Patient leaflet - Nurofen Pain Relief Max strength 512 mg tablets
1. What this medicine isand whatit is used for
- 2. Before youtake this medicine
- 3. How totakethis medicine
- 4. Possible side effects
- 5. How tostore thismedicine
- 6. Further Information
1.What this medicine is and what it is used for
The activeingredient (which makes this medicine work) is Ibuprofen. It belongsto a group ofmedicinesknown as non-steroidal anti-inflammatory drugs (NSAIDs). NSAIDs provide relief by changing the body's response to pain,swelling, andhightemperature.
This medicine is usedforthe relief of fever and mild tomoderate pain, suchas:
- headaches and migraine pain
- nervepain, backache, periodpain, rheumatic and muscular pain • cold and flusymptoms, sore throat
- dental pain
- thepainassociated with non serious arthritis
2. Before taking this medicine
Signs of an allergic reaction to this medicine, includingbreathing problems, swelling of theface and neckregion(angioedema), chest pain have been reported withibuprofen. Immediatelystop taking this medicine and contact your doctor or medical emergencies if you notice any of these signs. Do not take this medicine if you:
- areallergic toibuprofen or anyof the other ingredients (see section6) or to aspirin or otherpainkillers
- have(or have had twoor more episodes of) a stomach ulcer, perforation or bleeding
- havehad a worsening of asthma, skin rash, itchy runny nose or facial swelling when previouslytakingibuprofen, aspirin or similar medicines • havehad gastrointestinal bleeding orperforation whenpreviously taking NSAIDs (Non-steroidalanti-inflammatory drugs)
- havesevere liver or kidneyproblems
- havesevere heart problems
arein the last3 months of pregnancy
Check with your pharmacist or your doctor before taking this product if you:
- haveorhave had asthma
- havekidney,heart, liveror bowel problems
- havehigh cholesterol, high blood pressure orpreviously have hada heart attack or stroke
- havea historyof gastrointestinal disease(such as ulcerative colitis, Crohn's disease)
- haveSystemic LupusErythematosus(a condition of the immune system causing joint pain skin changesand otherorgan disorders) • area smoker
- arein the first6 months of pregnancy.
- areon a diet restricting your salt intake.
have an infection.This medicine may hide signsofinfectionssuch as fever and pain.It is thereforepossible that this medicine may delay
appropriate treatment ofinfection, which may leadto anincreased risk of complications.This hasbeenobserved in pneumonia causedby bacteria and bacterialskininfections relatedtochickenpox. If you take this medicine while you havean infection and yoursymptoms ofthe infectionpersist or worsen, consulta doctor withoutdelay.
Skin reactions
- Seriousskin reactionsincluding exfoliativedermatitis, erythemamultiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis,drugreactionwith eosinophilia andsystemic symptoms (DRESS),acutegeneralised exanthematous pustulosis (AGEP)have been reported in association with ibuprofen treatment. Stopusingthismedicineand seekmedicalattention immediately,if you noticeany of the symptoms related to theseserious skin reactions describedinsection 4.
Taking other medicines
This medicine may affect or beaffectedby some othermedicines. For example:
Avoid taking thisproductwithcorticosteroid tablets, quinolone antibiotics or drugs thatare prescribed
- as anti-coagulants(i.e. thin blood/prevent clotting
e.g.aspirin/acetylsalicylicacid, warfarin,ticlopidine)
- tostimulate your heart (e.g, glycosides)
- toreduce high bloodpressure(ACE-inhibitorssuchascaptopril, beta-blockers such asatenololmedicines, angiotensin-II receptor antagonistssuchas losartan)
- tohelpyou passingwater(diuretics)
- for the temporarysuppression of your immune system
(e.g, methotrexate, ciclosporin,tacrolimus)
- for mania or depression (e.g. Lithium or SSRls)
- 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 medicinebelongsto a group ofmedicineswhichmayimpair fertility in women.This is reversible onstoppingthe medicine. It is unlikely thatthis medicine usedoccasionallywillaffect your chances ofbecoming pregnant. However, tell your doctor before takingthismedicineif youhaveproblems becomingpregnant.
- Anti-inflammatory/pain-killer medicines suchas ibuprofen may be associated with a small increasedriskof heart attackor stroke,particularly when used athigh doses. Donot exceed the recommended doseor durationof treatment.
