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Undesirable effects may be minimised by using

RX the lowest effective dose for the shortest
duration necessary to control symptoms (see
IBUPROFEN FILM section 4.4).
Rheumatic diseases
COATED - initial treatment:2x400 mg tablets, three times
TABLETS daily, i.e. 2400 mg per day
- maintenance treatment : 1x400 mg tablets,
400MG three to four times daily, i.e. 1200 to 1600 mg
per day.
1.NAME OF THE MEDICINAL PRODUCT
An interval of at least 4-6 hours should be
Ibuprofen 400 mg film-coated tablets allowed between doses. The total daily dose
2. QUALITATIVE AND QUANTITATIVE must not exceed 2400mg in divided doses. Some
COMPOSITION patients can be maintained on 600 – 1200mg
daily.
Each film-coated tablet contains 400 mg
ibuprofen Juvenile Rheumatoid Arthritis
Excipient with known effect: each tablet For Juvenile Rheumatoid Arthritis, the
contains 47 mg lactose. recommended dose is 20mg-30mg/kg body
weight daily in 3 to 4 divided doses up to a
For the full list of excipients, see section 6.1. maximum of 40mg/kg body weight daily in
severe cases. In children weighing less than 40
3. PHARMACEUTICAL FORM
kg, use of a different strength or a liquid
Film-coated tablet formulation of ibuprofen should be considered
to aid accurate dosing.
Ibuprofen 400 mg film-coated tablets: pink
coloured, round, approximately 13 mm in Short term symptomatic treatment of fever and
diameter, biconvex film coated tablets pain of mild to moderate intensity:
4. CLINICAL PARTICULARS Adults and adolescents over 12 years (>40 kg)
4.1 Therapeutic indications One 400 mg tablet one to four times daily, as
In adults and children over 12 years (>40 kg): needed. An interval of at least 4-6 hours should
Short term treatment of fever and pain of mild to be allowed between doses. Single doses
moderate intensity, including dysmenorrhea. exceeding 400 mg have not been shown to have
any additional analgesic effect. The 400 mg
Long term symptomatic treatment of pain and tablet should only be used for more intense pain
inflammation in chronic inflammatory rheumatic or fever that are not relieved by a 200 mg
diseases. ibuprofen tablet.
4.2 Posology and method of administration Dysmenorrhoea
Posology One 400 mg tablet one to three times daily, as
The treatment should start with the lowest dose needed. An interval of at least 4-6 hours should
anticipated to be effective, which can be allowed between doses. Treatment is started
subsequently be adjusted, depending on the at the first sign of menstruation problems.
therapeutic response and any undesirable effects. Elderly
In long-term treatment a low maintenance dose
should be the aim. The elderly are at increased risk of serious
consequences of adverse reactions. If an NSAID
is considered necessary, the lowest effective Conditions involving an increased tendency to

dose should be used and for the shortest possible bleeding.
duration. The patient should be monitored
regularly for GI bleeding during NSAID Gastrointestinal bleeding or perforation in
therapy. If renal or hepatic function is impaired, connection with previous treatment with
dosage should be assessed individually. NSAIDs.
Renal impairment The third trimester of pregnancy (see section

4.6).
Caution should be taken with ibuprofen dosage
in patients with renal impairment. The dosage Because of cross-reactions, ibuprofen should not
be given to patients who have developed
should be assessed individually. The dose
hypersensitivity reactions, including symptoms
should be kept as low as possible and renal
function should be monitored (see sections 4.3, of asthma, rhinitis or urticaria after taking
acetylsalicylic acid or other NSAIDs.
4.4 and 5.2).
Hepatic impairment In patients with cerebrovascular or other acute
bleeding
Caution should be taken with dosage in patients
with hepatic impairment. The dosage should be Hematologic diseases (e.g. hemorrhagic
diathesis, hematopoetic disorder)
assessed individually and the dose should be
kept as low as possible (see sections 4.3, 4.4 and In patients with severe dehydration (caused by
5.2) vomiting, diarrhoea or insufficient fluid intake),
Method of administration Colitis ulcerosa
For oral use. 4.4 Special Warnings and precautions for use
It is recommended that patients with sensitive General precautions
stomachs take ibuprofen tablet with food. If
taken shortly after eating, the onset of action of Undesirable effects may be minimised by using
ibuprofen tablet may be delayed. To be taken the lowest effective dose for the shortest
preferably with or after food, with plenty of duration necessary to control symptoms (see
fluid. Ibuprofen tablets should be swallowed section 4.2, and gastrointestinal and
whole and not chewed, broken, crushed or cardiovascular effects below).
sucked on to avoid oral discomfort and throat As with other NSAIDs, ibuprofen may mask the
irritation. signs of infection.
4.3 Contraindications There is some evidence that drugs which inhibit
Hypersensitivity to the active substance or to cyclo-oxygenase/ prostaglandin synthesis may
any of the excipients listed in section 6.1. cause impairment of female fertility by an effect
Active gastric or duodenal ulcer or a history of on ovulation. This is reversible on withdrawal of
recurrent gastrointestinal ulcer/bleeding (two or treatment.
more clear episodes of demonstrable ulceration Ibuprofen tablets contain lactose monohydrate
or bleeding). and should not be given to patients with rare
Severe hepatic failure. hereditary problems of galactose intolerance,
Lapp lactase deficiency or glucose-galactose
Severe heart failure (NYHA Class IV) or malabsorption.
coronary heart disease.
Prolonged use of any type of painkiller for
Severe renal failure (glomerular filtration below headaches can make them worse. If this situation
30 mL/min). 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 Potentially fatal gastrointestinal bleeding,

