NUROFEN PAIN RELIEF 256MG TABLETS – patient leaflet, side effects, dosage

1.What this medicine is and what it is used for

The active ingredient (which makesthis medicine work)is Ibuprofen. It belongs to agroup of medicines knownas non-steroidalanti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s responseto pain, swelling, andhigh temperature.

This medicine isused for thereliefof feverandmildto moderatepain, suchas:

• headaches andmigraine pain
• nerve pain, backache,period pain,rheumaticand

muscular pain

• coldand flu symptoms
• dental pain.

2. Before taking this medicine

Signsof an allergicreaction to thismedicine, including breathing problems, swelling of the faceand neckregion (angioedema), chest pain have been reported with ibuprofen. Immediately stop taking this medicineandcontact yourdoctor ormedical emergencies if you notice any ofthese signs. Do not take this medicine if you:

• are allergicto ibuprofen or any of the otheringredients (see section6)or to aspirin or other painkillers
• have(or have had two or moreepisodes of) a stomach ulcer, perforation or bleeding
• havehad a worsening ofasthma, skin rash, itchyrunny nose orfacial swelling when previously taking ibuprofen, aspirin or similar medicines • havehad gastrointestinalbleeding orperforation whenpreviously taking NSAIDs (Nonsteroidalanti-inflammatory drugs)
• are takingother NSAID painkillers ormore than 75 mg aspirin a day • havesevere liveror kidney problems
• haveheart problems,high bloodpressureor blood coagulationdisorder. • havebreathing difficulties

• are in the last3 months of pregnancy

• are under 12years old.

Check with your pharmacist or your doctor before taking this product if you:

• haveor havehadasthma
• havekidney,heart, liveror bowel problems

• havehigh cholesterol or previously have had a heart attack orstroke • havea history ofgastrointestinal disease

  (such as ulcerative colitis, Crohn'sdisease)

• haveSystemic Lupus Erythematosus (a condition of the immunesystem causing joint pain skin changes andother organ disorders) • are asmoker
• are in the first 6 months of pregnancy.
• are on a diet restricting your salt intake.

• have an infection.This medicine may hidesignsof infections suchas

  fever and pain. It istherefore possiblethat this medicine may delay appropriatetreatmentof infection,which may leadtoan increased riskof complications.Thishasbeenobservedin pneumonia causedbybacteria and bacterial skin infections relatedto chickenpox. Ifyou takethis medicine while youhaveaninfectionandyoursymptomsoftheinfection persist or worsen, consultadoctorwithout delay.

  Skin reactions

  • Serious skinreactionsincludingexfoliativedermatitis, erythema multiforme, Stevens-Johnson syndrome,toxic epidermal necrolysis,drug reactionwith eosinophiliaandsystemic symptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) have been reported inassociation with ibuprofen treatment. Stop using this medicineand seek medicalattention immediately,if younoticeanyof thesymptomsrelated tothese serious skin reactions describedin section4.

Taking other medicines

This medicine may affect orbeaffectedbysome othermedicines.For example:

Avoid taking this product withcorticosteroid tablets, quinoloneantibioticsor drugs that areprescribed

• as anti-coagulants(i.e. thin blood/preventclotting

e.g.aspirin/acetylsalicylicacid, warfarin,ticlopidine)

• to stimulate your heart(e.g. glycosides)
• to reduce highblood pressure (ACE-inhibitors suchas captopril, beta-blockers suchasatenololmedicines, angiotensin-II receptor antagonists suchaslosartan)
• to helpyou passing water(diuretics)
• forthetemporarysuppression ofyourimmune system

(e.g. methotrexate,ciclosporin,tacrolimus)

• formaniaordepression(e.g. lithiumor SSRIs)
• forpregnancy termination(e.g. mifepristone)
• forHIVtreatment (e.g.zidovudine)

Some other medicines may also affect or be affected by the treatment of this medicine.You should therefore always seek the advice of your doctor or pharmacist before you use this medicine with other medicines. Other warnings:

• Thismedicinebelongstoagroup ofmedicines whichmayimpair fertility in women.This is reversibleon stopping themedicine. Itisunlikelythat this medicine, used occasionally willaffectyourchances ofbecoming pregnant. However, tellyourdoctorbeforetaking this medicine if you have problems becomingpregnant.
• Anti-inflammatory/pain-killermedicines such asibuprofenmaybe associated with asmallincreased risk of heart attack orstroke, particularly whenused at highdoses. Do not exceed therecommended dose or duration of treatment.

