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IBUPROFEN 400 MG CAPSULES SOFT

Active substance(s): IBUPROFEN

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SUMMARY OF PRODUCT CHARACTERISTICS

1

NAME OF THE MEDICINAL PRODUCT
Ibuprofen 400 mg capsules, soft

2

QUALITATIVE AND QUANTITATIVE COMPOSITION
Each soft capsule contains 400 mg Ibuprofen.
Excipient with known effect (per capsule):
96 mg sorbitol (E420).
For the full list of excipients, see section 6.1.

3

PHARMACEUTICAL FORM
Capsule, soft.
A clear oval transparent soft gelatin capsule.

4

CLINICAL PARTICULARS

4.1

Therapeutic indications
Ibuprofen 400 mg capsules, soft is indicated in adults and adolescents from ≥40 kg
(12 years of age and above) for the symptomatic relief of mild to moderate pain such
as headache, acute migraine headaches with or without aura, muscular pain, period
pain/dysmenorrhoea, feverishness and pain associated with a common cold

4.2

Posology and method of administration

For oral use.
For 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: If the medicinal product is required for more than 4 days for pain or 3 days for
fever and migraine headaches or if the symptoms worsen, the patient should consult a
doctor.
Adolescents (12 years of age and above): If in adolescents this medicinal product is
required for more than 3 days, or if symptoms worsen a doctor should be consulted.
If people experience mild indigestion it is recommended to take this medicine with
food or milk to avoid gastrointestinal problems.
Adults and adolescents from ≥40 kg in weight (12 years of age and above):
400 mg (one capsule) with water.
400 mg (one capsule) to be repeated, if necessary, with intervals of at least 6 hours.
Do not take more than 1200 mg ibuprofen (three capsules) in any 24 hour period.
Special patient groups
The elderly and patients with renal and hepatic impairment should always start
treatment with the lowest effective dose.
Paediatric population:
Ibuprofen 400 mg capsule, soft is contraindicated in adolescents under 40 kg body
weight and in children, see section 4.3.
Elderly:
No special dose adjustment is required. Because of the possible undesirable-effect
profile (see section 4.4), it is recommended to monitor the elderly particularly
carefully.
Renal insufficiency:
No dose reduction is required in patients with mild to moderate impairment to renal
function (patients with severe renal insufficiency, see section 4.3).
Hepatic insufficiency (see section 5.2):
No dose reduction is required in patients with mild to moderate impairment to hepatic
function (patients with severe hepatic dysfunction, see section 4.3).
4.3

Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in
section 6.1.
Patients who have previously shown hypersensitivity reactions (e.g.
bronchospasms, asthma, rhinitis, angioedema or urticaria) in response to
acetylsalicylic acid or other NSAIDs.
History of gastrointestinal bleeding or perforation, related to previous NSAIDs
therapy.

Active or history of recurrent peptic ulcer/haemorrhage (two or more distinct
episodes of proven ulceration or bleeding).
Bleeding diathesis or coagulation disorders.
Patients with severe hepatic failure, severe renal failure or severe heart failure
(NYHA Class IV) (see section 4.4).
Patients with cerebrovascular or other active bleeding.
Use with concomitant NSAIDs including cyclo-oxygenase-2 specific
inhibitors (see section 4.5).
Patients with unclarified blood-formation disturbances.
Patients with severe dehydration (caused by vomiting, diarrhoea or insufficient
fluid intake).
Use in third trimester of pregnancy (see section 4.6).
Adolescents under 40 kg body weight and children.

4.4

Special warnings and precautions for use
Caution is required in patients with certain conditions:
-

systemic lupus erythematosus as well as those with mixed connective
tissue disease, due to increased risk of aseptic meningitis (see section 4.8).

-

congenital disorder of porphyrin metabolism (e.g. acute intermittent
porphyria).

-

gastrointestinal disorders and chronic inflammatory intestinal disease as
these conditions may be exacerbated (ulcerative colitis, Crohn’s disease)
(see section 4.8).

-

oedema, hypertension and/or cardiac impairment as renal function may
deteriorate and/or fluid retention occur (see section 4.5).

-

renal impairment as renal function may further deteriorate (see section 4.3
and 4.8).

-

hepatic dysfunction (see section 4.3 and 4.8).

-

directly after major surgery.

-

in patients who react allergically to other substances, as an increased risk
of hypersensitivity reactions occurring also exists for them on use of
Ibuprofen 400 mg capsule, soft (see section 4.3).

