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Mylan IRE Healthcare Limited

Unit 35/36, Grange Parade, Baldoyle Industrial Estate, Dublin 13, Ireland
Medical Information Direct Line: +44 (0)1707 853000 press 1
Medical Information e-mail: info@mylan.co.uk

Summary of Product Characteristics last updated on medicines.ie: 6/6/2017
SPC Brufen 400mg film-coated Tablets

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Brufen 400mg film-coated tablets

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Each Brufen Tablet contains 400 mg of Ibuprofen.

Excipients with known effect: each tablet contains 26.7mg of lactose monohydrate

For a full list of excipients, see section 6.1.

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Film-coated tablet.

A white, pillow-shaped, film-coated tablet.

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4.1 Therapeutic indications

Brufen is indicated in the symptomatic management of various arthroses such as rheumatoid arthritis (including juvenile rheumatoid arthritis or Still's disease) and osteoarthritis, fibrositis, ankylosing spondylitis and other muscular syndromes, such as low back pain, soft tissue trauma and various inflammations of tendon, joint capsules and ligaments.

Brufen is also used as an analgesic in the relief of mild to moderate pain.

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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 adolescents older than 12 years (≥ 40kg):

The recommended dosage of Brufen is 1200-1800 mg daily in divided doses. Some patients can be maintained on 600-1200 mg daily. The total daily dose should not exceed 2400 mg.

Paediatric population:

The recommended dose of Brufen is 20-30 mg/kg bodyweight daily in divided doses but in juvenile rheumatoid arthritis, the daily dosage may be increased to 40 mg/kg bodyweight in severe cases.

In children weighing less than 30 kg, the total daily dose of Brufen should not exceed 500 mg (the liquid formulation should be used).

Elderly Population:

No specific dosage modifications are required for elderly patients, unless renal or hepatic function is impaired, in which case, dosage should be assessed individually.

NSAIDs (Nonsteroidal anti-inflammatories) should be used with particular caution in elderly patients who are more prone to adverse events. The lowest dose compatible with adequate safe clinical control should be employed (see section 4.4). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.

Renal impairment

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 impairment

No dose reduction is required in patients with mild to moderate impairment to hepatic function (patients with severe hepatic dysfunction, see section 4.3).

Method of Administration:

In order to achieve a faster onset of action, the dose may be taken on an empty stomach. It is recommended that patients with sensitive stomachs take ibuprofen with food.

Take Brufen tablets with plenty of fluid. Brufen tablets should be swallowed whole and not chewed, broken, crushed or sucked on to avoid oral discomfort and throat irritation.

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4.3 Contraindications

▪ Known hypersensitivity to the active substance or to any of the excipients listed in section 6.1.

▪ Brufen should not be given to patients who have experienced asthma, urticaria or allergic-type reactions after taking acetylsalicylic acid/ aspirin or other NSAIDs

▪ Severe heart failure (NYHA IV).

• Severe liver failure.

▪ Severe renal failure (glomerular filtration below 30mL/min).

▪ Conditions involving an increased tendency or active bleeding.

▪ History of gastrointestinal bleeding or perforation, related to previous NSAID therapy.

▪ Active, or history of ulcerative colitis, Crohn's disease, recurrent peptic ulceration or gastrointestinal haemorrhage (defined as two or more distinct episodes of proven ulceration or bleeding).

▪ During the third trimester of pregnancy

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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).

Patients treated with NSAIDs long-term should undergo regular medical supervision to monitor for adverse events.

Caution is required if Brufen is administered to patients suffering from, or with a previous history of, bronchial asthma since ibuprofen has been reported to cause bronchospasm in such patients.

Caution is required in patients with renal, hepatic or cardiac impairment since the use of NSAIDs may result in deterioration of renal function. The dose should be kept as low as possible and assessment of renal function should occur prior to the initiation of therapy and regularly thereafter, especially in long-term treated patients.

Caution is required in patients with a history of heart failure and/or hypertension as fluid retention and oedema has been reported in association with NSAID therapy.

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

Brufen 400mg film-coated tablets contain lactose monohydrate. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medication.

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

The use of Brufen with concomitant NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the potential for additive effects.

On prolonged use of any painkillers, headache may occur that must not be treated with increased doses of the medicinal product.

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.

