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Abbott Laboratories Ireland Limited

4051 Kingswood Drive, Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4691500
Medical Information Direct Line: +44 (0)1628 773 355
Medical Information e-mail: medinfo.shl@abbott.com


Summary of Product Characteristics last updated on medicines.ie: 20/06/2014
SPC Brufen 400mg film-coated Tablets



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1. NAME OF THE MEDICINAL PRODUCT

Brufen 400mg film-coated tablets


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2. QUALITATIVE AND QUANTITATIVE COMPOSITION

Each Brufen Tablet contains 400 mg of Ibuprofen.

Excipients: each tablet contains 26.7mg of lactose monohydrate

For a full list of excipients, see section 6.1.


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3. PHARMACEUTICAL FORM

Film-coated tablet.

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


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4. CLINICAL PARTICULARS

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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, Special warnings and special precautions for use).

Adults: 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.

Children: 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: 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, special warnings and special precautions for use). Treatment should be reviewed at regular intervals and discontinued if no benefit is seen or intolerance occurs.

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

For oral administration. To be taken preferably with or after food


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4.3 Contraindications

Brufen is contraindicated in patients with known hypersensitivity to the active substance or to any of the inactive ingredients.

Brufen is contraindicated in patients with a 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).

Brufen is contraindicated in patients with severe heart failure.

Brufen is contraindicated in patients with severe liver failure.

Brufen is contraindicated in patients with severe renal failure (glomerular filtration below 30mL/min).

Brufen should be given to patients with conditions involving an increased tendency to bleeding.

Brufen should not be used in patients with known hypersensitivity or who have experienced asthma, urticaria or allergic-type reactions after taking Brufen, aspirin or other NSAIDs.

Brufen is contraindicated during the third trimester of pregnancy (see section 4.6, Fertility, pregnancy and lactaction)


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4.4 Special warnings and precautions for use

General Precautions

Undesirable effects may be minimised by using the lowest effective dose for the shortest duration necessary to control symptoms (see section 4.2, Posology and method of administration, 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.

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.

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, Posology and method of administration).

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.

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, Contraindications), and in the elderly. These patients should commence treatment on the lowest dose available. Combination therapy with protective agents (e.g. misoprostol or proton pump inhibitors) should be considered for these patients, and also for patients requiring concomitant low dose aspirin, or other drugs likely to increase gastrointestinal risk (See below and section 4.5, Interaction with other medicinal products and other forms of interaction).

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 below and section 4.5, Interaction with other medicinal products and other forms of interaction).

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 aspirin (See below and section 4.5, Interaction with other medicinal products and other forms of interaction).

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

NSAIDs should be given with care to patients with a history of gastrointestinal disease (ulcerative colitis, Crohn's disease) as their condition may be exacerbated (See section 4.8 – undesirable effects).

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 trial data suggest that use of ibuprofen, particularly at a high dose (2400 mg/ daily) and in long term treatment 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 daily) is associated with an increased risk of myocardial infarction.

Patients with uncontrolled hypertension, congestive heart failure, established ischaemic heart disease, peripheral arterial disease, and/or cerebrovascular disease should only be treated with ibuprofen after careful consideration. Similar consideration should be made before initiating longer-term treatment of patients with risk factors for cardiovascular events (e.g. hypertension, hyperlipidaemia, diabetes mellitus, smoking).

Renal Effects

Caution should be used when initiating treatment with Brufen in patients with considerable dehydration.

There is a risk of renal impairment in dehydrated children and adolescents.

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 an NSAID may cause a dose-dependant reduction in prostaglandins formation and, secondarily, in renal blood flow, which may precipitate overt renal decompensation. 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 4.8, Undesirable effects). 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.

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:

Antihypertensives, beta-blockers and diuretics:

NSAIDs may reduce the effect of anti-hypertensives, such as ACE inhibitors, beta-blockers and diuretics.

Diuretics can also increase the risk of nephrotoxicity of NSAIDs.

Cardiac glycosides: NSAIDs may exacerbate cardiac failure, reduce GFR and increase plasma cardiac glycoside levels.

Lithium: NSAIDs may decrease elimination of lithium.

Methotrexate: NSAIDs may inhibit the tubular secretion of methotrexate and reduce clearanceof methotrexate.

Cyclosporin: increased risk of nephrotoxicity with NSAIDs.

Other analgesics including cyclooxygenase-2 selective inhibitors: avoid concomitant use of two or more NSAIDs, (including aspirin) as this may increase the risk of adverse effects (see section 4.4, special warnings and special precautions for use).

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding with NSAIDs (see section 4.4, special warnings and special precautions for use)

Anticoagulants: NSAIDs may enhance the effects of anticoagulants, such as warfarin (see section 4.4, special warnings and precautions for use ).

Aspirin: As with other products containing NSAIDs, concomitant administration of ibuprofen and aspirin is not generally recommended because of the potential of increased adverse effects.

Experimental data suggest that ibuprofen may 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 use (see section 5.1, pharmacodynamic properties).

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding with NSAIDs (See section 4.4, Special warnings and precautions for use).

Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides.

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

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

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

Probenacid: there have been no reports of interactions between probenacid and ibuprofen. However, probenacid produces a reduction in metabolism and elimination of some NSAIDs and metabolites.

Oral hypoglycaemic agents: inhibition of metabolism of sulfonylurea drugs, prolonged half-life and increased risk of hypoglycaemia.

