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

*
Pharmacy Only: Prescription
  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

Updated on 04 October 2023

File name

Adv SPC CI4400.5mg & 1mg IE - clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 04 October 2023

File name

Adv PIL CI 4300.5mg & 1mg IE & NI - clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 13 February 2023

File name

DEC202075790_Adv SPC CI 43_1 0.5mg & 1mg IE_clean.pdf

Reasons for updating

  • Document format updated

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 October 2021

File name

Adv PIL CI 42_2 0.5mg & 1mg IE & NI - clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 18 November 2020

File name

DEC202075790_Adv SPC CI 43_1 0.5mg & 1mg IE_clean.pdf

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

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The SPC has been updated as follows: to update to Section 4.4 of the SPC by adding to the excipient warnings sub-section a statement regarding Sodium content.

Updated on 18 November 2020

File name

DEC202075790_Adv PIL CI 41_1 0.5mg & 1mg IE_clean.pdf

Reasons for updating

  • Change to section 2 - excipient warnings
  • Change to section 6 - what the product contains
  • Change to section 6 - date of revision

Updated on 11 November 2020

File name

Adv SPC CI 42_0 0.5mg 1mg IE- clean.pdf

Reasons for updating

  • Change to Section 4.8 – Undesirable effects - how to report a side effect

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 11 November 2020

File name

Adv PIL CI 40_0 0.5mg 1mg IE Clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to other sources of information section

Updated on 18 November 2019

File name

DEC201963766_Adv PIL CI 39_0 0.5mg & 1mg IE & UK-clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change of distributor details

Updated on 23 July 2019

File name

DEC201938975_Adv PIL CI 38_0 0.5mg & 1mg IE & UK clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 23 July 2019

File name

DEC201938975_Adv SPC CI 41_0 0.5mg & 1mg UK & IRE clean.pdf

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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: Revision to section 6.5 to pack size description

Updated on 27 June 2019

File name

DEC201932647_Adv PIL CI 37_0 0.5mg & 1mg IE & UK clean.pdf

Reasons for updating

  • Change to section 3 - use in children/adolescents
  • Change to section 6 - date of revision

Updated on 27 June 2019

File name

DEC201932647_Adv SPC CI 40_0 0.5mg & 1mg UK & IRE clean.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 21 August 2018

File name

Adv PIL CI 36_0 0.5mg 1mg IE UK clean.pdf

Reasons for updating

  • Change to section 2 - driving and using machines
  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 21 August 2018

File name

Adv SPC CI 39_0 0.5mg 1mg UK IRE clean.pdf

Reasons for updating

  • Change to section 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

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The SPC has been updated as follows: transient loss of consciousness added to spc section 4.7 and 4.8

Updated on 03 August 2018

File name

Adv PIL CI 35_0 0.5mg 1mg IE UK clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 03 August 2018

File name

Adv SPC CI 38_0 0.5mg 1mg UK IRE clean.pdf

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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:
Section 4.8 MHRA ADR reporting details update

Section 7 – Change to MAH

Section 10 – Date of revision of text

Updated on 24 April 2018

File name

Adv_SPC_CI_37_0_0.5mg_&_1mg_UK_&_IRE_clean.docx

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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The SPC has been updated as follows (revision date only to align with leaflet update)

Updated on 19 April 2018

File name

Adv PIL CI 34_0 0.5mg & 1mg IE & UK clean.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - marketing authorisation number
  • Change to section 6 - manufacturer

Updated on 18 January 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 18 January 2018

File name

PIL_11581_456.pdf

Reasons for updating

  • New PIL for new product

Updated on 18 January 2018

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - Marketing authorisation number(s)

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 6.5 Nature and contents of container and section 8 MAH have been updated to include the 12 week packs.

Updated on 18 January 2018

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 17 January 2018

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents

Updated on 13 July 2017

Reasons for updating

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

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 11 July 2017

Reasons for updating

  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 04 August 2016

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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Update to section 10  - SPC is updated to carry the same revision date as the leaflet.

