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NUROFEN FOR CHILDREN

Active substance: IBUPROFEN

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alk to your doctor or pharmacist if:
• your child has or has had high blood
pressure, heart problems or a stroke
because there is a small increased risk of

3. How to use Nurofen for Children
Always shake the bottle thoroughly before
use.
To remove the cap, push it down and turn it
anti-clockwise.
There is a 5ml easy dosing syringe or a
two-ended measuring spoon (2.5ml and 5ml) in
the pack which should be used to give the
medicine
Using the two-ended measuring spoon
- Measure the correct dose using the 2.5ml or
5ml spoon ends.
- Wash and dry spoon between doses.
Wash the spoon in warm water and allow

WARNING:
Do not exceed the stated dose

If you forget to give the medicine
If you forget a dose, give the next dose when
needed, provided that the last dose was taken
at least 4 hours ago. Do not give a double
dose.

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Keep all medicines out of the reach and
sight of children

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Print and Technical Colours
Process Black

6. Further information

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LTH

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What is in this medicine?

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The active ingredient is Ibuprofen 100 mg
per 5 ml.
The other ingredients are:
Maltitol liquid, water, glycerol, citric acid,
sodium citrate, sodium chloride, sodium
saccharin, orange flavour, xanthan gum,
polysorbate 80, domiphen bromide.
What the medicine looks like
Nurofen for Children is an off-white liquid
available in 200ml, 150ml and 100ml bottles.
Each pack contains a dosing syringe
(CE 0543).
It contains 100mg of the active Ibuprofen in
every 5 ml of medicine.
Product licence holder: Reckitt Benckiser
Healthcare (UK) Ltd. Slough, SL1 4AQ
Syringe manufacturer: Crookes Healthcare
Limited, Nottingham, NG2 3AA
Manufacturer of medicine: Reckitt Benckiser
Healthcare UK Ltd, Hull, HU8 7DS
and
BCM Ltd, Nottingham NG2 3AA

This leaflet was revised: June 2011
The leaflet gives you the most important
information. If you have any questions after you
have read it, ask your doctor or pharmacist who
will be able to help.

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Edgemark Position:
Pharmacode No/NE:

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Do not use the medicine after the expiry date
shown on the bottle label and carton.
Store below 25ºC.

CAD Cam Ref: N-Lft-SE-D0125810-420x148mm
Printer:
Contego Packaging (Bradford, UK) Nampak
Substrate:
Paper - White

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5. How to store Nurofen for
Children

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Sally Mckinnon

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alk to your doctor
• If your child’s symptoms do not go away
as soon as possible or worsen.
• If you are not sure of your child’s illness
or it is accompanied by a rash,
breathing difficulties, diarrhoea or
excessive tiredness, speak to your doctor
Product license number: PL 00063/0665
straight away.
If anyone has taken too much medicine
If you accidentally give or take more than the
recommended dose, contact your doctor
straight away.

RBH Contact:

Bulk Code (if applicable):

Very rare:
• kidney problems may occur with Ibuprofen
• stroke or heart problems may occur with
Ibuprofen. This is unlikely at the dose level
given to children
• worsening of colitis and Crohn’s disease
• high blood pressure.

Nurofen
Paediatric
Paediatric
Nurofen For Children
Suspension 2%
Ibuprofen Orange
Leaflet
UK
21/07/11
26/07/11

150

Dose
One 2.5ml dose 3
times a day.
Do not use for more
than 24 hours
One 2.5ml dose 3 or
6 months – 12 months
4 times in 24 hours
One 5ml dose 3 times
1 year – 4 years
in 24 hours
One 7.5ml (5ml + 2.5ml)
4 years – 7 years
dose 3 times in 24 hours
One 10ml (5ml + 5ml)
Over 7 years
dose 3 times in 24 hours
• Doses should be given every 6 – 8 hours.
Leave at least 4 hours between doses.
• For Short-term use only
Do not give to babies aged 3 – 6 months
for longer than 24 hours.
Do not give to children aged 6 months or
over for longer than 3 days.
Age
3 months – 6 months
Weighing over 5kg

TR501156
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Fever, Pain and Symptoms of Cold and Flu

Rare:
• diarrhoea, wind or constipation. Tell your
doctor if these last for more than a few days
or become troublesome

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and Print Specification

COLOURS TO MATCH RECOGNISED STANDARDS

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Print
Free
Area

Uncommon:
• headache

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If necessary the second dose should be given
6 hours after the first dose.
• Do not give more than 2 doses in a 24 hour
period.
• Do not give to a child under 3months of
age, unless advised to do so by your
doctor.