patients who have frequent or daily headaches ulceration and perforation have been reported in
despite (or because of) the regular use of connection with treatment with all types of
headache medications. NSAID and have occurred at any time during
treatment, with or without warning symptoms or
Cardiovascular effects
previous episodes of severe gastrointestinal
Appropriate monitoring and advice are required events.
for patients with a history of hypertension and/or The risk of gastrointestinal bleeding, ulceration
mild to moderate heart failure as fluid retention
or perforation is higher at increased doses of
and oedema have been reported in association
NSAIDs in patients with a history of ulcer,
with NSAID therapy. NSAIDs might decrease especially if complicated with bleeding or
the effect of diuretics and other antihypertensive perforation (see section 4.3), and in the elderly.
agents (see section 4.5). Patients with the above-mentioned risk factors
Clinical studies suggest that use of ibuprofen, should commence treatment at the lowest
particularly at a high dose (2400 mg/ day) may possible dose.
be associated with a small increased risk of
Treatment with mucosa-protective drugs (e.g.
arterial thrombotic events (for example misoprostol or proton pump inhibitors) should
myocardial infarction or stroke). Overall, be considered for these patients as well as for
epidemiological studies do not suggest that low patients on low doses of a acetylsalicylic acid or
dose ibuprofen (e.g. ≤ 1200 mg/day) is other drugs that may increase the risk of
associated with an increased risk of arterial undesirable gastrointestinal effects (see below
thrombotic events. and section 4.5).
Patients with uncontrolled hypertension,
Patients with a history of gastrointestinal
congestive heart failure (NYHA II-III),
reactions, particularly elderly patients, should be
established ischaemic heart disease, peripheral told to watch out for any unusual abdominal
arterial disease, and/or cerebrovascular disease symptoms (especially gastrointestinal bleeding),
should only be treated with ibuprofen after particularly at the start of the treatment and, if
careful consideration and high doses (2400 such symptoms occur, to seek medical help.
mg/day) should be avoided.
Caution should be exercised in patients
Careful consideration should also be exercised receiving concomitant medication which could
before initiating long-term treatment of patients increase the risk of ulceration or bleeding, such
with risk factors for cardiovascular events (e.g. as oral corticosteroids, anticoagulants such as
hypertension, hyperlipidaemia, diabetes warfarin, selective serotonin re-uptake inhibitors
mellitus, smoking), particularly if high doses of
or antiplatelet drugs such as acetylsalicylic acid
ibuprofen (2400 mg/day) are required. (see section 4.5).
Gastrointestinal bleeding, ulceration and Treatment with ibuprofen should be withdrawn
perforation
if the patient suffers from gastrointestinal
There is a strong link between the dose and bleeding or ulceration.
severe gastrointestinal bleeding. The NSAIDs should be given with care to patients
concomitant administration of ibuprofen and with a history of gastrointestinal disease, e.g.
other NSAIDs, including selective
ulcerative colitis and Crohn's disease, as these
cyclooxygenase-2 (COX-2) inhibitors should be conditions may be exacerbated (see section 4.8).
avoided.
Renal effects
Elderly patients are at greater risk of
experiencing undesirable effects when treated Caution should be exercised with regard to
with an NSAID, especially gastrointestinal dehydrated patients. There is a risk of renal
bleeding and perforation, which may be fatal.
impairment in dehydrated children and Johnson syndrome and toxic epidermal

