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NUROFEN EXPRESS 400MG ORAL POWDER

Active substance: IBUPROFEN LYSINATE

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170 mm

PACKAGE LEAFLET:
INFORMATION FOR THE USER
Nurofen® Express 400mg Oral Powder
Ibuprofen
Read all of this leaflet carefully because it contains
important information for you.






This medicine is available without prescription. However,
you still need to take Nurofen® Express carefully to get the
best results from it.
Keep this leaflet. You may need to read it again.
Ask your pharmacist if you need more information or
advice.
You must contact a doctor if your symptoms worsen or do
not improve after 5 days when treating pain or 3 days
when treating fever.
If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist.

In this leaflet:
1. What Nurofen® Express is and what it is used for
2. Before you take Nurofen® Express
3. How to take Nurofen® Express
4. Possible side effects
5. How to store Nurofen® Express
6. Further information
1. WHAT NUROFEN® EXPRESS IS AND WHAT IT IS USED
FOR
Nurofen® Express contains ibuprofen 400mg as ibuprofen
lysinate. Ibuprofen belongs to a group of medicines called
Non-Steroidal Anti-Inflammatory Drugs (NSAIDs). These
medicines provide relief by changing the body’s response to
pain, swelling and high temperature.
Nurofen® Express is used to relieve:
• symptoms of mild to moderate pain such as headache,
toothache, period pains, rheumatic and muscular pain
and migraine.
• cold and flu symptoms such as sore throat and fever.

480 mm

2. BEFORE YOU TAKE NUROFEN® EXPRESS
Do not take Nurofen® Express if you:
• have (or have had two or more episodes of ) a stomach
ulcer, perforation or bleeding of the stomach
• are allergic to ibuprofen, tartrazine (E102) or any of the
other ingredients (see section 6) of Nurofen Express or to
acetylsalicylic acid (aspirin) or other anti-inflammatory
painkillers
• suffer from severe kidney, liver or heart problems
• have had gastrointestinal bleeding or perforation when
previously taking NSAIDs (Non-Steroidal
Anti-inflammatory drugs)
• have ever suffered from shortness of breath, have had a
worsening of asthma, skin rash, itchy runny nose or facial
swelling when previously taking ibuprofen, acetylsalicylic
acid (aspirin) or other similar painkillers (NSAIDs)
• are suffering from severe dehydration (caused by
vomiting, diarrhoea or insufficient fluid intake)
• are suffering from cerebrovascular or other active
bleeding
• are suffering from blood cell production or clotting
disorders
• are in the last three months of pregnancy (see below).
Please do not give to children under 12 years of age.
Speak to a pharmacist or your doctor before taking this
product if you:
• have or have had asthma
• have kidney, heart, liver or bowel problems
• have high blood pressure, diabetes, high cholesterol or
are a smoker
• have been told by your doctor that you have an
intolerance to some sugars
• have systemic lupus erythematosus (a condition of the
immune system causing joint pain, skin changes and
other organ disorders)
• have had a heart attack or stroke
• have a history of gastrointestinal disease (such as
ulcerative colitis or Crohn’s disease)
• are in the first 6 months of pregnancy
• have chicken pox (varicella).
Consult a doctor before using Nurofen® Express if any above
mentioned conditions concerns you.
Taking other medicines
Please tell your doctor or pharmacist if you are taking or have
recently taken any other medicines, including medicines
obtained without a prescription. In particular, tell them if you
are taking:
• blood thinning or anti-clotting medicines (anticoagulants)
such as acetylsalicylic acid (aspirin), warfarin, triciopine,
• glucocorticoids (medicinal products containing cortisone
or cortisone-like substances), aspirin, or other NSAIDs
(anti-inflammatories and analgesics): since these may
increase the risk of gastrointestinal ulcers or bleeding
• lithium (a medicine for manic depressive illness and
depression) since the effect of lithium may be enhanced
• selective serotonin reuptake inhibitors (a medicine used
for depression) as these may increase the risk of
gastrointestinal side effects.
• methotrexate (a medicine for cancer or rheumatism) since
the effect of methotrexate may be enhanced
• zidovudine: (a medicine for treating HIV infection) since
the use of Nurofen Express may result in an increased risk
of bleeding into a joint or a bleeding that leads to
swelling.
• ciclosporin and tacrolimus (to prevent transplant
rejection) as there could be an increased risk for the
kidney.
• medicines for high blood pressure (ACE-inhibitors
e.g.captopril, betareceptor blocking medicines,
angiotensin II antagonists) and water tablets (diuretics), as
NSAIDs may reduce the effects of these medicines and
there could be a possible increased risk for the kidney
(using potassium sparing diuretics with ibuprofen can
lead to high blood levels of potassium)
• sulfonylureas (antidiabetic medicine) as interactions may
be possible
• phenytoin (for epilepsy) as the effect may be enhanced
• quinolone antibiotics as the risk of convulsions may be
increased.
• cardiac glycosides such as digoxin
• mifepristone (used to terminate pregnancies) as the effect
may be reduced
• probenecid and sulfinpyrazones (medicines for gout): it
may take longer for ibuprofen to be broken down by the
body.