Updated on 02 August 2016

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 06 July 2016

Reasons for 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

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 04 July 2016

Reasons for updating

  • Change to side-effects
  • Change to information about pregnancy or lactation
  • Change to dosage and administration

Updated on 27 May 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

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 25 May 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 27 November 2015

Reasons for updating

  • Change to section 10 - Date of revision of the text

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 26 November 2015

Reasons for updating

  • Change to date of revision
  • Change to marketing authorisation holder

Updated on 26 June 2015

Reasons for updating

  • Change to MA holder contact details

Updated on 22 June 2015

Reasons for 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

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 18 June 2015

Reasons for updating

  • Change to information about drinking alcohol

Updated on 23 December 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

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 17 December 2014

Reasons for updating

  • Change to, or new use for medicine
  • Change to date of revision

Updated on 29 October 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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 01 October 2014

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 25 March 2014

Reasons for updating

  • Change to section 4.8 - Undesirable effects

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 4.8

Updated on 21 March 2014

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 07 January 2014

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Update to sections 4.2 & 5.1

Updated on 22 November 2013

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

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Update to Section 6.3

Updated on 05 August 2013

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

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 01 August 2013

Reasons for updating

  • Change to date of revision
  • Change to improve clarity and readability

Updated on 08 April 2013

Reasons for updating

  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

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 02 April 2013

Reasons for updating

  • Change to storage instructions

Updated on 25 March 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 4.8  – Seizures

Updated on 22 March 2013

Reasons for updating

  • Change to side-effects

Updated on 17 December 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Sections 4.4 and 5.1 – CVMA data

Updated on 30 November 2012

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 April 2012

Reasons for updating

  • Change to section 5.2 - Pharmacokinetic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

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Changes to section 5.2 of the SPC.

Updated on 03 April 2012

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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



Updated on 29 March 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 06 February 2012

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

The changes are in section 4.4 & 5.1 of CHAMPIX.

Updated on 07 December 2011

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Changes to section 4.4, 4.8 and 5.1.

Updated on 05 December 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 12 July 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Updates to section 4.8 of the SPC.

Updated on 07 July 2011

Reasons for updating

  • Change to side-effects

Updated on 18 January 2011

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 17 January 2011

Reasons for updating

  • Change to information about pregnancy or lactation
  • Change to dosage and administration

Updated on 22 November 2010

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

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Update to section 5.1 of the SPC.

Updated on 15 December 2009

Reasons for updating

  • Change to section 5.1 - Pharmacodynamic properties

Legal category:Product subject to medical prescription which may not be renewed (A)

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Section 5.1

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

Updated on 10 December 2009

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

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 07 December 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 30 September 2009

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 24 August 2009

Reasons for updating

  • Change to section 8 - MA number
  • Change to section 4.8 - Undesirable effects
  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

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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 21 August 2009

Reasons for updating

  • Introduction of new pack/pack size

Updated on 18 August 2009

Reasons for updating

  • Change to side-effects
  • Change to further information section
  • Change to date of revision

Updated on 22 April 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

Section 4.8 addition of Hallucinations

Updated on 22 April 2009

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 04 December 2008

Reasons for updating

  • Change to side-effects
  • Change to information about drinking alcohol
  • Change to date of revision

Updated on 03 December 2008

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 18 August 2008

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 15 August 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Product subject to medical prescription which may not be renewed (A)

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 24 April 2008

Reasons for updating

  • Change to date of revision
  • Change to name of manufacturer

Updated on 01 April 2008

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

Legal category:Product subject to medical prescription which may not be renewed (A)

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 31 March 2008

Reasons for updating

  • Change to date of revision
  • Change due to harmonisation of patient information leaflet

Updated on 06 March 2008

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to date of revision

Updated on 05 March 2008

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

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 28 February 2008

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 03 May 2007

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

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Section 4.8 – Addition of Myocardial infaction

Updated on 17 April 2007

Reasons for updating

  • Addition of marketing authorisation holder
  • Change to date of revision

Updated on 16 April 2007

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

Legal category:Product subject to medical prescription which may not be renewed (A)

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 23 January 2007

Reasons for updating

  • Change to date of revision

Updated on 02 January 2007

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

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Section 6.3: extend the shelf-life of Champix tablets from 18 months to 2 years.

Updated on 22 December 2006

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

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

Updated on 22 December 2006

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

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

Updated on 14 November 2006

Reasons for updating

  • New PIL for new product

Updated on 26 October 2006

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)