adolescents. necrolysis, have been reported very rarely in
connection with the use of NSAIDs (see section
As with other NSAIDs, the long-term 4.8). The risk of such reactions occurring is
administration of ibuprofen has resulted in greatest at the start of the treatment, the majority
papillary necrosis and other pathological of cases occurring during the first month.
changes in the kidney. Renal toxicity has also Treatment with ibuprofen should be withdrawn
been seen in patients in whom renal
at the first signs of skin rash, mucosal lesions or
prostaglandins have a compensatory role in the
other signs of hypersensitivity and if visual
maintenance of normal renal perfusion. In these disorders or persistent signs of hepatic
patients the administration of an NSAID may dysfunction appear.
cause a dose-dependent reduction in
prostaglandin formation and, secondarily, in SLE and mixed connective tissue disease
renal blood flow, which may cause kidney
In patients with systemic lupus erythematosus
failure. Those who are at greatest risk of this are
patients with renal impairment, heart failure, (SLE) and mixed connective tissue disorders
hepatic dysfunction, the elderly and patients on there may be an increased risk of aseptic
meningitis (see below and section 4.8).
diuretics or ACE inhibitors. Discontinuation of
NSAID therapy is usually followed by recovery Aseptic meningitis
to the pre-treatment state.
Aseptic meningitis has been observed on rare
Ibuprofen can cause fluid and sodium and occasions in patients on ibuprofen therapy.
potassium retention in patients who have never Although it is probably more likely to occur in
suffered from renal disorders due to its effects patients with systemic lupus erythematosus and
on renal perfusion. This can cause oedema or related connective tissue diseases, it has been
heart failure or hypertension in predisposed reported in patients who do not have an
subjects. underlying chronic disease.
In general, regular use of analgesics, especially Infections and infestations
combinations of various analgesic agents, has
the potential to cause permanent renal damage Exceptionally, varicella can be at the origin of
including the risk of renal failure (analgesics serious cutaneous and soft tissues infectious
nephropathy). complications.
Haematological Effects To date, the contributing role of NSAIDs in the