• You should discussyour treatment withyourdoctoror pharmacist before takingthis medicineifyou:

  • have heart problems includingheart failure,angina(chestpain),or if you have had aheart attack,bypasssurgery,peripheralarterydisease (poor circulationin the legs offeetdue tonarrowor blockedarteries),or anykindofstroke(including‘mini-stroke’ ortransient ischaemic attack 'TIA').
  • have high bloodpressure, diabetes,highcholesterol,havea family history of heart diseaseorstroke,or if you are asmoker. • There is a risk of kidney problems indehydratedchildren and adolescents. • Ifyou are takingthis medicine forlongerthan therecommended time orat higher than recommendeddoses youareat risk ofserious harm.These include serious harm tothe stomach/gutand kidneys, aswellas very low levels of potassiumin your blood.These canbe fatal(see section 4). Pregnancy and breast feeding

Do not take NurofenPain relief if you arein thelast 3 monthsofpregnancyas it could harmyour unborn childor cause problemsatdelivery.It cancause kidney and heart problems inyour unborn baby.It mayaffectyour andyour baby’s tendency tobleed andcause labour tobe laterorlonger than expected.Youshould not takeNurofenPainrelief duringthefirst6monthsof pregnancy unless absolutelynecessaryand advisedby yourdoctor.If you need treatment duringthisperiod orwhileyouare tryingtogetpregnant, the lowest dose for the shortesttime possibleshould be used. If takenformore thana few days from 20weeks ofpregnancyonward, Nurofen Pain relief can

cause kidneyproblems in yourunborn baby thatmay leadto lowlevelsof amniotic fluid that surroundsthe baby (oligohydramnios) or narrowingof a blood vessel (ductusarteriosus) in theheart ofthe baby. If you need treatment for longer than a fewdays, your doctormay recommendadditionalmonitoring. Do not take if you are breastfeeding. Speakto your doctor ifyou are inthefirst 6 months of pregnancy.

Important information about some of the ingredients of this medicine:

This medicine contains25.72 mg sodium (maincomponent ofcooking/table salt) in each tablet.This isequivalent to 1.29% of the recommended maximum daily dietary intake of sodiumforan adult.

This productcontains sucrose. Ifyou havebeen told byyourdoctorthat you havean intolerancetosomesugars,contact yourdoctorbeforetakingthis medicinal product.

3. How to take this medicine

This productis for short termuseonly.Thelowesteffective dose shouldbe usedfortheshortestduration necessary torelievesymptoms. Ifyou havean infection,consult adoctorwithout delay ifsymptoms(such asfever and pain) persist or worsen (see section 2).

Adults, the elderly and children and adolescents between 12 and 18 years:

Take 1 or 2 tablets with water, up tothree timesadayas required. Leave at least fourhours between doses. Do not take morethan6tablets in 24 hours.

Do not give to children under 12 years.

Do not take this medicine forlongerthan 10days unless yourdoctortells you to.

If symptoms persist orworsen,orif any newsymptomsoccur,consult your doctoror pharmacist.

In children and adolescents between 12 and 18 years:

If in children and adolescents thismedicinal productis required formore than 3 days, or if symptoms worsen, you should consult adoctor. If you have taken more of this medicine than you should, or if children have taken this medicine by accident always contact a doctor or nearest hospital to get an opinion of the risk and advice on action to be taken.

The symptomscan include nausea,stomach pain,vomiting(maybe blood streaked), headache, ringing in the ears, confusionandshaky eyemovement. At high doses, drowsiness,chest pain, palpitations, lossofconsciousness, convulsions(mainly in children), weaknessanddizziness,blood in urine,cold body feeling, andbreathing problems have beenreported. If you forget to take this medicine:

Do not take adoubledose tomake up for amissed dose.

Simply referto the directionsabove onhow totakethemedicineand donot takemore than is advised.

4. Possible side effects

This medicine isgenerally well tolerated bymostpeople.However side effects may occur.

STOPTAKING the medicine and seek immediate medical help if you develop:

• signs of intestinal bleeding suchas: bright red faeces (stools/motions), black tarry stools, vomiting blood ordarkparticles thatlooklikecoffee grounds.
• signs of serious allergic reactionsuch as:
• difficulties in breathing or unexplained wheezing
• dizziness or faster heartbeat
• reddish non-elevated, target-like orcircular patcheson thetrunk,oftenwith central blisters, skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can beprecededby feverand flu-like symptoms [exfoliative dermatitis, erythemamultiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis].
• swelling of your face,tongue or throat
• signs of kidney problems suchas:

passing lessor moreurine, cloudyurineorblood inurine, painintheback and/or swelling in the legs

• signs of aseptic meningitis with neck stiffness,headache,feeling sick, being sick, fever ordisorientation. Patientswithautoimmune disorders (lupus, mixed connective tissue disease) maybemore likelytobe affected. • a severe skin reaction known as DRESS syndrome canoccur. Symptoms ofDRESSinclude: skinrash,fever,swellingof lymphnodesand an increase of eosinophils

(a type ofwhite bloodcells).

