Nurofen Express 256 mg tablets – patient leaflet, side effects, dosage

1. What this medicine isand what it is used for

1. 2. Beforeyou take this medicine
2. 3. How totake this medicine
3. 4. Possible side effects
4. 5. How tostore this medicine
5. 6. Further Information
6. 1. What this medicine is and what it is used for

The activeingredient(which makes this medicine work)isIbuprofen. It belongs to agroup of medicines known as non-steroidal anti-inflammatory drugs (NSAIDs).NSAIDsprovide reliefby changingthe body’s response to pain, swelling, and high temperature.

This medicine isused for the relief of feverand mildto moderate pain, suchas :

• Headaches and migraine pain
• Neuralgia, Backache, period pain, rheumatic and muscular pain
• Cold and Flu symptoms, sore throat

2. Before taking this medicine

Signsof an allergicreactionto thismedicine, including breathing problems, swellingof the faceand neckregion (angioedema), chest pain have been reported with ibuprofen. Immediately stop taking this medicineandcontact your doctor or medical emergencies ifyou notice any of these signs. Do not take this medicine if you:

• are allergicto ibuprofenor anyof the other ingredients (seesection6)orto aspirinor otherpainkillers

• have (orhavehad two or more episodes of)

  a stomach ulcer, perforation or bleeding

• have hada worsening of asthma, skin rash, itchy runny nose or facial swellingwhen previously taking ibuprofen, aspirin or similar medicines • have hadgastrointestinalbleedingorperforation when previously taking NSAIDs (Non-steroidal anti-inflammatory drugs)
• have severe liver or kidney problems
• have severe heart problems
• are in the last 3months of pregnancy

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

• have or have hadasthma
• have kidney, heart, liveror bowel problems
• have high cholesterol, high bloodpressureor previously have had a heart attackor stroke

• have a history ofgastrointestinal disease

  (such as ulcerative colitis, Crohn's disease)

• have SystemicLupus Erythematosus (a condition of the immune system causing joint pain skin changes andother organ disorders) • are a smoker
• are in the first 6 months of pregnancy.
• are on a diet restricting your saltintake.

• have an infection. Thismedicinemay hide signsof infections such as fever and pain. It is therefore possible that this medicine maydelay

  appropriate treatment of infection, which may lead to anincreased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine whileyou have an infection and your symptoms of the infection persist orworsen, consult a doctor without delay. Skin reactions

  • Serious skin reactions including exfoliative dermatitis, erythema multiforme,Stevens-Johnson syndrome, toxic epidermal necrolysis, drug reaction with eosinophiliaand systemicsymptoms (DRESS), acute generalised exanthematous pustulosis (AGEP) havebeen reportedin association with ibuprofen treatment. Stop using thismedicineand seek medical attention immediately,if younoticeany of the symptoms related to theseserious skin reactions described in section 4. Taking other medicines

This medicine may affect or be affected bysome other medicines. For example:

Avoidtaking this product with corticosteroidtablets,quinolone antibiotics or drugs that areprescribed

• As anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic acid, warfarin, ticlopidine)
• To stimulate your heart (e.g. glycosides)
• To reduce high blood pressure(ACE-inhibitors suchas captopril, beta-blockerssuch as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
• To help you passing water (diuretics)
• For the temporarysuppression of your immune system (e.g, methotrexate, ciclosporin, tacrolimus)
• For mania or depression (e.g. Lithium orSSRIs)
• 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 a group of medicines which mayimpair fertility in women. Thisisreversible on stopping the medicine.It is unlikely that this medicine, usedoccasionally will affect your chances of becoming pregnant. However,tell yourdoctor before taking this medicine if you haveproblemsbecoming pregnant.
• Anti-inflammatory/pain-killer medicines such as ibuprofen may be associatedwithasmall increased riskofheart attackor stroke, particularlywhen used at high doses.Do not exceed the recommended doseor durationoftreatment.