worsening of these infections cannot be ruled
Ibuprofen can inhibit platelet aggregation, out. Thus, it is advisable to avoid use of
resulting in prolongation of bleeding time. ibuprofen in case of varicella.
Hence, careful monitoring of patients with
coagulation disorders or taking anticoagulants is Hypersensitivity reactions
recommended. Analgesics, antipyretics and non-steroidal anti-
Respiratory disorders inflammatory drugs (NSAIDs) can cause
potentially serious hypersensitivity reactions,
Caution is required if ibuprofen is administered including anaphylactic reactions, even in
to patients suffering from, or with a previous subjects with no previous exposure to this type
history of, bronchial asthma, chronic rhinitis or of drug. The risk of hypersensitivity after
allergic disease since ibuprofen have been ibuprofen intake appears to be higher in patients
reported to cause bronchospasm, urticaria or who have previously exhibited hypersensitivity
angioedema in such patients. to other analgesic agents, antipyretics, NSAIDs
Dermatological effects and in patients with bronchial hyper-
responsiveness (asthma), hay fever, nasal polyps
Severe skin reactions, some with a fatal or chronic obstructive pulmonary disease or
outcome, such as exfoliative dermatitis, Stevens- previous episodes of angioedema (see sections
4.3 and 4.8). The allergic reactions may present time. NSAIDs and the dicumarol group are
as asthma attacks (so-called analgesic asthma), metabolised by the same enzyme, CYP2C9.
Quincke's oedema or hives.
Anti-platelet agent: NSAIDs should not be
Severe hypersensitivity reactions (e.g. combined with antiplatelet agents such as
anaphylactic shock) have been rarely reported. ticlopidine due to the additive inhibition of the
The treatment with ibuprofen should be platelet function (see below).
immediately withdrawn at the first sign of
hypersensitivity reaction. Methotrexate: NSAIDs inhibit the tubular
secretion of methotrexate and some metabolic
Reduced cardiac, renal and hepatic function interaction with reduced clearance of
methotrexate may also occur as a result.
In patients with renal, cardiac, or hepatic
Accordingly, in high-dose treatment with
impairment, caution is required since the use of methotrexate one should always avoid
NSAIDs may result in deterioration of renal prescribing NSAIDs (see below).
function. This risk is further increased in
patients taking combinations of different Acetylsalicylic acid: Concomitant administration
analgesic agents regularly. The lowest effective of ibuprofen and acetylsalicylic acid is not
dose for the shortest period of time and periodic generally recommended because of the potential
monitoring of clinical and laboratory of increased adverse effects.
parameters, especially in case of prolonged
treatment, is recommended in patients with Experimental data suggest that ibuprofen may
renal, cardiac, or hepatic impairment (see competitively inhibit the effect of low dose
section 4.3). acetylsalicylic acid on platelet aggregation when
they are dosed concomitantly. Although there
Medication overuse headache are uncertainties regarding extrapolation of these
data to the clinical situation, the possibility that
Prolonged use of any type of painkiller for
regular, long-term use of ibuprofen may reduce
headaches can make them worse. If this situation
the cardioprotective effect of low-dose
is experienced or suspected, medical advice
acetylsalicylic acid cannot be excluded. No
should be obtained and treatment should be
clinically relevant effect is considered to be
discontinued. The diagnosis of medication likely for occasional ibuprofen use (see section
overuse headache (MOH) should be suspected in 5.1).
patients who have frequent or daily headaches
despite (or because of) the regular use of Cardiac glycosides: NSAIDs can exacerbate
headache medications. heart failure, reduce glomerular filtration and
increase plasma cardiac glycoside (e.g. digoxin)
Patients with gastrointestinal problems, SLE, levels.
haematological or coagulation disorders and
asthma should be treated with care and be Mifepristone: A decrease in the efficacy of the
closely monitored during NSAID treatment, medicinal product can theoretically occur due to
since their condition may be exacerbated by the the antiprostaglandin properties of non-steroidal
NSAID. anti-inflammatory drugs (NSAIDs) including
acetylsalicylic acid. Limited evidence suggests
4.5 Interaction with other medicinal products that co-administration of NSAIDs on the day of
and other forms of interaction prostaglandin administration does not adversely
The following combinations with Ibuprofen influence the effects of mifepristone or the
should be avoided: prostaglandin on cervical ripening or uterine
contractility and does not reduce the clinical
The dicumarol group: NSAIDs may increase the efficacy of medical termination of pregnancy
effect of anticoagulants such as warfarin
Experimental studies show that ibuprofen Sulfonylureas: NSAIDs may potentiate the
reinforces the effects of warfarin on bleeding effects of sulfonylurea medications. There are
rare reports of hypoglycaemia in patients on reduced uptake of serotonin in the platelets (see
sulfonylurea medications receiving ibuprofen. section 4.4).
Zidovudine: There is evidence of an increased Cyclosporine: The concomitant administration
risk of haemarthroses and haematoma in HIV(+) of NSAIDs and cyclosporine is thought to be
haemophiliacs receiving concurrent treatment capable of increasing the risk of nephrotoxicity
with zidovudine and ibuprofen. due to decreased synthesis of prostacyclin in the
kidney. Accordingly, in the event of
The following combinations with Ibuprofen may combination treatment, renal function must be
require dose adjustment: monitored closely.
Antihypertensives: NSAIDs can reduce the
Captopril: Experimental studies indicate that
effect of diuretics and other antihypertensive
ibuprofen counteracts the effect of captopril on
agents.
sodium excretion.
Aminoglycosides: NSAIDs may reduce the
Colestyramine: The concomitant administration
excretion of aminoglycosides. Children: Care of ibuprofen and colestyramine retards and
should be taken during concomitant treatment reduces (by 25%) the absorption of ibuprofen.
with ibuprofen and aminoglycosides.
These drugs should be given at an interval of at
Lithium: Ibuprofen reduces the renal clearance least 2 hours.
of lithium, as a result of which serum lithium Thiazides, thiazide-related preparations and
levels may rise. The combination should be loop diuretics: NSAIDs can counteract the
avoided unless frequent checks of serum lithium diuretic effect of furosemide and bumetanide,
can be carried out and a possible reduction in the possibly through inhibition of prostaglandin
dose of lithium made.
synthesis. They can also counteract the
ACE inhibitors and angiotensin-II antagonists: antihypertensive effect of thiazides.
There is an increased risk of acute renal failure, Tacrolimus: Concomitant administration of
usually reversible, in patients with renal NSAIDs and tacrolimus is thought to be capable
impairment (e.g. dehydrated and/or elderly of increasing the risk of nephrotoxicity due to
patients) when treatment with ACE inhibitors or decreased synthesis of prostacyclin in the
angiotensin-II antagonists is given at the same kidney. Accordingly, in the event of
time as NSAIDs, including selective combination treatment, renal function should be
cyclooxygenase-2 inhibitors. The combination monitored closely.
should, therefore, be given with care to patients Methotrexate: The risk of a potential interaction
with renal impairment, especially elderly between an NSAID and methotrexate should
patients. Patients should be adequately hydrated also be taken into account in connection with
and a check of renal function should be low-dose treatment with methotrexate,
considered after the initiation of combination especially in patients with renal impairment.
treatment and at regular intervals during Whenever combination treatment is given, renal
treatment (see section 4.4).
function should be monitored. Caution should be
Beta-blockers: NSAIDs counteract the exercised if both an NSAID and methotrexate