-

in patients who suffer from hayfever, nasal polyps or chronic obstructive
respiratory disorders as an increased risk exists for them of allergic
reactions occurring. These may present as asthma attacks (so-called
analgesic asthma), Quincke’s oedema or urticaria (see section 4.3).

-

bronchial asthma (see section 4.3 and 4.8).
Bronchospasm may be precipitated in patients suffering from or with a
previous history of bronchial asthma or allergic disease.

-

There is some evidence that drugs which inhibit cyclo-oxygenase /
prostaglandin synthesis may cause impairment of female fertility by an
effect on ovulation. This is reversible on withdrawal of treatment (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
gastrointestinal and cardiovascular risks below).
There is a risk of renal impairment in dehydrated adolescents.
Gastrointestinal effects
The use of Ibuprofen 400 mg capsule, soft with concomitant NSAIDs
including cyclooxygenase-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).
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 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 acetylsalicylic acid (see section 4.5).
When GI bleeding or ulceration occurs in patients receiving Ibuprofen 400 mg
capsule, soft, 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 their condition may be
exacerbated (see section 4.8).
Through concomitant consumption of alcohol, active substance-related
undesirable effects, particularly those that concern the gastrointestinal tract or
the central nervous system, may be increased on use of NSAIDs (see also
section 4.7).
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 IIIII), 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.
Dermatological effects
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 400 mg capsule, soft 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
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 400 mg capsule, soft in case of varicella.
Other notes
Severe acute hypersensitivity reactions (for example anaphylactic shock) are
observed very rarely. At the first signs of hypersensitivity reaction after
taking/administering Ibuprofen 400 mg capsule, soft therapy must be stopped.
Medically required measures, in line with the symptoms, must be initiated by
specialist personnel.
In prolonged administration of Ibuprofen 400 mg capsule, soft regular
checking of the liver values, the kidney function, as well as of the blood count,
is required.
Prolonged use of any type of painkiller for headaches can make them worse. If
this situation is experienced or suspected, medical advice should be obtained
and treatment should be discontinued. 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 headache medications.
In general terms, the habitual intake of painkillers, particularly on combination
of several pain-relieving active substances, may lead to permanent renal
damage with the risk of renal failure (analgesic nephropathy). This risk may be
increased under physical strain associated with loss of salt and dehydration.
Therefore it should be avoided.
The use of NSAIDs may mask the symptoms of infection.
This medicinal product contains sorbitol. Patients with rare hereditary
problems of fructose intolerance should not take this medicine.
4.5

Interaction with other medicinal products and other forms of interaction
Ibuprofen should not be used in combination with:
- Acetylsalicylic acid (above 75 mg daily): as this may increase the risk of
adverse reactions (see section 4.3).
-

Other NSAIDs, including cyclo-oxygenase-2 inhibitors: as these may
increase the risk of adverse reactions (see section 4.3 and 4.4).

Ibuprofen should be used with caution in combination with:
- 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).
-

Antiplatelet agents and selective serotonin-reuptake inhibitors (SSRIs):
increased risk of gastrointestinal bleeding (see section 4.4).

-

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding
(see section 4.4).

-

Diuretics, ACE inhibitors, betareceptor-blockers and angiotensin-II
antagonists: NSAIDs may reduce the effect of diuretics and other
antihypertensive medicinal products. In some patients with compromised
renal function (e.g. dehydrated patients or elderly patients with
compromised renal function) the co-administration of an ACE inhibitor,
betareceptor-blockers or angiotensin-II antagonists and agents that inhibit
cyclo-oxygenase may result in further deterioration of renal function,
including possible acute renal failure, which is usually reversible.
Therefore, the combination should be administered with caution,
especially in the elderly. Patients should be adequately hydrated and
consideration should be given to monitoring of renal function after
initiation of concomitant therapy, and periodically thereafter.
In particular, concomitant use of potassium-sparing diuretics may increase
the risk of hyperkalaemia.

-

Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such
as warfarin and ticlopidin (see section 4.4).

-

Lithium, digoxin and phenytoin: there is evidence for potential increase in
plasma levels of these medicinal products when co-administered with
ibuprofen. If used correctly (maximum dose for adults for 4 days),
monitoring of the plasma concentrations of lithium, digoxin or phenytoin
is usually not needed.

-

Probenecid and sulfinpyrazon: medicinal products that contain probenecid
or sulfinpyrazon may delay the excretion of ibuprofen.

-

Methotrexate: the administration of Ibuprofen 400 mg capsule, soft within
24 hours before or after administration of methotrexate may lead to
elevated concentrations of methotrexate and an increase of its toxic effect.

