ADVIL COLD & FLU

Main information

  • Trade name:
  • ADVIL COLD & FLU
  • Dosage:
  • 200/30 Milligram
  • Pharmaceutical form:
  • Coated Tablets
  • Medicine domain:
  • Humans
  • Medicine type:
  • Allopathic drug

Documents

Localization

  • Available in:
  • ADVIL COLD & FLU
    Ireland
  • Language:
  • English

Status

  • Source:
  • HPRA - Health Products Regulatory Authority - Ireland
  • Authorization number:
  • PA0172/024/001
  • Authorization date:
  • 08-09-1994
  • Last update:
  • 14-10-2016

Summary of Product characteristics: dosage, interactions, side effects

SummaryofProductCharacteristics

1NAMEOFTHEMEDICINALPRODUCT

AdvilCold&FluCoatedTablets

Ibuprofen200mg

PseudoephedrineHydrochloride30mg

2QUALITATIVEANDQUANTITATIVECOMPOSITION

Excipients:Eachtabletcontains174.6mgsucrose,0.003mgmethylparahydroxybenzoate(E218)and0.002mgpropyl

parahydroxybenzoate(E216)

Forafulllistofexcipients,seesection6.1.

3PHARMACEUTICALFORM

CoatedTablet

Oval-shaped,butterscotchcoloured,sugarcoatedtabletimprinted‘AdvilColdandFlu’inblackinkononeface.

4CLINICALPARTICULARS

4.1TherapeuticIndications

Inthesymptomaticreliefofthesymptomsassociatedwiththecommoncoldandinfluenzaincludingblockedsinuses.

4.2Posologyandmethodofadministration

Adults,theelderlyandyoungpersonsover12years:

1or2tabletsevery4-6hourstoamaximumof6tabletsin24hours.

Nottobegiventochildrenundertheageof12.

4.3Contraindications

Hypersensitivitytotheactivesubstancesortoanyoftheexcipients.

PatientswithallergytoaspirinorotherNon-SteroidalAnti-InflammatoryDrugs(NSAIDs)orwithahistoryof

hypersensitivityreactions(e.g.bronchospasm,rhinitis,urticaria)inresponsetoibuprofen,aspirinorNSAIDs.

Historyofgastrointestinalbleedingorperforation,relatedtopreviousNSAIDstherapy.

Activeorhistoryofrecurrentpepticulcer/haemorrhage(twoormoredistinctepisodesof

provenulcerationorbleeding)

Patientswithactivepepticulcerationorahistoryofpepticulceration.

Patientswithphaeochromocytoma,closedangleglaucoma,diabetesorthyroiddisease.

Patientswithkidneydisease.

Patientssufferingfromheartdisease,circulatoryproblems,hypertensionorcoronaryarterydisease.

PatientstakingotherNSAIDs,pain-relieversordecongestants.

Patientsreceivingtricyclicantidepressants.

Patientscurrentlyreceiving,orwhohavewithinthelasttwoweeksreceived,monoamineoxidaseinhibitors.

Patientswithsevereheartfailure.

ActiveSubstances mg/tablet

Ibuprofen 200

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4.4Specialwarningsandprecautionsforuse

TheuseofAdvilCold&FluwithconcomitantNSAIDsincludingcyclooxygenase-2selectiveinhibitorsshould

beavoided.

Undesirableeffectsmaybeminimizedbyusingtheminimumeffectivedosefortheshortestdurationnecessary

tocontrolsymptoms.

Ifsymptomsgetworseorlastmorethan3daysoryouexperienceanyothersymptomsnotrelatedtotheoriginal

condition,treatmentshouldbestoppedunlessdirectedotherwisebyadoctororhealthcareprofessional.

Elderly:TheelderlyhaveanincreasedfrequencyofadversereactionstoNSAIDsespeciallygastrointestinal

bleedingandperforationwhichmaybefatal(seesection4.2)

Gastrointestinalbleeding,ulcerationandperforation:GIbleeding,ulcerationorperforation,whichcanbefatal,

hasbeenreportedwithallNSAIDsatanytimeduringtreatment,withorwithoutwarningsymptomsoraprevious

historyofseriousGIevents.

TheriskifGIbleeding,ulcerationorperforationishigherwithincreasingNSAIDdoses,inpatientswitha

historyofulcer,particularlyifcomplicatedwithhaemorrhageorperforation(seesection4.3),andintheelderly.

