NUROFEN EXTRA STRENGTH 400MG LIQUID CAPSULES
Active substance: IBUPROFEN
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NurofenExtraStrength400mgLiquidCapsules Containsibuprofen
INFORMATIONFORTHEUSER Readallofthisleafletcarefullybecauseitcontainsimportantinformationfor you.Thismedicineisavailablewithoutprescription.However,youstillneedto useNurofenExtraStrength400mgLiquidCapsulescarefullytogetthebest resultsfromthem. Keepthisleaflet.Youmaywanttoreaditagain. Ifyouhaveanyfurtherquestionsafteryouhavereadit,askyourdoctoror pharmacist. Youmustcontactadoctorifyoursymptomsworsenordonotimproveafter10 days. Ifanysideeffectsgetserious,orifyounoticeanysideeffectnotlistedinthis leaflet,pleasetellyourdoctororpharmacist. Inthisleaflet: 1. WhatNurofenExtraStrength400mgLiquidCapsulesareandwhatthey areusedfor 2. BeforeyoutakeNurofenExtraStrength400mgLiquidCapsules 3. HowtotakeNurofenExtraStrength400mgLiquidCapsules 4. Possiblesideeffects 5. HowtostoreNurofenExtraStrength400mgLiquidCapsules 6. FurtherInformation 1.WhatNurofenExtraStrength400mgLiquidCapsulesareandwhatthey areusedfor Theactiveingredient(whichmakesthemedicinework)isIbuprofen.Itbelongs toagroupofmedicinesknownasnonsteroidalantiinflammatorydrugs (NSAIDs).NSAIDsprovidereliefbychangingthebodysresponsetopain, swelling,andhightemperature. NurofenExtraStrength400mgLiquidCapsulesisusedforthereliefof: Headachesandmigrainepain Dentalpainandneuralgia Periodpain Rheumatic,muscularandbackpain Feverishnessandsymptomsofcoldandflu Thepainofnonseriousarthritis. 2.BeforetakingNurofenExtraStrength400mgLiquidCapsules DonottakeNurofenExtraStrength400mgLiquidCapsulesifyou: areallergictoibuprofenoranyoftheotheringredients(seesection6)or toaspirinorotherpainkillers have(orhavehadtwoormoreepisodesof)astomachulcer,perforation orbleeding
havehadaworseningofasthma,skinrash,itchyrunnynoseorfacial swellingwhenpreviouslytakingibuprofen,aspirinorsimilarmedicines havehadgastrointestinalbleedingorperforationwhenpreviouslytaking NSAIDs(Nonsteroidalantiinflammatorydrugs) aretakingotherNSAIDpainkillersormorethan75mgaspirinaday havesevereliverorkidneyproblems haveheartproblems,highbloodpressureorbloodcoagulationdisorder. havebreathingdifficulties areinthelast3monthsofpregnancy areunder12yearsold. Checkwithyourpharmacistoryourdoctorbeforetakingthisproductifyou: haveorhavehadasthma havekidney,heart,liverorbowelproblems havehighcholesterolorpreviouslyhavehadaheartattackorstroke haveahistoryofgastrointestinaldisease(suchasulcerativecolitis, Crohn'sdisease) haveSystemicLupusErythematosus(aconditionoftheimmunesystem causingjointpainskinchangesandotherorgandisorders) areasmoker areinthefirst6monthsofpregnancy. havehereditaryproblemsoffructoseintoleranceorareonacontrolled potassiumdiet(SeeImportantinformationaboutsomeoftheingredientsof NurofenExtraStrength400mgLiquidCapsules) Takingothermedicines Toreducetheriskofsideeffects,donottakethisproductwithotherNSAID containingproducts(e.g,aspirin,ibuprofen) Somemedicinesmayaffectorbeaffectedbytreatmentwithibuprofen. Avoidtakingthisproductwithcorticosteroidtablets,quinoloneantibioticsor drugsthatareprescribed: tothinyourbloodorpreventclotting(e.g,warfarin), tostimulateyourheart(e.g,glycosides)ortreathighbloodpressure, tohelpyoupassingwater(diuretics), forthetemporarysuppressionofyourimmunesystem(e.g,methotrexate, ciclosporine,tacrolimus) formaniaordepression(e.g.,LithiumorSSRIs) forpregancytermination(e.g.,mifepristone) forHIVtreatment(e.g.,zidovudine) SpeaktoyourpharmacistordoctorbeforetakingIbuprofenwithother medicines Otherwarnings NurofenExtraStrength400mgLiquidCapsulesbelongstoagroupof medicineswhichmayimpairfertilityinwomen.Thisisreversibleonstopping themedicine.ItisunlikelythatNurofenExtraStrength400mgLiquidCapsules, usedoccasionallywillaffectyourchancesofbecomingpregnant.However,tell