You shoulddiscussyourtreatment withyour doctor or pharmacist before taking this medicineif you:
- have heartproblemsincludingheart failure,angina (chest pain), or if you have had a heartattack, bypasssurgery, peripheral arterydisease (poor circulation in thelegsof feetdue to narrowor blocked arteries),or any kindof stroke(including‘mini-stroke’ortransient ischaemicattack ‘TIA’).
- have high bloodpressure, diabetes,high cholesterol, have afamily historyof heart disease or stroke,or if you are a smoker. • Thereis a risk ofkidney problems in dehydrated children and adolescents • If you aretaking this medicine for longerthanthe recommended time or at higherthanrecommended doses youare at risk of seriousharm.These include serious harm tothestomach/gutand kidneys, as well as verylow levels of potassiuminyour blood.These canbe fatal (seesection 4). Pregnancy and breast feeding
Do not take this medicineif youare are in thelast 3months of pregnancyas itcould harm yourunbornchildor cause problems at delivery.It can cause kidneyand heart problemsin your unbornbaby. It may affectyour andyour baby’s tendency to bleed and cause labour to belater or longer than expected.You should nottake this medicine during the first6monthsof pregnancyunless absolutely necessary andadvised byyour doctor.Ifyou needtreatment duringthisperiod or whileyou are trying to get pregnant, the lowest dosefor the shortest time possible should be used. If taken formore than a few days from20 weeksofpregnancy onward,this medicine can
cause kidney problems inyourunbornbaby that may lead to lowlevelsof amniotic fluid that surrounds thebaby (oligohydramnios)ornarrowing of a blood vessel (ductusarteriosus) in theheart of the baby. If you need treatment for longer thanafew days, your doctormayrecommend additional monitoring. Do not take this medicine if you arebreastfeeding. Speaktoyour doctor if you arein the first 6 months ofyour pregnancy.
Important information about some of the ingredients of this medicine This medicine contains51.45 mgsodium (main component ofcooking/table salt) in each tablet or caplet.Thisis equivalent to 2.57 % of the recommended maximum daily dietary intakeof sodium for an adult.
This product contains sucrose. Ifyou have been told byyour doctor thatyou haveanintoleranceto somesugars,contactyourdoctorbeforetaking this medicinal product.
3. How to take this medicine
This product is for short term use only.The lowest effective dose shouldbe used for the shortestduration necessary torelievesymptoms. If you have an infection, consulta doctor without delay if symptoms(such asfeverand pain) persistor worsen(see section 2).
Adults, the elderly and children and adolescents between 12 and 18 years:
Take 1tabletwith water, up tothree times a day as required. Leave atleast fourhours between doses. Do not take morethan3tabletsin 24 hours.
Do not give to children under 12 years.
Do not take this medicine for longer than 10daysunlessyour doctor tells you to.
Ifsymptoms persist orthe pain worsens, or ifanynew symptoms occur, consult your doctor or pharmacist.
In children and adolescents between 12 and 18 years:
Ifin children and adolescents this medicinal product is required for more than 3 days, or if symptoms worsen adoctor should beconsulted. 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 can include nausea, stomach pain,vomiting (maybe blood streaked), headache,ringing inthe ears, confusionand shaky eye movement. At high doses, drowsiness, chestpain, palpitations, loss ofconsciousness, convulsions (mainly in children), weakness anddizziness, blood in urine,cold bodyfeeling, and breathing problemshavebeen reported.
If you forget to take this medicine
Do not take a double doseto make up for a misseddose.
Simply refertothedirections above on how to take the medicine anddonot take more than is advised.
4. Possible side effects
This medicine is generally well tolerated bymost people.However side effects may occur.
STOPTAKING the medicine and seek immediate medical help if you develop:
- signs of intestinal bleeding such as:bright redfaeces (stools/motions), black tarry stools, vomiting bloodor darkparticles that look like coffee grounds.
- signs of serious allergic reaction such as:
- difficulties in breathingor unexplainedwheezing
- dizzinessor faster heartbeat,
- Reddish non-elevated, target-like or circular patches on thetrunk,oftenwith centralblisters,skin peeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded by feverandflu-like symptoms (exfoliative dermatitis,erythema multiforme,Stevens-Johnson syndrome, toxic epidermal necrolysis).
- swellingof your face, tongueor throat
- signs of kidney problems such as:
passing less or moreurine, cloudyurine orblood inurine, pain intheback and/orswelling (particularly in thelegs)
- signs of aseptic meningitis withneck stiffness, headache, feeling sick, being sick, fever or disorientation. Patients with autoimmune disorders (lupus,mixedconnective tissue disease)maybe morelikelytobeaffected. • a severe skin reaction known as DRESS syndrome canoccur. Symptoms of DRESS include: skin rash, fever,swelling oflymph nodes and anincrease of eosinophils (atypeof whiteblood cells).
