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NUROFEN FOR CHILDREN 200MG/5ML STRAWBERRY ORAL SUSPENSION

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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Reckitt Benckiser

0023 DE-H-2343-002-DC Art 61(3)

PACKAGE LEAFLET: INFORMATION FOR THE USER
Nurofen for Children 200 mg/5 ml Strawberry Oral Suspension
Ibuprofen
PL 00063/0607
Read all of this leaflet carefully before you start using this medicine because it
contains important information for you.
-

Always use this medicine exactly as described in this leaflet or as your doctor or
pharmacist has told you. Keep this leaflet. You may need to read it again
Ask your pharmacist if you need more information or advice
If your child gets any side effects talk to your doctor or pharmacist. This includes any
possible side effects not listed in this leaflet. See section 4. You must talk to a doctor
if your child does not feel better or if your child feels worse after 3 days.

In this leaflet:
1. What Nurofen for Children is and what it is used for
2. What you need to know 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. Contents of the pack and other 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 and high body
temperature. This product has been specifically formulated for children as it is given by
mouth to:


reduce fever



relieve symptoms of mild to moderate pain

2

What you need to know before you use Nurofen for Children

Do not give Nurofen for Children to children who:










are allergic to ibuprofen or other similar painkillers (NSAIDs) or to any of the other
ingredients of this medicine (listed in section 6)
have ever suffered from shortness of breath, asthma, a runny nose, swelling on their
face and/or hands or hives after using aspirin (acetylsalicylic acid) or other similar
painkillers (NSAIDs)
have ever had a gastrointestinal bleeding or perforation, related to previous use of
NSAIDs
currently have or have had recurrent stomach/duodenal ulcers (peptic ulcers) or
bleeding (two or more episodes of proven ulceration and bleeding)
have severe liver or severe kidney failure
have severe heart failure
have inherited problems coping with fructose/fruit sugar (see important information
about the ingredients)
have bleeding of the brain (cerebrovascular bleeding) or other active bleeding
suffer from blood clotting disorders as ibuprofen may increase bleeding time

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0023 DE-H-2343-002-DC Art 61(3)

have unclarified blood-formation disturbances
have severe dehydration (caused by vomiting, diarrhoea or insufficient fluid intake)

Do not take if you are in the last 3 months of pregnancy
Warnings and precautions
Talk to your doctor or pharmacist before using this product if your child























has certain hereditary blood formation disorders (e.g. acute intermittent porphyria)
suffers from coagulation disturbances
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 or currently has high blood pressure and/or heart failure
has reduced renal function
has liver disorders. In prolonged administration of Nurofen regular checking of the
liver values, the kidney function, as well as of the blood count, is required.
caution should be advised if you take other medicines 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 (see section “taking other
medicines”).
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. . This risk may be increased under physical strain associated with
loss of salt and dehydration. Therefore it should be avoided.
Prolonged use of any type of painkiller for headaches can make them worse. If this
situation is experienced or suspected, medical advice should be obtained and
treatment should be discontinued. The diagnosis of medication overuse headache
(MOH) should be suspected in patients who have frequent or daily headaches
despite (or because of) the regular use of headache medications.
has or has had asthma or allergic diseases as shortness of breath may occur.
suffers from hayfever, nasal polyps or chronic obstructive respiratory disorders an
increased risk of allergic reactions exists. The allergic reactions may present as
asthma attacks (so-called analgesic asthma), Quincke’s oedema or urticaria
serious skin reactions (such as Steven-Johnson syndrome) have been reported very
rarely in association with the used 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.
during chicken pox (varicella) it is advisable to avoid use of Nurofen for Children
has just undergone major surgery as medical surveillance is required.
is dehydrated as there is a risk of renal impairment in dehydrated children
NSAIDs may mask symptoms of infection and fever

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,

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0023 DE-H-2343-002-DC Art 61(3)