Other side effects which may occur are:

BARCODE INFO
Not Known
Barcode Type:
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Barcode Number:
Magnification:
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BWR:
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Truncated by (smallest Bar): N/A
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Encoded Data:
All other aspects of the bar code to conform
to the current GS1 Operating Manual or
other agreed commercial standard.

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One 2.5ml dose up to
twice a day

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Babies and children
3 months and over
Weighing more than
5kg

CUSTOMER INFO:
Minimum Point Size = 10 pt

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Some of the ingredients can cause
problems
• This product contains maltitol. If you have
been told by a doctor that you have an
intolerance to fructose, contact your doctor
before taking this medicine.
• Maltitol may have a mild laxative effect.
Calorific value 2.3 kcal/g maltitol.

Dose

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Do not give this medicine to your child if:
• they have ever had a reaction (e.g.
asthma, runny nose, rash, swelling of the
face, tongue, lips or throat) after taking
ibuprofen, aspirin or other non steroidal
anti- inflammatory (NSAID) medicines
• they weigh less than 5kg or are under 3
months of age
• they are taking any other
anti-inflammatory (NSAID) painkillers, or
aspirin with a daily dose above 75 mg
• they have (or have had two or more
episodes) of a stomach ulcer, perforation
or bleeding
• they have severe kidney, heart or liver
failure
• they have inherited problems coping with
fructose/fruit sugar (hereditary fructose
intolerance). This is because the body can
make some fructose from the ingredient
maltitol.

Age

Connaught House, Connaught Road,
Kingswood Business Park, Hull, HU7 3AP, England.
T: +44 (0) 1482 828100

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This medicine is suitable for the majority of
people but certain people should not use it. Talk
to your pharmacist or doctor if you are at all
unsure.

Fever caused by Immunisation

Please note that any low resolution paper Canon colour
copies associated with this job should be referred to for
content, layout and colour separation only.
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Rebecca Milner

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2. Before giving Nurofen for
Children to your child

DO NOT give to babies under 3 months or
babies weighing less than 5kg.

If your child experiences any of the
following side effects, stop giving this
medicine and tell your doctor
• unexplained stomach pain, indigestion,
heartburn, nausea or vomiting
• yellowing of the eyes, pale stools and dark
urine
• severe sore throat with high fever
• unexplained bruising or tiredness or getting
more infections, such as colds, than normal.

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medicine work) is ibuprofen which is a
non-steroidal-anti-inflammatory (NSAID)
painkiller.
Ibuprofen is used as an analgesic (painkiller) for
the relief of mild to moderate pain, such as a
sore throat, teething pain, toothache, ear ache,
headache, minor aches and sprains, and
symptoms of cold and flu.
Nurofen for Children also brings down a high
temperature (fever) including fever caused by
immunisation.

How much medicine to use

If your child experiences any of the
following, stop giving this medicine and tell
your doctor immediately:
• blood in the stools (faeces/motions)
• black tarry stools
• vomiting blood or dark particles that look
like coffee grounds
• unexplained wheezing, shortness of breath,
skin rash (which may be severe with
blistering or peeling of the skin), itching or
bruising, racing heart, fluid retention (swollen
ankles or decreased levels of passing urine)
• stiff neck, headache, nausea, vomiting, fever
and disorientation.

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1. What Nurofen for Children is and
what it is used for

If you are an adult taking this medicine
The warnings and information given in this
section apply and in addition the
following:
• ibuprofen belongs to a group of
medicines which may impair fertility
in women. This is reversible on
stopping the medicine. It is unlikely
that this medicine, used occasionally, will
affect your chances of becoming pregnant,
however, tell your doctor before taking this
medicine if you have problems becoming
pregnant
• you should only take this product on a
doctor’s advice during the first 6 months of
pregnancy
• DO NOT take Nurofen for Children if you
are in the last 3 months of your pregnancy
• 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
• 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
• in limited studies, ibuprofen appears in the
breast milk in very low concentration and is
unlikely to affect the breast-fed infant
adversely
• if you are elderly talk to your doctor before
using this medicine.