• You should discuss yourtreatmentwith your doctor orpharmacist before taking thismedicineif you:

  • have heart problems including heart failure, angina (chest pain), or if you have hadaheartattack, bypass surgery, peripheral arterydisease (poor circulation inthe legsof feetdue to narrowor blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient ischaemic attack ‘TIA’).
  • have high blood pressure, diabetes, high cholesterol, have a family history of heart disease or stroke, or if youare a smoker. • Thereisa risk ofkidney problemsin dehydrated children and adolescents.
• Ifyou are takingthis medicine for longer thanthe recommended time or at higher than recommended doses you are at riskofserious harm. Theseinclude serious harm to the stomach/gut and kidneys,as well as verylow levels of potassium in your blood. These can be fatal(see section4).

Pregnancy and breast feeding

Do not take NurofenExpress if you are inthelast 3 months ofpregnancyas it could harmyour unborn child or cause problems at delivery.Itcan cause kidney and heartproblems inyour unborn baby. Itmay affect your and your baby’s tendency to bleed and cause labour to be later or longer than expected. You shouldnot take Nurofen Expressduring the first 6 monthsof pregnancy unless absolutely necessaryand advised by your doctor. If you need treatment during this period or while you are trying to get pregnant, the lowest dose for the shortest time possible should be used. If taken for more thanafew days from 20 weeks of pregnancy onward, Nurofen Express can cause kidney problems in yourunbornbaby that may leadto low levels of amniotic fluid that surrounds thebaby (oligohydramnios) ornarrowing of a blood vessel(ductus arteriosus) in the heart of thebaby. If you need treatment for longer thanafewdays, your doctor mayrecommend additional monitoring.

Speak toyour doctorbefore taking this medicine if youare inthe first6 months ofpregnancy orif you are breastfeeding.

Important information about some of the ingredients of this medicine

This medicine contains 25.72 mgsodium (maincomponent of cooking/table salt) in each tablet. This is equivalent to 1.29% of the recommended maximum daily dietary intake of sodium foranadult. This productcontains sucrose. If youhave been told by your doctor that you havean intolerance to some sugars, contact your doctor before taking this medicinal product.

3. How to take this medicine

This productis for short term use only. The lowest effective dose shouldbe usedfortheshortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms(suchas fever and pain)persist or worsen(seesection 2).

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

Take 1 or 2 tablet with water, up to three times a dayas required. Leave at least four hours betweendoses. Do not take more than

6 tabletsin24 hours.

Do not give to children under 12 years.

In children and adolescents between 12 and 18 years:

If in children and adolescents this medicinalproductis required for more than3 days, or if symptoms worsen a doctor should be consulted. In adults:

Do not take for longer than 10 days unless your doctor tells you to. If symptomspersist or thepain worsens,or if any new symptoms occur, consult yourdoctor orpharmacist.

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 (may be blood streaked), headache,ringing in the ears, confusionand shaky eye movement. Athigh doses, drowsiness, chest pain, palpitations,loss of consciousness, convulsions (mainly inchildren), weakness and dizziness, blood in urine, cold body feeling, and breathing problems have been reported.

If you forgot to take this medicine.

Simply refertothe directions above on how to take the medicine and do not take more than is advised.

4. Possible side effects

This medicine isgenerally well tolerated by most people. However side effects mayoccur.

STOP TAKING the medicine and seek immediate medical help if you develop:

• signs of intestinal bleeding such as: bright red faeces(stools/motions), black tarry stools,vomitingblood or dark particles thatlooklike coffee grounds.
• signs of serious allergic reaction such as:
• difficultiesin breathing or unexplained wheezing
• dizzinessor faster heartbeat
• reddish non-elevated, target-like or circular patches on thetrunk, often withcentral blisters, skin peeling,ulcers of mouth, throat, nose, genitals andeyes. Theseserious skin rashes can be preceded by fever and flu-like symptoms[exfoliative dermatitis, erythema multiforme, Stevens-Johnson syndrome, toxic epidermalnecrolysis]. - swelling of your face, tongue or throat
• signs of kidney problems such as:
• passing less or more urine
• cloudy urine or blood in urine
• pain in the back and/orswelling (particularly in the legs) • signs of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or disorientation. Patients with autoimmune disorders (lupus, mixedconnective tissue disease) may bemorelikely tobe affected.

