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Abbott Healthcare Products Limited
2.1 Woodford Business Park, Santry, Dublin 9, Ireland
Telephone: +353 1 8468793
Fax: +353 1 8468701
Medical Information Direct Line: +44 (0)2380 467 000
Medical Information e-mail: medinfo.shl@abbott.com
Medical Information Facsimile: +44 (0)2380 467052
Summary of Product Characteristics last updated on medicines.ie: 26/01/2011
SPC Brufen Retard

When a pharmaceutical company changes an SPC or PIL, 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 26/01/2011 and displayed until Current
Reasons for adding or 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
Date of revision of text on the SPC:   19-Jan-2011
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 08/11/2010 and displayed until 26/01/2011
Reasons for adding or 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
Date of revision of text on the SPC:   28-Oct-2010
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 26/10/2010 and displayed until 08/11/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.3 - Contraindications
  • Change to section 6.4 - Special precautions for storage
Date of revision of text on the SPC:   15-Oct-2010
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 12/01/2009 and displayed until 26/10/2010
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

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 27/08/2008 and displayed until 12/01/2009
Reasons for adding or updating:
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company
Change in date to reflect the renewal date
Updated on 21/06/2007 and displayed until 27/08/2008
Reasons for adding or 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
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

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 10/01/2007 and displayed until 21/06/2007
Reasons for adding or 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
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

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 16/08/2005 and displayed until 10/01/2007
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Updated on 09/08/2004 and displayed until 16/08/2005
Reasons for adding or updating:
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
Updated on 13/08/2003 and displayed until 09/08/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
  Ibuprofen