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Brufen Retard 800mg prolonged release tablets *

  • Company:

    Mylan IRE Healthcare Limited

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Ibuprofen

    *Additional information is available within the SPC or upon request to the company

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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 03 November 2020

File name

ie-spc-brufen-800mg-TIB-PRAC-excipients-clean_1604416710.pdf

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 10 - Date of revision of the text

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

Updated on 03 November 2020

File name

ie-pl-brufen-800mg-TIB-PRAC-excipients-clean_1604416670.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - how to take/use
  • Change to section 6 - date of revision

Updated on 09 January 2020

File name

ie-SmPC-BrufenRetard800mg-07Jan2019-CRN009GSD-TIAIN-clean_1578573853.pdf

Reasons for updating

  • 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)

Updated on 09 January 2020

File name

ie-PIL_BrufenRetard800mg-07Jan2019-CRN009GSD-TIAIN-eMC_1578573809.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 14 June 2019

File name

ie-SmPC-BrufenRetard800-10Apr2018-CRN2204117-clean_1560508606.pdf

Reasons for updating

  • Change to improve clarity and readability

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

Updated on 03 January 2019

File name

ie-PIL-BrufenRetard-TIAin_07-Dec-2018-Clean-EMC_1546525585.pdf

Reasons for updating

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

Updated on 16 May 2018

File name

ie-SmPC-BrufenRetard800-10Apr2018-CRN2204117-clean.doc

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.9 - Overdose

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

Updated on 26 April 2018

File name

ie-PIL-BrufenRetard-10Apr2018-CRN2204117-emc.pdf

Reasons for updating

  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 06 June 2017

Reasons for updating

  • New SPC for new product

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

Updated on 06 June 2017

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 02 June 2017

File name

PIL_9263_994.pdf

Reasons for updating

  • New PIL for new product

Updated on 02 June 2017

Reasons for updating

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

Updated on 13 December 2016

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 09 December 2016

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 - date of revision

Updated on 22 September 2016

Reasons for updating

  • Change to date of revision

Updated on 22 April 2016

Reasons for updating

  • Change of manufacturer

Updated on 07 January 2016

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 4.8 - Undesirable effects
  • 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

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 05 January 2016

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 21 September 2015

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 4.8 – Undesirable effects - how to report a side effect
  • 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

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

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 38/80/07 to PA 2010/2/7

Updated on 02 April 2015

Reasons for updating

  • Change to marketing authorisation holder

Updated on 24 July 2013

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to information about driving or using machinery

Updated on 22 April 2013

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

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

Updated on 18 April 2013

Reasons for updating

  • Change to name of manufacturer

Updated on 22 January 2013

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

Addition of the following text to section 4.2:

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.



Date of revision of text amended to Dec 2012

Updated on 17 January 2013

Reasons for updating

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

Updated on 08 August 2011

Reasons for updating

  • Improved electronic presentation

Updated on 20 April 2011

Reasons for updating

  • Change due to user-testing of patient information

Updated on 26 January 2011

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications
  • Change to section 6.1 - List of excipients
  • 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 2: the excipient soya lecithin has been removed.
Section 3: "----with 'Brufen Retard' printed in reddish brown on one surface" has been removed.
Section 4.3: Contraindication regarding allergy to soya & peanut has been removed.
Section 6.1: Opacode S-1-9460HV brown (contains shellac, red oxide oxide (E172), soya lecithin and polydimethysiloxane has been removed from the list of excipients.
Section 6.4: Storage requirements for plastic jar have been removed
Section 6.5: HDPE bottle presentation has been removed. Details of blister pack have been amended.  All pack sizes (except for 60 tablet pack) have been deleted.
Section10.  Date of revision has been revised to 19 January 2011.

Updated on 11 November 2010

Reasons for updating

  • Improved electronic presentation

Updated on 08 November 2010

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

Section 4.3:  the following added:

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

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.

Section 4.5: information added regarding ineteraction with NSAIDs and cyclooxygenase-2 selective inhibitors, aminoglycosides, mifepristone, tacrolimus & zidovudine

Section 4.6: The following added:
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.
Section 4.8: the following adverse events have been added, Stevens-Johns syndrome, heapatic failure, Pancreatitis

Section 4.9: The following symtoms added:
Convulsion, depression of CNS and respiratory system.

Updated on 02 November 2010

Reasons for updating

  • Change to side-effects
  • Change to drug interactions

Updated on 26 October 2010

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6.4 - Special precautions for storage

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

Free text change information supplied by the pharmaceutical company

In section 2,  "Excipients: also contains soya lecithin. For a full list of the excipients, see section 6.1." has been added.
In section 4.3, the following contraindication has been added: "These tablets contain soya lecithin. If you are allergic to soya or peanut, do not use this medicinal product."
In section 6.4, the storage statement has been chanhed to: 
"Blister pack: Do not store above 25°C. Store in the original package in order to protect from moisture.
Plastic jar: Do not store above 25°C. Keep the container tightly closed in order to protect from moisture. "

Updated on 13 January 2009

Reasons for updating

  • Change to drug interactions

Updated on 12 January 2009

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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

Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Change to section 5.1 - Pharmacodynamic Properties

Updated on 27 August 2008

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

Reasons for updating

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

Updated on 21 June 2007

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 11 January 2007

Reasons for updating

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

Updated on 10 January 2007

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 precautions 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 16 August 2005

Reasons for updating

  • Change to section 10 - Date of revision of the text

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

Updated on 25 November 2004

Reasons for updating

  • New PIL for new product

Updated on 09 August 2004

Reasons for updating

  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container

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

Updated on 13 August 2003

Reasons for updating

  • New SPC for medicines.ie

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