We use cookies to ensure that we give you the best experience on our website. If you continue without changing your settings, we'll assume that you are happy to receive all cookies on the medicines.ie website. Find out more

Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 13/07/2017
SPC LYRICA Capsules

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 13/07/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jul-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The SPC has been updated as follows: addition of Hepatobiliary disorders in section 4.8. (uncommon, rare and very rare)
Updated on 21/03/2017 and displayed until 13/07/2017
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Mar-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Addition of pack size for 25mg capsules
Updated on 18/11/2016 and displayed until 21/03/2017
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Nov-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows:

-        Update of section 4.9 of the SmPC to add information about seizures. The Package leaflet is updated accordingly
-        Update of the Product Information to QRD version 9.1 and a combined SmPCs for all strengths of pregabalin capsules is introduced.
Updated on 23/06/2016 and displayed until 18/11/2016
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jun-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

The SPC has been updated as follows: New revision date / Approval date only
Updated on 27/04/2015 and displayed until 23/06/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Mar-2015
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as follows:

Updated paediatric information in sections 4.2, 4.8, 5.1 and 5.2 as requested after assessment of studies A0081074 & A0081075 submitted as post authorisation measures under Article 46 and Article 45.
Updated on 26/01/2015 and displayed until 27/04/2015
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Dec-2014
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

SPC sections 4.6 (Fertility, pregnancy, and lactation) and 5.2 (Pharmacokinetic properties) have been updated to reflect new data available for lactation, based on the results of a recently completed study.
Updated on 06/08/2014 and displayed until 26/01/2015
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jul-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to sections 4.4 & 4.8
Updated on 29/05/2014 and displayed until 06/08/2014
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
Date of revision of text on the SPC:   01-May-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to:

Section 6.5 & 8  to add a new pack size of a 70 day pack for Lyrica 75mg capsules
Updated on 04/03/2014 and displayed until 29/05/2014
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Feb-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Updates to section 4.8 of the SPC to update the frequency categories for ADRs in the Lyrica SPC based on the all-causality adverse events clinical trial dataset

Updated on 04/12/2013 and displayed until 04/03/2014
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Nov-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to sections 4.4 & 4.8
Updated on 30/04/2013 and displayed until 04/12/2013
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
Date of revision of text on the SPC:   01-Apr-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



To remove the sentence " In overdose up to 15 g no unexpected reactions were reported" and to add a reference to cases of coma.(SPC Section 4.9 Overdose).

Updated on 26/02/2013 and displayed until 30/04/2013
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Date of revision of text on the SPC:   01-Feb-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Update of the sub heading in Section 4.5 of the SPC from Ethanol, lorazepam, oxycodone to CNS influencing medical products

Updated on 30/11/2011 and displayed until 26/02/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Nov-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update of section 4.8 of the Summary of Product Characteristics (SmPC) and relevant section of the PL to add “gynaecomastia” and to replace “hypertrophy breast” with the term “breast enlargement”, as per MedDRA dictionary.
Updated on 21/11/2011 and displayed until 30/11/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   17-Jun-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

.
Updated on 08/11/2011 and displayed until 21/11/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   17-Jun-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update section 5.1
Updated on 30/06/2011 and displayed until 08/11/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   17-Jun-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

SmPC (update of section 4.8 in term of frequency of headache)
Updated on 15/09/2010 and displayed until 30/06/2011
Reasons for adding or 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 4.5 - 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 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   26-Aug-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

SmPC
Administrative changes to sections 4.2, 4.4, 4.5, 4.6, 4.7, 4.8 & 5.1 of the SPC
Addition of text on fertility to sections 4.6 and 5.1 of the SPC


Updated on 01/07/2010 and displayed until 15/09/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   14-Jun-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

In section 4.4 : Side effects and Section 4.8 undesirbale effects.
Updated on 13/05/2010 and displayed until 01/07/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   29-Apr-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.4:

- Addition of anxiety as a discontinuation symptom

- Addition of possible paralytic ileus when pregabalin is co-administered with drugs known to reduce lower gastrointestinal tract function to section 4.4 (CDS has it under drug interactions rather than warning/precautions).

Section 4.8:

- Addition of anxiety as a discontinuation symptom

Updated on 08/03/2010 and displayed until 13/05/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   21-Dec-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



The addition of malaise and aggressions as ADRs with unknown frequency to section 4.8 of the SPC.

Updated on 15/09/2009 and displayed until 08/03/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   20-Aug-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.8 undesirable effect

Removal of side effects emanating from clinical trial data from trials for indications for which Lyrica is not indicated.

Updated on 07/01/2009 and displayed until 15/09/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   12/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4 - Addition of vision loss and suicidal ideation information

Section 4.8 - Addition of vision loss information

Updated on 22/04/2008 and displayed until 07/01/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

4.4  Addition of information on hypersensitivity reactions, including cases of angioedema and visual changes

 

4.8 Addition of angioedema & Keratitis as new adverse events and visual field defect

      described under eye disorders

 

5.1 Addition of clinical trial data for visual changes

Updated on 19/03/2008 and displayed until 22/04/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

1) Strengthening of Congestive Heart Failure wording in section 4.4 of the SmPC and addition of urinary retention to section 4.8 of the SmPC

 

2) Addition of Stevens Johnson Syndrome (SJS) to section 4.8 of the SmPC

Updated on 27/07/2007 and displayed until 19/03/2008
Reasons for adding or 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 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
Date of revision of text on the SPC:   06/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company


Section 4.4 Addition of post marketing reports of consciousness, confusion and mental impairment

Section 4.5 Addition of interaction with CNS depressant medication and effects of ethanol & lorazepam

Section 4.8 Addition of loss of consciousness, mental impairment and headache

Section 4.9 Update of this section with post-marketing information

Section 6.5 Addition of 100 hard capsule PVC/Aluminium blister pack (non-perforated)

Section 8 – Addition of further license numbers

 

 

Updated on 16/02/2007 and displayed until 27/07/2007
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 
Section 4.4 - special warning to use pregabalin with caution in patients with congestive heart failure
 
Section 4.8 - reformatting and addition of adverse events with unknown frequency.  In addition congestive heart failure is included to the list of adverse reactions
 
Section 6.6 - updated wording to 'Special precautions for disposal and other handling'
Updated on 25/09/2006 and displayed until 16/02/2007
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   09/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 2 - qualitative and quantitative composition, Change to section 4.1 - Therapeutic Indications, Change to section 4.4 - Special Warnings and Precautions for Use, Change to section 4.8 - Undesirable Effects, Change to section 5.1 - Pharmacodynamic
Updated on 17/08/2006 and displayed until 25/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   07/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Change to section 4.8 - Undesirable Effects
Updated on 14/08/2006 and displayed until 17/08/2006
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.1 - List of excipients
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
Updated on 21/04/2006 and displayed until 14/08/2006
Reasons for adding or 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
Updated on 21/12/2005 and displayed until 21/04/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Updated on 20/07/2005 and displayed until 21/12/2005
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
Updated on 16/05/2005 and displayed until 20/07/2005
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 16/11/2004 and displayed until 16/05/2005
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number
Updated on 21/10/2004 and displayed until 16/11/2004
Reasons for adding or updating:
  • New SPC for new product

Document Links

 
  View all medicines
from this company
View Document
Bookmark and Share

Active Ingredients

 
   pregabalin