Brufen 600mg film-coated tablets

  • Name:

    Brufen 600mg film-coated tablets

  • Company:
    info
  • Active Ingredients:

    Ibuprofen

  • Legal Category:

    Product subject to medical prescription which may be renewed (B)

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 17/01/19

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Summary of Product Characteristics last updated on medicines.ie: 14/6/2019

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Mylan IRE Healthcare Limited

Mylan IRE Healthcare Limited

Company Products

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Medicine Name ALDARA 5% CREAM Active Ingredients Imiquimod
Medicine Name Ancotil 2.5g/250ml Solution for Infusion Active Ingredients Flucytosine
Medicine Name Brufen 400mg film-coated Tablets Active Ingredients Ibuprofen
Medicine Name Brufen 600mg film-coated tablets Active Ingredients Ibuprofen
Medicine Name Brufen Paediatric 100mg/5ml Oral Suspension Active Ingredients Ibuprofen
Medicine Name Brufen Retard 800mg prolonged release tablets Active Ingredients Ibuprofen
Medicine Name Calvidin 600mg/400IU Chewable Tablets Active Ingredients Calcium Carbonate, Colecalciferol (Vitamin D3)
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Medicine Name Clozaril 100mg Tablets Active Ingredients Clozapine
Medicine Name Clozaril 25mg Tablets Active Ingredients Clozapine
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Medicine Name Colofac 135mg Tablets Active Ingredients Mebeverine Hydochloride
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Medicine Name Creon 25000 Gastro-resistant Capsules Active Ingredients Pancreatin
Medicine Name Creon for Children 5000 Gastro-resistant Granules Active Ingredients Pancreatin
Medicine Name Cyklokapron 500mg Tablets Active Ingredients Tranexamic Acid
Medicine Name Dalmane 15mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Dalmane 30mg Hard Capsules Active Ingredients Flurazepam monohydrochloride
Medicine Name Desunin 4000IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name Desunin 800IU Tablets Active Ingredients Colecalciferol (Vitamin D3)
Medicine Name DIFFLAM 3% CREAM Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM ORAL RINSE Active Ingredients Benzydamine Hydrochloride
Medicine Name DIFFLAM SPRAY Active Ingredients Benzydamine Hydrochloride
Medicine Name Dona 1500mg Powder for Oral Solution Active Ingredients Glucosamine Sulfate, Sodium Chloride
1 - 0 of 97 items.Total: Infinity pages

When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 14 June 2019 SmPC

Reasons for updating

  • Change to improve clarity and readability

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 17 January 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision

Updated on 3 January 2019 PIL

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 16 May 2018 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 26 April 2018 PIL

Reasons for updating

  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects

Updated on 6 June 2017 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 6 June 2017 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

7. MARKETING AUTHORISATION HOLDER
Mylan IRE Healthcare Limited
Unit 35/36
Grange Parade
Baldoyle Industrial Estate
Dublin 13
BGP Products Ireland Limited
4051 Kingswood Drive
Citywest Business Campus
Dublin 24

10. DATE OF REVISION OF THE TEXT
February 2017June 2017

Updated on 2 June 2017 PIL

Reasons for updating

  • New PIL for new product

Updated on 2 June 2017 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 14 December 2016 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

 Changes to SmPC affecting sections

4.2 Posology and Method of administration – to include age/weight  qualifiers and information related to use of product with renal and hepatic impairment

Section 4.4 Special warnings and precautions for use.

·         Warnings added with respect to use low dose especially in long term use.

·         Use may cause headaches do not take additional painkillers

·         Concomitant consumption of alcohol may increase adverse events (particularly those that are GI)

·         Addition of elderly when discussing risk of dehydrated patients

·         Warnings related to varicella have been added.


Section 4.7 Effects on ability to drive and use machines – advised risks enhanced if tablets and alcohol combined.

Section 4.8

Updated on 9 December 2016 PIL

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 2 - interactions with other medicines, food or drink
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents

Updated on 22 September 2016 PIL

Reasons for updating

  • Change to date of revision

Updated on 22 April 2016 PIL

Reasons for updating

  • Change of manufacturer

Updated on 8 January 2016 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.3 - Contraindications

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.3 - (Contraindications) added "NYHA IV after sever heart failure
Section 4.4 - (Special Warnings and Precautions for Use) in section Cardiovascular and cerebrovascular effects warnings updated based on clinical studies and warning of use of high doses.
Section 4.5 - (Interaction with Other medicinal products and other forms of interaction - table amended possible effects concomitant use with Acetylsalicylic acid/aspirin.
Section 4.8 - (Undesirable effects) - warnings changed in section "Cardiac disorders and vascular disorders"
Section 5.1 - (Pharmacodynamic properties) information changed relating from data/studies related to use with acetylsalicylic acid and possible reduction of cardioprotective effect of low dose aspirin.

