Brufen is indicated for its analgesic and anti-inflammatory effects in the treatment of rheumatoid arthritis
(including juvenile rheumatoid arthritis or Still's disease), ankylosing spondylitis, osteoarthritis and other
non-rheumatoid (seronegative) arthropathies.
In the treatment of non-articular rheumatic conditions, Brufen is indicated in periarticular conditions such
as frozen shoulder (capsulitis), bursitis, tendonitis, tenosynovitis and low back pain; Brufen can also be
used in soft tissue injuries such as sprains and strains.
Brufen 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 symptomatic relief of headache, including
migraine headache.
 

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 of age: The recommended dosage of Brufen
is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg 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 total daily dose does not exceed 2400 mg in divided doses.
In Juvenile Rheumatoid Arthritis, up to 40 mg/kg of body weight daily in
divided doses may be taken.
Tablets are not suitable for children under the age of 12 years.
Elderly: The elderly are at increased risk of 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. If renal or
hepatic function is impaired, dosage should be assessed individually.
Renal impairment:
Patients with mild to moderate renal impairment, (see section 4.4 – Special
warnings and precautions for use) and patients with severe renal insufficiency
(see section 4.3 – Contraindications)
Hepatic impairment:
For patients with mild to moderate hepatic impairment (see section 4.4 Special
warnings and precautions for use) and patients with severe hepatic dysfunction
(see section 4.3-Contraindications).
For oral administration. It is recommended that patients with sensitive
stomachs take Brufen with food. If taken shortly after eating, the onset of
action of Brufen may be delayed. To be taken preferably with or after food,
with plenty of fluid. Brufen tablets should be swallowed whole and not
chewed, broken, crushed or sucked on to avoid oral discomfort and throat
irritation.
The lowest effective dose should be used for the shortest duration necessary to
relieve symptoms (see section 4.4).

Brufen is contraindicated in patients with hypersensitivity to the active substance or to any of the excipients. Brufen should not be used in patients who have previously shown hypersensitivity reactions (e.g. asthma, urticaria, angioedema or rhinitis) after taking ibuprofen, aspirin or other NSAIDs. Brufen is also contraindicated in patients with a history of gastrointestinal bleeding or perforation, related to previous NSAID therapy. Brufen should not be used in patients with active, or history of, recurrent peptic ulcer or gastrointestinal haemorrhage (two or more distinct episodes of proven ulceration or bleeding). Brufen should not be given to patients with conditions involving an increased tendency to bleeding. Brufen is contraindicated in patients with severe heart failure (NYHA Class IV), hepatic failure and renal failure (see section 4.4). Brufen is contraindicated during the last trimester of pregnancy (see section 4.6).

