NUROFEN FOR CHILDREN STRAWBERRY 3 MTHS - 12 YRS
Active substance: IBUPROFEN
View full screen / Print PDF » Download PDF ⇩
Transcript
ContainsIbuprofen Readallofthisleafletcarefullybeforeyouusethismedicine. Itcontainsimportantinformation. Keepthisleaflet:youmightneeditagain. Ifyouhaveanyfurtherquestionsafteryouhavereaditaskyourdoctoror pharmacist. Thismedicineisdesignedtohelpbringdownahightemperature(fever andpostimmunisationfever),relievethesymptomsofcoldandfluand relievepainfromheadaches,sorethroats,minorachesandsprains, teethingandtoothache. Thismedicineissuitableformostbabiesover3monthsofage,children andadults. Followthedoseinstructionscarefully. Section3showsthedifferentamountthat childrenneed. Speaktoyourdoctorifyourchild: suffersfromanyoftheconditionslistedinSection2oftheleaflet istakingaspirinatadoseabove75mgaday.SeeSection2 istakingothermedicines.SeeSection2. isnotgettingbetter,oryoufeelatallconcerned.SeeSection3 developsarash,breathingproblemsordiarrhoeaandgetsverytired.See Section3. Donotusethismedicineandspeaktoyourdoctorifyouarepregnant, thinkyoumaybepregnantortryingtogetpregnantorarebreastfeeding. SeeSection2. Inthisleaflet: 1. WhatNurofenforChildrenStrawberryisandwhatitisusedfor 2. BeforegivingNurofenforChildrenStrawberrytoyourchild 3. HowtouseNurofenforChildrenStrawberry 4. Possiblesideeffects 5. HowtostoreNurofenforChildrenStrawberry 6. FurtherInformation 1. WhatNurofenforChildrenStrawberryisandwhatitisusedfor Theactiveingredient(whichmakesthismedicinework)isibuprofenwhichisa nonsteroidalantiinflammatory(NSAID)painkiller. Ibuprofenisusedasananalgesic(painkiller)forthereliefofsymptomsofcold andfluandmildtomoderatepain,suchasasorethroat,teethingpain, toothache,earache,headache,minorachesandsprains. NurofenforChildrenalsobringsdownahightemperature(fever)including fevercausedbyimmunisation. 2. BeforegivingNurofenforChildrenStrawberrytoyourchild
NurofenForChildrenStrawberry100mg/5mlOralSuspension
Thismedicineissuitableforthemajorityofpeoplebutcertainpeopleshouldnot useit.Talktoyourpharmacistordoctorifyouareatallunsure. Donotgivethismedicinetoyourchildif: theyhaveeverhadareaction(e.g.asthma,runnynose,rash,swellingof theface,tongue,lipsorthroat)aftertakingibuprofen,aspirinorother nonsteroidalantiinflammatory(NSAID)medicines theyweighlessthan5kgorareunder3monthsofage theyaretakinganyotherantiinflammatory(NSAID)painkillers,or aspirinwithadailydoseabove75mg theyhave(orhavehadtwoormoreepisodes)ofastomachulcer, perforationorbleeding theyhaveseverekidney,heartorliverfailure theyhaveinheritedproblemscopingwithfructose/fruitsugar (hereditaryfructoseintolerance).Thisisbecausethebodycanmake somefructosefromtheingredientmaltitol. Talktoyourdoctororpharmacistif: yourchildhasorhashadhighbloodpressure,heartproblemsorastroke becausethereisasmallincreasedriskofheartproblemswithibuprofen yourchildhasaconditionwhichmayputthematriskofheartproblems, suchasdiabetesorhighcholesterol yourchildhasasthmaoranyallergicdiseaseofthelungs yourchildhas,orhashadliver,kidney,heartorbowelproblems yourchildhasSLE(SystemicLupusErythematosus,aconditionofthe immunesystem)oranysimilardisease yourchildsuffersfromchronicinflammatoryboweldiseasesuchas Crohnsdiseaseorulcerativecolitis Youoryourchildaretakingothermedicinesespecially: o othermedicinescontainingibuprofenorotherNSAIDs,including thoseyoucanbuyoverthecounter o lowdoseaspirin(upto75mgaday) o diuretics(tohelpyoupasswater) o anticoagulants(bloodthinningmedicinese.g.warfarin) o medicinesforhighbloodpressure(e.g.captopril,atenolol, losartan) o lithium(formooddisorders) o methotrexate(forpsoriasis,arthritisandtypesofcancer) o zidovudine(forHIV) o corticosteroids(anantiinflammatorydrug) o cardiacglycosides(forheartproblems) o ciclosporinortacrolimus(topreventorganrejectionafter transplant) o mifepristone(forterminationofpregnancy) o quinoloneantibiotics(forinfections) o SSRIantidepressantdrugs o antiplateletdrugse.g.dipyridamole,clopidogrel. Seektheadviceofyourdoctororpharmacistifanyoftheaboveapply.
