NiQuitin 21mg/24hrs transdermal patches
*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 21 January 2022
File name
ie-pl-7mg-14mg-21mg-02-11-2021 mie.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change due to user-testing of patient information
Updated on 16 August 2021
File name
ie-pl-7mg-14mg-21mg-clean-06-08-2021.pdf
Reasons for updating
- New PIL for new product
Updated on 14 October 2020
File name
ie-pl-clean-shared.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 3 - use in children/adolescents
- Change to section 3 - how to take/use
- Change to section 4 - possible side effects
Updated on 14 October 2020
File name
ie-spc-clean-21mg.pdf
Reasons for updating
- 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 5.3 - Preclinical safety data
Legal category:Supply through general sale
Updated on 21 August 2019
File name
ie-pl-clean-pink-patches.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 21 August 2019
File name
ie-spc-7mg-17-07-19.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 10 April 2019
File name
ie-pl-clean-pink-patches-18-1-2-3[1].pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 4 - possible side effects
Updated on 10 April 2019
File name
ie-spc-clean-pink-21mg-18-3[1].pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
Legal category:Supply through general sale
Updated on 18 September 2018
File name
ie-mockup-pl-pink-patches.pdf
Reasons for updating
- New PIL for new product
Updated on 17 September 2018
File name
LicenseSPC_PA1186-018-003.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
Legal category:Supply through general sale
Updated on 10 May 2018
Reasons for updating
- New SPC for new product
Legal category:Supply through general sale
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
Chefaro Ireland DAC, Treasury Building, Lower Grand Canal Street, Dublin 2, Ireland
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
Free text change information supplied by the pharmaceutical company
Chefaro Ireland DAC, Treasury Building, Lower Grand Canal Street, Dublin 2, Ireland
Updated on 17 February 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
Chefaro Ireland Limited First Floor
Block A
The Crescent Building Northwood Office Park Dublin 9
Ireland
PA 1186/18/3
Revision - January 2016
Updated on 17 February 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
Free text change information supplied by the pharmaceutical company
Chefaro Ireland Limited First Floor
Block A
The Crescent Building Northwood Office Park Dublin 9
Ireland
PA 1186/18/3
Revision - January 2016
Updated on 14 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
MA Holder Address amended to:-
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Updated on 14 July 2015
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Free text change information supplied by the pharmaceutical company
MA Holder Address amended to:-
12 Riverwalk,
Citywest Business Campus,
Dublin 24,
Ireland
Updated on 10 March 2014
Reasons for updating
- 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
Updated on 10 March 2014
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Updated on 25 June 2013
Reasons for updating
- Change to section 4.9 - Overdose
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 25 June 2013
Reasons for updating
- Change to section 4.9 - Overdose
Free text change information supplied by the pharmaceutical company
Updated on 26 April 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
Updated on 26 April 2013
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
Free text change information supplied by the pharmaceutical company
Updated on 15 June 2011
Reasons for updating
- Change to section 6.1 - List of excipients
- 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
Printing Ink: Sunsharp PMS 465 Brown ink
Updated on 15 June 2011
Reasons for updating
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Printing Ink: Sunsharp PMS 465 Brown ink
Updated on 11 April 2011
Reasons for updating
- Correction of spelling/typing errors
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 11 April 2011
Reasons for updating
- Correction of spelling/typing errors
Free text change information supplied by the pharmaceutical company
Updated on 21 December 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- 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 4.2 Posology and method of administration: “/24hrs” was added after patch strengths.
In section 4.8, * were added to the undesirable effects of chest pain and pain in limb.
The phrase “attributable to nicotine” was deleted as it had been repeated.
In section 5.1 the pharmacotherapeutic classification was updated as follows:
“Pharmacotherapeutic group: Anti-smoking agents: N07BA, Nicotine 01
ATC code: N07BA01”
Section 6.6 was updated as follows:
“Nicotine residues in the used patches are a hazard to children and pets. Used patches should be folded, sticky sides together, put back in the empty sachet and disposed of.”
Section 10 was updated to December 2010
Updated on 21 December 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 4.2 Posology and method of administration: “/24hrs” was added after patch strengths.
In section 4.8, * were added to the undesirable effects of chest pain and pain in limb.
The phrase “attributable to nicotine” was deleted as it had been repeated.
In section 5.1 the pharmacotherapeutic classification was updated as follows:
“Pharmacotherapeutic group: Anti-smoking agents: N07BA, Nicotine 01
ATC code: N07BA01”
Section 6.6 was updated as follows:
“Nicotine residues in the used patches are a hazard to children and pets. Used patches should be folded, sticky sides together, put back in the empty sachet and disposed of.”
Section 10 was updated to December 2010
Updated on 04 August 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- 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
In section 4.4 (Special warnings and precautions for use).
- A typo was corrected. Alopic or eczematous dermatitis was changed to Atopic or eczematous dermatitis.
In section 4.8 (Undesirable effects)
- The opening four paragraphs (i.e. all of the texts before the undesirable effects are listed based on system and frequency) has been removed and replaced with three paragraphs the first of which states what the most common adverse reaction is and states that other adverse events may be related to pharmacological effects of nicotine or withdrawal effects related to stopping smoking. The second paragraph lists symptoms which may be experienced and states that they may be related to withdrawal symptoms associated with smoking cessation. The third paragraph is a single sentence stating that “The following undesirable effects have been reported in clinical trials and/or spontaneously post-marketing reports.”