Thesepatientsshouldcommencetreatmentonthelowestdoseavailable.Combinationtherapywithprotective

agents(e.g.misoprostolorprotonpumpinhibitors)shouldbeconsideredforthesepatientsandalsoforpatients

requiringconcomitantlowdoseaspirinorotherdrugslikelytoincreasegastrointestinalrisk(seebelowand4.5)

PatientswithahistoryofGItoxicity,particularlywhenelderly,shouldreportanyunusualabdominalsymptoms

(especiallyGIbleeding)particularlyintheinitialstagesoftreatment.

Cautionshouldbeadvisedinpatientsreceivingconcomitantmedicationswhichcouldincreasetheriskof

ulcerationorbleedingsuchasoralcorticosteroids,anticoagulantssuchaswarfarin,selectiveserotonin-reuptake

inhibitorsoranti-plateletagentssuchasaspirin(seesection4.5).

WhenGIbleedingorulcerationoccursinpatientsreceivingAdvilCold&Flu,thetreatmentshouldbe

withdrawn.

NSAIDsshouldbegivenwithcaretopatientswithahistoryofgastrointestinaldisease(ulcerativecolitis,

Crohn’sdisease)astheirconditionmaybeexacerbated(seesections4.8–undesirableeffects).

Inpatientswithcardiacorhepaticimpairment,cautionisrequiredsincetheuseofNSAIDsmayresultin

deteriorationinrenalfunction.

AdvilCold&Flushouldbeusedwithcautioninpatientswithahistoryofpepticulcerationorinflammatorybowel

disease.

Caution(discussionwithdoctororpharmacist)isrequiredpriortostartingtreatmentinpatientswithahistoryof

hypertensionand/orheartfailureasfluidretentionandoedemahavebeenreportedinassociationwithNSAIDtherapy.

Undesirableeffectsmaybeminimisedusingthelowesteffectivedosefortheshortestdurationnecessarytocontrol

symptoms(seeGIandcardiovascularrisksbelow)

Cardiovascularandcerebrovasculareffects:

ClinicaltrialandepidemiologicaldatasuggestthatuseofsomeNSAIDs(particularlyathighdoses(2400mg

daily)andinlongtermtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(for

examplemyocardialinfarctionorstroke).Overall,epidemiologicalstudiesdonotsuggestthatlowdoseibuprofen

(e.g. 1200mgdaily)isassociatedwithanincreasedriskofmyocardialinfarction.

Seriousskinreactions,someofthemfatal,includingexfoliativedermatitis,Stevens-Johnsonsyndromeandtoxic

epidermalnecrolysis,havebeenreportedveryrarelyinassociationwiththeuseofNSAIDs(seesection4.8).Patients

appeartobeathighestriskofthesereactionsearlyinthecourseoftherapy,theonsetofthereactionoccurringinthe

majorityofcaseswithinthefirstmonthoftreatment.AdvilCold&Flushouldbediscontinuedatthefirstappearance

ofskinrash,mucosallesions,oranyothersignofhypersensitivity.

AsNSAIDscaninterferewithplateletfunction,theyshouldbeusedwithcautioninpatientswithintra-cranial

haemorrhageandbleedingdiathesis.

Patientssufferingfromasthma,hypertension,heartdisease,diabetes,livercirrhosis,kidneydisease,thyroiddisease

orprostatichypertrophyshouldconsulttheirdoctorbeforeusingthisproduct.

Bronchospasmmaybeprecipitatedinpatientssufferingfromasthmaorallergicdisease.

Thereissomeevidencethatdrugswhichinhibitcyclo-oxygenase/prostaglandinsynthesismaycauseimpairmentof

femalefertilitybyaneffectonovulation.Thisisreversibleonwithdrawaloftreatment.

TheuseofNSAIDsmayimpairfemalefertilityandisnotrecommendedinwomenattemptingtoconceive.In

womenwhohavedifficultiesconceivingandwhoareundergoinginvestigationofinfertility,withdrawaloftheproduct

shouldbeconsidered.

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isomaltaseinsufficiencyshouldnottakethismedicine.

4.5Interactionwithothermedicinalproductsandotherformsofinteraction

ItisconsideredunsafetotakeIbuprofenincombinationwithwarfarinorheparinunlessunderdirectmedical

supervision.

Notrecommendedcombinations:

AnimalstudiesshowthatacetylsalicylicacidreducestheplasmaconcentrationsofIbuprofen.Ibuprofenshouldnotbe

usedwithotherpainrelieverssuchasNSAIDs.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationofex

vivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse(seesection5.1).

