Nicotinell Cool Mint 4mg medicated chewing gum
*Company:
Haleon Ireland LimitedStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
Updated on 20 April 2023
File name
ie-spc-nicotinell-coolmintgum-4mg-125-2-clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Legal category:Supply through general sale
Updated on 20 April 2023
File name
ie-pil-nicotinell-coolmint-4mg-125-2-clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 20 September 2021
File name
ie-pil-nico-coolmint-4mg-210824FM-combined.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-4mg-125-2_clean-210111FM.pdf
Reasons for updating
- Change to Section 1 - what the product is
- 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-4mg-125-2_clean-210111FM.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-4mg-mint.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 21 December 2020
File name
ie-spc-nicotinell-coolmint-4mg-excipient-approved-clean-200918BC.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-4mg-CRSF-clean.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 30 April 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 27 October 2016
File name
PIL_16736_213.pdf
Reasons for updating
- New PIL for new product
Updated on 27 October 2016
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
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
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 4mg 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