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IBUPROFEN CAPLETS 200 MG

Active substance(s): IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS
1

NAME OF THE MEDICINAL PRODUCT
Ibuprofen Caplets 200mg

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Active ingredient
Ibuprofen

mg/tablet
200mg

Each tablet contains 13.333mg lactose monohydrate.
For full list of excipients see section 6.1.

3

PHARMACEUTICAL FORM
Film-coated Tablets (Tablets)
A white, pillow-shaped, film-coated, tablet

4.

CLINICAL PARTICULARS

4.1.

Therapeutic Indications
POM:
For its analgesic anti-inflammatory effects in the treatment of rheumatoid arthritis (including
juvenile rheumatoid arthritis or Still’s disease), ankylosing spondylitis, osteoarthritis, other
non-rheumatoid (seronegative) arthropathies. In the treatment of non-articular rheumatic
conditions, ibuprofen is indicated in periarticular conditions such as frozen shoulder
(capsulitis), bursitis, tendonitis, tenosynovitis, low back pain and soft tissue injuries such as
sprains and strains.
Ibuprofen is also indicated for its analgesic effect in the relief of mild to moderate pain such as
dysmenorrhoea, dental and post-operative pain and for the symptomatic relief of headache,
including migraine headache.
P:
For the relief of pain of non-serious arthritic conditions and for the relief of rheumatic or
muscular pain, backache, neuralgia, headache including migraine headache, dental pain,
dysmenorrhoea, feverishness and the symptoms of colds and influenza.
GSL:
For the relief of rheumatic or muscular pain, backache, neuralgia, headache including
migraine headache, dental pain, dysmenorrhoea, feverishness and the symptoms of colds and
influenza.

4.2

Posology and method of administration
POM:
For oral administration.
To be taken preferably with or after food.

Undesirable effects may be minimised by using the lowest effective dose for
the shortest duration necessary to control symptoms (see section 4.4).
Adults and Children over 12 years:
The recommended dosage is 1200 - 1800mg daily in divided doses. Some patients can be
maintained on 600 - 1200mg daily. In severe or acute conditions it can be advantageous to
increase the dosage until the acute phase is brought under control, provided that the daily dose
does not exceed 2400mg in divided doses.
Children under 12 years:
The daily dosage is 20mg/kg of body weight in divided doses.
In juvenile rheumatoid arthritis up to 40mg/kg of body weight daily in divided doses may be
taken. Not recommended for children weighing less than 7kg.
Adolescents (12-18 years old):
If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor
should be consulted.
Elderly:
No special dosage modifications are required, unless renal or hepatic function is impaired, in
which case dosage should be assessed individually.
The elderly are at increased risk of the serious consequences of adverse reactions. If an
NSAID is considered necessary, the lowest effective dose should be used and for the shortest
possible duration. The patient should be monitored regularly for GI bleeding during NSAID
therapy.

P and GSL:
For oral administration and 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).
Adults, the elderly and children over 12 years:

The lowest effective dose should be used for the shortest duration necessary to
relieve symptoms. The patient should consult a doctor if symptoms persist or
worsen, or if the product is required for more than 10 days.
One to two (200-400 mg) tablets to be taken up to three times a day, as required.
Leave at least four hours between doses and do not take more than 6 tablets (1200mg) in any
24 hour period.
Adolescents (12-18 years old):
If this medicinal product is required for more than 3 days, or if symptoms worsen a doctor
should be consulted.
Children under 12 years:
Not suitable for children under 12 years.

4.3

Contraindications
POM, P/GSL
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 ibuprofen, 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.
Severe heart failure (NYHA Class IV), renal failure or hepatic failure (see section 4.4).
Last trimester of pregnancy (see section 4.6).

P/GSL only
Children under 12 years.

