NiQuitin CLEAR 14 mg/24 hours transdermal patch
*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 12 January 2022
File name
ie-mockup-pl-7mg-14mg-21mg-24hrs-patches-05-01-22 - dms.pdf
Reasons for updating
- Change to section 5 - how to store or dispose
- Change to section 6 - date of revision
- Change due to user-testing of patient information
Updated on 18 January 2021
File name
ie-pl-7mg-14mg-21mg-15-01-21.pdf
Reasons for updating
- Change of manufacturer
Updated on 21 October 2020
File name
ie-pl-clean-20-10-20.pdf
Reasons for updating
- 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 3 - dose and frequency
- Change to section 3 - use in children/adolescents
- Change to section 4 - possible side effects
Updated on 21 October 2020
File name
ie-spc-clean-14mg-20-10-20.pdf
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 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 5.3 - Preclinical safety data
- Change to section 6.6 - Special precautions for disposal and other handling
Legal category:Supply through general sale
Updated on 14 October 2020
File name
ie-pl-clean-shared.pdf
Reasons for updating
- 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 - 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 21 August 2019
File name
ie-pl-clean.pdf
Reasons for updating
- Change to section 6 - date of revision
- Change to MA holder contact details
Updated on 10 April 2019
File name
ie-pl-clean-clear-patches-4-5-6[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-clear-14mg-18-5[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-clear-patches.pdf
Reasons for updating
- New PIL for new product
Updated on 17 September 2018
File name
LicenseSPC_PA1186-018-005.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 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 08 January 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
First Floor
Block A
The Crescent Building
Northwood Office Park
Dublin 9
Ireland
PA 1186/18/5
December 2015
Updated on 08 January 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
First Floor
Block A
The Crescent Building
Northwood Office Park
Dublin 9
Ireland
PA 1186/18/5
December 2015
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 22 December 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- 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.
Section 4.7 was updated to include the following:
“There are no known effects of NiQuitin CLEAR transdermal patches on the ability to drive and use machines. However, users of nicotine replacement products should be aware that smoking cessation can cause behavioural changes.”
In section 4.8, * were added to the undesirable effects of chest pain and pain in limb.
The phrase “If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the NiQuitin CLEAR dose should be reduced or discontinued.” was deleted as it had been repeated.
In section 6.1 the printing ink was updated to: White ink 3015Z
Section 6.4 was updated to: This medicinal product does not require any special storage conditions.
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 22 December 2010
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.7 - Effects on ability to drive and use machines
- Change to section 4.8 - Undesirable effects
- Change to section 6.1 - List of excipients
- Change to section 6.4 - Special precautions for storage
- 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.
Section 4.7 was updated to include the following:
“There are no known effects of NiQuitin CLEAR transdermal patches on the ability to drive and use machines. However, users of nicotine replacement products should be aware that smoking cessation can cause behavioural changes.”
In section 4.8, * were added to the undesirable effects of chest pain and pain in limb.
The phrase “If there is a clinically significant increase in cardiovascular or other effects attributable to nicotine, the NiQuitin CLEAR dose should be reduced or discontinued.” was deleted as it had been repeated.
In section 6.1 the printing ink was updated to: White ink 3015Z
Section 6.4 was updated to: This medicinal product does not require any special storage conditions.
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 4.8 - 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
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 has been added as n very rare undesirable effect in this category. For Immune System Disorders Anaphylaxis reaction has been 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 10 (Date of revision of the text)
Text has been changed to July 2010.
Updated on 04 August 2010
Reasons for updating
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
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 has been added as n very rare undesirable effect in this category. For Immune System Disorders Anaphylaxis reaction has been 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 10 (Date of revision of the text)
Text has been changed to July 2010.
Updated on 13 July 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Section 10 - Updated date of revision
Updated on 13 July 2009
Reasons for updating
- Change to section 10 - Date of revision of the text
- Change to section 6.1 - List of excipients
Free text change information supplied by the pharmaceutical company
Section 10 - Updated date of revision
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 01 November 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
SECTION 1:
NiQuitin CQ CLEAR 14 mg/24 hours transdermal patch
Updated on 01 November 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
Free text change information supplied by the pharmaceutical company
SECTION 1:
NiQuitin CQ CLEAR 14 mg/24 hours transdermal patch
Updated on 16 July 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4 - Clinical particulars
- Change to section 5.1 - Pharmacodynamic properties
Legal category:Supply through general sale
Free text change information supplied by the pharmaceutical company
Updated on 16 July 2007
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4 - Clinical particulars
- Change to section 5.1 - Pharmacodynamic properties
Free text change information supplied by the pharmaceutical company
Updated on 21 June 2007
Reasons for updating
- New SPC for medicines.ie
Legal category:Supply through general sale
Updated on 21 June 2007
Reasons for updating
- New SPC for medicines.ie