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 lowest dose available. These patients should commence treatment on the 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 lowdose aspirin, or other drugs likely to increase gastrointestinal risk.
Anti-inflammatory/pain-killer medicines like ibuprofen may be associated with a small
increased risk of heart attack or stroke, particularly when used at high doses. Do not exceed
the recommended dose or duration of treatment.
You should discuss your treatment with your doctor or pharmacist before taking Nurofen for
Children if you:
- have heart problems including heart failure, angina (chest pain), or if you have had a heart
attack, bypass surgery, peripheral artery disease (poor circulation in the legs of feet due to
narrow or blocked arteries), or any kind of stroke (including ‘mini-stroke’ or transient
ischaemic attack “TIA”).
- have high blood pressure, diabetes, high cholesterol, have a family history of heart
disease or stroke, or if you are a smoker.
Consult a doctor before using Nurofen for Children if any of the above mentioned conditions
concern your child.
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

Other medicines and Nurofen for Children
Tell your doctor or pharmacist if your child is using or has recently used or might use any
other medicines.
Nurofen for Children may affect or be affected by some other medicines. For example:
- medicines that are anti-coagulants (i.e. thin blood/prevent clotting e.g. aspirin/acetylsalicylic
acid, warfarin, ticlopidine)
- medicines that reduce high blood pressure (ACE-inhibitors such as captopril, beta-blockers
such as atenolol medicines, angiotensin-II receptor antagonists such as losartan)
Some other medicines may also affect or be affected by the treatment of Nurofen for
Children. You should therefore always seek the advice of your doctor or pharmacist before
you use Nurofen for Children with 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:
Other NSAIDs including COX-2 inhibitors

Since this may increase the risk of side effects

Digoxin (for heart insufficiency)

Since the effect of digoxin may be enhanced

Glucocorticoids
(medicinal
products
cortisone or cortisone-like substances)

containing

1.3.1 Package Leaflet
Nurofen for Children DCP 200mg_5ml Strawberry - 2343

Since this may increase the risk of gastrointestinal
ulcers or bleeding

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0023 DE-H-2343-002-DC Art 61(3)

Anti-platelet agents

Since this may increase the risk of bleeding

Acetylsalicylic acid (low dose)

Since the blood-thinning effect may be impaired

Medicines for thinning the blood (such as warfarin)

Since ibuprofen may enhance the effects of these
medicines

Phenytoin (for epilepsy)

Since the effect of phenytoin may be enhanced

Selective serotonin reuptake inhibitors (medicines used
for depression)

As these may increase the risk of gastrointestinal
bleeding

Lithium (a medicine for manic depressive illness and
depression)

Since the effect of lithium may be enhanced

Probenecid and sulfinpyrazones (medicines for gout)

Since the excretion of ibuprofen may be delayed

Medicines for high blood pressure and water tablets

Since ibuprofens may diminish the effects of these
medicines and there could be a possible increased risk
for the kidney

Potassium sparing diuretics e.g. amiloride, potassium
canreoate, spironolactone, triamterene.

Since this may lead to hyperkalaemia

Methotrexate (a medicine for cancer or rheumatism)

Since the effect of methotrexate may be enhanced

Tacrolimus
medicines)

Since kidney damage may occur

and

cyclosporine

(immunosuppressive

Zidovudine: (a medicine for treating HIV/Aids)

Since the use of Nurofen may result in an increased
risk of bleeding into a joint or a bleeding that leads to
swelling in HIV (+) haemophiliacs

Sulfonylureas (antidiabetic medicines)

Since the blood sugar levels can be affected

Quinolone antibiotics

Since the risk for convulsions (fits) may be increased

Voriconazole and fluconazole (CYP2C9 inhibitors) used
for fungal infections

Since the effect of ibuprofen may increase. Reduction
of the ibuprofen dose should be considered,
particularly when high-dose ibuprofen is administered
with either voriconazole or fluconazole.

Baclofen

Baclofen toxicity may develop after starting ibuprofen.

Ritonavir

Ritonavir may increase the plasma concentrations of
NSAIDs.