Updated on 5 January 2016 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 21 September 2015 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2:
Updates to paragraph headers & addition of a paragraph relating to Method of Administration.

Section 4.3:
Update to the list of contraindications
Editorial changes

Section 4.4:
Editorial changes
Addition of excipient warning
Addition of respiratory disorder caution
 
Section 4.5:
Addition of new interaction table
 
Section 4.6:
Editorial changes

Section 4.8:
Addition of paragraphs relating to Infections and infestations and Skin and subcutaneous tissue disorder,  
Addition of a new MedDRA table
Addition of Adverse Event reporting details

Section 5.1:
Addition of pharmacotherapeutic classification
Editorial changes
Addition of paragraphs relating to Absorbtion, Distribution, Biotransformation, Elimination.
Addition of paragraphs relating to Special populations (Elderly, Paediatric population, Renal Impairment and Hepatic Impairment)

Section 5.3:
Editorial changes

Section 10:
Update to revision date

Updated on 18 September 2015 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to dosage and administration
  • Addition of information on reporting a side effect.

Updated on 14 April 2015 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 7:
MA Holder changed from Abbott Laboratories Ireland Limited to BGP Products Ireland Limited

Section 8:
PA number changed from PA 38/80/03 to PA 2010/2/2

Updated on 1 April 2015 PIL

Reasons for updating

  • Change to marketing authorisation holder

Updated on 20 June 2014 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.4 - Special Warnings and Precautions for use:-
Addition of "There is a risk of renal impairment in dehydrated children and adolescents"

Updated on 18 June 2014 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 July 2013 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 23 April 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Significant change to safety information

Updated on 18 April 2013 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery
  • Change to date of revision
  • Change to dosage and administration

Updated on 16 April 2013 PIL

Reasons for updating

  • Change to name of manufacturer

Updated on 22 January 2013 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 4.2 Posology: the following text was added:

"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."

Section 10 Date of revision of text was amended to Dec 2012

Updated on 17 January 2013 PIL

Reasons for updating

  • Change to date of revision
  • Change to dosage and administration

Updated on 8 August 2011 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 20 April 2011 PIL

Reasons for updating

  • Change due to user-testing of patient information

Updated on 26 January 2011 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Section 1: The trade name has been amended to read "Brufen 600 film-coated tablets".
Section 3: "----with 'Brufen 600' printed in black on one face" has been removed.
Section 6.1:  Details of printing ink (Opacode S-1-8152HV black, butanol or industrial methylated spirit) has been removed from the list of excipients.
Section 6.4: "Store in the original package in order to protect from moisture" has been added.
Section 6.5: HDPE bottle presentation have been removed and replaced with "Blister pack comprising of transparent polyvinyl chloride (PVC) or  polyvinyl chloride/polyvinylidene (PVC/PVDC) film with aluminium foil backing".  Pack size has changed to 60 tablets.
Section10.  Date of revision has been revised to 19 January 2011.

Updated on 8 November 2010 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

N/A

Updated on 27 May 2010 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 10 February 2010 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 5 February 2010 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

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 should not be used in patients with known hypersensitivity or with a history of bronchospasm, urticaria or rhinitis in response to Brufen, aspirin or other NSAIDs.

 

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.


 

4.5       Interactions with other Medicaments 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: NSAIDs may reduce the effect of anti-hypertensives, such as ACE inhibitors.reduced antihypertensive effect.

 

Diuretics: NSAIDs may reduce the reduced diuretic effect.  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 decreased elimination of lithium.

 

Methotrexate: NSAIDs may decreased elimination of methotrexate.

 

Cyclosporin: increased risk of nephrotoxicity with NSAIDs.

 

Other NSAIDs:  avoid concomitant use of two or more 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).

 

Corticosteroids: increased risk of gastrointestinal ulceration or bleeding with NSAIDs (See section 4.4)

 

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

 

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).

 

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

 

Aminoglycosides: NSAIDs may decrease the excretion of aminoglycosides.

 

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.

