NUROFEN FOR CHILDREN 200MG/5ML ORANGE ORAL SUSPENSION

Active substance: IBUPROFEN

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PACKAGE LEAFLET INFORMATION FOR THE USER

Nurofen for Children 200mg/5ml Orange oral suspension

Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Nurofen for
Children 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 child’s symptoms worsen or do not improve after 3
days.
- If any of the side effects get serious or if you notice any side effect not listed in this
leaflet, please tell your doctor or pharmacist.
Read all of this leaflet carefully before you start taking this medicine.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor or pharmacist
This medicine has been prescribed for you or your child. Do not pass it onto others. It may
harm them, even if their symptoms are the same as yours.
If any of the side effects gets serious, or if you notice any side effects not listed on this
leaflet, please tell your doctor or pharmacist.

In this leaflet:
1. What Nurofen for Children is and what it is used for
2. Before you use Nurofen for Children
3. How to use Nurofen for Children
4. Possible side effects
5. How to store Nurofen for Children
6. Further information
1. WHAT NUROFEN FOR CHILDREN IS AND WHAT IT IS USED FOR
Ibuprofen belongs to a group of medicines called Non-Steroidal Anti-Inflammatory Drugs
(NSAIDs). These medicines work by changing how the body responds to pain, inflammation
and high body temperature. Nurofen for children is for the short- term symptomatic
treatment of :


fever



mild to moderate pain

2. BEFORE YOU USE NUROFEN FOR CHILDREN
Do not give Nurofen for Children to children who:




are allergic (hypersensitive) to ibuprofen or other similar painkillers (NSAIDs) or to
any of the other ingredients of the product (see section 6 for further information)
have ever suffered from shortness of breath, asthma, a runny nose or hives after
using acetylsalicylic acid (aspirin) or other similar painkillers (NSAIDs)
have ever had gastrointestinal bleeding or perforation, related to previous use of
NSAIDs
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currently have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or
bleeding (two or more episodes of proven ulceration or bleeding)
have severe liver, kidney or heart failure
have bleeding of the brain (cerebrovascular bleeding) or other active bleeding
suffer from blood clotting disorders as ibuprofen may increase bleeding time
Unclarified blood-formation disturbances

If an adult is taking this product, do not take if you are in the last 3 months of pregnancy.
Take special care with Nurofen for Children if your child:




















is taking any other NSAID painkillers or acetylsalicyclic acid (aspirin) with a daily
dose above 75mg
has certain diseases of the skin (systemic lupus erythematosus (SLE) or mixed
connective tissue disease)
has or has ever had bowel disease (ulcerative colitis or Crohn’s disease) as these
conditions may be exacerbated (see section 4 ‘possible side effects’)
has ever had high blood pressure and/or heart failure
has reduced renal function
has liver disorders
caution should be advised if other medicines are taken which could increase the risk
of ulceration or bleeding, such as oral corticosteroids (such as prednisolone),
medicines for thinning the blood (such as warfarin), selective serotonin-reuptake
inhibitors (a medicine for depression) or anti-platelet agents (such as acetylsalicylic
acid).
is taking another NSAID medicine (including COX-2 inhibitors such as celecoxib or
etoricoxib) as taking these together should be avoided.
Undesirable effects may be minimised by using the minimum effective dose for the
shortest duration.
In general, the habitual use of (several sorts of) analgesics can lead to lasting severe
kidney problems.
Shortness of breath may occur if you have or have had asthma, a chronic runny
nose, nasal polyps or allergic diseases.
Serious skin reactions (such as Steven-Johnson syndrome) have been reported very
rarely in association with the use of NSAIDs. The use of Nurofen for Children should
be stopped immediately at the first appearance of skin rash, mucosal lesions, or any
other signs of allergic reactions.
If you have heart problems, previous stroke or think that you might be at risk of these
conditions (for example if you have high blood pressure, diabetes or high cholesterol
or are a smoker) you should discuss your treatment with your doctor or pharmacist.
During chicken pox (varicella) it is advisable to avoid use of Nurofen for Children
have just undergone major surgery
is dehydrated as there is an increased risk of kidney problems
Medicines such as Nurofen for Children may be associated with a small increased
risk of heart attack ("myocardial infarction") or stroke. Any risk is more likely with high
doses and prolonged treatment. Do not exceed the recommended dose or duration
of treatment [3 days].