4.4

Special warnings and precautions for use
POM
Undesirable effects may be minimised by using the lowest effective dose for the shortest
duration necessary to control symptoms (see section 4.2 and GI and cardiovascular risks
below).
The use of ibuprofen with concomitant NSAIDs including cyclo-oxygenase-2 selective
inhibitors should be avoided (see section 4.5).
Elderly:
The elderly have an increased frequency of adverse reactions to NSAIDs especially
gastrointestinal bleeding and perforation, which may be fatal (see section 4.2).
Respiratory disorders:
Caution is required if administered to patients suffering from, or with a previous history of,
bronchial asthma, since NSAIDs have been reported to precipitate bronchospasm in such
patients.
Cardiovascular, Renal and Hepatic impairment:
The administration of an NSAID may cause a dose dependent reduction in prostaglandin
formation and precipitate renal failure. Patients at greatest risk of this reaction are those with
impaired renal function, cardiac impairment, liver dysfunction, those taking diuretics and the
elderly. Renal function should be monitored in these patients (See also section 4.3).
There is a risk of renal impairment in dehydrated children and adolescents.
Cardiovascular and cerebrovascular effects:

Appropriate monitoring and advice are required for patients with a history of
hypertension and/or mild to moderate congestive heart failure as fluid
retention and oedema have been reported in association with NSAID therapy.

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400
mg/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. ≤ 1200 mg/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.
Gastrointestinal bleeding, ulceration and perforation:
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
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 section
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.
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).
SLE and mixed connective tissue disease:
In patients with systemic lupus erythematosus (SLE) and mixed connective tissue disorders
there may be an increased risk of aseptic meningitis (See section 4.8).

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.
Exceptionally, varicella can be at the origin of serious cutaneous and soft tissue 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 (see
section 4.8).

Impaired female fertility:
The use of ibuprofen may impair female fertility and is not recommended in women
attempting to conceive. In women who have difficulties conceiving or who are undergoing
investigation of infertility, withdrawal of ibuprofen should be considered.
P/GSL

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 cyclo-oxygenase-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 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
(2400 mg/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. ≤
1200 mg/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 limited evidence that drugs which inhibit cyclooxygense/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 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 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 NSAIDSs (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 tissue 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 (see
section 4.8).
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 or any other ingredient of the product, aspirin or other related
painkillers
are taking other NSAID painkillers, or aspirin with a daily dose above 75 mg

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

are a smoker

are pregnant

If symptoms persist or worsen, consult your doctor.

4.5

Interaction with other medicinal products and other forms of interaction
POM
Other analgesics including cyclo-oxygenase-2 selective inhibitors: Avoid concomitant use of
two or more NSAIDs (including aspirin) as this may increase the risk of adverse effects (see
section 4.4).
Acetylsalicylic Acid: Concomitant administration of ibuprofen and acetylsalicylic acid is not
generally recommended because of the potential of increased adverse effects.
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose
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).
Anti-hypertensives: Reduced anti-hypertensive effect.
Diuretics: Reduced diuretic effect. Diuretics can increase the risk of nephrotoxicity of
NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma
cardiac glycoside levels.
Lithium: Decreased elimination of lithium.
Methotrexate: Decreased elimination 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 effects of mifepristone.
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding (see section 4.4).
Anticoagulants: NSAIDs may enhance the effects of anti-coagulants, such as warfarin (see
section 4.4).
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.
Anti-platelet agents and selective serotonin-reuptake inhibitors (SSRIs): Increased risk of
gastrointestinal bleeding (see section 4.4).
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 of haemarthroses and haematoma in
HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

P/GSL
Ibuprofen should be avoided in combination with:
Acetylsalicylic acid: Unless low-dose aspirin (not above 75mg daily) has been
advised by a doctor. Concomitant administration of ibuprofen and
acetylsalicylic acid is not generally recommended because of the potential of
increased adverse effects (see section 4.4).
Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose
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 cyclo-oxygenase-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: Increased 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 of
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

POM
Congenital abnormalities have been reported in association with NSAID administration in
man; however, these are low in frequency and do not appear to follow any discernible pattern.
In view of the known effects of NSAIDs on the foetal cardiovascular system (risk of closure
of the ductus arteriosus) use in the last trimester of pregnancy is contraindicated. 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). NSAIDs should not be used during the first two trimesters
of pregnancy or labour unless the potential benefit to the patient outweighs the potential risk
to the foetus.
P/GSL

Whilst no teratogenic effects have been demonstrated in animal experiments,
the use of ibuprofen 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).
Lactation

POM
In limited studies so far available, NSAIDs can appear in breast milk in very low
concentrations. NSAIDs should, if possible, be avoided when breastfeeding.