Ifyouarenotsurewhattypesofmedicinesyourchildistaking,showthe medicinetothedoctororpharmacist. Ifyouareanadulttakingthismedicine Thewarningsandinformationgiveninthissectionapplyandinadditionthe following: ibuprofenbelongstoagroupofmedicineswhichmayimpairfertilityin women.Thisisreversibleonstoppingthemedicine.Itisunlikelythatthis medicine,usedoccasionally,willaffectyourchancesofbecoming pregnant,however,tellyourdoctorbeforetakingthismedicineifyou haveproblemsbecomingpregnant youshouldonlytakethisproductonadoctorsadviceduringthefirst6 monthsofpregnancy DONOTtakeNurofenforChildrenifyouareinthelast3monthsofyour pregnancy medicinessuchasNurofenforChildrenmaybeassociatedwithasmall increasedriskofheartattack("myocardialinfarction")orstroke.Anyrisk ismorelikelywithhighdosesandprolongedtreatment.Donotexceed therecommendeddoseordurationoftreatment ifyouhaveheartproblems,previousstrokeorthinkthatyoumightbeat riskoftheseconditions(forexampleifyouhavehighbloodpressure, diabetesorhighcholesterolorareasmoker)youshoulddiscussyour treatmentwithyourdoctororpharmacist inlimitedstudies,ibuprofenappearsinthebreastmilkinverylow concentrationandisunlikelytoaffectthebreastfedinfantadversely ifyouareelderlytalktoyourdoctorbeforeusingthismedicine. Someoftheingredientscancauseproblems Thisproductcontainsmaltitol.Ifyouhavebeentoldbyadoctorthatyou haveanintolerancetofructose,contactyourdoctorbeforetakingthis medicine. Maltitolmayhaveamildlaxativeeffect.Calorificvalue2.3kcal/gmaltitol. 3.HowtouseNurofenforChildrenStrawberry Alwaysshakethebottlethoroughlybeforeuse. Toremovethecap,pushitdownandturnitanticlockwise. Thereisa5mleasydosingsyringeoratwoendedmeasuringspoon(2.5mland 5ml)inthepackwhichshouldbeusedtogivethemedicine Usingthetwoendedmeasuringspoon Measurethecorrectdoseusingthe2.5mlor5mlspoonends. Washanddryspoonbetweendoses. Washthespooninwarmwaterandallowtodry,storeoutofthereachof children. Usingthe5mleasydosingsyringe Pushthesyringefirmlyintotheplug(hole)intheneckofthebottle. Tofillthesyringe,turnthebottleupsidedown.Whilstholdingthesyringe inplace,gentlypulltheplungerdowndrawingthemedicinetothecorrect markonthesyringe.SeesectionHowmuchmedicinetouse.
