NiQuitin Mini 4mg Mint Lozenges
*Company:
Chefaro Ireland DACStatus:
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 13 May 2022
File name
ie-pl-4mg.pdf
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - use in children and adolescents
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 2 - driving and using machines
- Change to section 3 - how to take/use
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
- Change due to user-testing of patient information
Updated on 26 May 2021
File name
ie-pl-clean-4mg.pdf
Reasons for updating
- Correction of spelling/typing errors
Updated on 09 April 2021
File name
ie-spc-clean_30-Mar-21.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.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.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.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.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.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.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.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].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.pdf
Reasons for updating
- Change to section 6 - manufacturer
Updated on 13 January 2019
File name
ie-spc-pa1186-18-12.pdf
Reasons for updating
- Change to MA holder contact details
Legal category:Supply through general sale
Updated on 08 November 2016
File name
PIL_14760_639.pdf
Reasons for updating
- New PIL for new product
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 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
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
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
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
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.
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Very rare (<1/10000): anaphylactic reactions |
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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