- The undesirable effects remain unchanged from the previous SPC except for under Skin and Subcutaneous Tissue Disorders the following has been changed:” Very rare >1/100000; <1/10000” is now “Very rare <1/10000” and photosensitivity was added as a very rare undesirable effect here.
- For Immune system disorders Anaphylaxis reactions was added as a very rare undesirable effect.
- The text below the * symbol saying see below has been changed to say that the majority of the topical reactions are minor and should resolve quickly following removal of the patches. The text saying that if there is a clinically significant increase in cardiovascular or other effects attributable to NiQuitin that the dose should be reduced or discontinued has stayed the same.
In section 5.2 Pharmacokinetic properties
- Underneath the subheading for Excretion anywhere the brand name NiQuitin is found it has been replaced with nicotine patches.
In section 10 (Date of revision of the text)
- September 2009 has been changed to July 2010.
Updated on 04 August 2010
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.2 - Pharmacokinetic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
In section 4.4 (Special warnings and precautions for use).
- A typo was corrected. Alopic or eczematous dermatitis was changed to Atopic or eczematous dermatitis.
In section 4.8 (Undesirable effects)
- The opening four paragraphs (i.e. all of the texts before the undesirable effects are listed based on system and frequency) has been removed and replaced with three paragraphs the first of which states what the most common adverse reaction is and states that other adverse events may be related to pharmacological effects of nicotine or withdrawal effects related to stopping smoking. The second paragraph lists symptoms which may be experienced and states that they may be related to withdrawal symptoms associated with smoking cessation. The third paragraph is a single sentence stating that “The following undesirable effects have been reported in clinical trials and/or spontaneously post-marketing reports.”
- The undesirable effects remain unchanged from the previous SPC except for under Skin and Subcutaneous Tissue Disorders the following has been changed:” Very rare >1/100000; <1/10000” is now “Very rare <1/10000” and photosensitivity was added as a very rare undesirable effect here.
- For Immune system disorders Anaphylaxis reactions was added as a very rare undesirable effect.
- The text below the * symbol saying see below has been changed to say that the majority of the topical reactions are minor and should resolve quickly following removal of the patches. The text saying that if there is a clinically significant increase in cardiovascular or other effects attributable to NiQuitin that the dose should be reduced or discontinued has stayed the same.
In section 5.2 Pharmacokinetic properties
- Underneath the subheading for Excretion anywhere the brand name NiQuitin is found it has been replaced with nicotine patches.
In section 10 (Date of revision of the text)
- September 2009 has been changed to July 2010.
Updated on 05 July 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
NiQuitin is not recommended for use in children under 12 years of age." was added
In section 4.8 (undesirable effects), under the subsection "General Disorders and Administration Site Conditions" a * was removed after "pain in limb"
In section 6.5 (Nature and contents of container) the text was reworded to read "
Each patch is contained in a laminate sheet. 7 or 14 patches in a carton. Not all pack sizes may be marketed."
In section 9 (Date of First Authorisation/Renewal of the Authorisation) September 2003 was changed to September 2008.
Updated on 05 July 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 6.5 - Nature and contents of container
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
NiQuitin is not recommended for use in children under 12 years of age." was added
In section 4.8 (undesirable effects), under the subsection "General Disorders and Administration Site Conditions" a * was removed after "pain in limb"
In section 6.5 (Nature and contents of container) the text was reworded to read "
Each patch is contained in a laminate sheet. 7 or 14 patches in a carton. Not all pack sizes may be marketed."
In section 9 (Date of First Authorisation/Renewal of the Authorisation) September 2003 was changed to September 2008.
Updated on 27 November 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- 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 1 - addition of /24hrs
Section 4.2 - Clarification of age groups
Section 4.3 - Updated contraindications
Section 4.4 - Expanded warnings
Section 4.6 - Additional warnings for pregnancy and lactation
Section 4.8 - Expanded adverse effects
Section 4.9 - Updated overdose information
Section 6.1 - Replacement of excipient with a comparable excipient
Section 10 - Date of Revision of text revised
Updated on 27 November 2009
Reasons for updating
- Change to section 1 - Name of medicinal product
- 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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.9 - Overdose
- Change to section 6.1 - List of excipients
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
Section 1 - addition of /24hrs
Section 4.2 - Clarification of age groups
Section 4.3 - Updated contraindications
Section 4.4 - Expanded warnings
Section 4.6 - Additional warnings for pregnancy and lactation
Section 4.8 - Expanded adverse effects
Section 4.9 - Updated overdose information
Section 6.1 - Replacement of excipient with a comparable excipient
Section 10 - Date of Revision of text revised
Updated on 19 August 2008
Reasons for updating
- Improved electronic presentation
Legal category:Supply through general sale
Updated on 19 August 2008
Reasons for updating
- Improved electronic presentation
Updated on 11 June 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Name change: Removal of 'CQ' from product name
Updated on 11 June 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
Free text change information supplied by the pharmaceutical company
Name change: Removal of 'CQ' from product name
Updated on 03 November 2005
Reasons for updating
- Change to section 4.8 - Undesirable effects
Legal category:Supply through general sale
Updated on 03 November 2005
Reasons for updating
- Change to section 4.8 - Undesirable effects
Updated on 06 September 2004
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 06 September 2004
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 10 - Date of revision of the text
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 26 June 2003
Reasons for updating
- New SPC for medicines.ie