yourdoctorbeforetakingthismedicineifyouhaveproblemsbecoming pregnant. MedicinessuchasNurofenExtraStrength400mgLiquidCapsulesmaybe associatedwithasmallincreasedriskofheartattackorstroke.Anyriskismore likelywithhighdosesorprolongedtreatment.Donotexceedtherecommended dose. Ifyouhaveheartproblems,previousstrokeorthinkthatyoumightbeat riskoftheseconditions(forexampleifyouhavehighbloodpressure,diabetes, orhighcholesterolorareasmoker),youshoulddiscussyourtreatmentwith yourdoctororpharmacist. Pregnancyandbreastfeeding Donottakeinthelast3monthsofpregnancyorifyouarebreastfeeding. Speaktoyourdoctorifyouareinthefirst6monthsofpregnancy. ImportantinformationaboutsomeoftheingredientsofNurofenExtraStrength 400mgLiquidCapsules Thismedicinecontains 50.5mgofsorbitolperdose,asourceof12.6mgoffructoseperdose Thismedicinecontains14mgofpotassiumperdose. 3.HowtotakeNurofenExtraStrength400mgLiquidCapsules Thisproductisforshorttermuseonly.Youshouldtakethelowestdoseforthe shortesttimenecessarytorelieveyoursymptoms. Adults,theelderlyandchildrenaged12yearsandolder: Take1capsulewithwater,uptothreetimesadayasrequired.Leaveatleast fourhoursbetweendoses.Donottakemorethan3capsulesin24hours. Donotgivetochildrenunder12years. Donottakeforlongerthan10daysunlessyourdoctortellsyouto.Ifsymptoms persistorthepainorfeverworsen,orifanynewsymptomsoccur,consultyour doctororpharmacist. IfyoutakemoreNurofenExtraStrength400mgLiquidCapsulesthanyou should,youmayfeeldrowsyornauseous.Youshouldseekimmediatemedical adviceintheeventofanoverdose,evenifyoufeelwell. IfyouforgottotakeNurofenExtraStrength400mgLiquidCapsules. Simplyrefertothedirectionsaboveonhowtotakethemedicineanddonottake morethanisadvised. 4.Possiblesideeffects STOPTAKINGthemedicineandseekimmediatemedicalhelpifyoudevelop: signsofintestinalbleedingsuchas:brightredfaeces(stools/motions), blacktarrystools,vomitingbloodordarkparticlesthatlooklikecoffeegrounds. signsofseriousallergicreactionsuchas: difficultiesinbreathingorunexplainedwheezing dizzinessorfasterheartbeat,
severeskinreaction(rashes,itchiness,peeling,flakingorblistering) swellingofyourfaceorthroat Tellyourdoctorifyouexperience: fever,flulikesymptoms,sorethroat,mouthulcers,headache,astiffneck, vomiting,unexplainedbleedingandbruising,severeexhaustion. indigestion,stomachorabdominalpain,constipation,diarrhoea, flatulenceorifyoufeelsick,chestpainorfast,irregularheartbeat. liverandkidneyproblemsassociatedwithswellinginyourarmsandlegs. MedicinessuchasNurofenExtraStrength400mgLiquidCapsulesmaybe associatedwithasmallincreasedriskofheartattack("myocardialinfarction") orstroke.(SeeSection2Otherwarnings.) Ifanyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnotlistedin thisleaflet,pleasetellyourdoctororpharmacist. 5.HowtostoreNurofenExtraStrength400mgLiquidCapsules Keepallmedicinesoutofthereachandsightofchildren. DonotuseaftertheexpirydatestatedonthecartonafterEXP.Theexpirydate referstothelastdayofthatmonth. Donotstoreabove25C.Storeintheoriginalpack. 6.Furtherinformation EachcapsulecontainstheactiveingredientIbuprofen400mg. Theyalsocontain:Macrogol600,Potassiumhydroxide50%solution(E525), Gelatin,SorbitolLiquid,PartiallyDehydrated(E420),PurifiedWater,Ponceau4R (E124),Lecithin(E322),Triglycerides(mediumchain),Ethanol,Whiteink (TitaniumDioxide(E171),PolyvinylAcetatePhthalate,Macrogol400, Ammoniumhydroxide(E527),PropyleneGlycol). NurofenExtraStrength400mgLiquidCapsulesareavailableinpacksof10,12, 16,18,20,24,28,30,32,36,48,96inblisterstrips. Notallpacksizeswillbemarketed. LicenceHolder:ReckittBenckiserHealthcare(UK)Ltd,Slough,SL14AQ. Manufacturer:ReckittBenckiserHealthcareInternationalLtd,NG23AA. Productlicencenumber:NurofenExtraStrength400mgLiquidCapsules:PL 00063/0653 Dateofrevision:January2011