P/GSL
In limited studies, ibuprofen appears in the breast milk in very low
concentration and is unlikely to affect the breast-fed infant adversely.

POM/P/GSL
See section 4.4 regarding female fertility.

4.7.

Effects on ability to drive and use machines
POM

Undesirable effects such as dizziness, drowsiness, fatigue and visual
disturbances are possible after taking NSAIDs. If affected, patients should not
drive or operate machinery.
P
None expected at recommended doses and duration of therapy.

4.8

Undesirable effects
The following frequencies are taken as a basis when evaluating undesirable

effects:
Very common:
Common:
Uncommon:
Rare:
Very rare:
Not known:

≥ 1/10
≥ 1/100 to < 1/10
≥ 1/1,000 to < 1/100
≥ 1/10,000 to < 1/1,000
> 1/10,000
cannot be estimated from the available data

POM
Infections and infestations:
Very rare: Exacerbation of infection-related inflammations (e.g. development
of necrotising fasciitis) coinciding with the use of non-steroidal antiinflammatory drugs has been described. This is possibly associated with the
mechanism of action of the non-steroidal anti-inflammatory drugs. If signs of
an infection occur or get worse during use of Ibuprofen the patient is therefore
recommended to go to a doctor without delay. It is to be investigated whether
there is an indication for anti-infective/antibiotic therapy.
Haematological:
Not known: Thrombocytopenia, neutropenia, agranulocytosis, aplastic
anaemia and haemolytic anaemia.
Hypersensitivity:
Not known: Hypersensitivity reactions have been reported following treatment
with NSAIDs. These may consist of (a) non-specific allergic reactions and
anaphylaxis, (b) respiratory tract reactivity comprising asthma, aggravated
asthma, bronchospasm or 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).
Neurological and special senses:
Not known: Visual disturbances, optic neuritis, headaches, paraesthesia,
reports of aseptic meningitis (especially in patients with existing auto-immune
disorders, such as systemic lupus erythematosus, mixed connective tissue
disease), with symptoms such as stiff neck, headache, nausea, vomiting, fever