Elderly population

Elderly patients have an increased frequency of adverse reactions to NSAIDs especially gastrointestinal bleeding and perforation which may be fatal.

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 acetylsalicylic acid/aspirin, or other drugs likely to increase gastrointestinal risk (See section 4.5).

The concomitant administration of Brufen and other NSAIDs, including cyclooxygenase-2 (Cox-2) selective inhibitors, should be avoided due to the increased risk of ulceration or bleeding (See section 4.5).

Patients with a history of GI disease, 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/aspirin (See section 4.5).

When GI bleeding or ulceration occurs in patients receiving Brufen, the treatment should be withdrawn.

Respiratory disorders

Caution is required if ibuprofen is administered to patients suffering from, or with a previous history of, bronchial asthma, chronic rhinitis or allergic diseases since ibuprofen has been reported to cause bronchospasm, urticaria or angioedema in such patients.

Cardiovascular and cerebrovascular effects

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

Clinical studies suggest that use of ibuprofen, particularly at a high dose (2400 mg/day) may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke). Overall, epidemiological studies do not suggest that low dose ibuprofen (e.g. ≤ 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 Brufen 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 Brufen has resulted in renal papillary necrosis and other renal pathological 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 NSAIDs may cause a dose-dependant reduction in prostaglandins 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 who are taking diuretics and ACE inhibitors and the elderly. Discontinuation of NSAID drug therapy is usually followed by recovery to the pre-treatment state.

Haematological effects

As NSAIDs can interfere with platelet function and may prolong bleeding time, Brufen should be used with caution in patients with intracranial haemorrhage and bleeding diathesis.

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 of 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. Brufen 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 in case of varicella.

Aseptic meningitis

Aseptic meningitis has been observed on rare occasions in patients with Brufen therapy. Although it is probably more likely to occur in patients with systematic lupus erythematosus and related connective tissue diseases, it has been reported in patients who do not have an underlying chronic disease.

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4.5 Interaction with other medicinal products and other forms of interaction

It is considered unsafe to take NSAIDs in combination with warfarin or heparin unless under direct medical supervision.

Care should be taken in patients treated with any of the following drugs as interactions have been reported:

Concomitant use of ibuprofen with:

Possible effects:

Other NSAIDs including cyclooxygenase-2 selective inhibitors

Concomitant use with other NSAIDs including cyclooxygenase-2 selective inhibitors should be avoided due to the potential for additive effects

Cardiac glycosides

NSAIDs may exacerbate heart failure, reduce glomerular filtration rate and increase plasma levels of cardiac glycosides


Increased risk of gastrointestinal ulceration or bleeding with NSAIDs


NSAIDs may enhance the effects of anticoagulants, such as warfarin

Antiplatelet agents & selective serotonin-reuptake inhibitors (SSRIs), e.g. clopidogrel and ticlopidine

Increased risk of gastrointestinal bleeding with NSAIDs

Acetylsalicylic acid/aspirin

As with other products containing NSAIDs, concomitant administration of ibuprofen and acetylsalicylic acid/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 acetylsalicylic acid/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 aspirin (acetylsalicylic acid) cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 5.1)


NSAIDs may decrease elimination of lithium

Anti-hypertensive, 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


NSAIDs may inhibit the tubular secretion of methotrexate and reduce clearance of methotrexate.


Increased risk of nephrotoxicity with NSAIDs


Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus


Increased risk of haematological toxicity with NSAIDs are given with zidovudine. There is evidence of an increased risk of hemarthrosis and hematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen

Quinolone antibiotics

Animal data indicate that NSAIDs can increase the risk of convulsions associated with quinolone antibiotics. Patients taking NSAIDs and quinolones may have an increased risk of developing convulsions.

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.


NSAIDs may potentiate the effects of sulfonylurea medications. There have been rare reports of hypoglycaemia in patients on sulfonylurea medications receiving ibuprofen.


The concomitant administration of ibuprofen and cholesytramine may reduce the absorption of ibuprofen in the gastrointestinal tract. However, the clinical significance is unknown.


NSAIDs may decrease the excretion of aminoglycosides.

Herbal extracts

Ginkgo biloba may potentiate the risk of bleeding with NSAIDs.