INFORMATIONFORTHEUSER Readallofthisleafletcarefullybecauseitcontainsimportantinformationfor you.Thismedicineisavailablewithoutprescription.However,youstillneedto useNurofenExtraStrength400mgLiquidCapsulescarefullytogetthebest resultsfromthem. Keepthisleaflet.Youmaywanttoreaditagain. Ifyouhaveanyfurtherquestionsafteryouhavereadit,askyourdoctoror pharmacist. Youmustcontactadoctorifyoursymptomsworsenordonotimproveafter10 days. Ifanysideeffectsgetserious,orifyounoticeanysideeffectnotlistedinthis leaflet,pleasetellyourdoctororpharmacist. Inthisleaflet: 1. WhatNurofenExtraStrength400mgLiquidCapsulesareandwhatthey areusedfor 2. BeforeyoutakeNurofenExtraStrength400mgLiquidCapsules 3. HowtotakeNurofenExtraStrength400mgLiquidCapsules 4. Possiblesideeffects 5. HowtostoreNurofenExtraStrength400mgLiquidCapsules 6. FurtherInformation 1.WhatNurofenExtraStrength400mgLiquidCapsulesareandwhatthey areusedfor Theactiveingredient(whichmakesthemedicinework)isIbuprofen.Itbelongs toagroupofmedicinesknownasnonsteroidalantiinflammatorydrugs (NSAIDs).NSAIDsprovidereliefbychangingthebodysresponsetopain, swelling,andhightemperature. NurofenExtraStrength400mgLiquidCapsulesisusedforthereliefof: Headachesandmigrainepain Dentalpainandneuralgia Periodpain Rheumatic,muscularandbackpain Feverishnessandsymptomsofcoldandflu Thepainofnonseriousarthritis. 2.BeforetakingNurofenExtraStrength400mgLiquidCapsules DonottakeNurofenExtraStrength400mgLiquidCapsulesifyou: areallergictoibuprofenoranyoftheotheringredients(seesection6)or toaspirinorotherpainkillers have(orhavehadtwoormoreepisodesof)astomachulcer,perforation orbleeding
havehadaworseningofasthma,skinrash,itchyrunnynoseorfacial swellingwhenpreviouslytakingibuprofen,aspirinorsimilarmedicines havehadgastrointestinalbleedingorperforationwhenpreviouslytaking NSAIDs(Nonsteroidalantiinflammatorydrugs) aretakingotherNSAIDpainkillersormorethan75mgaspirinaday havesevereliverorkidneyproblems haveheartproblems,highbloodpressureorbloodcoagulationdisorder. havebreathingdifficulties areinthelast3monthsofpregnancy areunder12yearsold. Checkwithyourpharmacistoryourdoctorbeforetakingthisproductifyou: haveorhavehadasthma havekidney,heart,liverorbowelproblems havehighcholesterolorpreviouslyhavehadaheartattackorstroke haveahistoryofgastrointestinaldisease(suchasulcerativecolitis, Crohn'sdisease) haveSystemicLupusErythematosus(aconditionoftheimmunesystem causingjointpainskinchangesandotherorgandisorders) areasmoker areinthefirst6monthsofpregnancy. havehereditaryproblemsoffructoseintoleranceorareonacontrolled potassiumdiet(SeeImportantinformationaboutsomeoftheingredientsof NurofenExtraStrength400mgLiquidCapsules) Takingothermedicines Toreducetheriskofsideeffects,donottakethisproductwithotherNSAID containingproducts(e.g,aspirin,ibuprofen) Somemedicinesmayaffectorbeaffectedbytreatmentwithibuprofen. Avoidtakingthisproductwithcorticosteroidtablets,quinoloneantibioticsor drugsthatareprescribed: tothinyourbloodorpreventclotting(e.g,warfarin), tostimulateyourheart(e.g,glycosides)ortreathighbloodpressure, tohelpyoupassingwater(diuretics), forthetemporarysuppressionofyourimmunesystem(e.g,methotrexate, ciclosporine,tacrolimus) formaniaordepression(e.g.,LithiumorSSRIs) forpregancytermination(e.g.,mifepristone) forHIVtreatment(e.g.,zidovudine) SpeaktoyourpharmacistordoctorbeforetakingIbuprofenwithother medicines Otherwarnings NurofenExtraStrength400mgLiquidCapsulesbelongstoagroupof medicineswhichmayimpairfertilityinwomen.Thisisreversibleonstopping themedicine.ItisunlikelythatNurofenExtraStrength400mgLiquidCapsules, usedoccasionallywillaffectyourchancesofbecomingpregnant.However,tell
