain,dyspepsia,nausea,abdominaldistentionandgastritis.

Rare: Diarrhoea,flatulence,constipationandvomiting

Veryrare: Pepticulcer,perforationorgastrointestinalhaemorrhage,melaenaand

haematemesis,sometimesfatal,particularlyintheelderly.Exacerbation

ofulcerativecolitisandCrohn’sdisease(seesection4.4).Mouth

ulceration.

Hepatobiliarydisorders Veryrare: Liverdisorders,especiallyinlong-termtreatment,hepatitisandjaundice

Skinandsubcutaneous

tissuedisorders Uncommon: Variousskinrashes.

Veryrare: Severeformsofskinreactionssuchaserythemamultiformeandtoxic

epidermalnecrolysiscanoccur.Stevens-JohnsonSyndrome.

Renalandurinary

disorders Veryrare: Renalfailure,interstitialnephritis,renalinsufficiency,nephritic

syndrome,renalpapillarynecrosis,hematuriaandproteinuria.

Generaldisordersand

administrationsite

conditions Veryrare: Oedema,peripheraloedema.

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Symptoms

MostpatientswhohaveingestedclinicallyimportantamountsofNSAIDswilldevelopnomorethannausea,vomiting,

epigastricpain,ormorerarelydiarrhoea.Tinnitus,headacheandgastrointestinalbleedingarealsopossible.Inmore

seriouspoisoning,toxicityisseeninthecentralnervoussystem,manifestingasvertigo,drowsiness,occasionally

excitationanddisorientationorcoma.Occasionallypatientsdevelopconvulsions.Inseriouspoisoninghyperkalaemia

andmetabolicacidosismayoccurandtheprothrombintime/INRmaybeprolonged,probablyduetointerferencewith

theactionsofcirculatingclottingfactors.Acuterenalfailure,liverdamage,hypotension,respiratorydepressionand

cyanosismayoccur.Exacerbationofasthmaispossibleinasthmatics.

Management

Managementshouldbesymptomaticandsupportiveandincludethemaintenanceofaclearairwayandmonitoringof

cardiacandvitalsignsuntilstable.Consideroraladministrationofactivatedcharcoalorgastricemptyingifthepatient

presentswithin1hourofingestionofapotentiallytoxicamount.Ifibuprofenhasalreadybeenabsorbed,alkaline

substancesmaybeadministeredtopromotetheexcretionofacidibuprofenintheurine.Whenfrequentorprolonged,

convulsionsshouldbetreatedwithintravenousdiazepamorlorazepam.Givebronchodilatorsforasthma.

5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Pharmacotherapeuticgroup:Propionicacidderivatives

ATCcode:M01AE01

IbuprofenisaphenylpropionicacidderivativeNSAIDthatexertsitsefficacyviainhibitionofprostaglandinsynthesis.

Inhumansibuprofenreducesinflammatorypain,swellingandfever.Furthermore,ibuprofenreversiblyinhibits

plateletaggregation.

Theeffectofibuprofeneffervescenttabletsonpainreliefwascomparedtoconventionalsolidibuprofentabletsintwo

randomisedtrialsandtoparacetamoleffervescenttabletsinonerandomisedtrial.

Theonsetoffirstperceptiblepainreliefforibuprofeneffervescenttabletswasobservedapproximately14minutesafter

administration,andinbothclinicalstudieswasstatisticallyfasterthanconventionalsolidibuprofentabletsindicatinga

morerapidonsetofanalgesiceffect.Themediantimetomeaningfulpainreliefwasobserved28-35minutesafter

dosingfortheibuprofeneffervescenttablets.Totalpainreliefover8hoursandtimetomeaningfulreliefwereshown

tobestatisticallysuperiorforibuprofeneffervescenttabletscomparedtoparacetamoleffervescenttablets.The

analgesiceffectofibuprofeneffervescenttablets(400mgdose)hasbeenshowntolastforatleast8hoursinonestudy

and7hoursinasecondstudy.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseacetylsalicylicacid/aspirinonplatelet

aggregationwhentheyaredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin

8hbeforeorwithin30minafterimmediatereleaseacetylsalicylicacid/aspirindosing,adecreasedeffectofASAon

theformationofthromboxaneorplateletaggregationoccurred.However,thelimitationsofthesedataandthe

uncertaintiesregardingextrapolationofexvivodatatotheclinicalsituationimplythatnofirmconclusionscanbe

madeforregularibuprofenuse,andnoclinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