Turnthebottletherightwayup,removethesyringefromthebottleplug bygentlytwistingthesyringe. Placetheendofthesyringeintothechildsmouthandgentlypressthe plungerdowntoslowlyandgentlyreleasethemedicine. Afterusereplacethebottlecap.Washthesyringeinwarmwaterand allowtodry.Storeoutofthereachofchildren.
Howmuchmedicinetouse DONOTgivetobabiesunder3monthsorbabiesweighinglessthan5kg. FevercausedbyImmunisation Age Dose Babiesandchildren3monthsandover One2.5mldoseuptotwiceaday Weighingmorethan5kg Ifnecessarytheseconddoseshouldbegiven6hoursafterthefirstdose. Donotgivemorethan2dosesina24hourperiod. Donotgivetoachildunder3monthsofage,unlessadvisedtodosoby yourdoctor. Fever,PainandSymptomsofColdandFlu Age Dose 3months6months One2.5mldose3timesaday. Weighingover5kg Donotuseformorethan24hours 6months12months One2.5mldose3or4timesin24 hours 1year4years One5mldose3timesin24hours 4years7years One7.5ml(5ml+2.5ml)dose3times in24hours Over7years One10ml(5ml+5ml)dose3timesin 24hours Dosesshouldbegivenevery68hours.Leaveatleast4hoursbetween doses. ForShorttermuseonly Donotgivetobabiesaged36monthsforlongerthan24hours. Donotgivetochildrenaged6monthsoroverforlongerthan3days. WARNING: Donotexceedthestateddose Talktoyourdoctor Ifyourchildssymptomsdonotgoawayassoonaspossibleorworsen. Ifyouarenotsureofyourchildsillnessoritisaccompaniedbyarash, breathingdifficulties,diarrhoeaorexcessivetiredness,speaktoyour doctorstraightaway. Ifanyonehastakentoomuchmedicine Ifyouaccidentallygiveortakemorethantherecommendeddose,contactyour doctorstraightaway. Ifyouforgettogivethemedicine
Ifyouforgetadose,givethenextdosewhenneeded,providedthatthelastdose wastakenatleast4hoursago.Donotgiveadoubledose. 4. Possiblesideeffects Likeallmedicines,NurofenforChildrencancausesideeffects,althoughnot everybodygetsthem. Themostcommonsideeffectisirritationofthestomachwhichcancause problemssuchasindigestionandheartburn. Ifyourchildexperiencesanyofthefollowing,stopgivingthismedicineandtell yourdoctorimmediately: bloodinthestools(faeces/motions) blacktarrystools vomitingbloodordarkparticlesthatlooklikecoffeegrounds unexplainedwheezing,shortnessofbreath,skinrash(whichmaybe severewithblisteringorpeelingoftheskin),itchingorbruising,racing heart,fluidretention(swollenanklesordecreasedlevelsofpassingurine) stiffneck,headache,nausea,vomiting,feveranddisorientation. Ifyourchildexperiencesanyofthefollowingsideeffects,stopgivingthis medicineandtellyourdoctor unexplainedstomachpain,indigestion,heartburn,nauseaorvomiting yellowingoftheeyes,palestoolsanddarkurine severesorethroatwithhighfever unexplainedbruisingortirednessorgettingmoreinfections,suchas colds,thannormal. Othersideeffectswhichmayoccurare: Uncommon: headache Rare: diarrhoea,windorconstipation.Tellyourdoctoriftheselastformore thanafewdaysorbecometroublesome Veryrare: kidneyproblemsmayoccurwithIbuprofen strokeorheartproblemsmayoccurwithIbuprofen.Thisisunlikelyatthe doselevelgiventochildren worseningofcolitisandCrohnsdisease highbloodpressure. 5. HowtostoreNurofenforChildrenStrawberry Donotusethemedicineaftertheexpirydateshownonthebottlelabeland carton. Storebelow25C. Keepallmedicinesoutofthereachandsightofchildren 6. Furtherinformation
