NUROFEN FOR CHILDREN COLD PAIN AND FEVER STRAWBERRY FLAVOUR 100MG/5ML ORAL SUSPENSION

Active substance: IBUPROFEN

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1.

NAME OF THE MEDICINAL PRODUCT
Nurofen for Children Strawberry Baby
Nurofen for Children 3 months to 9 years Strawberry
Nurofen for Children Cold, Pain and Fever Strawberry Flavour 100mg/5mL Oral
Suspension

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 100 mg/5ml (equivalent to 2.0% w/v).
For excipients, see 6.1.

3

PHARMACEUTICAL FORM
Oral suspension.
An off-white, strawberry-flavoured, syrupy suspension.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications

Prescription and OTC: For the fast and effective reduction of fever, including post
immunisation pyrexia and the fast and effective relief of the symptoms of colds and
influenza and mild to moderate pain, such as a sore throat, teething pain, toothache,
headache, minor aches and sprains.
4.2

Posology and method of administration
Undesirable effects may be minimised by using the lowest effective dose for the shortest
duration necessary to control symptoms (see section 4.4).
For pain, fever and symptoms of cold and infuenza: The daily dosage of Nurofen For
Children is 20-30 mg/kg bodyweight in divided doses. Using the spoon or syringe dosing
device provided this can be achieved as follows:

Infants 3 - 6 months weighing more than 5kg: One 2.5ml dose may be taken 3 times in 24
hours.
Infants 6 - 12 months: One 2.5ml dose may be taken 3 to 4 times in 24 hours.
Children 1 - 3 years: One 5ml dose may be taken 3 times in 24 hours.
Children 4 - 6 years: 7.5ml (5ml +2.5ml spoonful) may be taken 3 times in 24 hours.
Children 7 - 9 years: Two 5ml doses may be taken 3 times in 24 hours.
Doses should be given approximately every 6 to 8 hours, (or with a minimum of 4 hours
between each dose if required).
Not suitable for children under 3 months of age unless advised by your doctor.
For Juvenile Rheumatoid Arthritis: The usual daily dosage is 30 to 40 mg/kg/day in three
to four divided doses.
For post immunisation pyrexia: One 2.5 ml dose followed by one further 2.5 ml dose 6
hours later if necessary. No more than two 2.5ml doses in 24 hours. If the fever is not
reduced, consult your doctor.
For oral administration.
For short term use only.
For infants aged 3-6 months medical advice should be sought if symptoms worsen or not
later than 24 hours if symptoms persist.
If in children aged from 6months this medicinal product is required for more than 3 days,
or if symptoms worsen a doctor should be consulted.

4.3

Contraindications
Hypersensitivity to ibuprofen or any of the constituents in the product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma,
rhinitis, angioedema or urticaria) in response to aspirin or other non-steroidal antiinflammatory drugs.
Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct
episodes of proven ulceration or bleeding).

History of upper gastrointestinal bleeding or perforation, related to previous
NSAIDs therapy.
Severe hepatic failure, renal failure or heart failure (See section 4.4, Special
warnings and precautions for use)
Last trimester of pregnancy (See section 4.6 Pregnancy and lactation).

4.4

Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration necessary to control symptoms (see GI and cardiovascular risks
below).
The elderly have an increased frequency of adverse reactions to NSAIDs
especially gastrointestinal bleeding and perforation which may be fatal.
Respiratory:
Bronchospasm may be precipitated in patients suffering from or with a previous
history of bronchial asthma or allergic disease.
Other NSAIDs:
The use of Ibuprofen with concomitant NSAIDs including cyclooxygenase-2
selective inhibitors should be avoided (see section 4.5).
SLE and mixed connective tissue disease:
Systemic lupus erythematosus and mixed connective tissue disease - increased
risk of aseptic meningitis (see section 4.8 Undesirable effects)
Renal:
Renal impairment as renal function may further deteriorate (See section 4.3
Contraindications and Section 4.8 Undesirable effects)
There is a risk of renal impairment in dehydrated children

