NUROFEN EXPRESS 256 MG TABLETS

Active substance: SODIUM IBUPROFEN DIHYDRATE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nurofen Express 256 mg Tablets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen 200 mg (as sodium dihydrate).
Also contains the following excipients:
carmellose sodium
xylitol
sucrose
For a full list of excipients, see Section 6.1.

3

PHARMACEUTICAL FORM
Tablet
A white to off-white, biconvex, round, sugar coated tablet printed with an identifying
logo in black on one face.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the symptomatic relief of mild to moderate pain, such as headache, backache,
period pain, dental pain, neuralgia, rheumatic and muscular pain, migraine, cold and
flu symptoms, sore throat and fever.

4.2

Posology and method of administration
For oral administration and short-term use only.
Adults, the elderly and children and adolescents between 12 and 18 years:
The lowest effective dose should be used for the shortest duration necessary to relieve
symptoms.

If in children and adolescents this medicinal product is required for more than
3 days, or if symptoms worsen a doctor should be consulted.
Adults should consult a doctor if symptoms persist or worsen, or if the product is
required for more than 10 days.

Children and Adolescents between 12 and 18 years: Initial dose, 200mg to 400mg,
up to three times a day as required.
Adults: Initial dose, 200mg to 400mg, up to three times a day as required.
Leave at least four hours between doses and do not take more than 1200mg in any 24
hour period.
Not for use by children under 12 years of age.
Elderly: No special dosage modifications are required (see Section 4.4).

4.3

Contraindications

Patients with a known hypersensitivity to ibuprofen or any other constituent of the
medicinal product.
Patients who have previously shown hypersensitivity reactions (e.g. asthma, rhinitis,
angioderma 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 gastrointestinal bleeding or perforation, related to previous NSAIDs
therapy.
Patients with severe hepatic failure, severe renal failure or severe heart failure. See
also section 4.4.
Patients with rare hereditary problems of fructose intolerance, glucose-galatose
malabsorption or sucrase-isomaltase insufficiency should not take this medicine.
Use with concomitant NSAIDs, including cyclo-oxygenase-2 specific inhibitors –
increased risk of adverse reactions (see section 4.5).
During the last trimester of pregnancy 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 4.6).

4.4

Special warnings and precautions for use
Undesirable effects may be minimised by using the lowest effective dose for the
shortest possible 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 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).
Renal:
Renal impairment as renal function may further deteriorate (see sections 4.3 and 4.8).

There is a risk of renal impairment in dehydrated children and adolescents
Hepatic:
Hepatic dysfunction (see sections 4.3 and 4.8).
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 the use of ibuprofen, particularly
at high doses (2400 mg 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. 1200 mg daily) is associated with an increased risk of myocardial infarction.



Impaired female fertility:
There is some evidence that drugs which inhibit cyclooxygenase/prostaglandin
synthesis may cause impairment of female fertility by an effect on ovulation. This is
reversible on 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 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 the 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 of 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.
Each tablet contains 24.3 mg (approximately 1.06 mmol) sodium. This should be
considered in patients whose overall intake of sodium must be markedly restricted.
The label will include:
Read the enclosed leaflet before taking this product
Do not take if you:


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



are allergic to ibuprofen, to any of the ingredients, or to aspirin or other
painkillers



are taking other NSAID pain killers or aspirin with a daily dose above 75mg

Speak to a pharmacist or your doctor before taking if you:


have or have had asthma, diabetes, high cholesterol, high blood pressure, a stroke,
heart, liver, kidney or bowel problems or are dehydrated



are a smoker



are pregnant



are on a restricted sodium intake

If symptoms persist or worsen, or if new symptoms occur, consult your doctor or
pharmacist.

Interaction with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) 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).



4.5

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 (see section 4.4).

Ibuprofen should be used with caution in combination with:


Corticosteroids: as these may increase the risk of gastrointestinal ulceration
or bleeding (see Section 4.4)



Antihypertensives and diuretics: since NSAIDs may diminish the effects of
these drugs. Diuretics can increase the risk of nephrotoxicity of NSAIDs.



Anticoagulants. NSAIDs may enhance the effects of anti-coagulants, such as
warfarin (see section 4.4).



Antiplatelet agents and selective serotonin reuptake inhibitors (SSRIs): These
can increase the 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 increase in plasma levels of lithium.