Afteroraladministration,solubilisedibuprofenisquicklyabsorbedwhentheeffervescenttabletsareadministered

underfastingconditions.Peakplasmaconcentrationsareachievedwithin0.36hours(approximately22minutes)

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Summaryofkeypharmacokineticparameters:

Whentakenwithfood,peaklevelsareobservedafter1-2hourswithconventionalfilm-coatedtablets.

Ibuprofenproteinbindingisapproximately99%.Afteranoraldose,ibuprofenis75–85%excretedviakidneysduring

thefirst24hours(mainlyintheformoftwometabolites),theremainderbeingeliminatedinthefaecesfollowing

excretioninbile.Excretioniscompletewithin24hours.

Thehalf-lifeofibuprofenisabout2hours.

Inlimitedstudies,ibuprofenappearsinthebreastmilkinverylowconcentrations.

5.3Preclinicalsafetydata

Thesubchronicandchronictoxicityofibuprofeninanimalexperimentsconsistedmainlyoflesionsandulcerationsin

thegastro-intestinaltract.

In-vitroandin-vivoinvestigationshaveproducednoclinicallyrelevantevidenceofibuprofenhavingmutagenic

effects.Instudiesinratsandmice,noevidenceofcarcinogeniceffectsofibuprofenwasfound.

Ibuprofenledtoaninhibitionofovulationinrabbitsandimpairedimplantationinvariousanimalspecies(rabbit,rat,

mouse).Experimentalstudiesinratsandrabbitshaveshownthatibuprofencrossestheplacenta.Following

administrationofmaternotoxicdoses,anincreasedrateofmalformations(ventricularseptaldefects)occurredinthe

progenyofrats.

InanimalstudiesithasbeenobservedthattheuseofNSAIDs,knowntoinhibitprostaglandinsynthesis,mayincrease

theincidenceofdystociaanddelayedparturition.

6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

Potassiumcarbonate(E501)

Sodiumcarbonate,anhydrous(E500)

Citricacid,anhydrous(E330)

Monosodiumcitrate(E331)

Sodiumhydrogencarbonate(E500)

Hypromellose(E464)

Saccharinsodium(E954)

Saccharosepalmitate(containssucrose)

Mentholflavour

Grapefruitflavour

Product Dose AUC

0-inf µg.hr/ml C

µg/ml t

Ibuprofen400mg

EffervescentTablets 1x400mgtablet 127.6±28.28 46.7±8.79 0.36±0.11 2.56±0.52

Ibuprofen200mg

EffervescentTablets 2x200mgtablets 133.2±28.64 48.0±8.49 0.35±0.13 2.59±0.48

Ibuprofen200mgTablets 2x200mgtablets 134.0±26.76 30.8±4.84 1.56±0.82 2.47±0.39

Ibuprofen200mgSoft

GelatinCapsules 2x200mg

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6.2Incompatibilities

Notapplicable.

6.3ShelfLife

2years

6.4Specialprecautionsforstorage

Donotstoreabove30 0

Storeintheoriginalpackagetoprotectfrommoisture.

6.5Natureandcontentsofcontainer

Foilstrip,paper/PE/aluminium,inacardboardouter.

Packsizes:2,4,6,8,10,12,14,16and20effervescenttablets

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposalandotherhandling

Nospecialrequirements

7MARKETINGAUTHORISATIONHOLDER

PfizerConsumerHealthcareLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

8MARKETINGAUTHORISATIONNUMBER

PA172/29/7

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:5thFebruary2010

10DATEOFREVISIONOFTHETEXT

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