A decrease in the efficacy of the medicinal product can theoretically occur due to the antiprostaglandin properties of NSAIDs including acetylsalicylic acid. 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.

4.6 Fertility, pregnancy and lactation


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


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, ibuprofen should not be given unless clearly necessary. If ibuprofen 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, ibuprofen is contraindicated during the third trimester of pregnancy.

Labour and delivery:

Administration of ibuprofen is not recommended during labour and delivery. The onset of labour may be delayed and the duration increased with a greater bleeding tendency in both mother and child.


In limited studies to date, ibuprofen appears in breast milk in very low concentrations. Brufen is not recommended for use in nursing mothers.

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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. This applies to a greater extent in combination with alcohol. If affected, patients should not drive or operate machinery.

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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, exacerbation of colitis and Crohn's disease (See section 4.4) have been reported following administration. Less frequently, gastritis, duodenal ulcer & gastric ulcer and gastrointestinal perforation have been observed.

Immune system disorders:

Hypersensitivity reactions have been reported following treatment with ibuprofen. 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).

Infections and infestations:

Exacerbation of infection-related inflammations (e.g. development of necrotising fasciitis) coinciding with the use of NSAIDs has been described. If signs of an infection occur or get worse during the 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” and section 4.4)

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 (for example myocardial infarction or stroke)(see section 4.4).

The following are adverse reactions possibly related to ibuprofen, 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


Adverse reaction

Infections and infestations




Meningitis aseptic (see section 4.4)

Blood and lymphatic system disorders


Leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia

Immune system disorders




Anaphylactic reaction

Phychiatric disorders


Insomnia, anxiety


Depression, confusional state

Nervous system disorders


Headache, dizziness


Paraesthesia, somnolence


Optic neuritis

Eye disorders


Visual impairment


Toxic optic neuropathy

Ear and labyrinth disorders


Hearing impaired, tinnitus, vertigo

Respiratory, Thoracic and mediastinal disorders


Asthma, bronchospasm, dyspnea

Gastrointestinal disorders


Dyspepsia, diarrhoea, nausea, vomiting, abdominal pain, flatulence, constipation, melena, hematemesis, gastrointestinal haemorrhage


Gastritis, duodenal ulcer, gastric ulcer, mouth ulceration, gastrointestinal perforation

Very Rare


Not known

Exacerbation of Colitis and Crohn's disease

Hepatobiliary disorders


Hepatitis, jaundice, hepatic function abnormal

Very Rare

Hepatic failure

Skin and subcutaneous tissue




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).

Renal and urinary disorders


Nephrotoxicity in various forms, e.g. Tubulointerstitial nephritis, nephrotic syndrome and renal failure

General disorders and administration site conditions





Cardiac disorders

Very Rare

Cardiac failure, myocardial infarction (see also section 4.4)

Vascular disorders

Very Rare


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 HPRA Pharmacovigilance, Earlsfort Terrace, IRL - Dublin 2; Tel: +353 1 6764971; Fax: +353 1 6762517. Website: www.hpra.ie; e-mail: medsafety@hpra.ie

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4.9 Overdose


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.


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, apnea and depression of the CNS and respiratory system have also been rarely reported. Cardiovascular toxicity, including hypotension, bradycardia and tachycardia, has 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.


There is no specific antidote for ibuprofen overdose. Gastric emptying followed by supportive measures is recommended if the quantity ingested exceeds 400 mg/kg within the previous hour. For the most current information, contact the local poison control centre.

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5.1 Pharmacodynamic properties

Pharmacotherapeutic classification: Anti-inflammatory and anti-rheumatic products, non-steroidal, propionic acid derivatives.

ATC Code: M01AE01

Ibuprofen is a propionic acid derivative, non-steroidal anti-inflammatory drug (NSAID) with analgesic, anti-inflammatory and antipyretic effect. The drug's therapeutic effects as a NSAID are thought to result from its inhibitory effect on the enzyme cyclooxygenase, which results in a marked reduction in prostaglandin synthesis. These properties provide symptomatic relief of inflammation, pain and fever.

