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NUROFEN FOR CHILDREN 100 MG CHEWABLE CAPSULES SOFT

Active substance(s): IBUPROFEN / IBUPROFEN / IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Nurofen for children 100 mg, chewable capsules, soft

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each chewable capsule, soft contains 100 mg Ibuprofen.
Excipient with known effect:
Glucose, 358.1 mg per chewable capsule
Sucrose, 251.6 mg per chewable capsule
Soya Lecithin, 0.01mg per chewable capsule
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Chewable capsule, soft.
An orange, square shaped chewable soft gelatin capsule with “N100” print in white
ink. Typical dimensions of the soft gelatin capsule are approximately 5 to 8 mm in
width and approximately 15 to 17 mm in length.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Children from 7 to 12 years

For the reduction of fever and the relief of the symptoms of colds and influenza and
mild to moderate pain, such as a sore throat, dental pain, earache, headache, minor
aches and sprains.

4.2

Posology and method of administration
Posology
For short term use only.
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 influenza: The recommended daily dosage
of Ibuprofen is 20-30 mg/kg bodyweight divided into equal doses. This can be
achieved as follows:
Children 7 - 9 years: Two capsules may be taken 3 times in 24 hours.
Children 10 – 12 years: Three capsules may be taken 3 times in 24 hours.
Doses should be given approximately every 6 to 8 hours, (or with a minimum of 6
hours between each dose if required).
Not suitable for children under 7 years of age.
If in children this medicinal product is required for more than 3 days, or if symptoms
worsen, a doctor should be consulted.
Method of administration

For oral administration
The product should be chewed before swallowing

4.3

Contraindications
Hypersensitivity to ibuprofen or to any of the constituents listed in section 6.1
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis,
angioedema or urticaria) in response to aspirin or other non-steroidal antiinflammatory drugs (NSAIDs).
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 – Fertility, Pregnancy and lactation).
This medicinal product contains soya lecithin. If you are allergic to peanuts or soya
do not use this medicinal product

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).
Porphyrin metabolism:
Caution is required in patients with congenital disorder of porphyrin metabolism (e.g.
acute intermittent porphyria).
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 paediatric patients.

Hepatic:
Hepatic dysfunction (See section 4.3 Contraindications and Section 4.8 Undesirable
effects).
Surgery:
Caution is required directly after major surgery.
Allergy:
Caution is required in patients who react allergically to other substances, as an
increased risk of hypersensitivity reactions occurring also exists for them on use of
Ibuprofen.
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. Combination therapy with
protective agents (e.g. misoprostol or proton pump inhibitors) should be considered
for these patients, and also for patients requiring concomitant low dose aspirin, or
other drugs likely to increase gastrointestinal risk (see below and 4.5).

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 anti-platelet 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, StevensJohnson 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.
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissues
infectious complications. To date, the contributing role of NSAIDs in the worsening
of these infections cannot be ruled out. Thus, it is advisable to avoid use of Ibuprofen
in case of varicella.
Platelet function:
As NSAIDs can interfere with platelet function, they should be used with caution in
patients with idiopathic thrombocytopenic purpura (ITP), intracranial haemorrhage
and bleeding diathesis.
This product contains glucose. Patients with rare hereditary problems of galactose
intolerance e.g. galacotosaemia, or glucose-galactose malabsorption should not take
this medicine.
This product contains sucrose. Patients with rare hereditary problems of fructose
intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency
should not take this medicine.

4.5

Interaction with other medicinal products and other forms of interaction

Ibuprofen should be avoided 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 (ACE inhibitors and angiotensin II antagonists) and
diuretics: NSAIDs may diminish the effect of these drugs. Diuretics can
increase the risk of nephrotoxicity of NSAIDs.
In particular, concomitant use of potassium-sparing diuretics may increase
the risk of hyperkalaemia.



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 and phenytoin: There is evidence for potential increases in
plasma levels of these medicinal products when co-administered with
ibuprofen. If used correctly, monitoring of the plasma concentrations of
lithium or phenytoin is usually not needed.



Probenecid and sulfinpyrazon: Medicinal products that contain
probenecid or sulfinpyrazon may delay the excretion of ibuprofen.



Methotrexate: There is a potential for an increase in plasma methotrexate.

4.6



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.



Oral hypoglycemic agents: Inhibition of metabolism of sulfonylurea
drugs, prolonged half-life and increased risk of hypoglycaemia.