Hepatic:
Hepatic dysfunction (See section 4.3 Contraindications and Section 4.8
Undesirable effects)
Cardiovascular and cerebrovascular effects:
Caution (discussion with doctor or pharmacist) is required prior to starting
treatment in patients with a history of hypertension and/or heart failure as fluid
retention, hypertension and oedema have been reported in association with
NSAID therapy.
Clinical trial and epidemiological data suggest that use of ibuprofen, particularly
at high doses (2400mg daily) and in long-term treatment may be associated with a
small increased risk of arterial thrombotic events (for example myocardial

infarction or stroke). Overall, epidemiological studies do not suggest that low
dose ibuprofen (e.g. ≤ 1200mg daily) is associated with an increased risk of
myocardial infarction.
Impaired female fertility
There is limited evidence that drugs which inhibit cyclo-oxygenase/ prostaglandin
synthesis may cause impairment of female fertility by an effect on ovulation.
This is reversible upon withdrawal of treatment.

Gastrointestinal:
NSAIDs should be given with care to patients with a history of gastrointestinal
disease (ulcerative colitis, Crohn’s disease) as these conditions may be
exacerbated (see section 4.8).
GI 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 GI events.
The risk of GI 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 4.3), and in the elderly. These patients
should commence treatment on the lowest dose available.
Patients with a history of GI toxicity, particularly when elderly, should report any
unusual abdominal symptoms (especially GI bleeding) particularly in the initial
stages of treatment.
Caution should be advised in patients receiving concomitant medications which
could increase the risk of ulceration or bleeding, such as oral corticosteroids,
anticoagulants such as warfarin, selective serotonin-reuptake inhibitors or antiplatelet agents such as aspirin (see section 4.5).
When GI bleeding or ulceration occurs in patients receiving ibuprofen, the
treatment should be withdrawn.
Dermatological:
Serious skin reactions, some of them fatal, including exfoliative dermatitis,
Stevens-Johnson syndrome, and toxic epidermal necrolysis, have been reported
very rarely in association with the use of NSAIDs (see section 4.8). Patients
appear to be at highest risk for these reactions early in the course of therapy: the
onset of the reaction occurring in the majority of cases within the first month of
treatment. Ibuprofen should be discontinued at the first appearance of skin rash,
mucosal lesions, or any other sign of hypersensitivity.
Patients with a rare hereditary problems of fructose intolerance should not take
this medicine.

The label will state:
Read the leaflet carefully before use.
Do not give this product if your baby or child:


Is under 3 months old



has (or has had two or more episodes of ) a stomach ulcer, perforation or
bleeding



is allergic to ibuprofen or any other ingredient of the product, aspirin or
other related painkillers



are taking other NSAID painkillers, or aspirin with a daily dose above
75mg

Speak to your doctor or pharmacist before giving this product if baby or child:
• has or had asthma, diabetes, high cholesterol, high blood pressure, a
stroke, heart, liver, kidney or bowel problems or are dehydrated
This product is intended for children aged between 3 months and 12 years.
If you are an adult taking this product:
Speak to a pharmacist or your doctor before taking if:
• You are a pregnant


You are trying to get pregnant



Are elderly



Are a smoker

Do not exceed the stated dose.
Keep out of the reach and sight of children.
For short term use.
If symptoms persist or worsen, consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Ibuprofen should not be used in combination with:
Aspirin: Unless low-dose aspirin (not above 75mg daily) has been advised by a
doctor, as this may increase the risk of adverse reactions (see section 4.4).
Experimental data suggest that ibuprofen may inhibit the effect of low dose
aspirin on platelet aggregation when they are dosed concomitantly. However, the
limitations of these data and the uncertainties regarding extrapolation of ex vivo
data to the clinical situation imply that no firm conclusions can be made for