Mifepristone: A decrease in the efficacy of the medicinal product can theoretically occur due to the antiprostaglandin properties of NSAIDs. Limited evidence suggests that coadministration of NSAIDs on the day of prostaglandin administration does not adversely influence the effects of mifepristone or the prostaglandin on cervical ripening or uterine contractility.

Tacrolimus: Possible increased risk of nephrotoxicity when NSAIDs are given with tacrolimus.

Zidovudine: Increased risk of haematological toxicity when NSAIDs are given with zidovudine. There is evidence of an increased risk of haemarthroses and haematoma in HIV(+) haemophiliacs receiving concurrent treatment with zidovudine and ibuprofen.

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.

Ginkgo biloba may potentiate the risk of bleeding with NSAIDs.


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4.6 Pregnancy and lactation

Inhibition of prostaglandin synthesis may adversely affect the pregnancy and/or embryo/fetal 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. In animals, the administration of a prostaglandin synthesis inhibitor has been shown to result in increased pre- and post-implantation losses and embryo/fetal 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 fetus 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 labor.

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.

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


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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. 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, Special warnings and precautions for use ). Nausea, vomiting, diarrhoea, flatulence, constipation, dyspepsia, abdominal pain, melaena, haematemesis, ulcerative stomatitis, exacerbation of colitis and Crohn's disease (See section 4.4 - Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

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 , bullous dermatoses (including Stevens-Johnson syndrome, toxic epidermal necrolysis and erythema multiforme).

Cardiac disorders and vascular disorders: Oedema, hypertension and cardiac failure have been reported in association with NSAID treatment. Clinical trial and epidemiological data suggest that use of ibuprofen, particularly at high dose (2400 mg/daily), and in long term treatment may be associated with a small increased risk of arterial thrombotic events (for example myocardial infarction or stroke)(see section 4.4, special warnings and special precautions for use).

Other adverse events reported include:

Infections and infestations: rhinitis and meningitis aseptic

.

Blood and lymphatic system disorders: leukopenia, thrombocytopenia, neutropenia, agranulocytosis, aplastic anaemia and haemolytic anaemia.

Psychiatric disorders: insomnia, anxiety, depression, confusional state, hallucinations

Nervous system disorders: headaches, paraesthesia, dizziness, somnolence

Eye disorders: visual impairment, optic neuritis, toxic optic neuropathy.

Ear and labyrinth disorders: hearing impaired, vertigo, tinnitus

Hepatobiliary disorders: abnormal hepatic function, hepatic failure, hepatitis, jaundice

Skin and subcutaneous tissue disorders: photosensitivity reaction, bullous reactions including Steven's Johnson syndrome and toxic epidermal necrolysis (very rare).

Renal and urinary disorders: impaired renal function, toxic nephropathy in various forms, including interstitial nephritis, nephrotic syndrome and renal failure.

General disorders and administration site conditions: malaise, fatigue.


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4.9 Overdose

Toxicity:

Signs and symptoms of toxicity have generally not been observed at doses below 100 mg/kg in children or adults.

However, supportive care may be needed in some cases.

Children have been observed to manifest signs and symptoms of toxicity after ingestion of 400 mg/kg or greater.

Symptoms:

Most patients who have ingested significant amounts of ibuprofen will manifest symptoms within 4 to 6 hours.

The most frequently reported symptoms of overdose include nausea, vomiting, abdominal pain, lethargy and drowsiness. Central nervous system (CNS) effects include headache, tinnitus, dizziness, convulsion, and loss of consciousness. Nystagmus, metabolic acidosis, hypothermia, renal effects, gastrointestinal bleeding, coma, 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.

Treatment:

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 center.


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5. PHARMACOLOGICAL PROPERTIES

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5.1 Pharmacodynamic properties

ATC Code: M01AE01

Ibuprofen is a phenylpropionic acid derivative with analgesic, anti-inflammatory and antipyretic activity. The drug's therapeutic effects as a NSAID are thought to result from its inhibitory effect on the enzyme cyclo-oxygenase, which results in a marked reduction in prostaglandin synthesis.

Experimental data suggest that ibuprofen may inhibit the effect of low dose aspirin on platelet aggregation when they are dosed concomitantly. In one study, when a single dose of ibuprofen 400mg was taken within 8 hours before or within 30 minutes after immediate release aspirin dosing (81mg), a decreased effect of ASA on the formation of thromboxane or platelet aggregation occurred. 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.


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5.2 Pharmacokinetic properties

Ibuprofen is rapidly absorbed after oral administration, is strongly plasma protein bound, and is excreted mainly in the urine as metabolites. The drug has a plasma half-life of 2 hours.


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5.3 Preclinical safety data

Not applicable.


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6. PHARMACEUTICAL PARTICULARS

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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)

or

Hypromellose

plus

Talc

plus

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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7. MARKETING AUTHORISATION HOLDER

Abbott Laboratories Ireland Limited,

4051 Kingswood Drive,

Citywest Business Campus,

Dublin 24.


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8. MARKETING AUTHORISATION NUMBER(S)

PA 38/80/2


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9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION

Date of first authorisation: 14 April 1975

Date of last renewal: 14 April 2010


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10. DATE OF REVISION OF THE TEXT

June 2014



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Active Ingredients

 
   Ibuprofen