Fertility, pregnancy and lactation
Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the
embryo/foetal development.
Data from epidemiological studies suggest an increased risk of miscarriage and of
cardiac malformations and gastroschisis after use of prostaglandin synthesis inhibitors
in early pregnancy. The risk is believed to increase with dose and duration of therapy.
In animals, administration of a prostaglandin synthesis inhibitor has been shown to
result in increased pre- and post-implantation loss and embryo-foetal lethality. In
addition, increased incidences of various malformations, including cardiovascular,
have been reported in animals given a prostaglandin synthesis inhibitor during the
organogenetic period.
During the first and second trimester of pregnancy, ibuprofen should not be given
unless clearly necessary. If ibuprofen is used by a woman attempting to conceive, or
during the first and second trimester of pregnancy, the dose should be kept as low and
duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may
expose the foetus to:
-

cardiopulmonary toxicity (with premature closure of the ductus arteriosus and
pulmonary hypertension);

-

renal dysfunction, which may progress to renal failure with oligohydroamniosis; the mother and the neonate, at the end of pregnancy, to:

-

possible prolongation of bleeding time, an anti-aggregating effect which may
occur even at very low doses.

inhibition of uterine contractions resulting in delayed or prolonged labour.
Consequently, ibuprofen is contraindicated during the third trimester of pregnancy
(see section 4.3).
Breastfeeding
Ibuprofen and its metabolites pass only in low concentrations into breast milk. Since
harmful effects to infants have not become known to date, interruption of breastfeeding is usually not necessary during short-term treatment with the recommended
dose (see section 4.2).
Fertility
There is some evidence that drugs which inhibit cylooxygenase/prostglandin
synthesis may cause impairment of female fertility by an effect on ovulation. This is
reversible on withdrawal of treatment.
See section 4.4 regarding female fertility.

4.7

Effects on ability to drive and use machines
Ibuprofen has no expected influence 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) Assorted skin disorders, including rashes of various types, pruritus, urticaria,
purpura, 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 longterm 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, 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 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 StevensJohnson 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).
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is
important. It allows continued monitoring of the benefit/risk balance of the medicinal
product. Healthcare professionals are asked to report any suspected adverse reactions
via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard.

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 maintainance 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
ATC code: M01A E01 Propionic acid derivative NSAID
Ibuprofen is a propionic acid derivative NSAID that has demonstrated its efficacy by
inhibition of prostaglandin synthesis. In humans ibuprofen reduces inflammatory
pain, swellings and fever. Furthermore, ibuprofen reversibly inhibits platelet
aggregation.
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 within 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 clinically 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
The sub-chronic and chronic toxicity of ibuprofen in animal experiments showed up
mainly in form of lesions and ulcerations in the gastro-intestinal tract. In vitro and in
vivo studies gave no clinically relevant evidence of a mutagenic potential of
ibuprofen. In studies in rats and mice no evidence of carcinogenic effects of ibuprofen
was found. Ibuprofen led to an inhibition of ovulation in rabbits and impaired
implantation in various animal species (rabbit, rat, mouse). Experimental studies in
rats and rabbits have shown that ibuprofen crosses the placenta. Following
administration of maternotoxic doses, an increased rate of malformations (ventricular
septal defects) occurred in the progeny of rats.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Gelatin
Purified
water
Glucose,
liquid
Sucrose
Fumaric acid (E297)
Sucralose
Citric acid (E330)
Acesulfame K (E950)
Disodium edentate
Glycerin
Natural Orange
Flavour*
Red iron oxide (E172)
Yellow iron oxide
(E172)

*The flavour contains: (R)-p-mentha-1,8-diene (d-limonene), Ethyl acetate and
Alpha-Pinene

Capsule printing
Opacode White NS-78-18011**
**The ink contains: Purified water, titanium dioxide (E171), propylene glycol,
isopropyl alcohol, HPMC 2910/hypromellose 3cP (E464)
Processing Aids
Medium Chain
Triglycerides Isopropyl
alcohol
Lecithin (derived from soya)
Stearic acid

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
24 months.

6.4

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

6.5

Nature and contents of container
Blisters formed of PVC/PE/PVdC/Al packed into cartons.
Each carton may contain 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, or 32
capsules.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser Healthcare (UK) Ltd,
103 – 105 Bath Road,
Slough
SL1 3UH
UK

8

MARKETING AUTHORISATION NUMBER(S)
PL 00063/0721

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
14/11/2013

10

DATE OF REVISION OF THE TEXT
30/10/2015

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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