CHAMPIX 0.5 mg film-coated tablets; CHAMPIX 1 mg film-coated tablets
- Name:
CHAMPIX 0.5 mg film-coated tablets; CHAMPIX 1 mg film-coated tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/11/20
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Pfizer Healthcare Ireland
Company Products
When a pharmaceutical company changes any document, 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 18 November 2020 SPC
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
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 PIL
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 SPC
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 PIL
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 PIL
Reasons for updating
- Change to section 6 - date of revision
- Change of distributor details
Updated on 23 July 2019 PIL
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 SPC
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 PIL
Reasons for updating
- Change to section 3 - use in children/adolescents
- Change to section 6 - date of revision
Updated on 27 June 2019 SPC
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 PIL
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 SPC
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)
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows: transient loss of consciousness added to spc section 4.7 and 4.8
Updated on 3 August 2018 PIL
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 3 August 2018 SPC
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 SPC
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 as follows (revision date only to align with leaflet update)
Updated on 19 April 2018 PIL
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 PIL
Reasons for updating
- New PIL for new product
Updated on 18 January 2018 SPC
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 SPC
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 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 17 January 2018 PIL
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
Updated on 13 July 2017 SPC
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 PIL
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 4 August 2016 SPC
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 2 August 2016 PIL
Reasons for updating
- Change to drug interactions
- Change to date of revision
Updated on 6 July 2016 SPC
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 4 July 2016 PIL
Reasons for updating
- Change to side-effects
- Change to information about pregnancy or lactation
- Change to dosage and administration
Updated on 27 May 2016 SPC
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 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 27 November 2015 SPC
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 PIL
Reasons for updating
- Change to date of revision
- Change to marketing authorisation holder
Updated on 26 June 2015 PIL
Reasons for updating
- Change to MA holder contact details
Updated on 22 June 2015 SPC
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 PIL
Reasons for updating
- Change to information about drinking alcohol
Updated on 23 December 2014 SPC
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 PIL
Reasons for updating
- Change to, or new use for medicine
- Change to date of revision
Updated on 29 October 2014 SPC
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 1 October 2014 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 25 March 2014 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 7 January 2014 SPC
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 SPC
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
Updated on 5 August 2013 SPC
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 1 August 2013 PIL
Reasons for updating
- Change to date of revision
- Change to improve clarity and readability
Updated on 8 April 2013 SPC
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 2 April 2013 PIL
Reasons for updating
- Change to storage instructions
Updated on 25 March 2013 SPC
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 PIL
Reasons for updating
- Change to side-effects
Updated on 17 December 2012 SPC
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 30 November 2012 PIL
Reasons for updating
- Change to warnings or special precautions for use
Updated on 25 April 2012 SPC
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 3 April 2012 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 6 February 2012 SPC
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 7 December 2011 SPC
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
Updated on 5 December 2011 PIL
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 SPC
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 7 July 2011 PIL
Reasons for updating
- Change to side-effects
Updated on 18 January 2011 SPC
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 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to dosage and administration
Updated on 22 November 2010 SPC
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 SPC
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
Section 5.1
Include data from a recent clinical study in patients with cardiovascular disease.
Updated on 10 December 2009 SPC
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 7 December 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 30 September 2009 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to date of revision
Updated on 24 August 2009 SPC
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 PIL
Reasons for updating
- Introduction of new pack/pack size
Updated on 18 August 2009 PIL
Reasons for updating
- Change to side-effects
- Change to further information section
- Change to date of revision
Updated on 22 April 2009 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 22 April 2009 SPC
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 4 December 2008 PIL
Reasons for updating
- Change to side-effects
- Change to information about drinking alcohol
- Change to date of revision
Updated on 3 December 2008 SPC
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 PIL
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 15 August 2008 SPC
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 PIL
Reasons for updating
- Change to date of revision
- Change to name of manufacturer
Updated on 1 April 2008 SPC
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 PIL
Reasons for updating
- Change to date of revision
- Change due to harmonisation of patient information leaflet
Updated on 6 March 2008 PIL
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
- Change to date of revision
Updated on 5 March 2008 SPC
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 PIL
Reasons for updating
- Change due to harmonisation of patient information leaflet
Updated on 3 May 2007 SPC
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 Myocardial infaction
Updated on 17 April 2007 PIL
Reasons for updating
- Addition of marketing authorisation holder
- Change to date of revision
Updated on 16 April 2007 SPC
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
Updated on 23 January 2007 PIL
Reasons for updating
- Change to date of revision
Updated on 2 January 2007 SPC
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
Updated on 22 December 2006 SPC
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
Updated on 22 December 2006 SPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 26 October 2006 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)