Aminoglycosides

NSAIDs
may
aminoglycosides.

decrease

the

excretion

of

Nurofen for Children with alcohol
You should not drink alcohol while using Nurofen for Children. Some side effects, such as
those affecting the gastrointestinal tract or the central nervous system can be more likely
when alcohol is taken at the same time as Nurofen for Children.

Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a
baby, ask your doctor or pharmacist for advice before taking this medicine.
Pregnancy
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.
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Breast-feeding
Only small amounts of ibuprofen and its decomposition products pass into breast milk.
Nurofen for Children may be used during breast-feeding, if it used at the recommended dose
and for the shortest possible time.
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.

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



3.

Nurofen for Children contains maltitol. If you have been told by your doctor that you
have an intolerance to some sugars, contact your doctor before taking this medicinal
product.
This medicinal product contains 28.09 mg sodium per 15 ml suspension (= 1.87 mg
sodium per 1 ml suspension). To be taken into consideration by patients on a
controlled sodium diet.
HOW TO USE NUROFEN FOR CHILDREN

Always take this medicine exactly as your doctor has told you. Check with your doctor
or pharmacist if you are not sure.

The usual dose for pain and fever:
Child’s weight (age)

How much?

How often in 24h?*

20-29kg (6-9 years)

5ml (equivalent to 200 mg ibuprofen)

3 times

30-40 kg (10 – 12 years)

7.5ml (equivalent to 300 mg
ibuprofen) (use spoon twice: 5ml +
2.5ml)

3 times

*Doses should be given approximately every 6 to 8 hours.
Not intended for children under 6 years of age or under 20kg.
Shake well before use
WARNING: do not exceed the stated dose.
Method of administration using the spoon
For oral use
1. Shake the bottle well
2. Use the end of the spoon that corresponds to the required dose
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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.
Store out of the reach and sight of children
Duration of treatment
This medicine is for short-term use only. If this medicine is required for more than 3 days or if
symptoms worsen, a doctor should be consulted.

If you use more Nurofen for Children than you should:
Consult a doctor immediately. The following signs may occur: nausea, vomiting, stomach
pain or more rarely diarrhoea. In addition, headache, gastrointestinal bleeding, vertigo,
dizziness, drowsiness, nystagmus, blurred vision, ringing in the ear, low blood pressure
,excitation, disorientation, coma, convulsions, loss of consciousness, hyperkalaemia,
metabolic acidosis, increased prothrombin time/INR, acute renal failure, liver damage,
respiratory depression, cyanosis and exacerbation of asthma in asthmatics.
If you or your child forget to take Nurofen for children:
Do not take a double dose to make up for the forgotten dose. If you do forget to take a dose,
take it as soon as you remember and then take the next dose according to the dose interval
detailed above.
If you have any further questions on the use of this medicine ask your doctor or
pharmacist.