Whatisinthismedicine? TheactiveingredientisIbuprofen100mgper5ml. Theotheringredientsare: Maltitolliquid,water,glycerol,citricacid,sodiumcitrate,sodiumchloride, sodiumsaccharin,strawberryflavour,xanthangum,polysorbate80,domiphen bromide. Whatthemedicinelookslike: NurofenforChildrenStrawberryisanoffwhiteliquidavailablein200ml,150ml and100mlbottles.Eachpackcontainsadosingsyringe(CE0543). Itcontains100mgoftheactiveIbuprofeninevery5mlofmedicine. Productlicenceholder:ReckittBenckiserHealthcare(UK)Ltd.Slough,SL14AQ Syringemanufacturer:CrookesHealthcareLimited,Nottingham,NG23AA Manufacturerofmedicine:ReckittBenckiserHealthcareUKLtd,Hull,HU87DS andBCMLtd,NottinghamNG23AA Productlicensenumber:PL00063/0666 Thisleafletwasrevised:June2011 Theleafletgivesyouthemostimportantinformation.Ifyouhaveanyquestions afteryouhavereadit,askyourdoctororpharmacistwhowillbeabletohelp.
NurofenForChildrenStrawberry100mg/5mlOralSuspension
Thismedicineissuitableforthemajorityofpeoplebutcertainpeopleshouldnot useit.Talktoyourpharmacistordoctorifyouareatallunsure. Donotgivethismedicinetoyourchildif: theyhaveeverhadareaction(e.g.asthma,runnynose,rash,swellingof theface,tongue,lipsorthroat)aftertakingibuprofen,aspirinorother nonsteroidalantiinflammatory(NSAID)medicines theyweighlessthan5kgorareunder3monthsofage theyaretakinganyotherantiinflammatory(NSAID)painkillers,or aspirinwithadailydoseabove75mg theyhave(orhavehadtwoormoreepisodes)ofastomachulcer, perforationorbleeding theyhaveseverekidney,heartorliverfailure theyhaveinheritedproblemscopingwithfructose/fruitsugar (hereditaryfructoseintolerance).Thisisbecausethebodycanmake somefructosefromtheingredientmaltitol. Talktoyourdoctororpharmacistif: yourchildhasorhashadhighbloodpressure,heartproblemsorastroke becausethereisasmallincreasedriskofheartproblemswithibuprofen yourchildhasaconditionwhichmayputthematriskofheartproblems, suchasdiabetesorhighcholesterol yourchildhasasthmaoranyallergicdiseaseofthelungs yourchildhas,orhashadliver,kidney,heartorbowelproblems yourchildhasSLE(SystemicLupusErythematosus,aconditionofthe immunesystem)oranysimilardisease yourchildsuffersfromchronicinflammatoryboweldiseasesuchas Crohnsdiseaseorulcerativecolitis Youoryourchildaretakingothermedicinesespecially: o othermedicinescontainingibuprofenorotherNSAIDs,including thoseyoucanbuyoverthecounter o lowdoseaspirin(upto75mgaday) o diuretics(tohelpyoupasswater) o anticoagulants(bloodthinningmedicinese.g.warfarin) o medicinesforhighbloodpressure(e.g.captopril,atenolol, losartan) o lithium(formooddisorders) o methotrexate(forpsoriasis,arthritisandtypesofcancer) o zidovudine(forHIV) o corticosteroids(anantiinflammatorydrug) o cardiacglycosides(forheartproblems) o ciclosporinortacrolimus(topreventorganrejectionafter transplant) o mifepristone(forterminationofpregnancy) o quinoloneantibiotics(forinfections) o SSRIantidepressantdrugs o antiplateletdrugse.g.dipyridamole,clopidogrel. Seektheadviceofyourdoctororpharmacistifanyoftheaboveapply.