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).
As with other NSAIDs, ibuprofen may mask the signs of infection.
The use of Brufen with concomitant NSAIDs, including cyclooxygenase-2
selective inhibitors, should be avoided due to the increased risk of ulceration
or bleeding (see section 4.5).
The diagnosis of medication overuse headache (MOH) should be suspected in
patients who have frequent or daily headaches despite (or because of) the
regular use of analgesic medication. Patients with medication overuse
headache should not be treated by increasing the dose of the analgesic. In
such cases the use of analgesics
should be discontinued.
The concomitant consumption of excessive alcohol with NSAIDs, including
ibuprofen may increase the risk of adverse effects on the gastrointestinal tract,
such as GI haemorrhage or the central nervous system, possibly due to an
additive effect.
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).
Paediatric population
There is a risk of renal impairment in dehydrated children and adolescents.
Gastrointestinal bleeding, ulceration and perforation
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 section 4.5).
Patients with a history of gastrointestinal disease, particularly when elderly,
should report any unusual abdominal symptoms (especially gastrointestinal
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 Brufen, the
treatment should be withdrawn.
NSAIDs should be given with care to patients with a history of ulcerative
colitis or Crohn’s disease as these conditions may be exacerbated (see section
4.8).
Respiratory disorders and hypersensitivity reactions
Caution is required if Brufen is administered to patients suffering from, or
with a previous history of, bronchial asthma, chronic rhinitis or allergic
diseases since NSAIDs have been reported to precipitate bronchospasm,
urticaria or angioedema in such patients.
Cardiac, renal and hepatic impairment
The administration of an NSAID may cause a dose dependent reduction in
prostaglandin formation and precipitate renal failure. The habitual concomitant
intake of various similar painkillers further increases this risk. Patients at
greatest risk of this reaction are those with impaired renal function, cardiac
impairment, liver dysfunction, those taking diuretics and the elderly. For these
patients, use the lowest effective dose, for the shortest possible duration and
monitor renal function especially in long-term treated patients (see also section
4.3).
Brufen should be given with care to patients with a history of heart failure or
hypertension since oedema has been reported in association with ibuprofen
administration.
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 such as 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 IIIII),
established ischaemic heart disease, peripheral arterial disease, and/or
cerebrovascular disease should only be treated with ibuprofen after careful
consideration and high doses (2400mg/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 (2400mg/day) are required.
Cases of Kounis syndrome have been reported in patients treated with
ibuprofen. Kounis syndrome has been defined as cardiovascular symptoms
secondary to an allergic or hypersensitive reaction associated with constriction
of coronary arteries and potentially leading to myocardial infarction.
Renal effects
Caution should be used when initiating treatment with ibuprofen in patients
with considerable dehydration. There is a risk of renal impairment especially
in dehydrated children, adolescents and the elderly.
As with other NSAIDs, long-term administration of ibuprofen has resulted in
renal papillary necrosis and other renal pathologic changes. Renal toxicity has
also been seen in patients in whom renal prostaglandins have a compensatory
role in the maintenance of renal perfusion. In these patients, administration of
an NSAID may cause a dose-dependant reduction in prostaglandin formation
and, secondarily, in renal blood flow, which may cause renal failure. Patients
at greatest risk of this reaction are those with impaired renal function, heart
failure, liver dysfunction, those taking diuretics and ACE inhibitors and the
elderly. Discontinuation of NSAID therapy is usually followed by recovery to
the pre-treatment state.
Renal tubular acidosis and hypokalaemia may occur following acute overdose
and in patients taking ibuprofen products over long periods at high doses
(typically greater than 4 weeks), including doses exceeding the recommended
daily dose.
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
below and section 4.8).
Severe cutaneous adverse reactions (SCARs)
Severe cutaneous adverse reactions (SCARs), including exfoliative dermatitis,
erythema multiforme, Stevens-Johnson syndrome (SJS), Toxic Epidermal Necrolysis (TEN), Drug Reaction with Eosinophilia and Systemic Symptoms
(DRESS syndrome), and acute generalized exanthematous pustulosis (AGEP),
which can be life-threatening or fatal, have been reported in association with
the use of ibuprofen (see section 4.8). Most of these reactions occurred within
the first month. If signs and symptoms suggestive of these reactions appear
ibuprofen should be withdrawn immediately and an alternative treatment
considered (as appropriate).
In exceptional cases, 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.
Masking of symptoms of underlying infections
Brufen tablets can mask symptoms of infection, which may lead to delayed
initiation of appropriate treatment and thereby worsening the outcome of the
infection. This has been observed in bacterial community acquired pneumonia
and bacteria complications to varicella. When Brufen tablets is administered
for fever or pain relief in relation to infection, monitoring of infection is
advised. In nonhospital settings, the patient should consult a doctor if
symptoms persist or worsen.
Haematological effects
Ibuprofen, like other NSAIDs, can interfere with platelet aggregation and
prolong bleeding time in normal subjects.
Aseptic meningitis
Aseptic meningitis has been observed on rare occasions in patients on
ibuprofen therapy. Although it is probably more likely to occur in patients
with systemic lupus erythematosus and related connective tissue diseases, it
has been reported in patients who do not have an underlying chronic disease.
Impaired female fertility
The use of Brufen 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 Brufen should
be considered.
Excipients
Brufen tablets contain lactose monohydrate and should not be given to patients
with rare hereditary problems of galactose intolerance, total lactase deficiency
or glucose-galactose malabsorption.
This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to
say essentially ‘sodium-free’. 