regular ibuprofen use, and no clinically relevant effect is considered to be likely
for occasional ibuprofen use (see section 5.1).
Other NSAIDs including cyclooxygenase-2 selective inhibitors: Avoid
concomitant use of two or more NSAIDs as this may increase the risk of adverse
effects (see section 4.4)
Ibuprofen should be used with caution in combination with:
Anticoagulants: NSAIDS may enhance the effects of anti-coagulants, such as
warfarin (See section 4.4).
Antihypertensives and diuretics: NSAIDs may diminish the effect of these drugs.
Diuretics can increase the risk of nephrotoxicity of NSAIDs.
Corticosteroids: as these may increase the risk of gastrointestinal ulceration or
bleeding (see Section 4.4)
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased
risk of gastrointestinal bleeding (see section 4.4).
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and
increase plasma glycoside levels.
Lithium: There is evidence for potential increases in plasma levels of lithium.
Methotrexate: There is a potential for an increase in plasma methotrexate.
Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: NSAIDs should not be used for 8-12 days after mifepristone
administration as NSAIDs can reduce the effect of mifepristone.
Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given
with tacrolimus.
Zidovudine: Increased risk of haematological toxicity when NSAIDs are given
with zidovudine. There is evidence of an increased risk haemarthroses and
haematoma in HIV (+) haemophiliacs receiving concurrent treatment with
zidovudine and ibuprofen.
Quinolone antibiotics:Animal data indicate that NSAIDs can increase the risk of
convulsions associated with quinolone antibiotics. Patients taking NSAIDs and
quinolones may have an increased risk of developing convulsions.

4.6

Pregnancy and lactation
Whilst no teratogenic effects have been demonstrated in animal studies, the use of
this product should, if possible, be avoided during the first 6 months of
pregnancy.
During the 3rd trimester, ibuprofen is contraindicated as there is a risk of
premature closure of the foetal ductus arteriosus with possible persistent
pulmonary hypertension. The onset of labour may be delayed and the duration
increased with an increased bleeding tendency in both mother and child. (See
section 4.3 Contraindications).
In limited studies, ibuprofen appears in the breast milk in very low concentration
and is unlikely to affect the breast-fed infant adversely.

See section 4.4 regarding female fertility.

4.7

Effects on ability to drive and use machines
None expected at recommended doses and duration of therapy.

4.8

Undesirable effects
Hypersensitivity reactions have been reported and these may consist of:
(a) Non-specific allergic reactions and anaphylaxis
(b) Respiratory tract reactivity, eg asthma, aggravated asthma, bronchospasm,
dyspnoea
(c) Various skin reactions, e.g. pruritus, urticaria, angioedema and more rarely
exfoliative and bullous dermatoses (including epidermal necrolysis and erythema
multiforme)
The following list of adverse effects relates to those experienced with ibuprofen at
OTC doses, for short-term use. In the treatment of chronic conditions, under
long-term treatment, additional adverse effects may occur.
Hypersensitivity reactions:
Uncommon: Hypersensitivity reactions with urticaria and pruritus.
Very rare: severe hypersensitivity reactions. Symptoms could be: facial, tongue
and laryngeal swelling, dyspnoea, tachycardia, hypotension, (anaphylaxis,
angioedema or severe shock).
Exacerbation of asthma and bronchospasm.
Gastrointestinal:
The most commonly observed adverse events are gastrointestinal in nature.
Uncommon: abdominal pain, nausea and dyspepsia.
Rare: diarrhoea, flatulence, constipation, and vomiting.
Very rare: peptic ulcer, perforation or gastrointestinal haemorrhage, melaena,
haematemesis, sometimes fatal, particularly in the elderly. Ulcerative stomatitis,
gastritis.
Exacerbation of ulcerative colitis and Crohn’s disease (See section 4.4).
Nervous System:
Uncommon: Headache
Very rare: Aseptic meningitis – single cases have been reported very rarely.
Renal:
Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum urea and oedema.

Hepatic:
Very rare: liver disorders.
Haematological:
Very rare: Haematopoietic disorders (anaemia, leucopenia, thrombocytopenia,
pancytopenia, agranulocytosis). First signs are: fever, sore throat, superficial
mouth ulcers, flu-like symptoms, severe exhaustion, unexplained bleeding and
bruising.
Skin:
Uncommon: Various skin rashes
Very rare: Severe forms of skin reactions such as bullous reactions including
Stevens-Johnson syndrome, erythema multiforme and toxic epidermal necrolysis
can occur
Immune System:
In patients with existing auto-immune disorders (such as systemic lupus
erythematosus, mixed connective tissue disease) during treatment with ibuprofen,
single cases of symptoms of aseptic meningitis, such as stiff neck, headache,
nausea, vomiting, fever or disorientation have been observed (See section 4.4)
Cardiovascular and Cerebrovascular
Oedema, hypertension and cardiac failure, have been reported in association with
NSAID treatment.
Clinical trial and epidemiological data suggest that use of ibuprofen (particularly
at high doses 2400mg daily) and in long-term treatment may be associated with a
small increased risk of arterial thrombotic events (for example myocardial
infarction or stroke) (see section 4.4).