Gastro-intestinal bleeding, ulceration or perforation, which can be fatal, has been reported
with all NSAIDs at anytime during treatment, with or without warning symptoms or a previous
history of serious gastro-intestinal events. When gastrointestinal bleeding or ulceration
occurs, the treatment should be stopped immediately.The risk of gastrointestinal bleeding,
ulceration or perforation is higher with increasing NSAID doses, in patients with a history of
ulcer, particularly if complicated with haemorrhage or perforation (see section 2 Do not take
Nurofen for Children) and in the elderly. These patients should commence treatment on the
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lowest dose available. Combination therapy with protective agents (e.g. misoprostol or
proton pump inhibitors) should be considered for those patients, and also those requiring
concomitant low-dose aspirin, or other drugs likely to increase gastrointestinal risk.
NSAIDs such as ibuprofen may mask the symptoms of infection and fever
Consult a doctor before using Nurofen for Children if any of the above mentioned conditions
affect your child.
If an adult is taking this medicine:
Elderly
The elderly have an increased risk of adverse events when taking NSAIDs, particularly those
relating to the stomach and bowel. See section 4 ‘possible side effects’ for more information.
Patients with a history of gastro-intestinal toxicity, particularly when elderly, should report
any unusual abdominal symptoms (especially gastrointestinal bleeding) particularly in the
initial stages of treatment

Taking other medicines
Please tell your doctor or pharmacist if your child is taking or has recently taken any other
medicines, including medicines obtained without a prescription, in particular:













corticosteroids (such as prednisolone) since this may increase the risk of
gastrointestinal ulceration or bleeding
another NSAID medicine (including COX-2 inhibitors such as celecoxib or etoricoxib)
Some medicines that are anti-coagulants (against clotting) (e.g. acetylsalicylic
acid/aspirin, warfarin, ticlopidin), some medicines against high blood pressure (ACEinhibitors,e.g. captopril, betareceptor blocking medicines, angiotensin II antagonists),
and even some other medicines may affect of be affected by the treatment of
ibuprofen. Therefore always seek the advice of a doctor before you use ibuprofen
with other medicines.
anti-platelet agents (such as acetylsalicylic acid) and selective serotonin-reuptake
inhibitors (a medicine for depression) since this may increase the risk of
gastrointestinal side effects
medicines for high blood pressure and water tablets (diuretics) since NSAIDs may
diminish the effects of these medicines and there could be a possible increased risk
for the kidney. In this case make sure your child drinks enough water during the day.
lithium (a medicine for depression) since the effect of lithium may be enhanced
methotrexate (a medicine for cancer or rheumatism) since the effect of methotrexate
may be enhanced
tacrolimus (a medicine to suppress the immune reaction) since the risk of kidney
toxicity is increased
cyclosporin (a medicine to suppress the immune reaction) since there is limited
evidence of an increased risk for kidney toxicity.
Zidovudin (a medicine for treating Aids) since the use of Nurofen for Children may
result in an increased risk of bleeding into a joint or a bleeding that leads to swelling
in HIV (+) haemophiliacs
Sulphonylureas:
Clinical investigations have shown interactions between NSAIDs and antidiabetics
(sulphonylureas). Although interactions between ibuprofen and sulphonylureas have
not been described to date, a check of blood-glucose values is recommended as a
precaution on concomitant intake.
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Probenecid and sulfinpyrazone:
Medicinal products that contain probenecid or sulfinpyrazone may delay the excretion
of ibuprofen.
Digoxin, phenytoin and lithium: ibuprofen may increase plasma concentrations of
these medicines.
Quinolone antibiotics, since taking these and NSAIDs can increase the risk of having
convulsions.
Cholestyramine since taking NSAIDs with cholestyramine can delay and decrease
the uptake of NSAIDs
Voriconazole and fluconazole since taking these medicines can increase exposure to
NSAIDs

