Nicotinell Cool Mint 2mg medicated chewing gum *

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 20 September 2021

File name

ie-pil-nico-coolmint-2mg-210824FM-combined_1632152351.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Addition of manufacturer
  • Addition of joint PIL covering all presentations

Updated on 26 May 2021

File name

ie-pil-txt-nicotinell-coolmintgum-2mg-125-1_clean-210111FM_1622047118.pdf

Reasons for updating

  • Change to Section 1 - what the product is
  • Change to section 1 - what the product is used for
  • Change to section 2 - what you need to know - contraindications
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 2 - excipient warnings
  • Change to section 3 - how to take/use
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose

Updated on 26 May 2021

File name

ie-spc-nicotinell-coolmintgum-2mg-125-1_clean-210111FM_1622045811.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • 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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.3 - Shelf life

Legal category:Supply through general sale

Updated on 24 December 2020

File name

ie-pil-2mg-mint_1608850302.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Update to the excipient warnings

Updated on 24 December 2020

File name

ie-pil-2mg-mint_1608850302.pdf

Reasons for updating

  • Change to section 2 - excipient warnings

Free text change information supplied by the pharmaceutical company

Update to excipient warnings

Updated on 21 December 2020

File name

ie-spc-nicotinell-coolmint-2mg-excipient-approved-clean-200922BC_1608550671.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through general sale

Updated on 04 June 2020

File name

ie-spc-nicotinell-coolmint-2mg-CRSF-clean_1591266031.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

The shelf life has been increased to 30 months.

Updated on 30 April 2018

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 27 October 2016

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 27 October 2016

File name

PIL_16735_956.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 October 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 03 October 2016

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Sections 7, 8 & 10 updated following Change of Ownership approval

Updated on 16 May 2016

Reasons for updating

  • New PIL for medicines.ie

Updated on 04 September 2015

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Addition of legal category

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 2

“with known effect” added

Section 4.2

Information regarding method of use moved under separate heading “Method of administration”

Headings amended

Section 4.3

“listed in section 6.1”

Section 4.8

AE data tabulated and adverse event reporting details added

Section 9

Date of last renewal amended to 25 May 2010

Section 10

Date of revision amended from 1st July 2014 to 25th August 2015

Legal Category amended to Supply though general sale

Updated on 08 July 2014

Reasons for updating

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

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

SPC Update – Nicotinell Cool Mint 2mg medicated chewing-gum – 1 July 2014   

 

 

Section 7

 

Address changed to Camberley.

 

Section 10

 

Change of date from 20 January 2012 to 1 July 2014.

 

 

 

Updated on 27 March 2012

Reasons for updating

  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 9

Date of last renewal date changed from 25 May 2005 to 20 January 2012

 

Section 10

Change date from September 2010 to 20 January 2012

Updated on 08 March 2011

Reasons for updating

  • New individual SPC (was previously included in combined SPC)

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided