Patient leaflet - Nurofen Pain Relief 200 mg soft capsules
1.What this medicine is and what it is used for
- tohelpyoupassing water (diuretics)
- for the temporarysuppressionofyourimmunesystem (e.g. methotrexate,ciclosporin, tacrolimus)
The active ingredient (which makes thismedicine work) isibuprofen. It belongstoa groupof medicinesknown asnon-steroidal anti-inflammatory drugs (NSAIDs).NSAIDs provide relief bychanging thebody’sresponseto pain, swelling and high temperature.
- for maniaor depression (e.g. Lithium or SSRIs)
- for pregnancy termination(e.g.mifepristone)
- for HIV treatment(e.g.zidovudine)
Thismedicineis used for theeffectiverelief of feverandpain, such as: • headaches and migraine pain
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
- nerve pain, backache, periodpain,rheumatic and muscularpain • cold and flu symptoms
dentalpain.
- Thisproduct belongstoagroupofmedicines which mayimpair fertility in women.This isreversibleon stopping themedicine. It is unlikely that this product,ifused occasionally,will affectyour chances of becoming pregnant. However,tellyou doctorbeforetaking thismedicineifyouhave problems becomingpregnant.
2.What you need to know before you take this medicine
Signsof an allergic reactionto this medicine,including breathing problems, swelling of theface and neck region(angioedema), chestpain havebeen reported with ibuprofen. Immediately stoptaking this medicine and contact your doctor or medical emergencies if you notice anyof thesesigns. Do not take these capsules if you:
- Anti-inflammatory/pain-killermedicinessuchas ibuprofen may be associatedwith asmall increased riskofheartattackor stroke,particularly whenused at highdoses. Do not exceedthe recommended dose or duration of treatment.
- areallergic to ibuprofen or any of theother ingredients ofthisproduct (see section 6), or toaspirin orother related painkillers • have (orhave had two or more episodes of)a stomach ulcer, perforation or bleeding
Youshoulddiscuss your treatment withyourdoctoror pharmacist before taking thismedicine ifyou:
- have heart problems includingheartfailure,angina(chest pain), orif youhavehada heartattack,bypasssurgery,peripheral arterydisease (poor circulationin the legsof feetdue tonarrowor blockedarteries),or any kind of stroke (including‘mini-stroke’ or transientischaemicattack 'TIA').
- have had a worsening ofasthma,allergicrash or itchy,runnynoseor facial swellingwhentaking similar medicines
- ever had stomach bleedingora perforation when previously taking NSAIDs
aretakingother NSAIDs
have highbloodpressure,diabetes, high cholesterol, haveafamily history of heartdiseaseor stroke,or ifyou are asmoker. • There is arisk of kidneyproblemsindehydrated childrenand adolescents. • Ifyou aretaking this medicinefor longer than the recommendedtimeor at higher than recommendeddosesyou are at risk of serious harm.These includeserious harm tothe stomach/gut and kidneys, as well as very low levels ofpotassium inyourblood.These canbefatal(see section 4). Pregnancy and breast-feeding
- aretakingmore than 75 mg of aspirin a day.Ifyou are on low doseaspirin (up to75 mg daily) speak toyourdoctor or pharmacist beforeyoutake this medicine.
- have severe liver or kidney problems
- have heart problems, high blood pressure or bloodcoagulation disorder • have breathingdifficulties
- arein thelast 3 monthsof pregnancy
areunder 12 yearsold
Tellyour doctorifyou become pregnant whilsttakingthis product. Do nottake this medicineifyouareinthe last 3months ofpregnancyas it couldharmyour unborn childorcauseproblems at delivery.It can cause kidney and heartproblemsinyourunborn baby.It mayaffect yourandyour baby’s tendency to bleed andcause labourtobelaterorlonger than expected.Youshouldnottake thismedicine duringthe first6 monthsof pregnancy unlessabsolutely necessaryandadvisedbyyour doctor.If you needtreatment during this period orwhileyou aretrying to getpregnant,the lowestdosefor theshortesttimepossible shouldbeused. If taken formore thanafew days from20weeks ofpregnancy onward, this medicine can cause kidney problems inyour unbornbabythatmaylead to lowlevelsof amniotic fluidthatsurroundsthe baby (oligohydramnios)or narrowing of a bloodvessel (ductusarteriosus)inthe heartofthe baby.If youneed treatment forlonger thanafewdays, your doctor mayrecommendadditional monitoring.
Check with your doctor or pharmacist before taking this medicine if you:
- have or have hadasthma
- have kidney, heart,liver, or bowel problems
- have high cholesterol or previously havehad a heart attack orstroke • have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’sdisease)
- have systemic lupuserythematosus (acondition ofthe immune system causingjoint pain,skin changes and otherorgan disorders) • areasmoker
- arein thefirst 6 months ofpregnancy.
have an infection.This medicinemay hide signs of infectionssuch as fever and pain.Itis thereforepossible thatthismedicinemaydelay appropriate treatment of infection, which may lead to an increased riskof complications.This has beenobserved inpneumonia caused by bacteria and bacterialskin infections related to chickenpox.If you takethis medicine whileyou have aninfection and your symptoms of the infection persistorworsen, consult a doctor without delay.
Do nottake ifyou arebreastfeeding.
Avoid the useof this medicinein the first 6months of pregnancy,unlessthe doctor advises otherwise.
Speak to your doctor or pharmacist for advicebefore takinganymedicineif you are breast-feeding.
Important information about some of the ingredients of this medicine
These capsules contain
- sorbitol (21.28 mgper capsule). If you have been toldbyyour doctor that you have an intolerance to somesugars,contact your doctor before taking these capsules.
- potassium (18 mgper capsule).Tobetaken into considerationby patients with reduced kidney function or patientson a controlled potassium diet.
3. How to take this medicine
Thisproductis for short termuse only.You shouldtake thelowest dosefor the shortest time necessary torelieve yoursymptoms.
If you have an infection, consult a doctor without delayif symptoms (suchas fever and pain)persist or worsen(see section 2).
Adults, the elderly and children and adolescents between 12 and 18 years:
Take one or two capsules (200 mg – 400 mg), up to threetimes a day as required.
Leave at least 4hours between doses and donot take more than 6 capsules in24hours.
Do not give to children under 12 years.
Do not takethis medicinefor longerthan 10 days unless your doctor tells you to.
If symptomspersist or worsen,orif any new symptomsoccur, consultyour doctororpharmacist.
In children and adolescents between 12 and 18 years:
If inchildren and adolescents thismedicinal product isrequiredfor morethan 3 days, orif symptomsworsen a doctor shouldbe consulted. 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(may be blood streaked), headache, ringingin the ears, confusion andshaky eyemovement. Athigh doses,drowsiness, chest pain, palpitations, lossof consciousness, convulsions (mainly in children), weakness and dizziness, bloodin urine, cold body feeling,and breathing problems have beenreported. If you forget to take this medicine
Do not takea double dose, to make up for a missed dose.Simply refer to the directions above on howto takethe medicine and donot takemorethan is advised.
4. POSSIBLE SIDE EFFECTS
Like all medicines, this medicinecancause side effects,althoughnot everybody getsthem.
If you suffer from any of the following, at any time, during your treatment STOPTAKING the medicine and seek immediate medical help:
- pass bloodin your faeces (stools/motions)
- pass black tarry stools
- vomit any blood or dark particles thatlook likecoffee grounds • difficulty inbreathing,unexplained wheezing, worsening ofexisting asthma
- other allergictype reactions (e.g. swelling of the face or throat, low blood pressure, fast heart rate)
- asevereskin reactionknown as DRESSsyndromecan occur.Symptoms of DRESSinclude: skinrash,fever, swelling of lymph nodes and anincrease ofeosinophils (a type of white blood cells).
A red, scalywidespread rashwithbumpsunder the skin and blisters mainly localised on the skin folds, trunk, and upper extremities accompanied by feverat the initiation of treatment (acute generalised exanthematous pustulosis)(frequencynot known).
See alsosection2.
STOPTAKING the medicine and tell your doctor if you experience any of the following side effects, or anything unusual happens:
- indigestion or heartburn
- abdominal pain (pains inyour stomach) or other abnormal stomach symptoms.