are should be taken in patients treated with any of the following drugs as
interactions have been reported in some patients.
Antihypertensives, beta-blockers and diuretics: NSAIDs may reduce the effect
of anti-hypertensives, such as ACE inhibitors, angiotensin-II receptor
antagonists, beta-blockers and diuretics.
Diuretics can also increase the risk of nephrotoxicity of NSAIDs.
Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and
increase plasma cardiac glycoside levels.
Cholestyramine; The concomitant administration of ibuprofen and
cholestyramine may reduce the absorption of ibuprofen in the gastrointestinal
tract. However, the clinical significance is unknown.
Lithium: Decreased elimination of lithium.
Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and
reduce clearance of methotrexate.
Ciclosporin: Increased risk of nephrotoxicity.
Mifepristone: A decrease in the efficacy of the medicinal product can
theoretically occur due to the antiprostaglandin properties of NSAIDs. Limited
evidence suggests that coadministration of NSAIDs on the day of
prostaglandin administration does not adversely influence the effects of
mifepristone or the prostaglandin on cervical ripening or uterine contractility
and does not reduce the clinical efficacy of medicinal termination of
pregnancy.
Other analgesics and cyclooxygenase-2 selective inhibitors: Avoid
concomitant use of two or more NSAIDs, including Cox-2 inhibitors, as this
may increase the risk of adverse effects (see section 4.4).
Aspirin (Acetylsalicylic acid): As with other products containing NSAIDs,
concomitant administration of ibuprofen and aspirin 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 aspirin 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 use (see section 5.1).
Corticosteroids: Increased risk of gastrointestinal ulceration or bleeding with
NSAIDs (see section 4.4).
Anticoagulants: NSAIDs may enhance the effects of anticoagulants, 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.
Sulfonylureas: NSAIDs may potentiate the effects of sulfonylurea
medications. There have been rare reports of hypoglycaemia in patients on
sulfonylurea medications receiving ibuprofen.
Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs):
Increased risk of gastrointestinal bleeding with NSAIDs (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.
Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides.
Herbal extracts: Ginkgo biloba may potentiate the risk of bleeding with
NSAIDs.
CYP2C9 Inhibitors: Concomitant administration of ibuprofen with CYP2C9
inhibitors may increase the exposure to ibuprofen (CYP2C9 substrate). In a
study with voriconazole and fluconazole (CYP2C9 inhibitors), an increased
S(+)-ibuprofen exposure by approximately 80 to 100% has been shown.
Reduction of the ibuprofen dose should be considered when potent CYP2C9
inhibitors are administered concomitantly, particularly when high-dose
ibuprofen is administered with either voriconazole or fluconazole.

Pregnancy
Inhibition of prostaglandin synthesis may adversely affect the pregnancy
and/or embryo/foetal development. Data from epidemiological studies suggest
an increased risk of miscarriage and of cardiac malformation and gastroschisis
after the use of a prostaglandin synthesis inhibitor in early pregnancy. The risk
is believed to increase with dose and duration of therapy. In animals, the
administration of a prostaglandin synthesis inhibitor has been shown to result
in increased pre- and post-implantation losses 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. From the 20th week of pregnancy
onward, Brufen use may cause oligohydramnios resulting from foetal renal
dysfunction. This may occur shortly after treatment initiation and is usually  reversible upon discontinuation. In addition, there have been reports of ductus
arteriosus constriction following treatment in the second trimester, most of
which resolved after treatment cessation. Therefore, during the first and
second trimester of pregnancy, Brufen should not be given unless clearly
necessary. If Brufen is used by a woman attempting to conceive, or during the
first or second trimester of pregnancy, the dose should be kept as low and
duration of treatment as short as possible. Antenatal monitoring for
oligohydramnios and ductus arteriosus constriction should be considered after
exposure to ibuprofen for several days from gestational week 20 onward.
Brufen should be discontinued if oligohydramnios or ductus arteriosus
constriction are found.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors
may expose the foetus to the following:
• Cardiopulmonary toxicity (premature constriction/ closure of the ductus
arteriosus and pulmonary hypertension)
• Renal dysfunction, which may progress to renal failure with
oligohydramnios (see above).
At the end of pregnancy, prostaglandin synthesis inhibitors may expose the
mother and the neonate to the following:
• Possible prolongation of bleeding time
• Inhibition of uterine contractions, which may result in delayed or prolonged
labour.
Consequently, Brufen is contraindicated during the third trimester of
pregnancy.
Lactation
In the limited studies so far available, NSAIDs can appear in the breast milk in
very low concentrations. NSAIDs should, if possible, be avoided when
breastfeeding.
See section 4.4 Special warnings and precautions for use, regarding female
fertility.