Ifyouarenotsurewhattypesofmedicinesyourchildistaking,showthe medicinetothedoctororpharmacist. Ifyouareanadulttakingthismedicine Thewarningsandinformationgiveninthissectionapplyandinadditionthe following: ibuprofenbelongstoagroupofmedicineswhichmayimpairfertilityin women.Thisisreversibleonstoppingthemedicine.Itisunlikelythatthis medicine,usedoccasionally,willaffectyourchancesofbecoming pregnant,however,tellyourdoctorbeforetakingthismedicineifyou haveproblemsbecomingpregnant youshouldonlytakethisproductonadoctorsadviceduringthefirst6 monthsofpregnancy DONOTtakeNurofenforChildrenifyouareinthelast3monthsofyour pregnancy medicinessuchasNurofenforChildrenmaybeassociatedwithasmall increasedriskofheartattack("myocardialinfarction")orstroke.Anyrisk ismorelikelywithhighdosesandprolongedtreatment.Donotexceed therecommendeddoseordurationoftreatment ifyouhaveheartproblems,previousstrokeorthinkthatyoumightbeat riskoftheseconditions(forexampleifyouhavehighbloodpressure, diabetesorhighcholesterolorareasmoker)youshoulddiscussyour treatmentwithyourdoctororpharmacist inlimitedstudies,ibuprofenappearsinthebreastmilkinverylow concentrationandisunlikelytoaffectthebreastfedinfantadversely ifyouareelderlytalktoyourdoctorbeforeusingthismedicine. Someoftheingredientscancauseproblems Thisproductcontainsmaltitol.Ifyouhavebeentoldbyadoctorthatyou haveanintolerancetofructose,contactyourdoctorbeforetakingthis medicine. Maltitolmayhaveamildlaxativeeffect.Calorificvalue2.3kcal/gmaltitol. 3.HowtouseNurofenforChildrenStrawberry Alwaysshakethebottlethoroughlybeforeuse. Toremovethecap,pushitdownandturnitanticlockwise. Thereisa5mleasydosingsyringeoratwoendedmeasuringspoon(2.5mland 5ml)inthepackwhichshouldbeusedtogivethemedicine Usingthetwoendedmeasuringspoon Measurethecorrectdoseusingthe2.5mlor5mlspoonends. Washanddryspoonbetweendoses. Washthespooninwarmwaterandallowtodry,storeoutofthereachof children. Usingthe5mleasydosingsyringe Pushthesyringefirmlyintotheplug(hole)intheneckofthebottle. Tofillthesyringe,turnthebottleupsidedown.Whilstholdingthesyringe inplace,gentlypulltheplungerdowndrawingthemedicinetothecorrect markonthesyringe.SeesectionHowmuchmedicinetouse.
Turnthebottletherightwayup,removethesyringefromthebottleplug bygentlytwistingthesyringe. Placetheendofthesyringeintothechildsmouthandgentlypressthe plungerdowntoslowlyandgentlyreleasethemedicine. Afterusereplacethebottlecap.Washthesyringeinwarmwaterand allowtodry.Storeoutofthereachofchildren.