antihypertensive effect of beta-adrenoceptor are given within 24 hours, as the plasma levels
blocking drugs. of methotrexate can increase, resulting in
increased toxicity (see above).
Selective serotonin re-uptake inhibitors (SSRIs):
Corticosteroids: Concomitant treatment gives
SSRIs and NSAIDs each entail an increased risk rise to an increased risk of gastrointestinal
of bleeding, e.g. from the gastrointestinal tract. ulceration or bleeding.
This risk is increased by combination therapy.
The mechanism may possibly be linked to Antiplatelet drugs: Increased risk of
gastrointestinal bleeding (see above).
Quinolone antibiotics: Animal data indicate that epidemiological studies suggest an increased
NSAIDs can increase the risk of convulsions risk of miscarriage and of cardiac malformation
associated with quinolone antibiotics. Patients gastroschisis after the use of a prostaglandin
taking NSAIDs and quinolones may have an synthesis inhibitor in early pregnancy. The
increased risk of developing convulsions. absolute risk of cardiovascular malformation
was increased from less than 1% up to
Other analgesics and cyclooxygenase-2 selective approximately 1.5%. The risk is believed to
inhibitors: Avoid concomitant use of two or
increase with dose and duration of therapy. In
more NSAIDs, including Cox-2 inhibitors, as
animals the administration of a prostaglandin
this may increase the risk of adverse effects (see synthesis inhibitor has been shown to result in
section 4.4).
increased pre- and post-implantation losses and
Herbal extracts: Ginkgo biloba may potentiate embryo/foetal lethality. In addition, increased
the risk of bleeding with NSAIDs. incidences of various malformations, including
cardiovascular, has also been reported in animals
CYP2C9 Inhibitors: Concomitant administration given a prostaglandin synthesis inhibitor during
of ibuprofen with CYP2C9 inhibitors may the organogenetic period. During the first and
increase the exposure to ibuprofen (CYP2C9 second trimesters of pregnancy, ibuprofen
substrate). In a study with voriconazole and should not be given unless clearly necessary. If
fluconazole (CYP2C9 inhibitors) an increased ibuprofen is used by a woman attempting to
S(+)-ibuprofen exposure by approximately 80 to conceive or during the first and second trimester,
100% has been shown. Reduction of the the dose should be kept as low and duration of
ibuprofen dose should be considered when treatment as short as possible.
potent CYP2C9 inhibitors are administered
concomitantly, particularly when high-dose During the third trimester, all prostaglandin
ibuprofen is administered with either synthesis inhibitors may expose the foetus to:
voriconazole or fluconazole.
- Cardiopulmonary toxicity (with premature
Ritonavir: It is a possible increase in the closure of the ductus arteriosus and pulmonary
concentration of NSAIDs. hypertension),
Probenecid: It slows the excretion of NSAIDs, - Renal dysfunction, which may progress to
with possible increase of their plasma renal failure with oligohydramnios.
concentrations.
The mother and the neonate, at the end of
Pemetrexed: An interaction with pemetrexed as pregnancy, to:
there is an increased risk of its toxicity by - Prolongation of bleeding time,
decreased renal clearance. In patients with an
impaired renal function displaying a creatinine - Inhibition of uterine contractions, resulting in
clearance between 45-80 ml/min, this delayed or prolonged labour.
combination is to be avoided. In patients with
normal renal function, a precaution for use is Consequently ibuprofen is contraindicated
during the last trimester of pregnancy.
sufficient based on laboratory tests of the renal
function. Breast-feeding
Interaction studies have only been performed on Ibuprofen is excreted in breast milk, but with
adults. therapeutic doses during short term treatment the
risk for influence on infant seems unlikely. If,
4.6 Fertility, Pregnancy and lactation
however, longer treatment is prescribed, early
Pregnancy weaning should be considered.
Inhibition of prostaglandin synthesis may Fertility
adversely affect the pregnancy and/or
embryo/foetal development. Data from The use of ibuprofen may impair fertility and is
not recommended in women attempting to
conceive. In women who have difficulties Ear and labyrinth Uncommon Hearing impaired
conceiving or who are undergoing investigation disorders
Rare Tinnitus, vertigo
of infertility, withdrawal of ibuprofen should be Respiratory, thoracic Uncommon Asthma, bronchospasm,
considered. and mediastinal dyspnoea
disorders
4.7 Effects on ability to drive and use Gastrointestinal Common Dyspepsia, diarrhoea,
machines disorders nausea, vomiting,
abdominal pain, flatulence,
Following treatment with ibuprofen, the reaction constipation, melaena,
time of certain patients may be affected. This haematemesis,
should be taken into account where increased gastrointestinal
haemorrhage
vigilance is required. Undesirable effects such as
Uncommon Gastritis, duodenal ulcer,
dizziness, drowsiness, fatigue and visual gastric ulcer, mouth
disturbances are possible after taking NSAIDs. ulceration, gastrointestinal
If affected, patients should not drive or operate perforation
machinery. Very rare Pancreatitis
Not known Exacerbation of Colitis and
4.8 Undesirable Effects Crohn's disease
The undesirable effects are mainly associated Hepatobiliary Uncommon Hepatitis, jaundice,
with the pharmacological effect of ibuprofen on disorders abnormal hepatic function
prostaglandin synthesis. The most common Rare Liver injury
effects are dyspepsia and diarrhoea, which are Very rare Hepatic failure
estimated to occur in about 10–30% of treated Skin and Common Rash
subcutaneous tissue
patients. disorders Uncommon Urticaria, pruritus, purpura,
angioedema,
Adverse events at least possibly related to photosensitivity reaction
ibuprofen are displayed by MedDRA frequency Very rare Severe forms of skin
reactions (e.g. erythema
convention and system organ class database. The multiforme, bullous
following frequency groupings are used: Very reactions, including
common (≥1/10), Common (≥1/100 to <1/10), Stevens-Johnson
syndrome and toxic
Uncommon (≥1/1000 to <1/100), Rare epidermal necrolysis)
(≥1/10000 to <1/1000), Very rare (<1/10,000) Not known Drug reaction with
and Not known (cannot be estimated from the eosinophilia and systemic
available data). symptoms (DRESS
syndrome)
System organ class Frequency Adverse reaction Renal and urinary Uncommon Nephrotoxity in various
disorders forms e.g. tubulointerstitial
Infections and Uncommon Rhinitis
nephritis, nephrotic
infestations
Rare Aseptic meningitis syndrome and renal failure
Blood and lymphatic Uncommon Leukopenia, General disorders Common Fatigue
system disorders thrombocytopenia, and administration Rare Oedema
agranulocytosis, site conditions
neutropenia, aplastic Cardiac disorders Not known Cardiac failure, myocardial
anaemia and haemolytic infarction (also see section
anaemia 4.4)
Immune system Rare Anaphylactic reaction Vascular disorders Not known Hypertension
disorders
Psychiatric disorders Uncommon Insomnia, anxiety
Rare Depression, confusional Cardiac disorders and vascular disorders:
state
Oedema, hypertension and heart failure have
Nervous system Common Headache, dizziness
disorders
been reported in association with NSAID
Uncommon Paraesthesia, somnolence treatment. Clinical studies suggest that use of
Rare Optic neuritis ibuprofen, particularly at a high dose (2400
Eye disorders Uncommon Visual impairment mg/day) may be associated with a small
Rare Toxic optic neuropathy increased risk of arterial thrombotic events such
as myocardial infarction or stroke (see section Reporting suspected adverse reactions after
4.4). authorisation of the medicinal product is
important. It allows continued monitoring of the
Gastrointestinal disorders: The most commonly benefit/risk balance of the medicinal product.
observed adverse events are gastrointestinal in
nature. Peptic ulcers, perforation or GI bleeding, 4.9 Overdose
sometimes fatal, particularly in the elderly, may
occur (see section 4.4). Toxicity
Immune system disorders: Hypersensitivity Risk of symptoms at doses >80–100 mg/kg. At