• After use replace the bottle cap. Wash the
syringe in warm water and allow to dry.
Store out of the reach of children.

Like all medicines, Nurofen for Children can
cause side effects, although not everybody gets
them.
The most common side effect is irritation of the
stomach which can cause problems such as
indigestion and heartburn.

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In this leaflet:
1. What Nurofen for Children is and
what it is used for
2. Before giving Nurofen for Children to
your child
3. How to use Nurofen for Children
Possible side effects
5. How to store Nurofen for Children
6. Further Information

Seek the advice of your doctor or
pharmacist if any of the above apply.
If you are not sure what types of medicines
your child is taking, show the medicine to
the doctor or pharmacist.

Using the 5ml easy dosing syringe
• Push the syringe firmly into the plug (hole) in
the neck of the bottle.
• To fill the syringe, turn the bottle upside
down. Whilst holding the syringe in place,
gently pull the plunger down drawing the
medicine to the correct mark on the syringe.
See section “How much medicine to use”.
• Turn the bottle the right way up, remove the
syringe from the bottle plug by gently
twisting the syringe.
• Place the end of the syringe into the child’s
mouth and gently press the plunger down to
slowly and gently release the medicine.

Signed:

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Read all of this leaflet carefully before you
use this medicine.
It contains important information.
Keep this leaflet: you might need it again.
If you have any further questions after you have
read it ask your doctor or pharmacist.
• This medicine is designed to help bring
down a high temperature (fever and
post-immunisation fever), relieve the
symptoms of cold and flu and relieve pain
from headaches, sore throats, ear ache,
minor aches and sprains, teething and
toothache.
• This medicine is suitable for most babies
over 3 months of age, children and adults.
• Follow the dose instructions carefully.
Section 3 shows the different amount that
children need.
• Speak to your doctor if your child:
suffers from any of the conditions listed in
Section 2 of the leaflet
is taking aspirin at a dose above 75 mg
a day. See Section 2
is taking other medicines. See Section 2.
is not getting better, or you feel at all
concerned. See Section 3
develops a rash, breathing problems or
diarrhoea and gets very tired.
See Section 3.
• Do not use this medicine and speak to
your doctor if you are pregnant, think
you may be pregnant or trying to get
pregnant or are breast feeding.
See Section 2.

4. Possible side effects

to dry, store out of the reach of children.

Date:

UNDER NO CIRCUMSTANCES SHOULD THIS
ARTWORK BE ALTERED WITHOUT PRIOR
PERMISSION FROM TRIDENT.
Tel. Alan Smith: +44 (0)1482 710304

NOT APPROVED FOR COLOUR

mm 10

Contains Ibuprofen

RB004432

100mg / 5ml Oral Suspension

• your child has a condition which may put
them at risk of heart problems, such as
diabetes or high cholesterol
• your child has asthma or any allergic
disease of the lungs
• your child has, or has had liver, kidney,
heart or bowel problems
• your child has SLE (Systemic Lupus
Erythematosus, a condition of the immune
system) or any similar disease
• your child suffers from chronic
inflammatory bowel disease such as
Crohn’s disease or ulcerative colitis
• You or your child are taking other
medicines especially:
o other medicines containing ibuprofen or
other NSAIDs, including those you can buy
over the counter
o low dose aspirin (up to 75 mg a day)
o diuretics (to help you pass water)
o anticoagulants (blood thinning medicines
e.g. warfarin)
o medicines for high blood pressure
(e.g.captopril, atenolol, losartan)
o lithium (for mood disorders)
o methotrexate (for psoriasis, arthritis and
types of cancer)
o zidovudine (for HIV)
o corticosteroids (an anti-inflammatory drug)
o cardiac glycosides (for heart problems)
o ciclosporin or tacrolimus (to prevent organ
rejection after transplant)
o mifepristone (for termination of pregnancy)
o quinolone antibiotics (for infections)
o SSRI antidepressant drugs
o antiplatelet drugs e.g. dipyridamole,
clopidogrel.

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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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