Combinationsrequiringprecautions:

Careshouldbetakeninpatientstreatedwithanyofthefollowingdrugsasinteractionshavebeenreported.

Anticoagulants,antihypertensivesorthiazidediuretics:

NSAIDsmayenhancetheeffectsofanticoagulantsanddiminishtheeffectsofantihypertensiveorthiazidediuretics.

Diuretics:Reduceddiureticeffect.DiureticscanincreasetheriskofnephrotoxicityofNSAIDs.

CardiacGlycosides:NSAIDsmayexacerbatecardiacfailure,reduceGFRandincreaseplasmacardiacglycoside

levels.Serumdigitalisconcentrationsshouldthereforebemonitoredinpatientswithdecreasedrenalfunctionor

congestiveheartfailure.

Phenytoin:Ibuprofenmayincreasethepharmacologicallyactivefreephenytoin.PatientstakingIbuprofenforlong-

termuseshouldbemonitored.

Lithium:Decreasedeliminationoflithium.Thismayresultinclinicallysignificantincreasesinlithium

concentrations.

Methotrexate:ConcomitantadministrationofIbuprofenwithmoderateandhighdosesofmethotrexatemayleadto

seriousandfatalmethotrexatetoxicity.Patientswithreducedrenalfunctionmaybeatadditionalriskoftoxicityfrom

thecombinationevenwhenlowdosesofmethotrexate(20mg/week)areused.

Antacids:CertainantacidsmayincreasethegastrointestinalabsorptionofIbuprofen.Thisisconsideredtobeof

clinicalrelevanceparticularlyduringlong-termuseofIbuprofen.

Cyclosporin:IncreasedriskofnephrotoxicitywithNSAIDs.

Corticosteroids:Increasedriskofgastro-intestinalbleedingorulceration.

Anti-plateletagentsandselectiveserotoninreuptakeinhibitors(SSRIs):Increasedriskofgastrointestinalbleeding

(seesection4.4).

Aminoglycosides:Reductioninrenalfunctioninsusceptibleindividualsdecreasedeliminationofaminoglycosides

andincreasedplasmaconcentrations.

Pseudoephedrine:

Pseudoephedrinemayinteractwith:

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Theantibacterialagentfurazoline.

TheactionofPseudoephedrinemaybereducedby:

Guanethidine.

Reserpine.

Methyldopa.

TheactionofPseudoephedrinemaybereducedorenhancedby:

Tricyclicantidepressants.

Pseudoephedrinemayreducetheactionof:

Guanethidine.

Pseudoephedrinemayincreasethepossibilityofarrhythmiasinpatientstaking:

Digitalis.

Quinidine.

Tricyclicantidepressants.

4.6Fertility,pregnancyandlactation

Pregnancy:

Ibuprofen:

Whilstnoteratogeniceffecthasbeendemonstratedinanimalexperiments,useofibuprofenduringpregnancyshould

beavoidedduringthefirst6monthsofpregnancy.

Duringthethirdtrimester,ibuprofeniscontraindicatedasthereisariskofprematureclosureofthefoetalductus

arteriosuswithpossiblepersistentpulmonaryhypertension.Theonsetoflabourmaybedelayedanddurationoflabour

increasedwithanincreasedbleedingtendencyinbothmotherandchild(seeSection4.3).

Pseudoephedrine:

Dataonpregnancyoutcomesaftermaternalexposuretopseudoephedrinearelimited.Twoanalysesofhealth

maintenanceorganisationpharmacydataidentified9malformedinfantsamong902first-trimesterpseudoephedrine

exposuressuggestingnospecificassociationwithbirthdefectsoverall.Howevertherelatedcompoundsepinephrine,

ephedrineandphenylephrinehavebeenassociatedwithhaemorrhagesandcardiovascularandlimbmalformationsin

animalmodels.Thevasoconstrictiveeffectsofthesedrugsmayindicatethattheiruseinearlypregnancymight

increasestheriskofvasculardisruptiondefects.

Lactation:

Ibuprofen:

Inlimitedstudies,ibuprofenappearsinthebreastmilkinverylowconcentrations,andisunlikelytoaffectthebreast

fedinfantadversely.

Pseudoephedrine:

Pseudoephedrineisexcretedinbreastmilkinsmallquantities,buttheeffectofthisonbreast-fedinfantsisnotknown.