reactions have been reported following treatment doses >200 mg/kg there is a risk of severe
symptoms, though with considerable variations
with NSAIDs. These may consist of (a) non-
between individuals. A dose of 560 mg/kg in a
specific allergic reaction and anaphylaxis, (b)
respiratory tract reactivity comprising asthma, child aged 15 months gave severe intoxication,
aggravated asthma, bronchospasm or dyspnoea, 3.2 g in a 6-year-old mild to moderate
or (c) assorted skin disorders, including rashes intoxication, 2.8–4 g in a 1½-year-old and 6 g in
of various types, pruritus, urticaria, purpura, a 6-year-old severe intoxication even after
gastric lavage, 8 g in an adult moderate
angioedema and, very rarely, erythema
multiforme, bullous dermatoses (including intoxication and >20 g in an adult very severe
Stevens- Johnson syndrome and toxic epidermal intoxication. 8 g administered to a 16-year-old
necrolysis). affected the kidney and 12 g in combination
with alcohol administered to a teenager resulted
Infections and infestations: Rhinitis and aseptic in acute tubular necrosis.
meningitis (especially in patients with existing
Symptoms
autoimmune disorders, such as systemic lupus
erythematosus and mixed connective tissue Most patients who have ingested significant
disease) with symptoms of stiff neck, headache, amounts of ibuprofen will manifest symptoms
nausea, vomiting, fever or disorientation (see within 4 to 6 hours.
section 4.4).
The predominant symptoms of overdose are
Exacerbation of infection-related inflammations ones from the gastrointestinal tract, e.g. nausea,
(e.g. development of necrotising fasciitis) abdominal pain and vomiting (possibly blood-
coinciding with the use of NSAIDs has been streaked). Central nervous system effects
described. If signs of an infection occur or get include headache, tinnitus, confusion and
worse during use of Ibuprofen the patient is nystagmus. At high doses loss of consciousness
therefore recommended to go to a doctor without and convulsions (mainly in children) may occur.
delay. Cardiovascular toxicity, including bradycardia,
Skin and subcutaneous tissue disorders: In tachycardia and hypotension have been reported.
exceptional cases, severe skin infections and Hypernatraemia, kidney effects and haematuria
soft-tissue complications may occur during a may occur. In serious poisoning metabolic
acidosis may occur. In significant overdose,
varicella infection (see also "Infections and
infestations"). renal failure and liver damage are possible.
Hypothermia and ARDS have occasionally been
Ibuprofen can cause prolongation of bleeding reported.
time through reversible inhibition of platelet
aggregation. Treatment
Deterioration of ulcerative colitis and Crohn's Management should be symptomatic and