Undesirable effects such as dizziness, drowsiness, fatigue and visual
disturbances are possible after taking NSAIDs. If affected, patients should not
drive or operate machinery.

Gastrointestinal disorders: 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, gastrointestinal haemorrhage and exacerbation of colitis and Crohn’s disease (see section 4.4) have been
reported following ibuprofen administration. Less frequently, gastritis,
duodenal ulcer, gastric ulcer and gastrointestinal perforation have been
observed.
Immune system disorders: Hypersensitivity reactions have been reported
following treatment with NSAIDs. These may consist of (a) non-specific
allergic reaction 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 very rarely, erythema multiforme, bullous dermatoses
(including Stevens-Johnson syndrome and toxic epidermal necrolysis).
Cardiac disorders and vascular disorders: Oedema, hypertension and cardiac
failure have been reported in association with NSAID treatment. Clinical
studies suggest that use of ibuprofen, particularly at high dose (2400 mg/day)
may be associated with a small increased risk of arterial thrombotic events
such as myocardial infarction or stroke (see section 4.4).
Infections and infestations: Rhinitis and aseptic meningitis (especially in
patients with existing autoimmune disorders, such as systemic lupus
erythematosus and mixed connective tissue disease) with symptoms of stiff
neck, headache, nausea, vomiting, fever or disorientation (see section 4.4).
Exacerbation of infection-related inflammations coinciding with the use of
NSAIDs has been described. 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.
Skin and subcutaneous tissue disorders: In exceptional cases, severe skin
infections and soft-tissue complications may occur during a varicella infection
(see also "Infections and infestations").
The following adverse reactions possibly related to ibuprofen and displayed by
MedDRA frequency convention and system organ classification. Frequency
groupings are classified according to the subsequent conventions: very
common (≥1/10), Common (≥1/100 to <1/10), Uncommon (≥1/1,000 to
<1/100), Rare (≥1/10,000 to <1/1,000), Very rare (<1/10,000) and Not known
(cannot be estimated from the available data).

 

System organ class	Frequency	Adverse reaction
Infections and infestations	Uncommon	Rhinitis
	Rare	Meningitis aseptic (see section 4.4)
Blood and lymphatic system disorders	Rare	Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia , haemolytic anaemia
Immune system disorders	Uncommon Rare	Hypersensitivity Anaphylactic reaction
Psychiatric disorders	Uncommon	Insomnia, anxiety
	Rare	Depression, confusional state
Nervous system disorders	Common	Headache, dizziness
	Uncommon	Paraesthesia, somnolence
	Rare	Optic neuritis
Eye disorders	Uncommon	Visual impairment
	Rare	Toxic optic neuropathy
Ear and labyrinth disorders	Uncommon	Hearing impaired , tinnitus, vertigo
Respiratory, thoracic and mediastinal disorders	Uncommon	Asthma, bronchospasm, dyspnoea
Gastrointestinal disorders	Common	Dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, melaena, haematemesis, gastrointestinal haemorrhage
	Uncommon	Gastritis, duodenal ulcer, gastric ulcer, mouth ulceration, gastrointestinal perforation
	Very rare	Pancreatitis
	Not known	Exacerbation of Colitis and Crohn´s disease
Hepatobiliary disorders	Uncommon	Hepatitis, jaundice, hepatic function abnormal
	Very Rare	Hepatic failure
Skin and subcutaneous tissue disorders	Common	Rash
	Uncommon	Urticaria, pruritus, purpura, angioedema, photosensitivity reaction
	Very rare             Not known	Severe cutaneous adverse reactions (SCARs) (including Erythema multiforme, exfoliative dermatitis, Stevens-Johnson syndrome, and toxic epidermal necrolysis)     Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome) Acute generalised exanthematous pustulosis (AGEP)
Renal and urinary disorders	Uncommon   Not known	Nephrotoxity in various forms e.g.Tubulointerstitial nephritis, nephrotic syndrome and renal failure Renal tubular acidosis
General disorders and administration site conditions	Common	Fatigue
	Rare	Oedema
Cardiac disorders	Very rare   Not Known	Cardiac failure, myocardial infarction (also see section 4.4) Kounis sundrome
Vascular disorders       Metabolism and Nutritional Disorders	Very rare       Not known	Hypertension       Hypokalaemia