-

Cyclosporin: inhibition of renal prostaglandin activity by NSAIDs may
increase the plasma concentration of cyclosporin and the risk of
cyclosporin-induced nephrotoxicity.

-

Tacrolimus: the risk of nephrotoxicity is increased if ibuprofen and
tacrolimus are co-administered.

-

Zidovudine: there is evidence of an increased risk of haemarthroses and
haematoma in HIV positive haemophiliacs receiving concurrent treatment
with zidovudine and ibuprofen.

-

Sulphonylureas: there is evidence of interactions between NSAIDs and
antidiabetic medicinal products (sulphonylureas). Although no specific
interactions between ibuprofen and sulphonylureas have been described,
blood glucose values should be monitored as a precaution during coadministration of ibuprofen and sulphonylureas.

-

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.

-

Cholestyramine: Concomitant treatment with cholestyramine and
ibuprofen results in prolonged and reduced (25%) absorption of ibuprofen.
The medicinal products should be administered with at least one hour
interval.

-

Aminoglycosides: NSAIDs can slow down
aminoglycosides and increase their toxicity.

the

elimination

of

Experimental data suggest that ibuprofen may inhibit the effect of low dose
aspirin on platelet aggregation when they are dosed concomitantly. However,
the limitations of these data and the uncertainties regarding extrapolation of ex
vivo data to the clinical situation imply that no firm conclusions can be made
for regular ibuprofen use, and no clinically relevant effect is considered to be
likely for occasional ibuprofen use (see section 5.1).
4.6

Fertility, Pregnancy and Lactation
Fertility (see section 4.4):
There is some evidence that medicinal products which inhibit cyclooxygenase/prostaglandin synthesis may cause impairment of female fertility by an
effect on ovulation. This is reversible on withdrawal of treatment.
Pregnancy:
Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or the
embryo/foetal development. Data from epidemiological studies suggest an increased
risk of miscarriage and of cardiac malformation and gastroschisis after use of a
prostaglandin synthesis inhibitor in early pregnancy. The absolute risk for
cardiovascular malformation was increased from less than 1%, up to approximately
1.5%. The risk is believed to increase with dose and duration of therapy. In animals,
administration of a prostaglandin synthesis inhibitor has been shown to result in
increased pre- and post-implantation loss 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 trimesters of pregnancy, ibuprofen should not be
given unless clearly necessary. If ibuprofen is used by a woman attempting to

conceive, or during the first and second trimesters of pregnancy, the dose should be
kept as low and duration of treatment as short as possible.
During the third trimester of pregnancy, all prostaglandin synthesis inhibitors may
expose the foetus to:
-

cardiopulmonary toxicity (with premature closure of the ductus arteriosus and
pulmonary hypertension);

-

renal dysfunction, which may progress to renal failure with oligo-hydroamniosis;

the mother and the neonate, at the end of pregnancy, to:
-

possible prolongation of bleeding time, an anti-aggregating effect which may
occur even at very low doses;

-

inhibition of uterine contractions resulting in delayed or prolonged labour.

Consequently, ibuprofen is contraindicated during the third trimester of pregnancy.
Lactation:
In limited studies Ibuprofen and its metabolites appear in breast milk in very low
concentrations. Since no harmful effects to infants are known to date, it is usually not
necessary to interrupt breast-feeding during short-term use of Ibuprofen 400 mg
capsule, soft at the recommended doses.

4.7

Effects on ability to drive and use machines
Patients who experience dizziness, drowsiness, vertigo or visual disturbances while
they are taking ibuprofen, should avoid driving or using machinery. This remark
applies to a greater extent in combination with alcohol (see section 4.4). Single
administration or short term use of ibuprofen does not usually warrant the adoption of
any special precautions.

4.8

Undesirable effects
The list of the following undesirable effects comprises all undesirable effects
that have become known under treatment with ibuprofen, also those under
high-dose long-term therapy in rheumatism patients. The stated frequencies,
which extend beyond very rare reports, refer to the short-term use of daily

doses up to a maximum of 1200 mg ibuprofen for oral dosage forms and a
maximum of 1800 mg for suppositories.
With the following adverse drug reactions, it must be accounted for that they
are predominantly dose-dependent and vary interindividually.
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.
Oedema, hypertension, and cardiac failure, have been reported in association
with NSAID treatment.
Hypersensitivity reactions have been reported and these may consist of:
a) Anaphylaxis and non-specific allergic reactions,
b) Respiratory tract reactivity comprising bronchospasm, asthma, aggravated
asthma, or dyspnoea,
c) Various skin reactions, e.g. rarely, exfoliative and bullous dermatoses
(including toxic epidermal necrolysis and erythema multiforme),
angioedema, pruritus and urticaria.
Adverse reactions have been ranked under headings of frequency using the
following convention: 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); not known (cannot be estimated from the available data).
Within each frequency grouping, undesirable effects are presented in order of
decreasing seriousness.
Infections
and
infestations

