Nicorette QuickMist 1mg/spray Oromucosal Spray
*Company:
KenvueStatus:
No Recent UpdateLegal Category:
Supply through general saleActive Ingredient(s):
*Additional information is available within the SPC or upon request to the company
 NICORETTE QUICKMIST MINT 1MG DOUBLE_1637770918.jpeg)
 NICORETTE QUICKMIST MINT 1MG SINGLE_1637770918.jpeg)
Updated on 03 January 2024
File name
ie-leaflet-nicorette-quickmist-2506.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 January 2024
File name
ie-spc-v11-nicorette quickmist-2506.pdf
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
Updated on 14 August 2023
File name
ie-pl-nic-quickmist-2266.pdf
Reasons for updating
- Change to section 2 - what you need to know - contraindications
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 August 2023
File name
ie-spc-v10-nic-quickmist-2266.pdf
Reasons for updating
- Change to section 4.3 - Contraindications
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 17 August 2022
File name
ie-pl-nicorette-quickmist 2081.pdf
Reasons for updating
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
Updated on 17 August 2022
File name
ie-spc v9-nicorette-quickmist-2081.pdf
Reasons for updating
- Change to section 6.5 - Nature and contents of container
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 23 December 2020
File name
ie-pl-nicorette-quickmist 2101.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - use in children and adolescents
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
Updated on 23 December 2020
File name
ie-spc-v8-nicorette-quickmist 2101.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 6.3 - Shelf life
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 07 September 2020
File name
ie-pil-clean-mint-1941.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - contraindications
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 07 September 2020
File name
ie-spc-clean-1941-.pdf
Reasons for updating
- Change to section 4.1 - Therapeutic indications
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 23 May 2019
File name
NCF02 1877 SPC V6.pdf
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 04 February 2019
File name
ie-pil-clean-mint-BV 1759.pdf
Reasons for updating
- Change to section 2 - excipient warnings
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
Updated on 04 February 2019
File name
NCF02 BV 1759 SPC V 5.2.pdf
Reasons for updating
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- Change to section 10 - Date of revision of the text
Legal category:Supply through general sale
Updated on 21 June 2018
File name
Nicorette Quickmist .docx
Reasons for updating
- Previous version of SPC reinstated
Legal category:Supply through general sale
Updated on 10 May 2018
File name
spc.docx
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category:Supply through general sale
Updated on 08 January 2018
File name
PIL_15488_145.pdf
Reasons for updating
- New PIL for new product
Updated on 08 January 2018
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 23 March 2016
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Updated on 23 March 2016
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 10 changed date to "January 2016"
Updated on 23 November 2015
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 4.9 - Overdose
- 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
CCDS updates SNAS 1333
Section 4.4
The benefits of quitting smoking outweigh any risks associated with correctly administered nicotine replacement therapy (NRT).
A risk-benefit assessment should be made by an appropriate healthcare professional for patients with the following conditions:
• Cardiovascular disease: Dependent smokers with a recent myocardial infarction, unstable or worsening angina including Prinzmetal’s angina, severe cardiac arrhythmias, recent cerebrovascular accident and/or who suffer with uncontrolled hypertension should be encouraged to stop smoking with non-pharmacological interventions (such as counselling). If this fails, the oromucosal spray may be considered but as data on safety in this patient group are limited, initiation should only be under close medical supervision.
Section 4.6
Fertility
Smoking increases the risk for infertility in women and men. In vitro studies have shown that nicotine can adversely affect human sperm quality. In rats, impaired sperm quality and reduced fertility has been shown.
Section 4.8
Please refer to SPC for updates to Section 4.8
Section 4.9
If excessive amount of nicotine is swallowed, activated charcoal reduces the gastrointestinal absorption of nicotine.
Updated on 20 November 2015
Reasons for updating
- Change to warnings or special precautions for use
- Change to side-effects
Updated on 29 April 2015
Reasons for updating
- Change to dosage and administration
Updated on 17 April 2013
Reasons for updating
- Change to section 4.2 - Posology and method of administration
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 13 September 2012
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 12 September 2012
Reasons for updating
- New PIL for new product