A red, scaly widespread rash with bumpsundertheskin and blisters mainly localised onthe skin folds, trunk, and upperextremities accompanied by fever at theinitiationof treatment(acutegeneralised exanthematous pustulosis) (frequency not known). Seealso section 2.
STOPTAKING the medicine and tell your doctor if you experience the following uncommon side effects whichmayaffect up to 1in100 people: - indigestion,heartburn orfeeling sick
- painsinyour stomach (abdomen) or other abnormal stomachproblems Like all medicines,thismedicinecancauseside-effects, although not everybody getsthem.Tellyour doctor or pharmacist ifyou noticeanyof the following:
- Liver,kidney problems ordifficulty urinating
Thismedicine, especiallywhen takenathigher than recommendeddosesor for a prolongedperiodoftime, cancausedamageto your kidneys and affect themremovingacids properly from yourbloodinto the urine (renaltubular acidosis). It can also cause verylowlevels ofpotassium in yourblood (see section2).This is a veryserious condition and will require immediate treatment. Signsand symptomsincludemuscle weakness and light-headedness.
TELLYOUR DOCTOR if you have any of the following side effects,they become worse or you notice any effects not listed:
Uncommon: may affectup to1 in 100people:
- allergic reactions, such as skinrashes (urticaria), itching, peeling - headaches
Rare: may affectup to1 in 1,000 people:
- flatulence (wind), diarrhoea, constipationand vomiting Very rare: may affectup to1 in 10,000 people:
- blood disorderresultinginunexplained or unusualbruising orbleeding, fever,sore throat, mouth ulcers,flu-likesymptomsand severeexhaustion - drop in blood pressure or irregularheartbeat
- stomach orintestinal ulcers,sometimes withbleedingand perforation, inflammationof the lining ofthe mouthwith ulceration (ulcerative stomatitis), inflammation of the stomach(gastritis)
- liver problems
Not known: frequencycannot beestimatedfrom the available data - worseningof asthmaor bronchospasm
- swelling(oedema), highbloodpressure, heart failure or attack - chest pain,which canbe a signofapotentially seriousallergic reaction called Kounis syndrome
- worseningof colitis and Crohn's disease
- skinbecomes sensitive to light
Medicines such as this medicine may beassociatedwith a small increased ris
k of heartattack('myocardial infarction')or stroke.(Seesection 2'Other warnings'.)
Reporting of side effects
If you get anysideeffects, talk to yourdoctor, pharmacist ornurse.This include
s any possiblesideeffects notlistedinthis leaflet.You can alsoreport side effectsdirectly via theYellowCard Scheme at: www.mhra.gov.uk/yellowcard or search for MHRAYellowCard in the GooglePlay orAppleApp Store. By reporting side effects, youcanhelpprovide moreinformation onthesafety of this medicine.
5. How to store this medicine
Keepall medicinesout of the sightand reach ofchildren.
Do notuseafterthe expiry datestated onthecarton after EXP.The expiry date refersto the lastday ofthat month.
Store in the original pack.
6. Further information
Each tabletcontains the activeingredient Ibuprofen 400mg(as Sodium Ibuprofen512 mg).
Also contains: Croscarmellose sodium, Xylitol, Microcrystallinecellulose, Magnesiumstearate,Colloidalanhydrous silica, Carmellosesodium,Talc, Acacia spraydried,Sucrose,Titanium dioxide(E171),Macrogol 6000powder, andRedink (contains Shellac, IronOxideRed(E 172), PropyleneGlycol, Ammonium Hydroxide (E527), Simethicone).
Thismedicineisavailableinpacks of 12 or24 white, tabletsprintedwith an identifying red logo.
Not allpacks will bemarketed.
Manufacturers:
Reckitt Benckiser Healthcare International Ltd,
1Thane Road, NottinghamNG90 2DB, UK.
RBNLBrandsB.V.,WTC SchipholAirport,
SchipholBoulevard207, 1118BHSchiphol,NL.
Productlicence number: PL 00063/0412
Licenceholder:ReckittBenckiserHealthcare (UK) Ltd,Hull, HU8 7DS Date ofrevision: March2024
Reckitt
UK\0161571\PL-00063-0412 Nurofen Pain Relief Max Strength 512mg Tablets
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