or disorientation (see section 4.4), depression, confusion, hallucinations,
tinnitus, vertigo, dizziness, malaise, fatigue and drowsiness.
Gastrointestinal:
Not known: The most commonly observed adverse events are gastrointestinal
in nature. Peptic ulcers, perforation or GI bleeding, sometimes fatal,
particularly in the elderly, may occur (see section 4.4).
Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal
pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and
Crohn's disease (see section 4.4) have been reported following administration.
Less frequently, gastritis has been observed. Pancreatitis has been reported
very rarely.
Cardiovascular and cerebrovascular:
Not known: Oedema, hypertension and cardiac failure have been reported in
association with NSAID treatment.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400
mg/day) may be associated with a small increased risk of arterial thrombotic
events (for example myocardial infarction or stroke) (see section 4.4).
Hepatic:
Not known: Abnormal liver function, hepatitis and jaundice.
Skin and subcutaneous tissue disorders:
Very rare: Bullous reactions including Stevens Johnson syndrome and Toxic
Epidermal Necrolysis
Not known: In exceptional cases, severe skin infections and soft-tissue
complications may occur during a varicella infection (see also "Infections and
infestations"). Photosensitivity. Drug reaction with eosinophilia and systemic
symptoms (DRESS syndrome).
Renal:
Not known: Nephrotoxicity in various forms, including interstitial nephritis,
nephrotic syndrome and renal failure.
P/GSL
Infections and infestations:
Very rare: Exacerbation of infection-related inflammations (e.g. development
of necrotising fasciitis) coinciding with the use of non-steroidal antiinflammatory drugs has been described. This is possibly associated with the
mechanism of action of the non-steroidal anti-inflammatory drugs. If signs of
an infection occur or get worse during use of Ibuprofen the patient is therefore
recommended to go to a doctor without delay. It is to be investigated whether
there is an indication for anti-infective/antibiotic therapy.
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.
Immune System:
Not known: 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).
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).
Not known: Respiratory tract reactivity, e.g. asthma, aggravated asthma,
bronchospasm, dyspnoea. Exfoliative and bullous dermatoses (including
epidermal necrolysis and erythema multiforme).
Nervous System:
Uncommon: Headache.
Very rare: Aseptic meningitis – single cases have been reported very rarely.
Cardiovascular and Cerebrovascular:
Not known: Oedema, hypertension and cardiac failure have been reported in
association with NSAID treatment.
Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400
mg/day) may be associated with a small increased risk of arterial thrombotic
events (for example myocardial infarction or stroke) (see section 4.4).
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).
Hepatic:
Very rare: Liver disorders.
Skin and subcutaneous tissue disorders
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.
Not known: In exceptional cases, severe skin infections and soft-tissue
complications may occur during a varicella infection (see also "Infections and
infestations"). Drug reaction with eosinophilia and systemic symptoms
(DRESS syndrome).

Renal:
Very rare: Acute renal failure, papillary necrosis, especially in long-term use,
associated with increased serum urea and oedema.
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 Website
www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or
Apple App Store.

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 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
acetylsalicylic acid on platelet aggregation when they are dosed concomitantly. Some
pharmacodynamic studies show that when single doses of ibuprofen 400 mg were taken
within 8 h before or within 30 min after immediate release acetylsalicylic acid dosing (81 mg),
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).

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 data of relevance to the prescriber which are additional to that already
included.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Colloidal silicon dioxide
Sodium laurilsulfate
Magnesium stearate
Hypromellose
Talc
Titanium dioxide (E171)

6.2.

Incompatibilities
Not applicable.

6.3.

Shelf Life

36 months - Amber glass bottle
36 months - Aluminium blister (Cold Form)
36 months - Aluminium blister (PVC/PVDC)
24 months - HDPE Bottle

6.4

Special precautions for storage

Bottle packs:
None
Blister pack:
(cold form aluminium): Store in a cool, dry place; below 25°C
Blister pack: (PVC/PVDC and aluminium): Do not store above 30°C
6.5.
Nature and Contents of Container
The following containers will be used.

6.6.

1.

25, 30, 32, 36, 50, 84 or 100 tablets in an amber glass bottle with a polypropylene child resistant cap
with a waxed aluminium-faced pulpboard liner or an induction heat seal liner.

2.

25, 30, 32, 36, 50, 84 or 100 tablets in a white HDPE (high-density polyethylene) bottle with a
polyethylene/polypropylene child resistant cap with a waxed aluminium faced liner or an induction
heat sealed liner including aluminium/surlyn or aluminium/polyethylene.

3.

6, 8, 10, 12, 16, 18, 20, 24, 25, 30, 32, 36, 48 or 96 tablets in an aluminium cold form blister pack,
formed from an aluminium/ nylon laminate and aluminium foil.

4.

6, 8, 10, 12, 16, 18, 20, 24, 25, 30, 32, 36, 48, 80, 84, 88, 96, 100 or 104 tablets in an aluminium blister
pack , formed from opaque PVC/PVDC and aluminium foil.

Instruction for Use/Handling
Not applicable.

7

MARKETING AUTHORISATION HOLDER
The Boots Company PLC
1 Thane Road West
Nottingham NG2 3AA

8.

MARKETING AUTHORISATION NUMBER
PL 00014/0497

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION

26/10/2008

10

DATE OF REVISION OF THE TEXT
01/02/2018

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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