Itisestimatedthat0.4%to0.7%ofasingledoseofpseudoephedrineingestedbythemotherwillbeexcretedinbreast

milkover24hours.

Insummary,cautionshouldbeexercisedbybalancingthepotentialbenefitoftreatmentagainstanypossiblerisks.

4.7Effectsonabilitytodriveandusemachines

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4.8Undesirableeffects

Gastro-intestinal:Themostcommonobservedadverseeventsaregastrointestinalinnature.Pepticulcers,perforation

orGIbleeding,sometimesfatalintheelderly,mayoccur(seesection4.4).Nausea,vomiting,diarrhoea,flatulence,

constipation,dyspepsia,abdominalpain,abdominaldistension,mouthulcerations,melaena,haematemesis,ulcerative

stomatitis,exacerbationofcolitisandCrohn’sdisease(seesection4.4–Specialwarningsandprecautionsforuse)have

beenreportedfollowingadministration.Lessfrequently,gastritishasbeenobserved

HypersensitivityreactionshavebeenreportedfollowingtreatmentwithIbuprofen.Thesemayconsistof;

non-specificallergicreactionandanaphylaxis,

Breathing:respiratorytractreactivitycomprisingofasthma,aggravatedasthma,bronchospasmordyspnoea,

Skin:assortedskindisorders,includingrashesofvarioustypes,bruisingpruritis,urticaria,purpura,angiodema

and,lesscommonly,bullousdermatoses(includingepidermalnecrolysisanderythemamultiforme).

Veryrarely,bullousreactionsincludingSteven’s–Johnsonsyndromeandtoxicepidermalnecrolysis.

Cardiovascular:Clinicaltrialandepidemiologicaldatasuggesttheuseibuprofen(particularlyathighdoses2400mg

daily)andinlongtermtreatmentmaybeassociatedwithasmallincreasedriskofarterialthromboticevents(for

examplemyocardialinfarctionorstroke)(seesection4.4).Oedema,hypertension,anginapectorisandcardiacfailure

havebeenreportedinassociationwithNSAIDtreatment.

Haematological:Impairedcoagulation,bleeding,anaemia,haemolyticanaemia,leukopenia,thrombocytopenia,

occasionallyagranulocytosisandaplasticanaemia.

Renal:Haematuria,interstitialnephritis,renalpapillarynecrosis,nephroticsyndrome,proteinuriaandrenalfailure

haveoccasionallybeenreported.

Liver:AbnormalLFTs(Liverfunctiontests),hepatitis(occasionallyprogressingtoliverfailure),jaundice.

Other:Insomnia,dizziness,excitability,anxiety,agitation,irritability,nervousness,restlessness,tinnitus,vertigo,

visualdisturbances,tremor,palpitations,tachycardia,drymouth,lossofappetite,thirst,psychomotorhyperactivity,

chestpain.Lessfrequently,difficultyinmicturitionandhallucinations.Rarelyheadache,hearingdisturbance,

exacerbationofcolitismeningitisandasepticmeningitis.

4.9Overdose

Overdosagemayresultinnervousness,agitation,anxiety,irritability,restlessness,dizziness,tremor,vertigo,insomnia,

nausea,abdominalpain,vomiting,epigastricpain,diarrhoea,bradycardia,palpitation,tachycardia,tinnitus,headache

andgastrointestinalbleeding.Hyperkalemia,metabolicacidosis,hypertensionorhypotensionarealsopossiblesignsof

overdose.Toxicitymaymanifestasdrowsiness,excitation,disorientationorcoma.Thepatientmaydevelop

convulsions.Hepaticfunctionmaybeabnormal.Metabolicacidosismayoccurandtheprothrombintime/INRmaybe

prolonged.Acuterenalfailureandliverdamagemayoccur.Inasthmatics,exacerbationofasthmaispossible.

Duetotherapidabsorptionofthetwoactiveingredientsfromthegastro-intestinaltract,emeticsandgastriclavage

mustbeinstitutedwithinfourhoursofoverdosagetobeeffective.Charcoaliseffectiveonlyifgivenwithinonehour.

Cardiacstatusshouldbemonitoredandtheserumelectrolytesmeasured.