Very
rare

Exacerbation
of
infection-related
inflammations
(e.g.
development
of
necrotising fasciitis) coinciding with the use
of nonsteroidal antiinflammatory drugs has
been described. This is possibly associated
with the mechanism of action of the
nonsteroidal antiinflammatory drugs.
If signs of an infection occur or get worse
during use of Ibuprofen 400 mg capsule, soft,
the patient is therefore recommended to go to
a doctor without delay. It is to be investigated
whether there is an indication for an
antiinfective/antibiotic therapy.
The symptoms of aseptic meningitis with
neck stiffness, headache, nausea, vomiting,
fever or consciousness clouding have been

observed under ibuprofen. Patients with
autoimmune
disorders
(SLE,
mixed
connective-tissue disease) appear to be
predisposed.
Blood and
Lymphatic
System
Disorders

Very
rare

Disturbances to blood formation (anaemia,
leukopenia, thrombocytopenia, pancytopenia,
agranuloctosis,
aplastic
anaemia,
haematolytic anaemia). The first signs may be
fever, sore throat, superficial wounds in the
mouth, influenza-like complaints, severe
lassitude, nosebleeds and skin bleeding. In
such cases the patient should be advised to
discontinue the medicine immediately, to
avoid any self-medication with analgesics or
antipyretics and to consult a physician.
The blood count should be checked regularly
in long-term therapy.

Immune
System
Disorders

Uncom
mon

Hypersensitivity reactions with skin rashes
and itching, as well as asthma attacks
(possibly with drop in blood pressure).
The patient is to be instructed to inform a
doctor at once and no longer to take
Ibuprofen 400 mg capsule, soft in this case.

Very
rare

Severe general hypersensitivity reactions.
They may present as face oedema, swelling of
the tongue, swelling of the internal larynx
with constriction of the airways, respiratory
distress, racing heart, drop in blood pressure
up to life-threatening shock.
If one of these symptoms occurs, which can
happen even on first use, the immediate
assistance of a doctor is required.

Psychiatric
disorders

Very
rare

Psychotic reactions, depression, nervousness

Nervous
System
Disorders

Uncom
mon

Central nervous disturbances such as
headache, dizziness, sleeplessness, agitation,
irritability or tiredness

Eye
disorders

Uncom
mon

Visual disturbances

Ear and
labyrinth
disorders

Rare

Tinnitus

Cardiac
Disorders

Very
rare

Palpitations,
infarction

heart

failure,

myocardial

Vascular
disorders

Very
rare

Arterial hypertension

Respirator
y,
thoracic
and
mediastinal
disorders

Very
rare

Asthma, bronchospasm,
wheezing.

Gastrointes
tinal
Disorders

Commo
n

Gastro-intestinal
complaints
such
as
dyspepsia, pyrosis, abdominal pain, nausea,
vomiting, flatulence, diarrhoea, constipation
and slight gastro-intestinal blood losses that
may cause anaemia in exceptional cases.

Uncom
mon

Gastrointestinal ulcers, potentially with
bleeding
and
perforation.
Ulcerative
stomatitis, exacerbation of colitis and Crohn's
disease (see section 4.4), gastritis.

Very
rare

Oesophagitis, pancreatitis, formation
intestinal diaphragm-like strictures.

dyspnoea

and

of

The patient is to be instructed to withdraw the
medicinal product and to go to a doctor
immediately if severe pain in the upper
abdomen or melaena or haematemesis occurs.
Hepatobilia
ry
Disorders

Very
rare

Hepatic dysfunction, hepatic damage,
particularly in long-term therapy, hepatic
failure, acute hepatitis.

Skin and
Subcutaneo
us Tissue
Disorders

Uncom
mon

Various skin rashes

Very
rare

Bullous reactions including Stevens-Johnson
syndrome and toxic epidermal necrolysis. In
exceptional cases, severe skin infections and
soft-tissue complications may occur during a
varicella infection (see also "Infections and
infestations").

