NiQuitin Mini 4mg Mint Lozenges

Product Information *

  • Company:

    Chefaro Ireland DAC
  • Status:

    No Recent Update
  • Active Ingredients :

    *Additional information is available upon request

  • Legal Category:

    Supply through general sale

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 26 May 2021

File name

ie-pl-clean-4mg_1622049458.pdf

Reasons for updating

  • Correction of spelling/typing errors

Updated on 09 April 2021

File name

ie-spc-clean_30-Mar-21_1617972540.pdf

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category:Supply through general sale

Updated on 04 November 2020

File name

ie-spc-clean-4mg_22-10-2020_1604491018.pdf

Reasons for updating

  • 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 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text
  • Improved presentation of SPC

Legal category:Supply through general sale

Updated on 04 November 2020

File name

ie-pl-clean-4mg_22-10-2020_1604490856.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 - 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 - pregnancy, breast feeding and fertility
  • Change to section 2 - driving and using machines
  • Change to section 2 - excipient warnings
  • Change to section 3 - dose and frequency
  • Change to section 3 - use in children/adolescents
  • Change to section 3 - how to take/use
  • Change to section 3 - duration of treatment
  • Change to section 3 - overdose, missed or forgotten doses
  • Change to section 4 - possible side effects
  • Change to section 4 - how to report a side effect
  • Change to section 5 - how to store or dispose
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 25 June 2020

File name

ie-spc-4mg-17-6-20_1593096441.pdf

Reasons for updating

  • Change to section 3 - Pharmaceutical form
  • Change to section 6.1 - List of excipients
  • 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 25 June 2020

File name

ie-pl-4 mg-17-6-20_1593096368.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - date of revision
  • Change of inactive ingredient

Updated on 31 July 2019

File name

ie-pl-clean-mini-combined-18-07-19_1564567044.pdf

Reasons for updating

  • Change to section 6 - what the product looks like and pack contents
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision
  • Change to marketing authorisation holder

Updated on 31 July 2019

File name

ie-spc-clean-4mg-18-07-19_1564567085.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 11 April 2019

File name

ie-mockup-pl-combined-20s_1554992395.pdf

Reasons for updating

  • Change to section 2 - what you need to know - warnings and precautions
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains

Updated on 10 April 2019

File name

ie-spc-clean-4mg-app 04-04-19[1]_1554890368.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 4.7 - 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 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling

Legal category:Supply through general sale

Updated on 14 January 2019

File name

ie-mockup-pl-1.5-4mg-20-pack APP 30-07-18_1547416666.pdf

Reasons for updating

  • Change to section 6 - manufacturer

Updated on 13 January 2019

File name

ie-spc-pa1186-18-12_1547416733.pdf

Reasons for updating

  • Change to MA holder contact details

Legal category:Supply through general sale

Updated on 08 November 2016

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

MAH name and address updated to:


Chefaro Ireland DAC, Treasury Building, Lower Grand Canal Street,
Dublin 2, Ireland

Updated on 08 November 2016

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Updated on 08 November 2016

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 08 November 2016

File name

PIL_14760_639.pdf

Reasons for updating

  • New PIL for new product

Updated on 28 July 2016

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

7 MARKETING AUTHORISATION HOLDER

Chefaro Ireland Limited First Floor, Block A The Crescent Building Northwood Office Park Dublin 9
Ireland

8 MARKETING AUTHORISATION NUMBER

PA1186/018/012

Updated on 11 July 2016

Reasons for updating

  • Change to MA holder contact details

Updated on 10 July 2015

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 7

Marketing Authorisation Holder address updated to:

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 13 November 2014

Reasons for updating

  • Improved electronic presentation

Updated on 09 December 2013

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 4.9 - Overdose

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Revision of Text : August 2013

Overdosage - update of info

Updated on 21 August 2013

Reasons for updating

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

Additional sentence about change in drug therapy during smoking cessation.

Updated on 22 November 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 15 June 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • 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

Certain symptoms which have been reported such as depression, irritability, anxiety, increased appetite and insomnia may be related to withdrawal symptoms associated with smoking cessation.  Subjects quitting smoking by any means could expect to suffer from headache, dizziness, sleep disturbance, increased coughing or a cold.

 

 

Immune system disorder

 

 

Very rare (<1/10000): anaphylactic reactions

 

Updated on 13 August 2010

Reasons for updating

  • New PIL for medicines.ie

Updated on 27 November 2009

Reasons for updating

  • New SPC for new product

Legal category:Supply through general sale

Free text change information supplied by the pharmaceutical company

None provided