- skin reactions suchasreddishnon-elevated, target-like or circular patches onthe trunk, oftenwithcentral blisters, skinpeeling, ulcers of mouth, throat, nose, genitals and eyes. These serious skin rashes can be preceded byfever andflu-like symptoms (exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermal necrolysis). Medicinessuch as this medicine maybe associatedwith a small increased risk ofheart attack (myocardialinfarction) orstroke.
Please tell your doctor or pharmacist if you experience any of the following side effects, they become worse or if you notice any other effects not listed.
oedema (fluid retention), highblood pressure (hypertension)and heart failure
- chest pain, which canbea sign of a potentially seriousallergicreaction called Kounissyndrome
- headache
- nausea, diarrhoea, constipation, vomiting and flatulence(wind) • skin peeling
- kidney and liver disorders
- blood disorders.Thefirstsignscan be fever, sore throat,mouth ulcers, ‘flu-like’ symptoms,severeexhaustion,unexplainedbleeding and bruising. • meningitissymptomssuchas fever andchills, severeheadache,nausea, vomiting and stiff neck(in patientswithexistingauto-immunedisorders suchassystemiclupus erythematosus).
worseningofcolitis orCrohn’sdisease (inflammationofthebowel). • skin becomes sensitive to light (frequency not known) If any of thesideeffects getsserious, or if you notice any sideeffectsnotliste
d inthis leaflet pleasetell your doctororpharmacist.
Like all medicines, this medicinecancauseside-effects,although not everybody gets them.Tell your doctoror pharmacist ifyou noticeanyof the following:
- Liver, kidney problems ordifficultyurinating
Thismedicine, especiallywhen taken at higher than recommended dosesor for a prolonged periodoftime, cancausedamage toyourkidneys andaffect them removingacidsproperly fromyourbloodintotheurine(renal tubular acidosis). It canalsocauseverylow levelsofpotassium in yourblood(see section 2).Thisisa very seriouscondition andwillrequireimmediate treatment.Signs and symptoms include muscleweaknessand light-headedness.
Reporting of side effects
If you getanyside effects,talkto yourdoctor,pharmacistor nurse.This includes any possible side effects notlisted in thisleaflet.You canalsoreport side effectsdirectlyviatheYellowCard Scheme at:
www.mhra.gov.uk/yellowcard orsearch for MHRAYellowCard intheGoogle Play orAppleAppStore. Byreportingside effects,you canhelpprovide more information on the safetyofthismedicine.
5. How to store this medicine
Keep all medicines out of the sight and reach of children.
Do not use thesecapsulesafter the expiry date printed on the blister or carton.The expirydate refersto thelastdayof that month. Keep the capsules intheoriginal pack.
Do not store above 25°C.
In case ofpoorstorage conditions,this productmaydeteriorate. If you notice anysigns of leakageofthe capsulesorchangeincolour, you should discard the capsules.
Medicinesshouldnot be disposedofviawastewateror household waste.Ask your pharmacisthowtodispose of medicines nolongerrequired.These measures willhelp toprotect the environment.
6. Contents of the pack and other information
What this medicine contains
The active ingredient is:ibuprofen 200 mg.
The other ingredients are: macrogol600, potassiumhydroxide, gelatine, sorbitol (E420),purified water,OpacodeWB white NS-78-18011 (titanium dioxide(E171), hypromellose, propylene glycol).
(seealsoend ofsection2 'Importantinformationabout some of the ingredients of this medicine').
What this medicine looks like and contents of the pack
Each Soft capsule isan ovalclearcapsuleprintedinwhitewith alogo.
Thisproduct isavailableinpacks of 4, 10 and16 capsules.Not allpack sizes may be marketed.
MarketingAuthorisation Holder
ReckittBenckiser Healthcare(UK) Ltd
103-105Bath Road
Slough,SL13UH
United Kingdom
Manufacturer
ReckittBenckiser HealthcareInternationalLtd
Thane Road
Nottingham
NG90 2DB, UK
Or
Banner Pharmacaps Europe B.V.
De Posthoornstraat 7
Tilburg
5048AS,TheNetherlands
PL 00063/0651
Text revised: March2024
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