 

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: NSAIDs should not be used for 8-12 days after mifepristone administration as NSAIDs can reduce the effect of mifepristone.

 

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.

 

Ginkgo biloba may potentiate the risk of bleeding with NSAIDs.

 

 

4.6       Pregnancy and Lactation

 

            Whilst no teratogenic effects have been demonstrated in animal toxicology studies, the use of ibuprofen during pregnancy should be avoided except under compelling circumstances. Congenital abnormalities have been reported in association with ibuprofen administration in man; however, these are low in frequency and do not appear to follow any discernible pattern. In view of the known effects of NSAIDs on the foetal cardiovascular system (closure of ductus arteriosus), ibuprofen should not be used in 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.

 

4.8              Undesirable Effects

 

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

           

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 - Special warnings and precautions for use) have been reported following administration. Less frequently, gastritis has been observed. Pancreatitis has been reported very rarely.

 

Other adverse event reports include:

 

Cardiovascular: 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).

 

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

 

Psychiatric disorders: depression, confusion, hallucinations

 

Nervous system disorders: headaches, paraesthesia, dizziness, drowsiness

 

Eye disorders: disturbances of vision, optic neuritis

 

Ear and labyrinth disorders: vertigo, tinnitus

 

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

 

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

 

General disorders and administration site conditions: malaise, fatigue

 

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

4.9       Overdose

 

            Symptoms include nausea, vomiting, dizziness, convulsion, and rarely, loss of consciousness and depression of the CNS and respiratory system.  Large overdoses are generally well tolerated when no other drugs are involved.

Updated on 17 August 2009 PIL

Reasons for updating

  • Change to drug interactions

Updated on 3 August 2009 SmPC

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

2.         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

Each tablet contains 600 mg of Ibuprofen.

 

Also includes lactose monohydrate, 40mg per tablet.

 

For a full list of excipients, see section 6.1.

 

3.         PHARMACEUTICAL FORM

           

Film-coated tablet (tablet)

A white, pillow-shaped, film-coated tablet with ‘Brufen 600’ printed in black on one face.

4.5       Interactions with other Medicaments and other forms of Interaction

 

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

 

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

 

Antihypertensives: reduced antihypertensive effect.

 

Diuretics: reduced diuretic effect.  Diuretics can increase the risk of nephrotoxicity of NSAIDs.

 

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

 

Lithium: decreased elimination of lithium.

 

Methotrexate: decreased elimination of methotrexate.

 

Cyclosporin: increased risk of nephrotoxicity  with NSAIDs.

 

Other NSAIDs: avoid concomitant use of two or more NSAIDs.

 

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

 

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

 

Aspirin: 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).

 

Anti-platelet agents and selective serotonin reuptake inhibitors (SSRIs): increased risk of gastrointestinal bleeding (See section 4.4).

 

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

 

Aminoglycosides: Reduced in renal function in susceptible individuals, decreased elimination of aminoglycoside and increased plasma concentration.

 

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.

 

Ginkgo biloba may potentiate the risk of bleeding with NSAIDs.



5.1       Pharmacodynamic Properties

 

            Ibuprofen is a phenylpropionic acid derivative with analgesic, anti-inflammatory and antipyretic activity.  The drug's therapeutic effects as an 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 dose 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.

Updated on 27 August 2008 SmPC

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change in date to reflect the renewal date

Updated on 25 June 2007 PIL

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions

Updated on 21 June 2007 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.2 - Posology and Method of Administration
Change to section 4.3 - Contra-indications

Change to section 4.4 - Special warnings and Precautions

Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction

Change to section 4.8 - Undesirable Effects 

 

Updated on 10 January 2007 PIL

Reasons for updating

  • Change of contraindications
  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to side-effects

Updated on 9 January 2007 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects

Legal category: Product subject to medical prescription which may be renewed (B)

Free text change information supplied by the pharmaceutical company

Change to section 4.3 - Contra-indications

Change to section 4.4 - Warnings or special  precauitons for use

Change to section 4.5 - Drug interactions

Change to section 4.6 - Pregnancy or lactation

Change to section 4.8 - Side-effects  

 

Updated on 23 November 2004 PIL

Reasons for updating

  • New PIL for new product

Updated on 23 November 2004 SmPC

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 13 August 2004 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 9 August 2004 SmPC

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients

Legal category: Product subject to medical prescription which may be renewed (B)

Updated on 24 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Product subject to medical prescription which may be renewed (B)