Other warnings
• Medicines such as Nurofen Express may be associated
with a small increased risk of heart attack or stroke. Any
risk is more likely with high doses and prolonged
treatment. If you have heart problems, have had a stroke
or think that you might be at risk of these conditions (for
example if you have high blood pressure, diabetes, high
cholesterol or are a smoker), you should discuss your
treatment with your doctor or pharmacist.
• Taking a painkiller for headaches for too long can make
them worse.
Fertility, pregnancy and breast-feeding
Do not take in the last 3 months of pregnancy. Speak to your
doctor or pharmacist before taking this product if you are in
the first 6 months of pregnancy or are breast-feeding.









This medicine passes into breast milk but may be used during
breast-feeding if it is used at the recommended dose and for
the shortest possible time.
Nurofen Express belongs to a group of medicines which may
impair fertility in women. This is reversible on stopping the
medicine. It is unlikely that Nurofen Express, used
occasionally will affect your chances of becoming pregnant.
However, tell your doctor before taking this medicine if you
have problems becoming pregnant.
Driving and using machines
For short-term use and at normal dosage this medicine has
no or negligible influence on the ability to drive and use
machines. If side-effects such as tiredness or dizziness occur
do not drive or operate machines. Alcohol consumption
increases the risk of these side-effect.
Important information about some of the ingredients of
Nurofen® Express.
Nurofen Express contains sucrose. If you have been told by
your doctor that you have an intolerance to some sugars,
contact your doctor before taking this medicinal product.
Nurofen Express contains tartrazine (E102). This may cause
allergic reactions.
3. HOW TO TAKE NUROFEN® EXPRESS
This product is for short term use only. You should take the
lowest dose for the shortest time necessary to relieve your
symptoms.
Always take Nurofen® Express exactly as stated in this
package leaflet. You should check with your doctor or
pharmacist if you are not sure. The standard dose is:
Adults and children aged 12 years and older:
For oral use after dissolving in water.
Dissolve the content of one sachet in a glass of water, stir,
then drink immediately.
You can take one sachet up to three times a day as required.
Leave at least six hours between doses.
Do not take more than three sachets in any 24 hour
period.
Not to be given to children under 12 years of age
You should not take Nurofen Express for longer than 5 days
when treating pain and 3 days when treating fever unless
your doctor tells you to. If symptoms persist or worsen
consult your doctor.
Please speak to the doctor or pharmacist if you feel that the
effect of this medicine is greater or less than you expected.
If you take more Nurofen® Express than you should
Consult a doctor immediately. The following signs may occur:
nausea, vomiting, stomach pain, headache, dizziness,
drowsiness, nystagmus, blurred vision, ringing in the ear.
Rarely: low blood pressure and loss of consciousness.
If you have any further questions on the use of this product,
ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Nurofen Express can cause side effects,
although not everybody gets them. Side effects may be
minimised by taking the lowest dose for the shortest time
necessary to relieve the symptoms. Although side effects are
uncommon, you may suffer one of the known side effects of
NSAIDs. If you do, or if you have concerns, stop taking this
medicine and talk to your doctor as soon as possible. Elderly
people using this product are at increased risk of developing
problems associated with side effects.



