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:
    info
  • Active Ingredients:

    Varenicline tartrate

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 18/11/19

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Summary of Product Characteristics last updated on medicines.ie: 23/7/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

Company Products

Medicine NameActive Ingredients
Medicine Name Accupro 10 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 20 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 40 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accupro 5 mg Film - Coated tablets Active Ingredients Quinapril hydrochloride
Medicine Name Accuretic 20 mg/12.5 mg Tablets Active Ingredients Hydrochlorothiazide, Quinapril hydrochloride
Medicine Name Aciclovir 25 mg/ml Concentrate for Solution for Infusion. Active Ingredients Aciclovir sodium
Medicine Name Aldactone 100mg film coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 25mg film-coated tablets Active Ingredients Spironolactone
Medicine Name Aldactone 50 mg Film-coated tablets. Active Ingredients Spironolactone
Medicine Name Amlodipine Pfizer 10 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Amlodipine Pfizer 5 mg Tablets Active Ingredients Amlodipine besilate
Medicine Name Anugesic HC Cream Active Ingredients Balsam Peru, Benzyl Benzoate, Bismuth Oxide, Hydrocortisone Acetate, Pramocaine Hydrochloride, Zinc Oxide
Medicine Name ARICEPT 10 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name ARICEPT 5 mg film coated tablets Active Ingredients Donepezil Hydrochloride
Medicine Name Aromasin 25 mg coated tablets Active Ingredients Exemestane
Medicine Name Arthrotec 50 Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Arthrotec 75 modified-release tablets Active Ingredients Diclofenac Sodium, Misoprostol
Medicine Name Ativan 1mg Tablets Active Ingredients Lorazepam
Medicine Name ATIVAN INJECTION Active Ingredients Lorazepam
Medicine Name BeneFIX Active Ingredients nonacog alfa
Medicine Name BESPONSA 1 mg powder for concentrate for solution for infusion Active Ingredients Inotuzumab ozogamicin
Medicine Name Bosulif 100 mg, 400 mg & 500 mg film-coated tablets Active Ingredients Bosutinib monohydrate
Medicine Name Cabaser 1mg Tablet Active Ingredients Cabergoline
Medicine Name Cabaser 2mg Tablet Active Ingredients Cabergoline
Medicine Name CAMPTO 20 mg/ml, concentrate for solution for infusion Active Ingredients Irinotecan hydrochloride trihydrate
1 - 0 of 232 items.Total: Infinity pages

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 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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 18 January 2018 SmPC

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 SmPC

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 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 SmPC

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

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

Updated on 2 August 2016 PIL

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 6 July 2016 SmPC

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 SmPC

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 PIL

Reasons for updating

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

Updated on 27 November 2015 SmPC

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 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 SmPC

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 SmPC

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 PIL

Reasons for updating

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

Updated on 29 October 2014 SmPC

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 1 October 2014 PIL

Reasons for updating

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

Updated on 25 March 2014 SmPC

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 SmPC

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 SmPC

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

Update to Section 6.3

Updated on 5 August 2013 SmPC

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 1 August 2013 PIL

Reasons for updating

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

Updated on 8 April 2013 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to side-effects

Updated on 17 December 2012 SmPC

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 PIL

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 25 April 2012 SmPC

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

Changes to section 5.2 of the SPC.

Updated on 3 April 2012 SmPC

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 PIL

Reasons for updating

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

Updated on 6 February 2012 SmPC

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 7 December 2011 SmPC

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 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 SmPC

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 7 July 2011 PIL

Reasons for updating

  • Change to side-effects

Updated on 18 January 2011 SmPC

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 PIL

Reasons for updating

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

Updated on 22 November 2010 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 PIL

Reasons for updating

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

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 SmPC

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 PIL

Reasons for updating

  • Change to date of revision

Updated on 2 January 2007 SmPC

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 the shelf-life of Champix tablets from 18 months to 2 years.

Updated on 22 December 2006 SmPC

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 22 December 2006 SmPC

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 SmPC

Reasons for updating

  • New SPC for new product

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