Nurofen Pain Relief Caplets 256 mg tablets – patient leaflet, side effects, dosage

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

The active ingredient (which makes this medicine work) is Ibuprofen. It belongs to a group of medicines knownas non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body’s response to pain, swelling,and high temperature.

This medicine is usedfor therelief of fever and mild to moderate pain, such as: - headaches and migraine pain

• nervepain, backache,period pain, rheumatic and muscular pain - cold and flu symptoms,
• dental pain.

2. Before taking this medicine

Signsof an allergic reactionto this medicine, including breathing problems, swelling of the face and neckregion (angioedema), chest pain have been reported with ibuprofen. Immediately stop takingthis medicineand contact your doctor ormedical emergencies if you notice any of these signs. Do not take this medicine if you:

• are allergic to ibuprofen orany of the other ingredients

  (see section 6) or to aspirin or other painkillers

• have (or have had twoor more episodes of) a stomach ulcer, perforation or bleeding
• have hada worsening of asthma, skin rash, itchy runny nose orfacial swelling when previously taking ibuprofen, aspirin or similar medicines - have hadgastrointestinal bleeding or perforation when previously taking NSAIDs (Nonsteroidal anti-inflammatory drugs)
• are takingother NSAID painkillers or more than75 mg aspirin a day - have severeliver orkidneyproblems
• have heart problems, high blood pressureor blood coagulation disorder. - have breathingdifficulties

• are inthe last 3 months of pregnancy are under12 yearsold. Check with your pharmacist or your doctor before taking this product if you:

• have or have had asthma
• have kidney, heart, liver or bowelproblems
• have high cholesterolor previously havehad a heart attack or stroke. - have a historyof gastrointestinal disease(such as ulcerative colitis, Crohn's disease)
• have Systemic Lupus Erythematosus (a condition of theimmune system causing joint pain skin changes andother organ disorders) - are a smoker

• are inthe first 6 months of pregnancy.

  • are on adiet restrictingyour saltintake.
  • have an infection.Thismedicine mayhidesignsof infections such asfever andpain.It is thereforepossiblethat thismedicine maydelay appropriate treatmentof infection,whichmayleadto anincreased risk ofcomplications. This has been observed in pneumoniacaused bybacteria andbacterial skin infections related to chickenpox.Ifyou takethismedicine whileyou have an infectionand your symptomsoftheinfectionpersist orworsen,consulta doctor without delay.

Skin reactions

• Serious skin reactionsincludingexfoliativedermatitis, erythema multiforme, Stevens-Johnson syndrome,toxic epidermal necrolysis,drugreactionwith eosinophilia and systemicsymptoms (DRESS),acutegeneralised exanthematous pustulosis(AGEP)havebeen reportedin association with ibuprofentreatment. Stopusing thismedicine andseekmedical attention immediately, if younoticeany of thesymptoms relatedtotheseseriousskin reactionsdescribedinsection4.

Taking other medicines

This medicine may affectorbe affected bysomeothermedicines.Forexample: Avoid taking this productwith corticosteroidtablets,quinoloneantibiotics or drugs that are prescribed

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

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

• to stimulate your heart (e.g.glycosides)
• to reduce highbloodpressure(ACE-inhibitors such ascaptopril, beta-blockers suchasatenololmedicines,angiotensin-IIreceptor antagonistssuchas losartan)
• to help you passingwater(diuretics)

• for the temporary suppressionof yourimmunesystem

  (e.g. methotrexate,ciclosporin, tacrolimus)

• for mania ordepression(e.g. LithiumorSSRIs)
• for pregnancy termination(e.g.mifepristone)
• for HIV treatment (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:

• This medicine belongs to agroup of medicineswhich mayimpair fertility in women.This isreversible on stopping the medicine.Itisunlikely that this medicine used occasionally willaffect your chances of becomingpregnant. However, tellyour doctorbeforetakingthismedicine ifyouhaveproblems becoming pregnant.

