NUROFEN EXPRESS 400MG ORAL POWDER

Active substance: IBUPROFEN LYSINATE

View full screen / Print PDF » Download PDF ⇩

Transcript
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 3 days in children and adolescents

after 5 days when treating pain and 3 days when treating fever in adults

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.
2. BEFORE YOU TAKE NUROFEN® EXPRESS
Do not take this medicine 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 antiinflammatory painkillers
 suffer from sever 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 hadf 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 colitisor Crohn’s
disease)
 are in the first 6 months of pregnancy
 have chicken pox (varicella).
Consult a doctor or pharmacist 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.
 There is a risk of renal impairment in dehydrated children and adolescents.
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 breastfeeding.
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
In children and adolescents
If in children and adolescents between 12 and 18 years Nurofen Express is required
for more than 3 days, or if symptoms worsen a doctor should be consulted.
In adults
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 experience 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.

The following frequencies are taken as a basis when evaluating side effects:
very common: affects more than 1 user in 10
common: affects 1 to 10 users in 100
uncommon: affects 1 to 10 users in 1,000
rare: affects 1 to 10 users in 10,000
very rare: affects less than 1 user in 10,000
not known: 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 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). 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 sight and reach 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 single-dose sachets.
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) Limited
Manufacturer
Laboratorio de aplicaciones farmacodinámicas, s.a. (fardi)
Grassot, 16
08025 BARCELONA (SPAIN)
Or
Reckitt Benckiser Healthcare International Limited,
Thane Road, Nottingham,
NG90 2DB, United Kingdom.
This medicinal product is authorised in the Member States of the EEA under
the following names:
Poland
United kingdom

Nurofen Ultra Forte do rozpuszczania
Nurofen Express 400mg oral powder

Licence Number: PL 00063/0616
This leaflet was last approved in September 2014

Expand view ⇕

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.

Hide
(web2)