If an adult is taking this medicine:
Pregnancy and breast–feeding
Pregnancy
Tell your doctor if you become pregnant during intake of Nurofen for Children. Do not use
this medicine if you are in the last 3 months of pregnancy. Avoid the use of this medicine in
the first 6 months of pregnancy unless your doctor advises you otherwise.
Breast-feeding
Only small amounts of ibuprofen and its decomposition products pass into breast milk. As no
harmful effects to infants are known to date, it is not usually necessary to interrupt breastfeeding during short-term use of ibuprofen at the recommended doses.
Female fertility
Nurofen for Children belongs to a group of medicines (NSAIDs) which may impair the fertility
in women. This effect is reversible on stopping the medicine.
Ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines
For short-term use this medicine has no or negligible influence on the ability to drive and use
machines.
Important information about some of the ingredients of Nurofen for Children




Nurofen for Children contains maltitol liquid. 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 for Children contains wheat starch. Suitable for people with coeliac disease.
Patients with wheat allergy (different from coeliac disease) should not take this
medicine.

3. HOW TO USE NUROFEN FOR CHILDREN
Always use Nurofen for Children exactly as indicated. You should check with your
doctor or pharmacist if you are unsure.
For oral use
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The usual dose for pain and fever:
Child’s Age (Weight)

How much?

How often in 24h?*

6 – 9 years (20-30kg)

5ml

3 times

9– 12 years (30-40kg)

7.5ml (use spoon twice: 5ml +
2.5ml)

3 times

*Doses should be given approximately every 6 to 8 hours.
Not intended for use in children under 6 years of age or under 20kg
For patients with sensitive stomachs it is recommended that Nurofen for children is taken
during a meal
WARNING: do not exceed the stated dose.
Method of administration using the spoon
1. Shake the bottle well
2. Use the end of the spoon that corresponds to the required dose
3. Pour the medicine onto the spoon
4. Place the spoon in the child’s mouth and administer the dose
5. After use replace the cap. Wash the spoon in warm water and allow to dry.

Duration of treatment
This medicine is for short-term use only. If the child’s symptoms persist for more than
3 days seek medical advice

If symptoms worsen consult your doctor.
If your child takes more Nurofen for Children than they should:
If you accidentally give or take more than the recommended dose Nurofen for
Children, contact your doctor straight away. Symptoms of an overdose include
feeling sick, being sick, pain in the abdomen, headache, dizziness, feeling sleepy,
twitchy eyes, blurred vision, ringing in the ears, and rarely low blood pressure, blood
composition changes, kidney problems and loss of consciousness.
If you or your child forget to take Nurofen for Children:
Do not take or give a double dose to make up for a forgotten dose. If you do forget to take or
give a dose, take or give it as soon as you remember and then take or give the next dose
according to the dosing interval detailed above.
If you have any further questions on the use of this product ask your doctor or
pharmacist.

