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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 01/12/2011
SPC Lyrica Capsules

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 01/12/2011 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-Nov-2011
Legal Category:   POM
Black Triangle (CHM):   NO

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 01/12/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   17-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 09/11/2011 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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update section 5.1
Updated on 27/06/2011 and displayed until 09/11/2011
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:   POM
Black Triangle (CHM):   NO

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 27/06/2011
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:   POM
Black Triangle (CHM):   NO

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 02/07/2010 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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 4.4 - Encephalopathy was added


In section 4.8 - Abuse Potential
Updated on 13/05/2010 and displayed until 02/07/2010
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:   29-Apr-2010
Legal Category:   POM
Black Triangle (CHM):   NO

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  (CDS has it under drug interactions rather than warning/precautions).

Section 4.8:

- Addition of anxiety as a discontinuation symptom to section 4.8.

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:   POM
Black Triangle (CHM):   YES

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 09/09/2009 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:   POM
Black Triangle (CHM):   YES

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 09/01/2009 and displayed until 09/09/2009
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:   01-Dec-2008
Legal Category:   POM
Black Triangle (CHM):   YES

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 01/05/2008 and displayed until 09/01/2009
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:   01-Mar-2008
Legal Category:   POM
Black Triangle (CHM):   YES

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 26/03/2008 and displayed until 01/05/2008
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:   POM
Black Triangle (CHM):   YES

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 23/07/2007 and displayed until 26/03/2008
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 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   06/2007
Legal Category:   POM
Black Triangle (CHM):   YES

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 07/02/2007 and displayed until 23/07/2007
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 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   YES

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 disposaland other handling'
Updated on 04/10/2006 and displayed until 07/02/2007
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:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section:  2
Change to section:  4.1
Change to section:  4.4
Change to section:  4.8
Change to section:  5.1
 
Updated on 29/09/2006 and displayed until 04/10/2006
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
  • Pending awaiting re-submission
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

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 Properties
Updated on 26/09/2006 and displayed until 29/09/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 4.4 - Special Warnings and Precautions for Use
Date of revision of text on the SPC:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Reason for Submission: Change to section 2 - qualitative and quantitative composition, Change to section 4.1 - Therapeutic Indications, Change to section 4.8 - Undesirable Effects, Change to section 5.1 - Pharmacodynamic Properties, Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 17/08/2006 and displayed until 26/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 4.8 - Undesirable Effects
Updated on 06/06/2006 and displayed until 17/08/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • 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 (partial) revision of the text
Date of revision of text on the SPC:   01/05/2006
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Change to section 1 - trade name, 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 (partial) revision of the text
Updated on 24/04/2006 and displayed until 06/06/2006
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 - Interactions with other Medicaments 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 24/04/2006
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 10/03/2005 and displayed until 20/07/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/11/2004 and displayed until 10/03/2005
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
Updated on 18/11/2004 and displayed until 18/11/2004
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
  • Pending awaiting re-submission
Updated on 16/11/2004 and displayed until 18/11/2004
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MA number
  • Pending awaiting re-submission
Updated on 08/07/2004 and displayed until 16/11/2004
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 08/07/2004 and displayed until 08/07/2004
Reasons for adding or updating:
  • Addition of Black Triangle
Updated on 08/07/2004 and displayed until 08/07/2004
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  pregabalin