yourdoctorbeforetakingthismedicineifyouhaveproblemsbecoming pregnant. MedicinessuchasNurofenExtraStrength400mgLiquidCapsulesmaybe associatedwithasmallincreasedriskofheartattackorstroke.Anyriskismore likelywithhighdosesorprolongedtreatment.Donotexceedtherecommended dose. Ifyouhaveheartproblems,previousstrokeorthinkthatyoumightbeat riskoftheseconditions(forexampleifyouhavehighbloodpressure,diabetes, orhighcholesterolorareasmoker),youshoulddiscussyourtreatmentwith yourdoctororpharmacist. Pregnancyandbreastfeeding Donottakeinthelast3monthsofpregnancyorifyouarebreastfeeding. Speaktoyourdoctorifyouareinthefirst6monthsofpregnancy. ImportantinformationaboutsomeoftheingredientsofNurofenExtraStrength 400mgLiquidCapsules Thismedicinecontains 50.5mgofsorbitolperdose,asourceof12.6mgoffructoseperdose Thismedicinecontains14mgofpotassiumperdose. 3.HowtotakeNurofenExtraStrength400mgLiquidCapsules Thisproductisforshorttermuseonly.Youshouldtakethelowestdoseforthe shortesttimenecessarytorelieveyoursymptoms. Adults,theelderlyandchildrenaged12yearsandolder: Take1capsulewithwater,uptothreetimesadayasrequired.Leaveatleast fourhoursbetweendoses.Donottakemorethan3capsulesin24hours. Donotgivetochildrenunder12years. Donottakeforlongerthan10daysunlessyourdoctortellsyouto.Ifsymptoms persistorthepainorfeverworsen,orifanynewsymptomsoccur,consultyour doctororpharmacist. IfyoutakemoreNurofenExtraStrength400mgLiquidCapsulesthanyou should,youmayfeeldrowsyornauseous.Youshouldseekimmediatemedical adviceintheeventofanoverdose,evenifyoufeelwell. IfyouforgottotakeNurofenExtraStrength400mgLiquidCapsules. Simplyrefertothedirectionsaboveonhowtotakethemedicineanddonottake morethanisadvised. 4.Possiblesideeffects STOPTAKINGthemedicineandseekimmediatemedicalhelpifyoudevelop: signsofintestinalbleedingsuchas:brightredfaeces(stools/motions), blacktarrystools,vomitingbloodordarkparticlesthatlooklikecoffeegrounds. signsofseriousallergicreactionsuchas: difficultiesinbreathingorunexplainedwheezing dizzinessorfasterheartbeat,
severeskinreaction(rashes,itchiness,peeling,flakingorblistering) swellingofyourfaceorthroat Tellyourdoctorifyouexperience: fever,flulikesymptoms,sorethroat,mouthulcers,headache,astiffneck, vomiting,unexplainedbleedingandbruising,severeexhaustion. indigestion,stomachorabdominalpain,constipation,diarrhoea, flatulenceorifyoufeelsick,chestpainorfast,irregularheartbeat. liverandkidneyproblemsassociatedwithswellinginyourarmsandlegs. MedicinessuchasNurofenExtraStrength400mgLiquidCapsulesmaybe associatedwithasmallincreasedriskofheartattack("myocardialinfarction") orstroke.(SeeSection2Otherwarnings.) Ifanyofthesideeffectsgetsserious,orifyounoticeanysideeffectsnotlistedin thisleaflet,pleasetellyourdoctororpharmacist. 5.HowtostoreNurofenExtraStrength400mgLiquidCapsules Keepallmedicinesoutofthereachandsightofchildren. DonotuseaftertheexpirydatestatedonthecartonafterEXP.Theexpirydate referstothelastdayofthatmonth. Donotstoreabove25C.Storeintheoriginalpack. 6.Furtherinformation EachcapsulecontainstheactiveingredientIbuprofen400mg. Theyalsocontain:Macrogol600,Potassiumhydroxide50%solution(E525), Gelatin,SorbitolLiquid,PartiallyDehydrated(E420),PurifiedWater,Ponceau4R (E124),Lecithin(E322),Triglycerides(mediumchain),Ethanol,Whiteink (TitaniumDioxide(E171),PolyvinylAcetatePhthalate,Macrogol400, Ammoniumhydroxide(E527),PropyleneGlycol). NurofenExtraStrength400mgLiquidCapsulesareavailableinpacksof10,12, 16,18,20,24,28,30,32,36,48,96inblisterstrips. Notallpacksizeswillbemarketed. LicenceHolder:ReckittBenckiserHealthcare(UK)Ltd,Slough,SL14AQ. Manufacturer:ReckittBenckiserHealthcareInternationalLtd,NG23AA. Productlicencenumber:NurofenExtraStrength400mgLiquidCapsules:PL 00063/0653 Dateofrevision:January2011
Source: Medicines and Healthcare Products Regulatory Agency
Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
