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NUROFEN EXPRESS 684MG CAPLETS

Active substance(s): IBUPROFEN LYSINE / IBUPROFEN LYSINE / IBUPROFEN LYSINE

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Nurofen Maximum Strength Migraine Pain 684mg Caplets
Nurofen Express 684mg Caplets

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Ibuprofen Lysine 684mg/tablet (equivalent to 400mg ibuprofen)
For excipients, see 6.1

3

PHARMACEUTICAL FORM
Coated tablet
A white, film-coated, capsule-shaped tablet, printed with an identifying logo in
black on one face.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
For the relief of headache and migraine

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:
Undesirable effects may be minimised by using the lowest effective dose for the
shortest duration necessary to control symptoms (see section 4.4).

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: Take 1 caplet with water,

up to three times a day as required.
Adults: Take 1 caplet with water, up to three times a day as required.
Leave at least 4 hours between doses.
Do not take more than 3 caplets in any 24 hour period.

4.3

Contraindications
Hypersensitivity to ibuprofen or any of the excipients 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
anti-inflammatory 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.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see
section 4.4)
Last trimester of pregnancy (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 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 studies suggest that use of ibuprofen, particularly at a high dose
(2400mg/day) 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/day) is associated with an increased risk of arterial thrombotic
events.
Patients with uncontrolled hypertension, congestive heart failure (NYHA II-III),
established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular
disease should only be treated with ibuprofen after careful consideration and high
doses (2400 mg/day) should be avoided.
Careful consideration should also be exercised before initiating long-term treatment
of patients with risk factors for cardiovascular events (e.g. hypertension,
hyperlipidaemia, diabetes mellitus, smoking), particularly if high doses of ibuprofen
(2400 mg/day) are required.

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 any time 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,
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.
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
• or the patient is under 12 years of age.
Speak to your doctor or pharmacist before use if you
• have or have had asthma, diabetes, high cholesterol, high blood pressure, a
stroke, heart, liver, kidney or bowel problems
• are a smoker
• are pregnant
If symptoms persist or worsen, or if new symptoms occur, consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
Ibuprofen (like other NSAIDs) should be avoided in combination with:
Aspirin (acetylsalicylic acid):
Concomitant administration of ibuprofen and acetylsalicylic acid is not
generally recommended because of the potential of increased adverse effects,
unless low-dose aspirin (not above 75mg daily) has been advised by a doctor
(see section 4.4).
Experimental data suggest that ibuprofen may competitively inhibit the effect
of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are
dosed concomitantly. Although there are uncertainties regarding extrapolation
of these data to the clinical situation, the possibility that regular, long-term use
of ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic
acid cannot be excluded. 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:
Corticosteroids: as these may increase the risk of gastrointestinal ulceration or
bleeding (see section 4.4)
Antihypertensives (ACE inhibitors and Angiotensin II Antagonists) and
diuretics: since NSAIDs may diminish the effects of these drugs. In some
patients with compromised renal function (e.g. dehydrated patients or elderly
patients with compromised renal function) the co-administration of an ACE
inhibitor or Angiotensin II antagonist and agents that inhibit cyclo-oxygenase
may result in further deterioration of renal function, including possible acute
renal failure, which is usually reversible. These interactions should be
considered in patients taking a coxib concomitantly with ACE inhibitors or
angiotensin II antagonists. Therefore, the combination should be administered
with caution, especially in the elderly. Patients should be adequately hydrated
and consideration should be given to monitoring of renal function after
initiation of concomitant therapy, and periodically thereafter. 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):
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 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
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 malformation and

gastroschisis after use of a prostaglandin synthesis inhibitor in early
pregnancy. The absolute risk for cardiovascular malformation was increased
from less than 1%, up to approximately 1.5%. 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 preand post-implantation loss and embryofoetal 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, Nurofen should not be
given unless clearly necessary. If Nurofen 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 the 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, Nurofen is contraindicated during the third trimester of
pregnancy.
Lactation/Breastfeeding:
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
Adverse events which have been associated with Ibuprofen are given below,
listed by system organ class and frequency. Frequencies are defined as: very
common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to
<1/100), rare (≥1/10,000 to <1/1000), very rare (<1/10,000) and not known
(cannot be estimated from the available data). Within each frequency
grouping, adverse events are presented in order of decreasing seriousness.
The list of the following adverse effects relates to those experienced with
ibuprofen at OTC doses (maximum 1200mg per day) for short-term use. In the
treatment of chronic conditions, under long-term treatment, additional adverse
effects may occur.
The adverse events observed most often are gastrointestinal in nature. Adverse
events are mostly dose-dependent, in particular the risk of occurrence of
gastrointestinal bleeding is dependent on the dosage range and duration of
treatment.
Clinical studies suggest that the use of ibuprofen, particularly at a high dose
(2400mg/day) may be associated with a small increased risk of arterial
thrombotic events (for example myocardial infarction or stroke) (see section
4.4).
System Organ
Class

Frequency

Adverse Event

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.
Hypersensitivity reactions
consisting of1:

Blood and
Lymphatic
System Disorders

Immune System
Disorders
Uncommon

Urticaria and pruritus
Very rare

Not Known

Severe hypersensitivity
reactions.
Symptoms could be facial,
tongue and laryngeal swelling,
dyspnoea, tachycardia,
hypotension (anaphylaxis,
angioedema or severe shock).
Respiratory tract reactivity
comprising asthma, aggravated

asthma, bronchospasm or
dyspnoea.
Nervous System
Disorders

Uncommon

Headache

Very rare

Aseptic meningitis2

Cardiac Disorders

Not Known

Cardiac failure and oedema

Vascular Disorders

Not Known

Hypertension

Gastrointestinal
Disorders

Uncommon

Abdominal pain, nausea,
dyspepsia

Rare

Very rare

Not Known

Diarrhoea, flatulence,
constipation and
vomiting
Peptic ulcer, perforation or
gastrointestinal haemorrhage,
melaena, haematemesis,
sometimes fatal, particularly in
the elderly. Ulcerative
stomatitis, gastritis

Hepatobiliary
Disorders
Skin and
Subcutaneous
Tissue Disorders

Very rare

Exacerbation of colitis and
Crohn's disease (section 4.4).
Liver disorders

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.

Renal and Urinary
Disorders

Very rare

Acute renal failure, papillary
necrosis, especially in long-term
use, associated with increased
serum urea and oedema.

Not Known
Renal insufficiency
Investigations

Very rare

Description of Selected Adverse Reactions

Decreased haemoglobin levels

1

Hypersensitivity reactions have been reported following treatment with
ibuprofen. These may consist of (a) non-specific allergic reactions and
anaphylaxis, (b) respiratory tract activity comprising asthma, aggravated
asthma, bronchospasm, dyspnoea or (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).

2

The pathogenic mechanism of drug-Induced aseptic meningitis is not fully
understood. However, the available data on NSAID-related aseptic meningitis
points to a hypersensitivity reaction (due to a temporal relationship with drug
intake, and disappearance of symptoms after drug discontinuation). Of note,
single cases of symptoms of aseptic meningitis (such as stiff neck, headache,
nausea, vomiting, fever or disorientation) have been observed during treatment
with ibuprofen, in patients with existing auto-immune disorders (such as
systemic lupus erythematosus, mixed connective tissue disease).
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 400mg/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.

5.1

Pharmacodynamic properties
ATC Code: M01AE01 Pharmacotherapeutic group: Anti-inflammatory and
anti-rheumatic products, non-steroids; propionic acid derivative.Ibuprofen
lysine is the lysine salt of ibuprofen. 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 competitively inhibit the effect
of low dose aspirin (acetylsalicylic acid) on platelet aggregation when they are
dosed concomitantly. Some pharmacodynamics studies show that when single
doses of ibuprofen 400mg were taken within 8 h before or within 30 min after
immediate release aspirin (acetylsalicylic acid) dosing (81mg), a decreased
effect of (acetylsalicylic acid) on the formation of thromboxane or platelet
aggregation occurred. Although there are uncertainties regarding extrapolation
of these data to the clinical situation, the possibility that regular, long-term use of
ibuprofen may reduce the cardioprotective effect of low-dose acetylsalicylic acid
cannot be excluded. No clinically relevant effect is considered to be likely for

occasional ibuprofen use (see section 4.5).
Each tablet contains 684mg of ibuprofen lysine. Following oral administration,
ibuprofen lysine dissociates to ibuprofen acid and lysine. Lysine has no
recognised pharmacological activity. The pharmacological properties of
ibuprofen lysine, therefore, are the same as those of ibuprofen acid.

5.2

Pharmacokinetic properties

Most pharmacokinetic data obtained following the administration of ibuprofen
acid also apply to ibuprofen lysine.
Ibuprofen is well absorbed from the gastrointestinal tract. Ibuprofen is
extensively bound to plasma proteins. Maximum plasma concentrations are
reached 45 minutes after ingestion if taken on an empty stomach. When taken
with food peak serum concentration occurs 1 - 2 hours after administration.
However, ibuprofen is more rapidly absorbed from the gastrointestinal tract
following the administration of Ibuprofen Lysine 400mg Tablets, with peak
serum concentration occurring approximately 38 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 SmPC.

6.1

List of excipients

Povidone, sodium starch glycollate, magnesium stearate, hypromellose, talc,
Opaspray White M-1-7111B (contains hypromellose and titanium dioxide (E171))
and Black Printing Ink (contains shellac, Iron oxide black (E172) and propylene
glycol).
6.2

Incompatibilities
Not applicable

6.3

Shelf life
36 months

6.4

Special precautions for storage
Do not store above 25ºC. Store in the original container.

6.5

Nature and contents of container

A blister pack consisting of opaque, white 250μm polyvinyl chloride
(PVC)/40gsm polyvinylidene chloride (PVdC) laminate heat sealed to 20μm
aluminium foil. The blisters are packed in cardboard cartons.
Or
A blister pack consisting of opaque, white 250μm polyvinyl chloride
(PVC)/90gm² polyvinylidene chloride (PVdC) laminate heat sealed to 20μm
aluminium foil. The blisters are packed in cardboard cartons.
Or
A blister pack consisting of opaque, white 250μm polyvinyl chloride
(PVC)/120gm² polyvinylidene chloride (PVdC) laminate heat sealed to 20μm
aluminium foil. The blisters are packed in cardboard cartons.
Pack sizes: 4, 6, 8, 10, 12, 16, 24 tablets
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 00063/0384

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
17/01/2006

/

24/11/2010

10

DATE OF REVISION OF THE TEXT
01/12/2015

11

DOSIMETRY (IF APPLICABLE)

12

INSTRUCTIONS FOR PREPARATION OF
RADIOPHARMACEUTICALS (IF APPLICABLE)

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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