Experimental data suggest that ibuprofen may competitively inhibit the effect of low dose acetylsalicylic acid/aspirin on platelet aggregation when they are dosed concomitantly. Some pharmacodynamics studies show that when single doses of ibuprofen 400mg were taken within 8 h before or within 30 min after immediate release acetylsalicylic acid/aspirin dosing (81mg), a decreased effect of ASA 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/aspirin cannot be excluded. No clinically relevant effect is considered to be likely for occasional ibuprofen use (see section 4.5).

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5.2 Pharmacokinetic properties

Ibuprofen is a racemic mixture of [+]S- and [-]R-enantiomers.

Studies including a standard meal, show that food does not markedly affect total bioavailability.


Ibuprofen is rapidly absorbed from the gastrointestinal tract with a bioavailability of 80-90%. Peak serum concentrations occur one to two hours after administration of immediate release formulations.


Ibuprofen is extensively bound to plasma proteins (99%). Ibuprofen has a small volume of distribution being about 0.12-0.2 L/kg in adults.


Ibuprofen is rapidly metabolized in the liver through cytochrome P450, preferentially CYP2C9, to two primary inactive metabolites, 2-hydroxyibuprofen and 3-carboxyibuprofen. Following oral ingestion of the drug, slightly less than 90% of an oral dose if ibuprofen can be accounted for in the urine as oxidative metabolites and their glucuronic conjugates. Very little ibuprofen is excreted unchanged in the urine.


Excretion by the kidney is both rapid and complete. The elminiation half-life of immediate release formulations is approximately two hours. The excretion of ibuprofen is virtually complete 24 hours after the last dose.

Special populations:


Given that no renal impairment exists, there are only small, clinically insignificant differences in the pharmacokinetic profile and urinary excretion between young and elderly.

Paediatric population

The systemic exposure of ibuprofen following weight adjusted therapeutic dosage (5mg/kg to 10mg/kg bodyweight) in children aged 1 year or over, appears similar to that in adults. Children 3 months to 2.5 years appeared to have a higher volume of distribution (L/kg) and clearance (l/kg/h) of ibuprofen than did children ˃2.5 to 12 years of age.

Renal impairment

For patients with mild renal impairment, increased plasma level of (S)-ibuprofen, higher AUC values for (S)-ibuprofen and increased enantiomeric AUC(S/R) ratios as compared with healthy controls have been reported. In end-stage renal disease patients receiving dialysis, the mean free fraction of ibuprofen was about 3% compared with about 1% in healthy volunteers. Severe impairment of renal function may result in accumulation of ibuprofen metabolites. The significance of this effect is unknown. The metabolites can be removed by haemodialysis (see sections 4.2, 4.3 and 4.4).

Hepatic impairment

Alcoholic liver disease with mild to moderate hepatic impairment did not result in substantially altered pharmacokinetic parameters.

In cirrhotic patients with moderate hepatic impairment (Child Pugh's score 6-10) treated with racemic ibuprofen, an average 2-fold prolongation of the half-life was observed and the enantiomeric AUC ratio (S.R) was significantly lower compared to healthy controls, suggesting an impairment of metabolic inversion of (R)-ibuprofen to the active (S)-enantiomer (see sections 4.2, 4.3 and 4.4).

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5.3 Preclinical safety data

There are no preclinical data of relevant for the safety assessments, apart from what has already been taken into account.

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6.1 List of excipient(s)

Microcrystalline cellulose

Croscarmellose sodium

Lactose monohydrate

Colloidal anhydrous silica

Sodium laurilsulfate

Magnesium stearate

Opadry white (containing hypromellose, titanium dioxide and talc)






Opaspray white M-1-7111B (contains: Titanium Dioxide (E171) and Hypromellose)

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6.2 Incompatibilities

Not applicable.

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6.3 Shelf life

3 years.

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6.4 Special precautions for storage

Do not store above 25°C.

Store in the original package in order to protect from moisture.

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6.5 Nature and contents of container

Blister pack comprising of transparent polyvinyl chloride (PVC) or polyvinyl chloride/polyvinylidene (PVC/PVDC) film with aluminium foil backing.

Pack size 60 tablets.

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6.6 Special precautions for disposal and other handling

No special requirements

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Mylan IRE Healthcare Limited,

Unit 35/36,

Grange Parade,

Baldoyle Industrial Estate,

Dublin 13,


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PA 2010/2/1

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Date of first authorisation: 14 April 1975

Date of last renewal: 14 April 2010

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June 2017

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