This product is for short term use only. The lowest effective dose should be used for the shortest duration necessary to relieve symptoms. If you have an infection, consult a doctor without delay if symptoms (such as fever and pain) persist or worsen.

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

Take 1 caplet with water, up to three times a day as required. Leave at least four hours between doses. Do not take more than 3 caplets in 24 hours.

Do not give to children under 12 years.

In children and adolescents between 12 and 18 years:

If in children and adolescents this medicinal product is required for more than 3 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 symptoms persist or the pain worsens or if any new symptoms occur, consult your doctor or pharmacist.

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
• Ringing in the ears
• Confusion and shaky eye movement.

At high doses, drowsiness, chest pain, palpitations, loss of consciousness, convulsions (mainly in children), weakness and dizziness, blood in urine, cold body feeling and breathing problems have been reported.

If you forget to take this medicine:

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

Like all medicines, this medicine can cause side effects, although not everybody gets them.Some side effects may be minimised by taking the lowest dose for the shortest time necessary to relieve the symptoms.If any of the side effects get serious or if you notice any side effects not listed in this leaflet, tell your doctor or pharmacist.

Side Effects

• Headaches
• Dizziness
• Drowsiness
• Upset stomach or nausea
• Indigestion or stomach pain

Serious Side Effects

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, vomiting blood or dark particles that look like coffee grounds.

Signs of serious allergic reaction such as:

• Difficulties in breathing or unexplained wheezing
• Dizziness or faster heartbeat,
• Severe forms of skin reactions such as itchiness, skin rash with redness, peeling, flaking or blistering (e.g.: Steven-Johnson syndrome)
• 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/or swelling (particularly in the legs)

Signs of aseptic meningitis with neck stiffness, headache, feeling sick, being sick, fever or disorientation.Patients with autoimmune disorders (lupus, mixed connective tissue disease) may be more likely to be affected.

A severe skin reaction known as DRESS syndrome can occur. Symptoms of DRESS include:

• Skin rash
• Fever
• Swelling of lymph nodes and an increase of eosinophils (a type of white blood cells).

A red, scaly widespread rash with bumps under the skin and blisters mainly localised on the skin folds, trunk and upper extremities accompanied by fever at the initiation of treatment (acute generalised exanthematous pustulosis) (frequency not known)

STOP TAKING the medicine and tell your doctor if you experience the following uncommon side effects which may affect up to 1 in 100 people:

• Indigestion, heartburn or feeling sick
• Pains in your stomach (abdomen) or other abnormal stomach problems

Tell your doctor or pharmacist if you notice any of the following:

• Liver, kidney problems or difficulty urinating

This medicine, especially when taken at higher than recommended doses or for a prolonged period of time, can cause damage to your kidneys and affect them removing acids properly from your blood into the urine (renal tubular acidosis). It can also cause very low levels of potassium in your blood.

This is a very serious 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 in 1,000 people:

Flatulence (wind), diarrhoea, constipation and vomiting

Very rare: may affect up to 1 in 10,000 people:

• Blood disorder resulting in unexplained or unusual bruising or bleeding, fever, sore throat, mouth ulcers, flu-like symptoms and severe exhaustion
• Drop in blood pressure
• Stomach or intestinal ulcers, sometimes with bleeding and perforation, inflammation of the lining of the mouth with ulceration (ulcerative stomatitis) ,inflammation of the stomach (gastritis)
• Liver problems

Not known: frequency cannot be estimated from the available data

• Worsening of asthma or bronchospasm
• Swelling (oedema), high blood pressure, heart failure or attack
• Worsening of colitis and Crohn’s disease
• Skin becomes sensitive to light

Medicines such as this medicine may be associated with a small increased risk of heart attack (‘myocardial infarction’) or stroke.

If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects, you can help provide more information on the safety of this medicine.

Warning & Precautions

Do not take this medicine if you:

• Are allergic to ibuprofen or any of the other ingredients or to aspirin or other painkillers
• Have (or have had two or more episodes of) a stomach ulcer, perforation or bleeding
• Have had a worsening of asthma, skin rash, itchy runny nose or facial swelling when previously taking ibuprofen, aspirin or similar medicines
• Have had gastrointestinal bleeding or perforation when previously taking NSAIDs (Non-steroidal anti-inflammatory drugs)
• Are taking other NSAID painkillers or more than 75 mg aspirin a day
• Have severe liver or kidney problems
• Have heart problems, high blood pressure or blood coagulation disorder.
• Have breathing difficulties
• Are under 12 years old.

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

• Have or have had asthma
• Have kidney, heart, liver or bowel problems
• Have high cholesterol or previously have had a heart attack or stroke
• Have a history of gastrointestinal disease (such as ulcerative colitis, Crohn’s disease)
• Have Systemic Lupus Erythematosus (a condition of the immune system causing joint pain skin changes and other organ disorders)
• Are a smoker
• Have an infection. This medicine may hide signs of infections such as fever and pain.It is therefore possible that this medicine may delay appropriate treatment of infection, which may lead to an increased risk of complications. This has been observed in pneumonia caused by bacteria and bacterial skin infections related to chickenpox. If you take this medicine while you have an infection and your symptoms of the infection persist or worsen, consult a doctor without delay.

Skin reactions:

• Serious skin reactions have been reported in association with this medicine.You should stop taking this medicine and seek medical attention immediately, if you develop any skin rash, lesion of the mucous membranes, blisters or other signs of allergy since this can be the first signs of a very serious skin reaction.

Age restrictions

Do not give to children under 12 years.

Other Medicine & Conditions

To reduce the risk of side effects, do not take this product with other NSAID containing products (e.g,aspirin,ibuprofen…)

This medicine may affect or be affected by some other medicines.

Avoid taking this product with corticosteroid tablets,quinolone antibiotics or

drugs that are prescribed:

• 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 such as captopril, beta-blockers such as atenolol medicines,angiotensin-II receptor antagonists such as losartan)
• To help you passing water (diuretics)
• For the temporary suppression of your immune system (e.g, methotrexate, ciclosporin, )
• For mania or depression (e.g.Lithium or SSRIs)
• For pregnancy termination (e.g.mifepristone)
• For HIV treatment ( e.g. zidovudine)

Pregnancy and Breastfeeding

Not recommended for use in Pregnancy and Breastfeeding

Patient Information Leaflet

https://www.medicines.org.uk/emc/files/pil.395.pdf

Ingredients

• Active Ingredients: Each caplet contains the active ingredient Ibuprofen 400 mg (as Ibuprofen Lysine 684 mg).
• Other Ingredients: Povidone, Sodium Starch Glycollate Type A, Magnesium Stearate, Hypromellose, Talc, Opaspray White M-1-7111B (contains Hypromellose and Titanium Dioxide (E171) and Black Printing Ink (contains shellac, Iron oxide black (E172) and propylene glycol).

Product Information

• Brand Name: Nurofen
• Route of Administration: Oral
• Legal Classification: P
• Strength: 684mg Ibuprofen lysine
• Dosage Form: Tablet

Storage

• Keep all medicines out of the sight and reach of children.
• Do not use after the expiry date stated on the carton after EXP. The expiry date refers to the last day of that month.
• Do not store above 25°C.Store in the original pack.

Advice & Helpful Links

https://www.nhs.uk/conditions/migraine/