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NUROFEN COLD AND FLU

Active substance: PSEUDOEPHEDRINE HYDROCHLORIDE

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NurofenSinusRelief PLEASEREADALLOFTHISLEAFLETCAREFULLYBEFOREYOUSTARTTOTAKE YOURMEDICINE ItgivesyouimportantinformationaboutNurofenSinusRelief. Keepthisleaflet.Youmaywanttoreaditagain. Ifyouhaveanyquestionsafteryouhavereadit,askyourdoctororpharmacist. 1.Whatisthismedicineandwhatisitusedfor? NurofenSinusRelieftabletscontaintwoactiveingredients(whichmakethe medicinework).ThesearelbuprofenandPseudoephedrineHydrochloride. lbuprofenbelongstoagroupofmedicinesknownasnonsteroidalanti inflammatorydrugs(NSAIDs).NSAIDsprovidereliefbyreducingpain,swelling andhightemperature.Pseudoephedrinebelongstoagroupofdrugscalled vasoconstrictorswhichactonthebloodvesselsinthenosetorelievenasal congestion. NurofenSinusRelief clearsablockednoseandsinuses relievesaches,pains,headacheandhightemperature(fever) easesthediscomfortofasorethroat. 2.Beforetakingthismedicine DonottakeNurofenSinusReliefifyou: have(orhavehadtwoormoreepisodesof)astomachulcer,perforation orbleeding havehadaworseningofasthma,skinrash,itchyrunnynoseorfacial swellingwhenpreviouslytakingibuprofen,aspirinorsimilarmedicines havehadgastrointestinalbleedingorperforationwhenpreviouslytaking (nonsteroidalantiinflammatorydrugs)(NSAIDs). aretakingotherNSAIDpainkillersormorethan75mgaspirinaday aretakingMonoamineOxidaseInhibitors(fordepressionandknownas MAOIs)orhavetakentheseinthelast14days. havesevereliverorkidneyproblems haveheartproblems,highbloodpressure,prostateproblemsoran overactivethyroid havediabetesorglaucoma. areunder12yearsofage arepregnantorbreastfeeding. CheckwithyourpharmacistordoctorbeforetakingNurofenSinusReliefifyou: haveasthma havekidneyorliverproblems havehighcholesterolorhavepreviouslyhadaheartattackorastroke haveahistoryofgastrointestinaldisease(suchasulcerativecolitis, Crohnsdisease) haveSystemicLupusErythematosus(SLE)anillnessaffectingthe immunesystemcausingjointpain,skinchangesandotherproblems

areasmoker. CanyoutakeNurofenSinusReliefwithothermedicines? Somemedicinesthatareanticoagulants(i.e.thinblood/preventclottinge.g. aspirin/acetylsalicylicacid,warfarin,ticlopidine),somemedicinesthatreduce highbloodpressure(ACEinhibitorssuchascaptopril,betablockerssuchas atenolol,orangiotensinllreceptorantagonistssuchaslosartan),andother medicinesmayaffectorbeaffectedbytreatmentwithibuprofen. Somemedicinesfordepression(lithium,selectiveserotoninuptakeinhibitors andmonoamineoxidaseinhibitors(knownasMAOIs))mayaffectorbeaffected bytreatmentwithpseudoephedrine. Youshouldthereforealwaysseektheadviceofyourdoctororpharmacistbefore youtakeibuprofenorpseudoephedrinewithothermedicines. Otherwarnings NurofenSinusReliefbelongtoagroupofmedicineswhichmayimpair fertilityinwomen.Thisisreversibleonstoppingthemedicine.Itisunlikelythat NurofenSinusRelief,usedoccasionally,willaffectyourchancesofbecoming pregnant.However,tellyourdoctorbeforetakingthismedicineifyouhave problemsbecomingpregnant. MedicinessuchasNurofenSinusReliefmaybeassociatedwithasmall increasedriskofheartattackorstroke.Anyriskismorelikelywithhighdosesor prolongedtreatment.Donotexceedtherecommendeddoseortakelongerthan necessarytocontrolyoursymptoms(10days). Ifyouhaveheartproblems,havehadastrokeorthinkthatyoumightbe atriskoftheseconditions(forexampleifyouhavehighbloodpressure,diabetes, highcholesterolorareasmoker),youshoulddiscussyourtreatmentwithyour doctororpharmacist. 3.Howtotakethismedicine Thisproductisforshorttermuseonly.Youshouldtakethelowestdoseforthe shortesttimenecessarytorelieveyoursymptoms.Donottakeitforlongerthan 10daysunlessyourdoctortellsyouto. Adults,theelderlyandchildrenof12yearsandolder: Take1or2tabletswithwater,uptothreetimesadayasrequired. Leaveatleast4hoursbetweendoses. Donottakemorethan6tabletsin24hours. Notsuitableforchildrenunder12years. WhilsttakingNurofenSinusRelief: Ifsymptomspersistorpainorfeverworsen,orifanynewsymptomsoccur, consultyourdoctororpharmacist. Ifyoutaketoomanytabletsbymistake,contactyourdoctororpharmacist straightawayortelephoneyourlocalcasualtydepartmentforadvice. 4.Possiblesideeffects

NurofenSinusReliefisgenerallywelltoleratedbymostpeople.Howeverside effectsmayoccur. STOPTAKINGthemedicineandseekimmediatemedicalhelpifyoudevelop signsofintestinalbleedingsuchas: brightredfaeces(stools/motions),blacktarrystools,vomitingbloodor darkparticlesthatlooklikecoffeegrounds. signsofaseriousallergicreactionsuchassevereskinrashes,peeling, flakingorblisteringskin,facialswelling,unexplainedwheeziness,shortnessof breath,easybruising. Tellyourdoctorifyouexperience: indigestionorheartburn stomachpainorotherabnormalstomachsymptoms rashes,itching worseningofasthma, sweating,thirst,muscleweaknessortremors,sleeplessness,chestpainor fast,irregularheartbeat liverandkidneyproblems headache,dizzinessandhearingdisturbance,difficultyinurinating,mood changese.g.restlessness. 5.Howtostore Keepallmedicinesoutofthereachandsightofchildren.Donotuseafterthe expirydateshownonthepack. Storeinadryplace. 6.Furtherinformation Eachtabletcontainstheactiveingredientsibuprofen200mgand PseudoephedrineHydrochloride30mg. Alsocontains:CalciumPhosphate,MicrocrystallineCellulose,Polyvinyl Pyrrolidone,SodiumCarboxymethylCellulose,MagnesiumStearate, HydroxypropylmethylCellulose,Talc,TitaniumDioxide,QuinolineYellowand SunsetYellow(containsAluminiumandE110),blackprintingink(contains shellac,IronOxideBlack(E172)andpropyleneglycol). NurofenSinusReliefisavailableinpacksof12and24tablets. LicenceHolder:ReckittBenckiserHealthcare(UK)Ltd,Slough,SL14AQ. Manufacturer:ReckittBenckiserHealthcareInternationalLtd,NG902DB. ProductLicenceNo.PL00063/0375 DateofrevisionFebruary2012.

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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.

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