SUMMARY OF PRODUCT CHARACTERISTICS

1 NAME OF THE MEDICINAL PRODUCT

Brufen Granules

2 QUALITATIVE AND QUANTITATIVE COMPOSITION

Ibuprofen BP 600 mg

Excipients: Sodium (197 mg/sachet)

Sucrose (3333 mg/sachet)

For a full list of excipients see section 6.1.

3 PHARMACEUTICAL FORM

Effervescent granules

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Brufen Granules are indicated for their analgesic and anti-inflammatory effects
in the treatment of rheumatoid arthritis, ankylosing spondylitis, osteoarthritis
and other non-rheumatoid (seronegative) arthropathies.

In the treatment of non-articular rheumatic conditions, Brufen Granules are

indicated in peri-articular conditions such as frozen shoulder (capsulitis),
bursitis, tendinitis, tenosynovitis and low back pain; Brufen Granules can also
be used in soft-tissue injuries such as sprains and strains.

Brufen Granules are also indicated for their 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.

4.2. Posology and Method of Administration

 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. Total daily dose should not exceed 2400 mg.

Children: Brufen Granules are not suitable for use in children under 12 years.

The lowest effective dose should be used for the shortest duration necessary to
relieve symptoms (see section 4.4).

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.

Ensure the Brufen Granules are dissolved in plenty of water. A transient

sensation of burning in the mouth or throat may occur with Brufen Granules.

4.3 Contraindications

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).

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 section 4.2, and GI
and cardiovascular risks below).

Each Brufen Granules sachet contains 3333mg of sucrose per dose. This
should be taken into account in patients with diabetes mellitus Patients with
rare hereditary problems of fructose intolerance, glucose-galactose
malabsorption or sucrase-isomaltase insufficiency should not take this
medicine.

As with other NSAIDs, ibuprofen may mask the signs of infection.

This medicinal product contains 197 mg sodium per sachet, equivalent to 9.9%
of the WHO recommended maximum daily intake of 2 g sodium for an adult.
The maximum daily dose of this product is equivalent to 39.6 % of the WHO
recommended maximum daily intake for sodium.
Brufen Granules is considered high in sodium. This should be particularly taken
into account for those on a low salt diet.

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 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 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 (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.

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.
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 skin reactions

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 of these reactions early in the course of
therapy, the onset of the reaction occurring within the first month of treatment
in the majority of cases. Acute generalised exanthematous pustulosis (AGEP)
has been reported in relation to ibuprofen-containing products. Brufen should
be discontinued at the first appearance of skin rash, mucosal lesions, or any
other sign of hypersensitivity.

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.

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.

Masking of symptoms of underlying infections

Brufen granules 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 bacterial complications to varicella. When Brufen granules 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.
4.5 Interaction with other medicinal products and other forms of interaction

Care 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.

4.6 Pregnancy and lactation

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.

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.

During the third trimester of pregnancy, all prostaglandin synthesis inhibitors

may expose the foetus to the following:
• Cardiopulmonary toxicity (with premature closure of the ductus
arteriosus and pulmonary hypertension)
• Renal dysfunction, which may progress to renal failure with
oligohydramnios.

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.

4.7. Effects on Ability to Drive and Use Machines

Undesirable effects such as dizziness, drowsiness, fatigue and visual

disturbances are possible after taking NSAIDs. If affected, patients should not
drive or operate machinery.

4.8. Undesirable Effects

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.
A transient sensation of burning in the mouth or throat may occur with Brufen
Granules.

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 Uncommon Rhinitis

infestations Rare Meningitis aseptic (see section
4.4)
Blood and lymphatic Rare Leukopenia, thrombocytopenia,
system disorders neutropenia, agranulocytosis,
aplastic anaemia, haemolytic
anaemia
Immune system Uncommon Hypersensitivity
disorders Rare Anaphylactic reaction
Psychiatric disorders Uncommon Insomnia, anxiety
 Rare Depression, confusional state
Nervous system Common Headache, dizziness
disorders Uncommon Paraesthesia, somnolence
Rare Optic neuritis
Eye disorders Uncommon Visual impairment
Rare Toxic optic neuropathy
Ear and labyrinth Uncommon Hearing impaired, tinnitus,
disorders vertigo
Respiratory, thoracic Uncommon Asthma, bronchospasm,
and mediastinal dyspnoea
disorders
Gastrointestinal Common Dyspepsia, diarrhoea, nausea,
disorders 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 Common Rash
tissue disorders Uncommon Urticaria, pruritus, purpura,
angioedema, photosensitivity
reaction
Very rare Severe forms of skin reactions
(e.g. Erythema multiforme,
bullous reactions, including
Stevens-Johnson syndrome, and
toxic epidermal necrolysis)
Not known Drug reaction with eosinophilia
and systemic symptoms (DRESS
syndrome)
Acute generalised
exanthematous pustulosis
(AGEP)
Renal and urinary Uncommon Nephrotoxity in various forms
disorders e.g.Tubulointerstitial nephritis,
nephrotic syndrome and renal
failure
General disorders and Common Fatigue
administration site Rare Oedema
conditions
Cardiac disorders Very rare Cardiac failure, myocardial
infarction (also
 see section 4.4)
Vascular disorders Very rare Hypertension

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 or search for MHRA Yellow Card in the
Google Play or Apple App Store.

4.9. Overdose

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. 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.

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.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

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)

5.2 Pharmacokinetic properties

Ibuprofen is rapidly absorbed from the gastrointestinal tract, peak serum

concentrations occurring 1-2 hours after administration. The elimination half-
life 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.

5.3 Preclinical safety data

Not applicable.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

Croscarmellose sodium
Anhydrous sodium carbonate
Malic acid
Microcrystalline cellulose
Sodium saccharin
Sucrose
Povidone
Sodium bicarbonate
Orange flavour
Sodium lauryl sulfate

6.2 Incompatibilities

Not applicable.

6.3 Shelf life

3 years.

6.4 Special precautions for storage

Store below 25°C.

6.5 Nature and contents of container

 A heat-sealed sachet consisting of a paper/polythene/aluminium foil/polythene
laminate.

Pack sizes: 2, 3, 20, 21, 50, 100.

6.6 Special precautions for disposal

None stated.

7 MARKETING AUTHORISATION HOLDER

Mylan Products Ltd.

20 Station Close
Potters Bar
Herts
EN6 1TL
United Kingdom

8 MARKETING AUTHORISATION NUMBER(S)

PL 46302/0007

9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

25/02/2009

10 DATE OF REVISION OF THE TEXT

05/11/2020