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. Although side effects are uncommon, 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.
STOP USING this medicine and seek immediate medical help if your child develop:
 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 if your child has any of the following side effects, they become worse
or you notice any effects not listed.
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Common (may affect up to 1 to 10 people)
 Stomach and intestinal complaints such as as acid burn, stomach pain and nausea,
indigestion, diarrhoea, vomiting, flatulence (wind) and constipation and slight blood
losses in stomach and/or bowel that may cause anaemia in exceptional cases..
Uncommon (may affect up to 1 to 100 people)
 gastrointestinal ulcers, perforation or bleeding, inflammation of the mucous membrane of
the mouth with ulceration, worsening of existing bowel disease (colitis or Crohn’s
disease), gastritis
 headache, dizziness, sleeplessness, agitation, irritability or tiredness
 visual disturbances
 various skin rashes
 hypersensitivity reactions with hives and itch
Rare (may affect up to 1 to 1000 people)
 tinnitus (ringing in the ears)
 increased urea concentrations in blood, pain in the flanks and/or the abdomen, blood in
the urine and a fever may be signs of damage to kidneys (papillary necrosis)
 increased uric acid concentrations in the blood
 decreased haemoglobin levels
Very rare (may affect up to 1 in 10,000 people)
 oesophagitis, pancreatitis, and formation of intestinal diaphragm-like strictures
 heart failure, heart attack and swelling in the face or hands (oedema)
 passing less urine than normal and swelling (especially in patients with high blood
pressure or reduced kidney function), swelling (oedema) and cloudy urine (nephrotic
syndrome); inflammatory kidney disease (interstitial nephritis) that may lead to acute
kidney failure. If one of the above mentioned symptoms occur or if you have a general
miserable feeling, stop taking Nurofen and consult your doctor immediately as these
could be first signs of a kidney damage or kidney failure.
 Psychotic reactions, depression
 high blood pressure, vasculitis
 palpitations
 liver dysfunction, damage to the liver (first signs could be discoloration of the skin),
especially during long-term treatment, liver failure, acute inflammation of the liver
(hepatitis)
 problems in the blood cell production - first signs are: fever, sore throat, superficial mouth
ulcers, flu-like symptoms, severe exhaustion, nose and skin bleeding and unexplained
bruising. In these cases you must stop the therapy immediately and consult a doctor. Any
self-treatment with pain killers or medicinal products that reduce fever (antipyretic
medicinal products) mustn’t be done.
 severe skin infections and soft tissue complications during chicken pox (varicella)
infection
 worsening of infection-related inflammations (e.g. necrotizing fasciitis) associated with the
use of certain painkillers (NSAIDs) has been described. If signs of an infection occur or
get worse, you must go to the doctor without delay. It is to be investigated whether there
is an indication for an anti-infective/antibiotic therapy
 symptoms of aseptic meningitis with stiff neck, headache, nausea, vomiting, fever or
clouding of consciousness 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.

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0023 DE-H-2343-002-DC Art 61(3)

severe forms of skin reactions such as skin rash with redness and blistering (e.g.
Stevens-Johnson syndrome, erythema multiforme, toxic epidermal necrolysis/Lyell’s
syndrome), hair loss (alopecia)

Not known: (frequency cannot be estimated from the available data)
 Respiratory tract reactivity comprising asthma, bronchospasm or dyspnoea.
Medicines such as this may be associated with a small increased risk of heart attack
(myocardial infarction) or stroke.
Reporting side effects
If your child gets 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.
By reporting side effects you can help provide more information on the safety of this
medicine.
5.
HOW TO STORE NUROFEN FOR CHILDREN
Keep out of sight and reach 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
Do not throw away any medicines via waste water. Ask your pharmacist how to throw
away medicines that you no longer use. These measures will help to protect the
environment.

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Contents of the pack and other information

What Nurofen for Children contains:
Each 1ml oral suspension contains 40mg ibuprofen
Each 5ml spoonful of oral suspension contains 200mg ibuprofen.
Each 2.5ml spoonful of oral suspension contains 100mg ibuprofen.
The ibuprofen content is equivalent to 4.0%w/v
The other ingredients are; citric acid monohydrate, sodium citrate, sodium chloride, sodium
saccharin, polysorbate 80, domiphen bromide, maltitol liquid, glycerol, xanthan gum,
strawberry flavour (containing propylene glycol) and purified water.
What Nurofen for Children looks like and contents of the pack
Nurofen for Children is an off-white, viscous suspension with strawberry flavour.
Each bottle contains either 30ml, 50ml, 100ml, 150ml, or 200ml.
The pack contains a double-ended measuring spoon (with a 2.5 ml bowl with 1.25ml inner
mark at one end and a 5 ml bowl at the other end) to measure the dose correctly. Not all
pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder:
Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS, United Kingdom
Manufacturer:
Reckitt Benckiser Healthcare (UK) Ltd, Dansom Lane, Hull, HU8 7DS, United Kingdom
Measuring spoon manufacturer:
Massmould Ltd, Unit 21 Cosgrove Way, Luton, Bedfordshire, LU1 1XL
CE mark with the notified body under the CE marking.
The CE mark relates to the measuring spoon only
This leaflet was last updated in 08/2016

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Expand Transcript

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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