• a severe skin reaction known as DRESS syndrome canoccur. Symptoms of DRESS include:skin rash,fever, swelling of lymph nodes and an increase ofeosinophils (a type of white blood cells). • A red,scaly widespread rash with bumps under the skin andblisters mainly localised on the skin folds, trunk, and upper extremities accompanied byfever at the initiation of treatment (acute generalised exanthematous pustulosis) (frequency not known). See also section 2. STOP TAKING the medicine and tell your doctor if you experience the following uncommon side effects which may affectupto 1 in 100 people: - indigestion, heartburn or feeling sick

  • pains in your stomach (abdomen) orother abnormal stomach problems Likeall medicines, this medicine cancause side-effects, although not everybody gets them.Tellyour doctoror pharmacist if you notice any ofthe following:
  • Liver,kidney problemsor difficultyurinating

This medicine, especially when taken at higher thanrecommended doses o

r for aprolonged periodoftime, can causedamage to your kidneys and affectthem removingacids properly from yourbloodinto theurine(renal tubular acidosis). It can also causevery low levels of potassium in your blood (see section 2). This is a veryserious condition and will require immediate treatment.Signs and symptoms include muscle weakness and light-headedness.

TELL YOUR DOCTOR if you have any of the following side effects, they become worse or you notice any effects not listed:

Uncommon: may affect up to 1 in 100 people:

• allergic reactions, such as skin rashes (urticaria), itching,peeling - headaches

Rare: may affect up to 1 in1,000 people:

• flatulence(wind),diarrhoea,constipation and vomiting Very rare: may affect up to 1 in 10,000people:
• blood disorder resulting in unexplained orunusual bruisingor bleeding, fever,sore throat, mouth ulcers, flu-like symptomsandsevere exhaustion - dropin bloodpressure orirregular heart beat
• stomach orintestinal ulcers, sometimes with bleedingand perforation, inflammation of the lining of the mouth with ulceration(ulcerative stomatitis),inflammation of the stomach (gastritis)
• liverproblems

Not known: frequency cannot be estimatedfrom the available data - worseningof asthma or bronchospasm

• swelling (oedema), high bloodpressure, heart failure or attack - chest pain, whichcan be asign ofa potentially serious allergicreaction called Kounissyndrome
• worseningof colitis and Crohn's disease
• skin becomes sensitive to light

Medicines such as this medicine maybe associated witha smallincreased risk of heart attack(’myocardial infarction’) or stroke.

(Seesection2 Otherwarnings.)

If any of the side effects gets serious, or ifyou notice any side effects not listed in this leaflet, pleasetell your doctor or pharmacist. Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist ornurse.This includes any possibleside effects not listedinthis leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard orsearch for MHRAYellow Card in the Google Play or AppleApp Store.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store this medicine

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

Do not use after theexpiry date stated on the carton after EXP. The expiry date refers to the last day ofthat month.

Store in theoriginal pack.

6. Further information

Each tablet containstheactive ingredient Ibuprofen 200 mg (as Sodium Ibuprofen256 mg).

Alsocontains: Croscarmellosesodium,Xylitol, Microcrystalline cellulose, Magnesium stearate, Colloidal anhydrous silica, Carmellose sodium,Talc, Acacia spraydried, Sucrose, Titaniumdioxide(E171), Macrogol6000 powder, and Black ink (contains shellac, ironoxide black (E172) and propylene glycol).

This medicine isavailable inpacksof 2, 3, 4, 5, 6, 8, 10, 12,14, 15, and 16 white tablets printed withan identifying black logo.

Not all packsizes will bemarketed.

Manufacturers:

Reckitt Benckiser Healthcare International Ltd,

1 Thane Road, Nottingham NG902DB, UK.

RB NL BrandsB.V., WTC SchipholAirport,

Schiphol Boulevard 207,1118 BH Schiphol, NL.

Product licence number: PL 00063/0372

Licenceholder :Reckitt Benckiser

Healthcare (UK) Ltd,Hull, HU8 7DS

Dateof revision: March 2024

EXPRESS 256 mg Tablets

Contains Ibuprofen