supportive as required. Within one hour of
disease have been reported in connection with
NSAID treatment. ingestion of a potentially toxic amount, activated
charcoal should be considered. Alternatively, in
Reporting of suspected adverse reactions adults, gastric lavage should be considered
within one hour of ingestion of a potentially life- likely for occasional ibuprofen use (see section
threatening overdose. 4.5).
In the event of gastrointestinal problems, Ibuprofen inhibits renal prostaglandin synthesis.
administer antacids. In the event of hypotension, In patients with normal renal function this effect
intravenous fluid and, if required, inotropic is of no particular significance. In patients with
support. Ensure adequate diuresis. Correct acid- chronic renal insufficiency, decompensated heart
base and electrolyte disorders. or liver insufficiency as well as conditions
involving changes in plasma volume, the
Patients should be observed for at least four
inhibited prostaglandin synthesis can lead to
hours after ingestion of potentially toxic
acute renal insufficiency, fluid retention and
amounts.
heart failure (see section 4.3).
5. PHARMACOLOGICAL PROPERTIES 5.2 Pharmacokinetic properties
5.1 Pharmacodynamic properties Absorption
Pharmacotherapeutic group: Anti-inflammatory
and antirheumatic products, nonsteroids; Ibuprofen is rapidly absorbed from the
propionic acid derivatives. gastrointestinal tract with a bioavailability of 80-
90%. Peak serum concentrations occur one to
Mechanism of action
two hours after administration. If administered
Ibuprofen belongs to the group of non-steroidal with food, peak serum concentrations are lower
anti-inflammatory drugs (NSAIDs). It contains and achieved more slowly than when taken on
the propionic acid derivative p-isobutyl- an empty stomach Food does not affect
hydrothropic acid. Ibuprofen has anti- markedly total bioavailability.
inflammatory, analgesic and antipyretic effects. Distribution
The anti-phlogistic effect is comparable with
that of acetylsalicylic acid and indometacin. The Ibuprofen is extensively bound to plasma
pharmacological effect of ibuprofen is probably proteins (99%). Ibuprofen has a small volume of
associated with its ability to inhibit distribution being about 0.12-0.2 L/kg in adults.
prostaglandin synthesis. Ibuprofen prolongs
Biotransformation
bleeding time through reversible inhibition of
platelet aggregation. Ibuprofen is rapidly metabolized in the liver
Clinical efficacy and safety through cytochrome P450, preferentially
CYP2C9, to two primary inactive metabolites,
Experimental data suggest that ibuprofen may 2-hydroxyibuprofen and 3-carboxyibuprofen.
competitively inhibit the effect of low dose Following oral ingestion of the drug, slightly
acetylsalicylic acid on platelet aggregation when less than 90% of an oral dose of ibuprofen can
they are dosed concomitantly. Some be accounted for in the urine as oxidative
pharmacodynamic studies show that when single metabolites and their glucuronic conjugates.
doses of ibuprofen 400 mg were taken within 8 h Very little ibuprofen is excreted unchanged in
before or within 30 min after immediate release the urine.
acetylsalicylic acid dosing (81 mg), a decreased
Elimination
effect of acetylsalicylic acid on the formation of
thromboxane or platelet aggregation occurred. Excretion by the kidney is both rapid and
Although there are uncertainties regarding complete. The elimination half-life is
extrapolation of these data to the clinical approximately 2 hours. The excretion of
situation, the possibility that regular, long-term ibuprofen is virtually complete 24 hours after the
use of ibuprofen may reduce the last dose.
cardioprotective effect of low-dose
acetylsalicylic acid cannot be excluded. No Special populations
clinically relevant effect is considered to be Elderly
Given that no renal impairment exists, there are 6. PHARMACEUTICAL PARTICULARS