In general, the habitual use of (several sorts of ) analgesics
can lead in rare cases to lasting severe kidney problems.
blood disorders resulting in unexplained or unusual
bruising or bleeding, fever, sore throat, mouth ulcers,
flu-like symptoms and severe exhaustion
psychotic reactions and depression
worsening of inflammation due to infection
high blood pressure, arterial hypertension, palpitations,
heart failure, heart attack
liver problems or inflammation of the liver. Liver failure or
damage, particularly in long-term term use, shown by
yellowing of the skin and eyes or pale stools and dark
urine.
the symptoms of aseptic meningitis with neck stiffness,
headache, feeling sick, being sick, fever or consciousness
clouding have been observed when using ibuprofen.
Patients with autoimmune disorders (SLE, mixed
connective-tissue disease) may be more likely to be
affected. Contact a doctor at once, if these occur.
swelling of skin tissue such as hands, feet or face.

Medicines such as Nurofen Express may be associated with a
small increased risk of heart attack (‘’myocardial infarction’’) or
stroke.
If any of the side effects get serious, or if you notice any
side effects not listed in the leaflet, please tell your doctor
or pharmacist.
5. HOW TO STORE NUROFEN® EXPRESS
Keep out of the reach and sight of children.
This medicinal product does not require any special
temperature storage conditions.
Do not use Nurofen® Express after the expiry date which is
stated on the carton and sachet. The expiry date refers to the
last day of that month.
Medicines should not be disposed of via wastewater or
household waste. Ask the pharmacist how to dispose of
medicines no longer required. These measures will help to
protect the environment.
6. FURTHER INFORMATION
What Nurofen® Express contains:
Each sachet contains 400mg of the active substance
ibuprofen (as ibuprofen lysinate).
The other ingredients are:
Betadex
Lemon essence (containing natural flavouring substances and
preparations, maltodextrin, modified maize starch and
tartrazine E102)
Saccharin sodium (E954)
Sodium cyclamate (E952)
Sodium citrate (E331)
Sucrose
What Nurofen® Express looks like and contents of the
pack:
This medicine is a white, lemon flavoured powder supplied in
sachets.
Single-dose sachet made of a heat-sealable paper/aluminium
sheet /polythene complex.
Outer carton containing 1, 2, 3, 4, 5, 6, 7 and 8 sachets.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Reckitt Benckiser Healthcare (UK) Ltd, HU8 7DS.
PL 00063/0616
Manufacturer
Laboratorio de aplicaciones farmacodinámicas, s.a. (fardi)
Grassot, 16
08025 BARCELONA (SPAIN)
This medicinal product is authorised in the Member
States of the EEA under the following names:
Poland
Nurofen Ultra Forte do rozpuszczania
United kingdom Nurofen Express 400mg oral powder
This leaflet was last approved in November 2011.

The following frequencies are taken as a basis when
evaluating side effects:
very common:
common:
uncommon:
rare:
very rare:
not known:

affects more than 1 user in 10
affects 1 to 10 users in 100
affects 1 to 10 users in 1,000
affects 1 to 10 users in 10,000
affects less than 1 user in 10,000
frequency cannot be estimated from the
available data

STOP TAKING this medicine and seek immediate medical
help if you develop:
• signs of intestinal bleeding such as: severe pain in the
abdomen, black tarry stools, blood in your faeces
(stools/motions), vomiting blood or dark particles that
look like coffee grounds.
• signs of rare but serious allergic reaction such as
worsening of asthma, unexplained wheezing or shortness
of breath, swelling of the face, tongue or throat, difficulty
breathing, racing heart, drop in blood pressure leading to
shock. These can happen even on first use of this
medicine.
• severe skin reactions such as rashes covering the whole
body, peeling, blistering or flaking skin.
Tell your doctor if you have any of the following side
effects, they become worse or you notice any effects not
listed.
Common
• heart burn, abdominal pain, feeling sick and indigestion
Uncommon
• inflammation of the stomach, worsening of colitis and
Crohn's disease
• headache, dizziness, sleeplessness, agitation, irritability or
tiredness
• visual disturbances
• flatulence (wind), diarrhoea, constipation and vomiting
• allergic reactions , such as skin rashes, itching and asthma
attacks
Rare
• tinnitus (ringing in the ears)
• kidney damage and the development of gout
Very rare
• inflammation of the oesophagus or pancreas, blockages
in the gut
• serious infections of the skin have occurred during
chicken pox
• kidney disorders that may be shown by passing less or
more urine than normal, cloudy urine, blood in the urine,
pain in the back and/or swelling (particularly of the legs).
RB004517

RB004517

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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