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4. POSSIBLE SIDE EFFECTS
Like all medicines, Nurofen for Children can cause side effects, although not everyone gets
them. Side effects may be minimised by taking the lowest dose for the shortest time
necessary to relieve the symptoms. Your child may get one of the known side effects of
NSAIDs. If they do, or if you have concerns, stop giving this medicine to your child 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 your child develops:
 signs of intestinal bleeding such as: severe pain in the abdomen, black tarry stools,
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. If any of these symptoms occur, call a doctor at once.
 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 (affects 1 to 10 users in 100)
 heart burn, abdominal pain, feeling sick, being sick, flatulence (wind), diarrhoea,
constipation.
Uncommon (affects 1 to 10 users in 1,000)
 inflammation of the stomach, worsening of colitis and Crohn's disease
 headache, dizziness, sleeplessness, agitation, irritability or tiredness
 visual disturbances
 gastrointestinal ulcers which may bleed or burst
 mouth ulcers and/or swelling and irritation of the mouth
 hypersensitivity reactions with skin rashes and itching, and asthma attacks (possibly with
drop in blood pressure)
Rare (affects 1 to 10 users in 10,000)
 tinnitus (ringing in the ears)
Very rare (affects less than 1 user in 10,000
 inflammation of the oesophagus or pancreas, blockages in the gut
 severe forms of skin reactions including rash with redness and blistering which may peel,
accompanied by fever, chills aching muscles and feeling unwell, Stevens-Johnson
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syndrome. In exceptional cases, serious infections of the skin have occurred during
chicken pox (varicella).
passing less urine than normal and swelling (acute kidney failure or inflammation may be
possible). Damage to the kidney or increased urea concentrations in the blood (first
signs are passing less urine than normal, cloudy urine, blood in the urine, back pain,
swelling possibly of the legs and generally feeling miserable)
problems in blood cell production (first signs are fever, sore throat, superficial mouth
ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding, unexplained or
unusual bruising.
psychotic reactions and depression
worsening of inflammation due to infection. If signs of an infection occur or get worse
during use of Nurofen for Children, speak to your doctor.
swelling, high blood pressure, palpitations, heart failure, heart attack.
liver problems or inflammation of the liver. Liver failure or damage, particularly in longterm term use, shown by yellowing of the skin and eyes or pale stools and dark urine.
very rarely, 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.

Medicines such as this 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 FOR CHILDREN
Keep out of reach and sight of children.
Do not use Nurofen for Children after the expiry date which is stated on the carton and label.
The expiry date refers to the last day of that month. Do not store above 25 °C.
Shelf life after opening the bottle: 6 months.
Medicines should not be disposed of via waste water or household waste. Ask your
pharmacist how to dispose of medicines that are no longer required. These measures
will help to protect the environment.
6. FURTHER INFORMATION
What Nurofen for Children contains:
The active substance is ibuprofen. Each 1ml oral suspension contains 40mg ibuprofen.
The other ingredients are; citric acid monohydrate, sodium citrate, sodium chloride, sodium
saccharin, polysorbate 80, domiphen bromide, maltitol liquid, glycerol, xanthan gum, orange
flavour (containing wheat starch) and purified water.

What Nurofen for Children looks like and contents of the pack
Nurofen for Children is an off-white, oral suspension.
Each bottle contains either 30ml, 50ml, 100ml or 150ml.
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The pack contains a spoon (with a 2.5ml bowl with a 1.25ml inner mark at one end and a
5ml bowl at the other end).
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Reckitt Benckiser (UK) Ltd, Dansom Lane, Hull HU8 7DS UK
Manufacturer:
Reckitt Benckiser (UK) Ltd, Dansom Lane, Hull HU8 7DS UK
This medicinal product is authorised in the Member States of the EEA under the
following names:
Belgium

Nurofen voor Suikervrij 4%

Bulgaria

Nurofen for Children 4% orange

Cyprus

Nurofen για Παιδιά 4% Πορτοκάλι

Czech Republic

Nurofen proděti 4% pomeranč

France

Nurofen 40mg /ml enfants orange

Finland

Nurofen Junior 4%

Germany

Nurodon Junior Fieber- und Schmerzsaft Orange 40 mg/ml Suspension zum
Einnehmen.

Hungary

Nurofen narancsízű 4% szuszpenzió gyermekeknek

Iceland

Nurofen Junior 4%

Ireland

Nurofen for Children Orange 200mg/5ml Oral Suspension

Luxembourg

Nurofen pour Enfants 4% suspension orale

Netherlands

Nurofen voor Kinderen Sinaasappel suikervrije suspensie, suspensie 200
mg/5ml

Norway

Nurofen Junior 4%

Poland

NUROFEN DLA DZIECI JUNIOR POMARANCZOWY

Romania

Nurofen Junior, cu aromǎ de portocale, 200 mg/5 ml, suspensie oralǎ

Slovak Republic

Nurofen pre deti 4% pomeranč

Slovenia

Nurofen za otroke z okusom pomaranče 40 mg/ml peroralna suspenzija

Sweden

Nurofen Junior 4%

UK

Nurofen for Children 200mg/5ml Orange Oral Suspension

This leaflet was last approved in 06/2011

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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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