only small, clinically insignificant differences in
the pharmacokinetic profile and urinary 6.1 List of excipients
excretion between young and elderly. Tablet Core
Children Lactose monohydrate
The systemic exposure of ibuprofen following Maize starch
weight adjusted therapeutic dosage (5mg/kg to
Croscarmellose sodium
10 mg/kg bodyweight) in children aged 1 year or
over, appears similar to that in adults. Colloidal anhydrous Silica
Children 3 months to 2.5 years appeared to have Microcrystalline cellulose
a higher volume of distribution (L/kg) and
clearance (L/kg/h) of ibuprofen than did children Magnesium stearate
>2.5 to 12 years of age. Tablet Coating
Renal impairment Hypromellose
For patients with mild renal impairment Triacetin
increased unbound (S)-ibuprofen, higher AUC
values for (S)-ibuprofen and increased Titanium dioxide (E171)
enantiomeric AUC (S/R) ratios as compared Erythrosine aluminum lake (E127)
with healthy controls have been reported.
6.2 Incompatibilities
In end-stage renal disease patients receiving Not applicable.
dialysis the mean free fraction of ibuprofen was
about 3% compared with about 1% in healthy 6.3 Shelf life
volunteers. Severe impairment of renal function 5 years.
may result in accumulation of ibuprofen
6.4 Special precautions for storage
metabolites. The significance of this effect is
This medicinal product does not require any
unknown. The metabolites can be removed by
special storage conditions.
haemodialysis (see sections 4.2, 4.3 and 4.4).
6.5 Nature and contents of container
Hepatic impairment
PVC - Aluminium blisters or PVC/PVdC –
Alcoholic liver disease with mild to moderate
Aluminium Blisters
hepatic impairment did not result in substantially
altered pharmacokinetic parameters. Pack sizes: 10, 12, 14, 20, 21, 24, 28, 30, 40, 42,
48, 50, 60, 84, 100 or 500 film-coated tablets in
In cirrhotic patients with moderate hepatic
carton.
impairment (Child Pugh's score 6-10) treated
with racemic ibuprofen an average 2-fold Not all pack sizes may be marketed.
prolongation of the half-life was observed and
the enantiomeric AUC ratio (S/R) was 6.6 Special precautions for disposal and other
significantly lower compared to healthy controls handling
suggesting an impairment of metabolic inversion No special requirements.
of (R)-ibuprofen to the active (S)-enantiomer
7. MANUFACTURER:
(see sections 4.2, 4.3 and 4.4).
5.3 Preclinical safety data
There are no preclinical data of relevance for the
safety assessment, apart from what has already Manufactured in India by:
been taken into account in this summary of TAJ PHARMACEUTICALS LTD.
product characteristics. Mumbai, India
At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad

438225, Gujarat, INDIA
This leaflet was last revised in October 2019

Ibuprofen 400 MG Film-Coated Tablets SMPC - Taj Pharmaceuticals

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Ibuprofen 400 mg fil m-coated tablets SMPC, Taj Phar mac euticals

Undesirable effects may be minimised by using

is considered necessary, the lowest effective Conditions involving an increased tendency to

Renal impairment The third trimester of pregnancy (see section

overuse headache (MOH) should be suspected in Potentially fatal gastrointestinal bleeding,

impairment in dehydrated children and Johnson syndrome and toxic epidermal

Haematological Effects To date, the contributing role of NSAIDs in the

prostaglandin synthesis. The most common Rare Liver injury

Immune system disorders: Hypersensitivity Risk of symptoms at doses >80–100 mg/kg. At

Deterioration of ulcerative colitis and Crohn's Management should be symptomatic and

Given that no renal impairment exists, there are 6. PHARMACEUTICAL PARTICULARS

At: 615, GIDC, Kerala, Bavla, Dist. Ahmedabad

This leaflet was last revised in October 2019

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