Howmuchmedicinetouse DONOTgivetobabiesunder3monthsorbabiesweighinglessthan5kg. FevercausedbyImmunisation Age Dose Babiesandchildren3monthsandover One2.5mldoseuptotwiceaday Weighingmorethan5kg Ifnecessarytheseconddoseshouldbegiven6hoursafterthefirstdose. Donotgivemorethan2dosesina24hourperiod. Donotgivetoachildunder3monthsofage,unlessadvisedtodosoby yourdoctor. Fever,PainandSymptomsofColdandFlu Age Dose 3months6months One2.5mldose3timesaday. Weighingover5kg Donotuseformorethan24hours 6months12months One2.5mldose3or4timesin24 hours 1year4years One5mldose3timesin24hours 4years7years One7.5ml(5ml+2.5ml)dose3times in24hours Over7years One10ml(5ml+5ml)dose3timesin 24hours Dosesshouldbegivenevery68hours.Leaveatleast4hoursbetween doses. ForShorttermuseonly Donotgivetobabiesaged36monthsforlongerthan24hours. Donotgivetochildrenaged6monthsoroverforlongerthan3days. WARNING: Donotexceedthestateddose Talktoyourdoctor Ifyourchildssymptomsdonotgoawayassoonaspossibleorworsen. Ifyouarenotsureofyourchildsillnessoritisaccompaniedbyarash, breathingdifficulties,diarrhoeaorexcessivetiredness,speaktoyour doctorstraightaway. Ifanyonehastakentoomuchmedicine Ifyouaccidentallygiveortakemorethantherecommendeddose,contactyour doctorstraightaway. Ifyouforgettogivethemedicine
Ifyouforgetadose,givethenextdosewhenneeded,providedthatthelastdose wastakenatleast4hoursago.Donotgiveadoubledose. 4. Possiblesideeffects Likeallmedicines,NurofenforChildrencancausesideeffects,althoughnot everybodygetsthem. Themostcommonsideeffectisirritationofthestomachwhichcancause problemssuchasindigestionandheartburn. Ifyourchildexperiencesanyofthefollowing,stopgivingthismedicineandtell yourdoctorimmediately: bloodinthestools(faeces/motions) blacktarrystools vomitingbloodordarkparticlesthatlooklikecoffeegrounds unexplainedwheezing,shortnessofbreath,skinrash(whichmaybe severewithblisteringorpeelingoftheskin),itchingorbruising,racing heart,fluidretention(swollenanklesordecreasedlevelsofpassingurine) stiffneck,headache,nausea,vomiting,feveranddisorientation. Ifyourchildexperiencesanyofthefollowingsideeffects,stopgivingthis medicineandtellyourdoctor unexplainedstomachpain,indigestion,heartburn,nauseaorvomiting yellowingoftheeyes,palestoolsanddarkurine severesorethroatwithhighfever unexplainedbruisingortirednessorgettingmoreinfections,suchas colds,thannormal. Othersideeffectswhichmayoccurare: Uncommon: headache Rare: diarrhoea,windorconstipation.Tellyourdoctoriftheselastformore thanafewdaysorbecometroublesome Veryrare: kidneyproblemsmayoccurwithIbuprofen strokeorheartproblemsmayoccurwithIbuprofen.Thisisunlikelyatthe doselevelgiventochildren worseningofcolitisandCrohnsdisease highbloodpressure. 5. HowtostoreNurofenforChildrenStrawberry Donotusethemedicineaftertheexpirydateshownonthebottlelabeland carton. Storebelow25C. Keepallmedicinesoutofthereachandsightofchildren 6. Furtherinformation
Whatisinthismedicine? TheactiveingredientisIbuprofen100mgper5ml. Theotheringredientsare: Maltitolliquid,water,glycerol,citricacid,sodiumcitrate,sodiumchloride, sodiumsaccharin,strawberryflavour,xanthangum,polysorbate80,domiphen bromide. Whatthemedicinelookslike: NurofenforChildrenStrawberryisanoffwhiteliquidavailablein200ml,150ml and100mlbottles.Eachpackcontainsadosingsyringe(CE0543). Itcontains100mgoftheactiveIbuprofeninevery5mlofmedicine. Productlicenceholder:ReckittBenckiserHealthcare(UK)Ltd.Slough,SL14AQ Syringemanufacturer:CrookesHealthcareLimited,Nottingham,NG23AA Manufacturerofmedicine:ReckittBenckiserHealthcareUKLtd,Hull,HU87DS andBCMLtd,NottinghamNG23AA Productlicensenumber:PL00063/0666 Thisleafletwasrevised:June2011 Theleafletgivesyouthemostimportantinformation.Ifyouhaveanyquestions afteryouhavereadit,askyourdoctororpharmacistwhowillbeabletohelp.
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.
