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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 CHAMPIX 0.5 mg film-coated tablets; CHAMPIX 1 mg film-coated tablets

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 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
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:

Sections 4.6 and 5.1 of the SPC with safety information based on the final results from PASS Clinical Study A3051078, a varenicline Pregnancy Cohort Study. The Package Leaflet was also updated accordingly. 
 
Section 5.1 of the SPC with safety information based on final results from PASS Clinical Study A3051148 (A Phase 4, Non-Treatment Follow-Up for Cardiac Assessments Following Use of Smoking Cessation Treatments in Subjects With and Without a History of Psychiatric Disorders). 
 
The opportunity was taken to bring the labelling in line with the latest EMA Quality Review of Documents) (QRD) group template - Version 10.

Updated on 04/08/2016 and displayed until 13/07/2017
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Jul-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company

Update to section 10  - SPC is updated to carry the same revision date as the leaflet.
Updated on 06/07/2016 and displayed until 04/08/2016
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
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: Renewal:

Update to section 4.2 Posology and method of administration – deleted information

Update to section 4.6 Fertility, pregnancy and lactation – update of pregnancy section

Update to section 4.8 Undesirable Effects – change in frequencies from not know to rare / uncommon.
Updated on 27/05/2016 and displayed until 06/07/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Apr-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: Type II variation to: update Sections 4.4 and 5.1 of the SmPC to reflect the outcomes from Study A3051123 (EAGLES).
Updated on 27/11/2015 and displayed until 27/05/2016
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Nov-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 with a revised revision date.
Updated on 22/06/2015 and displayed until 27/11/2015
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 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-May-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:

Updates to Section 4.4 and 5.1 to include information on neuropsychiatric safety and update to Section 4.5 to include further information on the effects of taking Champix with alcohol – please see attached SPC.

Updated on 23/12/2014 and displayed until 22/06/2015
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Nov-2014
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 to Sections 4.2 and 5.1 based on the results of study A3051075.
Updated on 29/10/2014 and displayed until 23/12/2014
Reasons for adding or updating:
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   01-Oct-2014
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

SPC revision date should be updated to October 2014 as an administrative update only to align with the PIL revision date.
Updated on 25/03/2014 and displayed until 29/10/2014
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



Update to section 4.8

Updated on 07/01/2014 and displayed until 25/03/2014
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Dec-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to sections 4.2 & 5.1
Updated on 22/11/2013 and displayed until 07/01/2014
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
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 Section 6.3
Updated on 05/08/2013 and displayed until 22/11/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Jul-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Update to sections 4.8 & 5.1 update to the SPC in line with clinical study results from a safety and efficacy study in smoking cessation in subjects with depression, update in line with QRD 9 and addition of Croatian details – CP.
Updated on 08/04/2013 and displayed until 05/08/2013
Reasons for adding or updating:
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   20-Mar-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 6.4 and 6.5 to introduce to storage precautions “store below 30C” for blisters and include new blister configurations).

Updated on 25/03/2013 and displayed until 08/04/2013
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-Mar-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8  – Seizures
Updated on 17/12/2012 and displayed until 25/03/2013
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   19-Nov-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Sections 4.4 and 5.1 – CVMA data
Updated on 25/04/2012 and displayed until 17/12/2012
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   13-Apr-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Changes to section 5.2 of the SPC.
Updated on 03/04/2012 and displayed until 25/04/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   26-Mar-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

SPC - The changes are in section 4.8 of the CHAMPIX▼ SPC.



Updated on 06/02/2012 and displayed until 03/04/2012
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   20-Jan-2012
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

The changes are in section 4.4 & 5.1 of CHAMPIX.
Updated on 07/12/2011 and displayed until 06/02/2012
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:   21-Nov-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Changes to section 4.4, 4.8 and 5.1.
Updated on 12/07/2011 and displayed until 07/12/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   27-Jun-2011
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.
Updated on 18/01/2011 and displayed until 12/07/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   01-Jan-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Updates to section 4.2, 4.6, 5.1 & 5.2 of the SPC
Updated on 22/11/2010 and displayed until 18/01/2011
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   01-Oct-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Update to section 5.1 of the SPC.

Updated on 15/12/2009 and displayed until 22/11/2010
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic properties
Date of revision of text on the SPC:   03-Dec-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 5.1

Include data from a recent clinical study in patients with cardiovascular disease.

Updated on 10/12/2009 and displayed until 15/12/2009
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:   30-Nov-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.4

-          addition of ‘Changes in behaviour or thinking, anxiety, psychosis, mood swings, aggressive behaviour,

-     addition of  post marketing reports on cutaneous reactions, including Stevens-Johnson Syndrome and Erythema Multiforme in patients using varenicline. 

 

Section 4.8

The above is added in the post marketing cases of reported side effects.

Updated on 24/08/2009 and displayed until 10/12/2009
Reasons for adding or updating:
  • Change to section 8 - MA number
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   03-Aug-2009
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 4.8: Addition of Aggression and irrational behaviour

Section 6.5: Aclar / PVC blisters with aluminium foil backing in a pack containing 140 x 1 mg film-coated tablets in secondary heat sealed card packaging.

Section 8: New EU number - EU/1/06/360/013

Updated on 22/04/2009 and displayed until 24/08/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.8 addition of Hallucinations
Updated on 03/12/2008 and displayed until 22/04/2009
Reasons for adding or updating:
  • 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 10 - Date of revision of the text
Date of revision of text on the SPC:   11/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

4.5 - Text relating to interaction with alcohol has been moved.

4.8 - Addition of hypersensitivity reactions.

10 - Date of revision updated.

Updated on 15/08/2008 and displayed until 03/12/2008
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
Date of revision of text on the SPC:   08/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 4.4 of the SmPC: regarding a statement on discontinuation of varenicline treatment in the case of serious neuropsychiatric symptoms

Updated on 01/04/2008 and displayed until 15/08/2008
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:   03/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

6.5 – Change in Pack size

8    – New MA number added for new pack size 

Updated on 05/03/2008 and displayed until 01/04/2008
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

 

4.4 – to include information on depression, suicidal ideation and suicidal attemp

4.8 – to include information on depression, suicidal ideation and suicidal attemp  

Updated on 03/05/2007 and displayed until 05/03/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 

Section 4.8 – Addition of Myocardial infaction

Updated on 16/04/2007 and displayed until 03/05/2007
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:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 
Section 6.5 New pack size added; Aclar/PVC/blisters with aluminium foil backing in a pack containing 112 x 1mg film coated tablets in a carton
 
Section 8 Additional pack licence number = EU/1/06/360/011
 
 
Updated on 02/01/2007 and displayed until 16/04/2007
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 6.3: extend the shelf-life of Champix tablets from 18 months to 2 years.
Updated on 22/12/2006 and displayed until 02/01/2007
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 6.3: extend shelf life from 18 months to 24 months
Updated on 22/12/2006 and displayed until 22/12/2006
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   12/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Section 6.3: extend shelf life from 18 months to 24 months

Updated on 26/10/2006 and displayed until 22/12/2006
Reasons for adding or updating:
  • New SPC for new product

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Active Ingredients

 
   Varenicline tartrate