• Anti-inflammatory/pain-killermedicinessuchasibuprofen may beassociated with a small increased risk ofheartattackorstroke,particularlywhen usedat high doses. Do not exceedthe recommendeddoseordurationoftreatment. • Youshould discussyourtreatment withyourdoctor orpharmacistbefore takingthis medicineifyou:

  • have heart problemsincludingheart failure,angina(chest pain),or ifyou have had a heartattack,bypasssurgery, peripheralarterydisease(poor circulation in the legsoffeetduetonarrow orblockedarteries), oranykind of stroke(including‘mini-stroke’ortransient ischaemicattack“TIA”). - have high bloodpressure,diabetes,highcholesterol, have afamilyhistory of heart diseaseorstroke, orif you area smoker.
• There is a risk of kidneyproblemsindehydratedchildrenand adolescents. • If youare taking thismedicineforlongerthanthe recommended time orat higher than recommendeddosesyouareatriskof serious harm.These include serious harm to the stomach/gutand kidneys,as wellasverylow levels of potassiuminyourblood.Thesecanbefatal(seesection 4). Pregnancy and breast feeding

Do not take thismedicineifyou areare in the last3months ofpregnancy asit could harm your unbornchild orcauseproblems at delivery.Itcancausekidney andheart problems inyour unborn baby.It may affect yourandyourbaby’s tendency to bleed and cause labour tobelateror longerthanexpected.You shouldnot take this medicineduring thefirst 6monthsof pregnancy unless absolutely necessary andadvisedby your doctor.If you needtreatmentduring this period orwhile youare trying to getpregnant,thelowestdosefor the shortesttime possibleshould beused. If takenformore thana fewdaysfrom 20 weeks of pregnancy onward, this medicinecan cause kidney problems in your unborn baby that maylead to lowlevels of amnioticfluidthatsurroundsthe baby (oligohydramnios) ornarrowing of abloodvessel (ductusarteriosus)inthe heart of the baby. If you needtreatmentforlongerthanafewdays,yourdoctor may recommend additionalmonitoring. Do not takethismedicineifyou are

breastfeeding. Speak to your doctorif youare in the first6 monthsofyour pregnancy.

Important information about some of the ingredients of this medicine:

This medicine contains25.72 mg sodium (maincomponentofcooking/table salt) in each tablet.This isequivalent to 1.29%ofthe recommended maximum daily dietary intake of sodium for anadult.

This product contains sucrose. If you have beentoldbyyour doctorthat youhave an intoleranceto somesugars, contact your doctorbeforetaking thismedicinal product.

3. How to take this medicine

This product is for short term use only.The lowesteffectivedose shouldbe used for the shortest durationnecessary to relievesymptoms. Ifyou have an infection, consult a doctor withoutdelayifsymptoms(such asfeverand pain) persist or worsen (see section 2).

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

Take 1 or2 caplets with water, up to three times aday asrequired. Leave at least four hours between doses.Donot takemorethan6capletsin24 hours.

Do not give to children under 12years.

Do not take thismedicine for longer than 10 daysunlessyour doctortellsyouto. If symptomspersist orworsen,or if anynewsymptomsoccur,consultyourdoctor or pharmacist.

In children and adolescents between 12 and 18 years:

If in children and adolescents thismedicinal productis requiredfor more than 3 days, or if symptoms worsen adoctor shouldbeconsulted.

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 symptoms caninclude nausea, stomachpain, vomiting (may beblood streaked), headache, ringing in theears, confusionand shaky eyemovement.At high doses, drowsiness, chestpain, palpitations, loss ofconsciousness, convulsions (mainly inchildren), weaknessand dizziness,bloodin urine, cold body feeling, and breathing problems havebeen reported.

If you forget to take this medicine

Simply referto the directions above on howtotakethemedicineand donottake morethanis advised.

4. Possible side effects

This medicine is generally well toleratedbymost people. Howeverside effects may occur.

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

• signs of intestinal bleeding suchas:brightredfaeces (stools/motions), black tarry stools, vomiting blood or dark particlesthatlooklikecoffee grounds. • signs of serious allergic reactionsuchas:
• difficulties inbreathing orunexplained wheezing
• dizziness or faster heartbeat
• reddish non-elevated,target-like or circularpatches on the trunk,often with central blisters,skinpeeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can bepreceded by feverandflu-like symptoms (exfoliative dermatitis,erythema multiforme,Stevens-Johnson syndrome, toxic epidermal necrolysis).
• swellingof your faceor throat

• signs of kidney problems such as:

  Passing less or moreurine

  Cloudy urine or blood in urine

  Pain in the back and/or swelling (particularlyinthelegs)

• signs of aseptic meningitis with neck stiffness,headache, feelingsick,being sick, fever or disorientation. Patientswith autoimmunedisorders (lupus, mixed connective tissue disease) may bemorelikelytobe affected. • a severe skin reaction known as DRESS syndromecan occur. Symptoms of DRESS include: skinrash, fever, swelling oflymphnodes andanincrease of eosinophils(a type of white blood cells).
• A red,scaly widespread rash with bumps undertheskin andblistersmainly localisedon the skin folds, trunk,andupperextremities accompanied by fever at the initiation of treatment (acute generalisedexanthematous pustulosis) (frequencynotknown).See alsosection2.

