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Nicotinell Mint 1mg Compressed Lozenges

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General Sale: Non-prescription
  • nicomint1mg.jpeg

Updated on 20 April 2023

File name

ie-spc-nicotinell-lozenge-1mg-123-4-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-1mg-clean.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 18 August 2020

File name

ie-mockup-pil-nicotinell mint 1mg-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-1mg-123-4-final-clean.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 - how to report a side effect
  • Change to section 4.9 - Overdose

Legal category:Supply through general sale

Updated on 27 February 2020

File name

ie-spc-nicotinell-lozenge-1mg-123-4-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-1mg-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_16737_592.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 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 10

Date of revision updated to 22 Sept 2015

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 4.4 - 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 - 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

Added “Nicotinell Mint lozenge 1 mg may be used alone or in combination with Nicotinell transdermal patch”

“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” and treatment in combination with Nicotinell patch sections added.

Section 4.4

“with moderate to severe hepatic and/or severe renal impairment” and “For special warnings and precautions for the Nicotinell patch, see the Summary of Product Characteristics for the specific product.”added

Section 4.5

“For interactions for the Nicotinell patch, see the Summary of Product Characteristics for the specific product.”added

Section 4.6

Heading updated to include “Fertility”

Section 4.7

“gum” replaced with “lozenge”

Section 4.8

“Reporting of suspected adverse reactions” advice and “For undesirable effects for the Nicotinell patch, see the Summary of Product Characteristics for the specific product.” 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 12 November 2013

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 12 June 2009 2010 to 4 November 2013

Updated on 17 November 2009

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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 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 9

Date change from 16 December 2003 to 16 December 2008

 

Section 10

Date change from October 2008 to June 2009.

Updated on 13 May 2009

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 4.4 - Special warnings and precautions for use
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.7 - Effects on ability to drive and use machines
  • 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 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 10 - Date of revision of the text
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.3 - Contraindications

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company



 

 

Section 1

New

Nicotinell Mint 1 mg compressed lozenges

Old

Nicotinell Mint 1 mg lozenge

 

 

Section 2

Quantities of excipients added.

 

 

Section 3

Reword:

 

New

Compressed lozenge

Old

Lozenge

 

 

Section 4.1

Reword:

 

New

Patient counselling and support normally improve the success rate.

Old

Advice and support normally improve the success rate

 

 

Section 4.2

Adults and elderly

Reword:

 

New

Nicotinell Mint 1 mg lozenge is recommended in smokers with a  low to
moderate nicotine dependency.

Old

Nicotinell Mint 1 mg lozenge is recommended in smokers with a medium
nicotine dependency.

 

 

Deletion of text :

Old

…nicotine dependency (eg smokers smoking more than 30 cigarettes per day).

 

Omitted from new SPC

 

 

Addition of a new table for selection of optimal dosage form.

 

 

 

If an adverse event occurs with the use of the high dose form (2 mg
lozenge), use of the low dose form (1 mg lozenge) should be considered.

 

 

 

Directions for use:

New

Patients who have been using oral nicotine replacement therapy beyond
9 months are advised to seek additional help and information from health
care professionals.

New

Counselling may help smokers to quit.

Reword of warning regarding acidic beverages.

 

 

Section 4.3

Cardiovascular contraindications moved to precautions.

Addition of 'hypersensitivity to nicotine'.

 

 

Section 4.4

Previous cardiovascular warnings moved from contraindications into warnings.

 

 

Addition of new text :

Nicotinell Mint 1 mg lozenge contains aspartame which metabolises to phenylalanine,
which is of relevance for patients with phenylketonuria.

 

 

Section 4.5

Section changed to separate out actual drug interactions and interactions related to
smoking cessation.

 

 

Section 4.6

Reorder of information.

 

 

Section 4.7

Addition of 'One should take into consideration that…' to the sentence 'smoking cessation
can cause behavioural changes'.

 

 

Section 4.8

Addition of 'Non dose-dependent adverse reactions are as follows: hypersensitivity,
angioneurotic oedema and anaphylactic reactions.'

Addition of 'Increased frequency of aphthous ulcer may occur after abstinence from
smoking.'

Addition of 'Immune system disorders:  Hypersensitivity, Angioneurotic oedema and
anaphylactic reactions'.

Addition of new headings to side effect groupings.

 

 

Section 4.9

Wording revised and suggested timeframes given. 

Addition of 'Nicotine toxicity after ingestion will most likely be minimised as a result of
early nausea and vomiting that occur following excessive nicotine exposure.'

Section 5.1

Additional information given regarding nicotine.

 

 

Section 5.2

Change of word 'medicinal products' for drugs

 

 

Section 5.3

Rewording of statement re genotoxicity tests.

Deletion of text relating to epidemiological studies on smoking.

Addition of 'Animal experiments have shown that nicotine induces post-implantation loss
and reduces the growth of foetuses.'

 

 

Section 6.1

Addition of E numbers and updates to naming conventions added.

 

 

Date of revision of the text

Date of revision changed from March 2008 to October 2008

Updated on 09 July 2008

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • 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 3: addition of “white, mint flavoured, round biconvex lozenge

 

Section 6.5: addition of 72,144, 204 pack sizes and text describing the blister packs

 

Section 10: change of revision date to March 2008

Updated on 10 August 2004

Reasons for updating

  • New SPC for new product
  • New SPC for medicines.ie

Legal category:Supply through general sale