4.9

Overdose
In children ingestion of more than 400 mg/kg may cause symptoms. In adults the
dose response effect is less clear-cut. The half-life in overdose is 1.5-3 hours.
Symptoms
Most patients who have ingested clinically important amounts of NSAIDs will
develop no more than nausea, vomiting, epigastric pain, or more rarely diarrhoea.
Tinnitus, headache and gastrointestinal bleeding are also possible. In more serious
poisoning, toxicity is seen in the central nervous system, manifesting as
drowsiness, occasionally excitation and disorientation or coma. Occasionally
patients develop convulsions. In serious poisoning metabolic acidosis may occur

and the prothrombin time/ INR may be prolonged, probably due to interference
with the actions of circulating clotting factors. Acute renal failure and liver
damage may occur. Exacerbation of asthma is possible in asthmatics.
Management
Management should be symptomatic and supportive and include the maintenance
of a clear airway and monitoring of cardiac and vital signs until stable. Consider
oral administration of activated charcoal if the patient presents within 1 hour of
ingestion of a potentially toxic amount. If frequent or prolonged, convulsions
should be treated with intravenous diazepam or lorazepam. Give bronchodilators
for asthma.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties
Ibuprofen is a proprionic acid derivative NSAID which has analgesic, antipyretic
and anti-inflammatory properties. Ibuprofen inhibits prostaglandin synthesis,
furthermore, ibuprofen reversibly inhibits platelet aggregation
Ibuprofen has been shown to an have onset of both analgesic and antipyretic
action within 30 minutes.
ATC Code, M01A E01
Experimental data suggest that ibuprofen may inhibit the effect of low dose
aspirin on platelet aggregation when they are dosed concomitantly. In one study,
when a single dose of ibuprofen 400mg was taken with 8 h before or within 30
min after immediate release aspirin dosing (81mg), a decreased effect of ASA on
the formation of thromboxane or platelet aggregation occurred. However, the
limitations of these data and the uncertainties regarding extrapolation of ex vivo
data to the clinical situation imply that no firm conclusions can be made for
regular ibuprofen use, and no relevant effect is considered to be likely for
occasional use.

5.2

Pharmacokinetic properties
Ibuprofen is rapidly absorbed following administration and is rapidly distributed
throughout the whole body. The excretion is rapid and complete via the kidneys.
Maximum plasma concentrations are reached 45 minutes after ingestion if taken
on an empty stomach. When taken with food, peak levels are observed after 1 to
2 hours. These times may vary with different dosage forms.

The half-life of ibuprofen is about 2 hours.
In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3

Preclinical safety data
There are no preclinical safety data of relevance to the consumer.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Citric acid
Sodium citrate
Sodium chloride
Sodium saccharin
Domiphen bromide
Purified water
Polysorbate 80
Maltitol liquid
Xanthan gum
Strawberry flavour
Glycerol.

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
100 ml - 3 years

6.4

Special precautions for storage
Do not store above 25°C.

6.5

Nature and contents of container
Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant closure
fitted with a low density polyethylene liner. The bottle contains 100 ml of product. A
double-ended spoon with measures of 2.5 ml and 5 ml will be provided.
OR
Amber-coloured polyethylene terephthalate (PET) bottle with a child-resistant closure
fitted with a low density polyethylene liner. The bottle contains 100 ml of product. A
syringe composed of a polypropylene barrel and a PE piston with measures of 2.5 ml
and 5 ml will be provided.
Not all pack sizes will be marketed.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd
Slough
SL1 4AQ

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0667

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
02/03/2011

10

DATE OF REVISION OF THE TEXT
05/09/2014

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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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