Iftherearesignsofcardiactoxicity,propanololmaybeadministeredintravenously.Aslowinfusionofadilutesolution

ofpotassiumchlorideshouldbeinitiatedintheeventofadropintheserumpotassiumlevel.Despitehypokalaemia,the

patientisunlikelytobepotassiumdepleted,thereforeoverloadmustbeavoided.Continuedmonitoringoftheserum

potassiumisadvisableforseveralhoursafteradministrationofthesalt.Fordeliriumorconvulsions,intravenous

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5PHARMACOLOGICALPROPERTIES

5.1Pharmacodynamicproperties

Ibuprofen

Pharmacotherapeuticgroup:Propionicacidderivatives.

ATCcode:M01AE51

PseudoephedrineHydrochloride

Pharmacotherapeuticgroup:Nasaldecongestantsforsystemicuse,sympathomimetrics.

ATCcode:R01BA52

Ibuprofenisanonsteroidalanti-inflammatoryagentbelongingtothePropionicAcidclassofdrugs.Ithasanalgesic,

antipyreticandanti-inflammatoryproperties.PseudoephedrineHydrochlorideisasympathomimeticagentwhich

causesvasoconstrictionofnasalmucosa,therebyreducingrhinorrhoeaandnasalcongestion.

Experimentaldatasuggestthatibuprofenmayinhibittheeffectoflowdoseaspirinonplateletaggregationwhenthey

aredosedconcomitantly.Inonestudy,whenasingledoseofibuprofen400mgwastakenwithin8hbeforeorwithin

30minafterimmediatereleaseaspirindosing(81mg),adecreasedeffectofASAontheformationofthromboxaneor

plateletaggregationoccurred.However,thelimitationsofthesedataandtheuncertaintiesregardingextrapolationof

exvivodatatotheclinicalsituationimplythatnofirmconclusionscanbemadeforregularibuprofenuse,andno

clinicallyrelevanteffectisconsideredtobelikelyforoccasionalibuprofenuse.

5.2Pharmacokineticproperties

Ibuprofenisrapidlyabsorbedfromthegastro-intestinaltractwithpeakconcentrationsbeingachieved45-90minutes

later.Itisover90%plasmaproteinboundinthecirculationandhasashorteliminationhalf-lifeof0.9–2.5hours.

Ibuprofenisprimarilymetabolisedintheliverto2-Hydroxyibuprofenand2-carboxyibuprofen.Theseareexcretedin

theurinealongwithapproximately9%ofunchangeddrug.

PseudoephedrineHydrochlorideisrapidlyabsorbedfromthegastro-intestinaltractwithpeakplasmalevelsat1-3

hours.Itispartlymetabolisedintheliverlikemostsympathomimetics,butexcretedunchangedintheurine.

5.3Preclinicalsafetydata

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6PHARMACEUTICALPARTICULARS

6.1Listofexcipients

TabletCore:

Maizestarch

Starch,pregelatinised

Croscarmellosesodium

Colloidalanhydroussilica

Sodiumlaurilsulfate

Stearicacid

TabletCoat:

Sucrose

Microcrystallinecellulose

Carnaubawax(yellow)

OpaluxButterscotchAS-3739:

-Sucrose

-Titaniumdioxide(E171)

-Ironoxideyellow(E172)

-Ironoxidered(E172)

-Povidone

-Methylparahydroxybenzoate(E218)

-Propylparahydroxybenzoate(E216)

OpaglosGS-2-0310:

-IndustrialMethylatedSpirit

-Pharmaceuticalshellac

-Povidone

-Acetylatedmonoglyceride

OpacodeS-1-27794blackprintingink:

-Shellacglaze

-Ironoxideblack(E172)

-Propyleneglycol

OpacodeS-1-17823blackprintingink:

-Shellacglaze

-Ironoxideblack(E172)

-Propyleneglycol

-Ammoniumhydroxide

6.2Incompatibilities

Notapplicable.

6.3Shelflife

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6.4Specialprecautionsforstorage

Donotstoreabove25 o

6.5Natureandcontentsofcontainer

uPVCAluminiumblisterpacksincardboardcartonscontaining2,4,10,12,20,24,48or96tablets.

Notallpacksizesmaybemarketed.

6.6Specialprecautionsfordisposal

Nospecialrequirements.

7MARKETINGAUTHORISATIONHOLDER

PfizerConsumerHealthcareLtd

RamsgateRoad

Sandwich

Kent

CT139NJ

UnitedKingdom

8MARKETINGAUTHORISATIONNUMBER

PA172/24/1

9DATEOFFIRSTAUTHORISATION/RENEWALOFTHEAUTHORISATION

Dateoffirstauthorisation:08September1994

Dateoflastrenewal:08September2009

10DATEOFREVISIONOFTHETEXT

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