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Nicotinell Mint 2mg compressed Lozenges

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General Sale: Non-prescription
  • nicomint2mg.jpeg

Updated on 20 April 2023

File name

ie-spc-nicotinell-lozenge-2mg-123-5-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-mint-lozenge-2mg-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 18 August 2020

File name

ie-mockup-pil-nicotinell mint 2mg -gdsv7-190304AW.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 - warnings and precautions
  • Change to section 2 - use in children and adolescents
  • Change to section 2 - pregnancy, breast feeding and fertility
  • Change to section 3 - dose and frequency
  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 5 - how to store or dispose
  • Change to section 6 - date of revision

Updated on 18 August 2020

File name

ie-spc-nicotinell-lozenge-2mg-123-5-final-clean-gdsv7-190304AW.pdf

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 10 - Date of revision of the text

Legal category:Supply through general sale

Updated on 27 February 2020

File name

ie-spc-nicotinell-lozenge-2mg-123-5-clean.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 11 December 2018

File name

ie-mockup-nico-2mg-proposed-pl-nov2018.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Improved presentation of PIL

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_16738_769.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

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 November 2015

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 6.5

Additional tube packaging description added

Section 9

Date of first authorisation corrected to 11 August 1999

Section 10

Date of revision updated to 22 Sept 2015

Updated on 04 September 2015

Reasons for updating

  • Addition of legal category

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Legal Category amended to Supply though general sale

Updated on 22 January 2015

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • 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 - how to report a side effect
  • 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 4.1

Expansion of indication to:

Nicotinell is indicated in adults.

Treatment of tobacco dependence by providing relief of nicotine withdrawal symptoms, including cravings (see section 5.1), thereby facilitating smoking cessation or temporary smoking reduction in smokers motivated to quit smoking. Permanent cessation of tobacco use is the eventual objective.

Section 4.2

“For smoking cessation and smoking reduction with Nicotinell lozenge,” added before the maximum daily dose.

“Nicotinell lozenge should primarly be used for smoking cessation.” Added

 “Smoking reduction” section added

Section 4.6

Heading updated to include “Fertility”

Section 4.8

“Reporting of suspected adverse reactions” advice added

Section 10

Date of revision changed from 25/06/2014 to 18 December 2014

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

Section 7

Address changed from Horsham to Camberley.

Section 10

Date of revision changed from 4th November 2013 to 25th June 2014.

Updated on 06 January 2014

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

Section 6.3

 

Shelf-life changed from 3 to 2 years

 

Section 10

Date changed from September 2009 to 4 November 2013

Updated on 17 November 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 6.4 - Special precautions for storage
  • Change to section 7 - Marketing authorisation holder
  • 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

Nicotinell Mint 2mg Compressed Lozenge –

SPC changes 25 September 2009

 

Section 4.8

New wording added:

 

Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (³1/10), common (³1/100 to <1/10), uncommon (³1/1,000 to <1/100), rare (³1/10,000, <1/1,000) or very rare (<1/10,000).

 

Section 6.4

Additional words:  Store in the original package

 

Section 7

Additional words:  Trading as Novartis Consumer Health

 

Section 9

Date of last renewal changed from 16 December 2005 to 16 December 2008

 

Section 10

Date changed from October 2008 to September 2009

Updated on 13 May 2009

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.9 - Overdose
  • Change to section 4.4 - Special warnings and precautions for use

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company



Section 2

 

Addition of 'piece of' to "Each piece of lozenge contains".

The words 'and sodium (9.8 mg)' added to list of excipients.

 

 

Section 4.1

New

Relief of nicotine withdrawal symptoms, in nicotine dependency as an aid
to smoking cessation.

 

The 2 mg strength is used when severe withdrawal symptoms are
experienced.  Patient counselling and support normally improve the
success rate.

 

Replaces:

Old

Nicotinell treatment is indicated for the relief of nicotine withdrawal
symptoms, in nicotine dependency as an aid to smoking cessation.

 

Advice and support normally improve the success rate.

 

 

Section 4.2

Optimal dosage form table layout changed, text remains the same.

 

 

Section 4.4

Addition of E951 to description of aspartame.

Addition of 'a source of fructose' to description of maltitol.

 

 

Section 4.5

New : Smoking may lead to reduced analgesic effects of propoxyphene, reduced diuretic
response to furosemide (frusemide), reduced effect of propranolol on blood pressure and
heart rate and reduced responder rates in ulcer healing with H2-antagonists.

The words 'reduction and' omitted after 'heart rate and'

 

 

Section 4.8

New text added.  'Non dose-dependent adverse reactions are as follows: hypersensitivity,

angioneurotic oedema and anaphylactic reactions.'

New text added.  'Increased frequency of aphthous ulcer may occur after abstinence
from smoking.'

 

 

Section 4.9

New

Treatment of overdose should be immediate as symptoms may develop
rapidly. Emesis …

Old

Following overdose, symptoms may be rapid particularly in children. 
Emesis…..

 

 

Section 10

Revision of date from 20 March 2008 to October 2008.

Updated on 09 July 2008

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.7 - Effects on ability to drive and use machines
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • 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

Free text change information supplied by the pharmaceutical company

Section 2: addition of excipient quantities

Section 3: addition of “compressed”

Section 4.1: “ re-word” of indication

Section 4.2 : “re-wording” and addition of optimal dosage form table

Section 4.3 : Cardiovascular related contraindications moved to section 4.4

Section 4.4 : Previous cardiovascular contraindications moved to precautions. Addition of sub heading “Special warnings about excipients”

Section 4.5: section changed to separate out actual drug interactions and interactions related to smoking cessation

Section 4.6: minor re-word

Section  4.7: minor re-word

Section 4.8: addition of Rare -Immune system disorders : hypersensitivity, angioneurotic oedema, anaphylactic reactions

Section 5.1: additional information given re nicotine

Section 5.3: re-worded

Section 6.1: E Nos added

Section 6.5: additional pack sizes 72, 144 added

Section 10: Revision date changed

Updated on 10 August 2004

Reasons for updating

  • New SPC for medicines.ie

Legal category:Supply through general sale