Methotrexate: There is evidence for the potential increase in plasma levels of
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
No specific studies have been conducted with sodium ibuprofen.
Whilst no teratogenic effects have been demonstrated with ibuprofen acid in animal
experiments, the use of the product during pregnancy should, if possible, be avoided
during the first 6 months of pregnancy. It should not be used for the last trimester of
pregnancy 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
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 dose 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 e.g. 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 list of the following 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 pruritis.
Very rare: severe hypersensitivity reactions. Symptoms could be facial, tongue and
larynx swelling, dysponoea, tachycardia, hypotension, (anaphylaxis, angioedema or
severe shock).
Exacerbation of asthma and bronchospasm.
Gastrointestinal disorders:
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 (see section 4.4). 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.
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.
Blood:
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.
Dermatological:
Very rare: Severe forms of skin reactions such as bullous reaction, including StevensJohnson Syndrome, erythema multiform and toxic epidermal necrolysis can occur.
Uncommon: Various skin rashes.
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
Pharmacotherapeutic group: propionic acid derivative
ATC Code: M01A E01
Ibuprofen is an NSAID that has demonstrated its efficacy in the common animal
experimental inflammation models by inhibition of prostaglandin synthesis. In
humans, ibuprofen reduces inflammatory pain, swellings and fever. Furthermore,
ibuprofen reversibly inhibits platelet aggregation.
The clinical efficacy of ibuprofen has been demonstrated in pain associated with
headache, toothache and dysmenorrhoea and fever; furthermore in patients with pain
and fever associated with cold and flu and in pain models such as sore throat,
muscular pain or soft tissue injury and backache.
A study in dental pain has shown that patients experienced statistically significant
pain relief in 15 minutes after the administration of 2 x Nurofen Express 256 mg
Tablets, compared with placebo. In this study, significantly more patients achieved
meaningful pain relief after administration of 2 x Nurofen Express 256 mg Tablets
than after administration of paracetamol tablets (96.3% vs 67.9%). These patients also
achieved significantly greater reduction in pain intensity and greater pain relief over 6
hours compared with patients receiving paracetamol. Using measures of
distractibility, patients receiving sodium ibuprofen experienced significantly greater
benefit than those receiving placebo.
Clinical evidence demonstrates that ibuprofen, in the form of salts such as ibuprofen
sodium and ibuprofen lysine, acts significantly faster than standard ibuprofen acid
tablets for the relief of mild-moderate pain.
Clinical evidence demonstrates that when 400mg of ibuprofen is taken the pain
relieving effects can last for up to 8 hours.
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 relevant effect is considered to be likely for occasional ibuprofen use.

5.2

Pharmacokinetic properties
Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is extensively
bound to plasma proteins. Ibuprofen diffuses into the synovial fluid.
Maximum plasma concentrations of ibuprofen are reached 45 minutes after ingestion
if taken on an empty stomach. When taken with food, peak plasma concentration of
ibuprofen occurs 1 - 2 hours after administration. However, ibuprofen is more rapidly
absorbed from the gastrointestinal tract following the administration of Nurofen
Express 256mg Tablets, with peak plasma concentration occurring approximately 35
minutes after administration when taken on an empty stomach.
Ibuprofen is metabolised in the liver to two major metabolites with primary excretion
via the kidneys, either as such or as major conjugates, together with a negligible
amount of unchanged ibuprofen. Excretion by the kidney is both rapid and complete.
Elimination half-life is approximately 2 hours.
No significant differences in pharmacokinetic profile are observed in the elderly.
In limited studies, ibuprofen appears in the breast milk in very low concentrations.

5.3

Preclinical safety data
No relevant information, additional to that contained elsewhere in the SPC.

6.1

List of excipients
Tablet core
Croscarmellose sodium (E468)
Xylitol (E967)
Microcrystalline cellulose (E460)
Magnesium stearate (E572)
Colloidal anhydrous silica (E551)
Coating ingredients
Carmellose sodium (E466),
Talc (E553b),
Acacia spray dried (E414),
Sucrose,
Titanium dioxide (E171),
Macrogol 6000 powder,

Tablet printing

Black Printing Ink
The ink contains the following residual materials after application: shellac (E904),
iron oxide black (E172), propylene glycol (E1520).

6.2

Incompatibilities
Not applicable.

6.3

Shelf life
2 years.

6.4

Special precautions for storage
Store in the original package.

6.5

Nature and contents of container
A push through laminate blister tray consisting of opaque, white 250 micron PVC
with 40 gsm polyvinylidene chloride (PVdC), heat-sealed to 20 micron aluminium
foil.
The blister trays are packed into either a cardboard carton or a plastic, moulded
acrylonitrile butadiene styrene (ABS) case.
Each carton will contain 2, 3, 4, 5, 6, 8, 10, 12, 14, 15, 16 tablets
Not all packs will be marketed.

6.6

Special precautions for disposal
Not applicable.

7

MARKETING AUTHORISATION HOLDER
Reckitt Benckiser (UK) Ltd, Dansom Lane, Hull HU8 7DS UK

8

MARKETING AUTHORISATION NUMBER(S)
00063/0372

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
03/06/2008

10

DATE OF REVISION OF THE TEXT
16/09/2014

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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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