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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: 06/02/2012
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 the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 06/02/2012 and displayed until Current
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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
The changes are in section 4.4 & 5.1 spc for CHAMPIX.
Updated on 05/12/2011 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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
SPC changes to section 4.4, 4.8 and 5.1
Updated on 07/07/2011 and displayed until 05/12/2011
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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Updates to section 4.8 of the SPC.
Updated on 03/02/2011 and displayed until 07/07/2011
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:   POM
Black Triangle (CHM):   YES

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 15/11/2010 and displayed until 03/02/2011
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:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company


Update to section 5.1 of the SPC.

Updated on 21/12/2009 and displayed until 15/11/2010
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:   POM
Black Triangle (CHM):   NO

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 21/12/2009
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:   POM
Black Triangle (CHM):   NO

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 25/08/2009 and displayed until 10/12/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • 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:   03-Aug-2009
Legal Category:   POM
Black Triangle (CHM):   YES

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 27/04/2009 and displayed until 25/08/2009
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   08-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
Section 4.8 – addition of hallucinations information
Updated on 05/12/2008 and displayed until 27/04/2009
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:   25-Nov-2008
Legal Category:   POM
Black Triangle (CHM):   YES

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 21/08/2008 and displayed until 05/12/2008
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-Aug-2008
Legal Category:   POM
Black Triangle (CHM):   YES

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 31/03/2008 and displayed until 21/08/2008
Reasons for adding or updating:
  • 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:   03/2008
Legal Category:   POM
Black Triangle (CHM):   YES

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 10/03/2008 and displayed until 31/03/2008
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
 

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 10/03/2008
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   YES

Free-text change information supplied by the pharmaceutical company
 

Section 4.8 – Addition of Myocardial infaction
Updated on 17/04/2007 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 - MARKETING AUTHORISATION NUMBER(S)
Date of revision of text on the SPC:   03/2007
Legal Category:   POM
Black Triangle (CHM):   YES

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 17/04/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Date of revision of text on the SPC:   12/2006
Legal Category:   POM
Black Triangle (CHM):   YES

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
Updated on 22/12/2006 and displayed until 22/12/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
Updated on 26/10/2006 and displayed until 22/12/2006
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  varenicline tartrate