CHAMPIX 0.5 mg film-coated tablets; CHAMPIX 1 mg film-coated tablets
*Company:
Pfizer Healthcare Ireland Unlimited CompanyStatus:
No Recent UpdateLegal 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)
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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)
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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
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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.
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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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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
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
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
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
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
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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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
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
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)
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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)
Free text change information supplied by the pharmaceutical company
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
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
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)
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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
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
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)
Free text change information supplied by the pharmaceutical company
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)
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 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
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)
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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)
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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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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)
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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)