• A red, scaly widespread rash with bumps undertheskinandblistersmainly localised onthe skin folds, trunk, andupper extremitiesaccompaniedby fever attheinitiation of treatment (acute generalisedexanthematous pustulosis) (frequency not known). See also section2.

  STOPTAKING the medicine and tell your doctor if you experience the following uncommon side effects whichmay affect upto 1in 100 people: - indigestion, heartburnor feelingsick

  • pains inyourstomach(abdomen)or otherabnormalstomach problems. Like allmedicines,this medicinecancause side-effects,althoughnoteverybody gets them.Tellyour doctoror pharmacist ifyou noticeany ofthe following: - Liver,kidneyproblemsordifficultyurinating

This medicine, especiallywhen takenathigherthan recommended doses orfor aprolongedperiod oftime,cancausedamageto your kidneysandaffect them removingacids properlyfrom yourbloodintotheurine(renaltubular acidosis). Itcanalso cause verylowlevels ofpotassium inyour blood (seesection2).This isaveryseriousconditionandwill requireimmediatetreatment. Signs and symptoms include muscleweakness and light-headedness. Tell your doctor or pharmacist if you have any of the following side effects,they become worse or you notice any affects not listed: Uncommon:mayaffectup to 1 in100 people:

• allergicreactions such as skinrashes(urticaria), itching, peeling - headaches

Rare:mayaffectup to 1 in1,000 people:

• flatulence (wind)diarrhoea, constipation andvomiting

Very rare:mayaffectup to 1 in10,000people:

• blood disorder resultinginunexplained orunusual bleeding, fever,sore throat,mouthulcers,flu-likesymptomsand severeexhaustion - dropinbloodpressureorirregularheartbeat

• stomach or intestinalulcers,sometimes with bleeding and perforation, inflammationof theliningof the mouthwithulceration, inflammationof th

  e stomach

• liverproblems
• dropin haemoglobin levels which cancausetiredness, paleskinand gums,feeling shortof breath and more noticeable heartbeats. Not known: frequencycannotbe estimatedfromtheavailable data - worsening of asthma orbronchospasm
• swelling(oedema),high bloodpressure, heartfailure orattack - chest pain,which can bea signofapotentially seriousallergicreaction calledKounissyndrome
• worsening of colitisandCrohn’s disease.
• skinbecomessensitivetolight

Medicinessuchasthis medicine maybe associated with a smallincreased risk ofheart attack (’myocardial infarction’)or stroke.(Seesection 2 'Other warnings'.)

If any of the side effectsgets serious, or ifyou noticeany sideeffects notlisted in thisleaflet, please tell your doctor orpharmacist.

Reporting of side effects

If you getanysideeffects,talk toyourdoctor,pharmacistor nurse.This includes anypossiblesideeffectsnot listed inthisleaflet.You can also report side effectsdirectlyvia theYellow Card Schemeat:

www.mhra.gov.uk/yellowcardor search for MHRAYellow CardintheGoogle Play orAppleAppStore.

Byreportingsideeffects,youcanhelpprovide more informationonthesafety ofthismedicine.

5. How to store this medicine

Keep all medicines out of the sight and reach of children.

Do not useafter the expiry datestatedonthecartonafter EXP.The expirydate refers to the lastday of thatmonth.

Storeintheoriginalpack.

6. Further information

Each tablet contains the active ingredientIbuprofen 200 mg (as Sodium Ibuprofen 256mg).

Also contains:Croscarmellosesodium,Xylitol,Microcrystallinecellulose, Magnesium stearate,Colloidal anhydroussilica, Carmellose sodium,Talc, Acacia spraydried,Sucrose,Titaniumdioxide (E171),Macrogol6000powder, andBlack ink (containsshellac,ironoxide black (E172) andpropylene glycol)

.

This medicine is availablein packsof 6, 12and16whitetablets printedwithan identifying black logo.Not all packsaremarketed Manufacturers:

ReckittBenckiserHealthcareInternationalLtd,

1ThaneRoad, Nottingham NG902DB, UK.

RBNLBrandsB.V.,WTCSchipholAirport,

Schiphol Boulevard 207,1118BH Schiphol, NL.

Productlicence number:PL00063/0373

Licenceholder: ReckittBenckiser Healthcare(UK) Ltd, Hull,HU87DS Date ofrevision:March2024

Reckitt

UK\0161568\PL-00063-0373 Nurofen Pain Relief 256mg Tablets

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