 

Renal tubular acidosis and hypokalaemia have been reported in the postmarketing
setting typically following prolonged use of the ibuprofen
component at higher than recommended doses.
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:

To report any side effect(s):

National Pharmacovigilance Center (NPC)

o Fax: +966-11-205-7662

o SFDA Call Center: 19999

o E-mail: npc.drug@sfda.gov.sa

o Website: https://ade.sfda.gov.sa

Toxicity
Signs and symptoms of toxicity have generally not been observed at doses
below 100 mg/kg in children or adults. However, supportive care may be
needed in some cases. Children have been observed to manifest signs and
symptoms of toxicity after ingestion of 400 mg/kg or greater.
Symptoms
Most patients who have ingested significant amounts of ibuprofen will
manifest symptoms within 4 to 6 hours.
The most frequently reported symptoms of overdose include nausea, vomiting,
abdominal pain, lethargy and drowsiness. Central nervous system (CNS)
effects include headache, tinnitus, dizziness, convulsion, and loss of
consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects,
gastrointestinal bleeding, coma, apnoea, diarrhoea and depression of the CNS
and respiratory system have also been rarely reported. 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. Disorientation, excitation, fainting and cardiovascular toxicity,
including hypotension, bradycardia and tachycardia have been reported. In
cases of significant overdose, renal failure and liver damage are possible.
Large overdoses are generally well tolerated when no other drugs are being
taken.
Prolonged use at higher than recommended doses may result in severe
hypokalaemia and renal tubular acidosis. Symptoms may include reduced
level of consciousness and generalised weakness (see section 4.4 and section
4.8).
Therapeutic measures
Patients should be treated symptomatically as required. Within one hour of
ingestion of a potentially toxic amount, activated charcoal should be
considered. Alternatively, in adults, gastric lavage should be considered
within one hour of ingestion of a potentially life-threatening overdose.
Good urine output should be ensured.
Renal and liver function should be closely monitored.
Patients should be observed for at least four hours after ingestion of potentially
toxic amounts.
Frequent or prolonged convulsions should be treated with intravenous
diazepam. Other measures may be indicated by the patient’s clinical condition.

Pharmacotherapeutic classification: Anti-inflammatory and antirheumatic
products, nonsteroidal; propionic acid derivatives.
ATC code: M01AE01
Ibuprofen is a propionic acid derivative with analgesic, anti-inflammatory and
anti-pyretic activity. The drug's therapeutic effects as an NSAID is thought to
result from its inhibitory effect on the enzyme cyclo-oxygenase, which results
in a marked reduction in prostaglandin synthesis.
Experimental data suggest that ibuprofen may competitively inhibit the effect
of low dose aspirin on platelet aggregation when they are dosed
concomitantly. Some pharmacodynamic studies show that when single doses
of ibuprofen 400mg were taken within 8 hours before or within 30 minutes
after immediate release aspirin dosing (81mg), a decreased effect of aspirin 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)

Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum
concentrations occurring 1-2 hours after administration. The elimination halflife
is approximately 2 hours.
Ibuprofen is metabolised in the liver to two inactive metabolites and these,
together with unchanged ibuprofen, are excreted by the kidney either as such
or as conjugates. Excretion by the kidney is both rapid and complete.
Ibuprofen is extensively bound to plasma proteins.

Not applicable.

Microcrystalline cellulose
Croscarmellose sodium
Lactose monohydrate
Colloidal anhydrous silica
Sodium laurilsulfate
Magnesium stearate
Extragranular excipients:
Opaspray white M-1-7111B*
Dry colour dispersion, white 06A28611**
*Opaspray white M-1-7111B comprises industrial methylated spirit, purified
water, hypromellose 2910 and titanium dioxide
** or combination of Opaspray white M-1-7111B, hypromellose and talc
NB industrial methylated spirit and purified water are removed during the
drying process.

Not applicable.

36 months

Store below 25°C, store in the original package.

PVC or PVC/PVDC blister packs: Store below 25C, store in the original
package.

None.