Rare

Kidney-tissue damage (papillary necrosis)
and elevated uric acid concentrations in the
blood may also occur rarely.

Very
rare

Formation of oedemas, particularly in patients
with arterial hypertension or renal
insufficiency, nephrotic syndrome, interstitial
nephritis that may be accompanied by acute

Renal and
Urinary
Disorders

renal insufficiency. Renal function should
therefore be checked regularly.
Investigatio
ns

Very
rare

Decreased haematocrit and haemoglobin
levels.

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).
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.
4.9

Overdose
In adolescents and adults, the dose response effect is not 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 dizziness,
drowsiness, occasionally excitation and disorientation or coma. Occasionally patients
develop convulsions. In serious poisoning metabolic acidosis may occur and the
prothrombin time/INR may be prolonged, probably due to interference with the
actions of circulating clotting factors. Acute renal failure and liver damage may
occur. Exacerbation of asthma is possible in asthmatics.

Management
Management should be symptomatic and supportive and include the maintenance of a
clear airway and monitoring of cardiac and vital signs until stable. Consider oral
administration of activated charcoal if the patient presents within 1 hour of ingestion
of a potentially toxic amount. If frequent or prolonged, convulsions should be treated
with intravenous diazepam or lorazepam. Give bronchodilators for asthma.

5

PHARMACOLOGICAL PROPERTIES

5.1

Pharmacodynamic properties

Pharmacotherapeutic group: Anti-inflammatory and antirheumatic products, nonsteroids; propionic acid derivative, ATC Code: M01A E01.
Ibuprofen is a phenylpropionic 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 pharmacodynamics 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 lowdose 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 gastro-intestinal tract, peak serum
concentrations occurring 1-2 hours after administration of conventional film-coated
tablets ibuprofen. However, ibuprofen is more rapidly absorbed from the
gastrointestinal tract following the administration of Ibuprofen 400 mg capsule, soft,
with peak plasma concentrations occurring approximately 46 minutes after
administration in the fasting state.
When taken with food, peak levels are observed after 1-2 hours with conventional
film-coated tablets.
Ibuprofen protein binding is approximately 99%. After an oral dose, ibuprofen is 75–
85% excreted via kidneys during the first 24 hours (mainly in the form of two
metabolites), the remainder being eliminated in the faeces following excretion in bile.
Excretion is complete within 24 hours.
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
The subchronic and chronic toxicity of ibuprofen in animal experiments consisted
mainly of lesions and ulcerations in the gastro-intestinal tract.

In-vitro and in-vivo investigations have produced no clinically relevant evidence of
ibuprofen having mutagenic effects. In studies in rats and mice, no evidence of
carcinogenic effects of ibuprofen was found.
Ibuprofen led to an inhibition of ovulation in rabbits and impaired implantation in
various animal species (rabbit, rat, mouse). Experimental studies in rats and rabbits
have shown that ibuprofen crosses the placenta. Following administration of
maternotoxic doses, an increased rate of malformations (ventricular septal defects)
occurred in the progeny of rats.
In animal studies it has been observed that the use of NSAIDs, known to inhibit
prostaglandin synthesis, may increase the incidence of dystocia and delayed
parturition.

6

PHARMACEUTICAL PARTICULARS

6.1

List of excipients
Macrogol 600
Potassium hydroxide
Purified water
Capsule shell
Gelatin
Sorbitol Liquid, Partially Dehydrated (E420)
Capsule printing
Opacode WB black NS-78-17821 *
*The ink contains: Black iron oxide, HPMC 2910/Hypromellose 6cP

6.2

Incompatibilities
Not applicable

6.3

Shelf life
2 years

6.4

Special precautions for storage
This medicinal product does not require any special storage conditions.

6.5

Nature and contents of container
Blisters formed of PVC/PE/PVdC/Al packed into cartons and
PVC/PE/PVdC/Al/PET packed into cartons.
Each carton may contain 4, 10, 12, 15, 16, 20 or 30 capsules in blisters.
Not all pack sizes may be marketed.

6.6

Special precautions for disposal
No special requirements.

7

MARKETING AUTHORISATION HOLDER
Banner Pharmacaps Europe B.V.
De Posthoornstraat 7
5048 AS Tilburg
The Netherlands

8

MARKETING AUTHORISATION NUMBER(S)
PL 14338/0005

9

DATE OF FIRST AUTHORISATION/RENEWAL OF THE
AUTHORISATION
29/11/2011

10

DATE OF REVISION OF THE TEXT
11/12/2015

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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