STOPTAKING the medicine and tell your doctor if you experience the following uncommon side effects whichmayaffectup to 1 in 100 people: - indigestion, heartburn or feeling sick

• pains in your stomach (abdomen)orotherabnormalstomachproblems.

  • Likeall medicines, thismedicinecan causeside-effects,althoughnot everybody gets them.Tell your doctoror pharmacist if younoticeanyofthe following:
  • Liver,kidney problemsordifficultyurinating

This medicine,especially when taken athigherthan recommendeddosesor for a prolongedperiodoftime,cancausedamageto yourkidneys and affectthem removingacids properlyfromyourblood into the urine(renaltubularacidosis). It can also causeverylow levelsofpotassiuminyourblood(see section 2).This isa veryseriousconditionandwill requireimmediatetreatment. Signsandsymptoms includemuscle weaknessand light-headedness.

Tell your doctor if you have any of the following side effects,they become worse or you notice any affects not listed:

Uncommon:mayaffectup to1 in 100people:

• allergicreactions suchasskinrashes(urticaria), itching,peeling - headaches

Rare:mayaffectup to1 in 1,000people:

• flatulence(wind)diarrhoea,constipation andvomiting

Very rare:mayaffectup to1 in 10,000 people:

• blood disorder resultingin unexplainedorunusualbleeding,fever, sorethroat, mouth ulcers,flu-like symptoms andsevereexhaustion
• drop inbloodpressureor irregular heartbeat
• stomachor intestinal ulcers,sometimeswith bleedingandperforation, inflammationofthe liningofthemouthwithulceration(ulcerativestomatitis), inflammationofthe stomach (gastritis)
• liver problems
• drop inhaemoglobinlevelswhichcan cause tiredness, pale skinand gums, feeling short of breath and more noticeableheartbeats.

Not known:frequency cannot beestimatedfrom theavailable data: - worsening ofasthmaorbronchospasm

• swelling(oedema),highbloodpressure,heart failureorattack - chestpain,whichcan be asignof apotentiallyserious allergic reactioncalled Kounissyndrome
• worsening ofcolitis andCrohn’s disease
• skinbecomessensitive to light

Medicinessuchasthis medicine may beassociated witha smallincreasedrisko

f heartattack(’myocardialinfarction’) orstroke.(Seesection 2‘Otherwarnings’.) If any ofthesideeffectsgetsserious,or if younotice anyside effects notlisted in thisleaflet,pleasetell yourdoctor or pharmacist.

Reporting of side effectsIf you getany sideeffects,talkto your doctor, pharmacistornurse.This includes any possible side effects not listedinthis leafle

t.

Youcanalso reportsideeffectsdirectly via theYellowCardScheme at: www.mhra.gov.uk/yellowcardorsearch for MHRAYellow Cardinthe Google Play orAppleAppStore.By reportingside effects,youcan helpprovidemore information onthe safety of thismedicine.

5. How to store this medicine

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

Do not use after the expiry datestated onthecarton after EXP.The expiry date referstothe lastdayof that month.

Store inthe originalpack.

6. FURTHER INFORMATION

Each caplet containsthe activeingredientIbuprofen200mg (asSodium Ibuprofen256mg).

Alsocontains:Croscarmellosesodium, Xylitol(E967),Microcrystallinecellulose, Magnesium stearate, Colloidal anhydrous silica,Carmellose sodium,Talc,Acacia spraydried,Sucrose,

Titanium dioxide

(E171), Macrogol 6000 powder,and Blackink(containsshellac,ironoxide black (E172)and propyleneglycol).

This medicine is available in packs of2, 3, 4,5,6, 8, 10,12,14,15, 16 tablets printed withanidentifyingblacklogo.Notallpacksaremarketed. Manufacturers:

ReckittBenckiser HealthcareInternationalLtd,

1ThaneRoad,Nottingham NG90 2DB, UK.

RB NLBrandsB.V.,WTC SchipholAirport,

SchipholBoulevard 207,1118BHSchiphol, NL.

Productlicencenumber: PL00063/0411

Licence holder:ReckittBenckiser Healthcare (UK)Ltd,Hull,HU8 7DS Date ofrevision:March 2024

Pain Relief Caplets

256 mg Tablets

Contains Sodium Ibuprofen