NiQuitin CLEAR 14 mg/24 hours transdermal patch

  • Name:

    NiQuitin CLEAR 14 mg/24 hours transdermal patch

  • Company:
    info
  • Active Ingredients:

    Nicotine

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 21/08/19

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Summary of Product Characteristics last updated on medicines.ie: 10/4/2019

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Chefaro Ireland Ltd

Chefaro Ireland Ltd

Company Products

Medicine NameActive Ingredients
Medicine Name Abidec Drops Active Ingredients Ascorbic acid, nicotinamide (B3), Pyridoxine Hydrochloride (Vitamin B6), Riboflavine (Vitamin B2), Thiamine Hydrochloride (Vitamin B1), Vitamin A (Palmitate), Vitamin D2 (ergocalciferol)
Medicine Name Beconase Hayfever Active Ingredients Beclometasone Dipropionate Monohydrate
Medicine Name Buttercup Bronchostop Berry Flavour Cough Pastilles Active Ingredients Thyme herb extract
Medicine Name Buttercup Bronchostop Cough Syrup Active Ingredients Marshmallow root extract, Thyme herb extract
Medicine Name Cetirizine dihydrochloride 10mg Film-coated Tablets Active Ingredients Cetirizine Dihydrochloride
Medicine Name Lyclear Creme Rinse Active Ingredients Permethrin
Medicine Name Metatone Tonic Active Ingredients Calcium glycerophosphate, Manganese glycerophosphate, Potassium glycerophosphate, Sodium glycerophosphate, Thiamine Hydrochloride (Vitamin B1)
Medicine Name Milk of Magnesia Active Ingredients Magnesium Hydroxide
Medicine Name NiQuitin 14 mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin 21mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin 7mg/24hrs transdermal patches Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 14 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 21 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR 7 mg/24 hours transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin CLEAR transdermal patch Active Ingredients Nicotine
Medicine Name NiQuitin Mini 1.5mg mint lozenges Active Ingredients Nicotine resinate
Medicine Name NiQuitin Mini 4mg mint lozenges Active Ingredients Nicotine resinate
Medicine Name Paracetamol 500 mg Film-Coated Tablets (GSL) Active Ingredients Paracetamol
Medicine Name Paracetamol 500 mg Film-Coated Tablets (p) Active Ingredients Paracetamol
Medicine Name PrevAllergy Tablets Active Ingredients Cetirizine Dihydrochloride
Medicine Name Solpa-Extra Soluble Tablets Active Ingredients Caffeine, Paracetamol
Medicine Name Solpa-Plus tablets Active Ingredients Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name solpa-plus with caffeine soluble tablets Active Ingredients Caffeine, Codeine Phosphate Hemihydrate, Paracetamol
Medicine Name Solpa-Sinus Film-coated Tablets Active Ingredients Paracetamol, Pseudoephedrine Hydrochloride
Medicine Name Solpadeine Capsules Active Ingredients Caffeine, Codeine Phosphate Hemihydrate, Paracetamol
1 - 0 of 33 items.Total: Infinity pages

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 21 August 2019 PIL

Reasons for updating

  • Change to section 6 - date of revision
  • Change to MA holder contact details

Updated on 10 April 2019 PIL

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 SmPC

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 PIL

Reasons for updating

  • New PIL for new product

Updated on 17 September 2018 SmPC

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 8 November 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 8 November 2016 SmPC

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 8 November 2016 PIL

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

MAH name and address updated to:


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

Updated on 8 January 2016 PIL

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 1186/18/5

December 2015

Updated on 8 January 2016 SmPC

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 1186/18/5

December 2015

Updated on 14 July 2015 SmPC

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

MA Holder Address amended to:-

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 14 July 2015 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Free text change information supplied by the pharmaceutical company

Section 7

MA Holder Address amended to:-

12 Riverwalk,

Citywest Business Campus,

Dublin 24,

Ireland

Updated on 10 March 2014 PIL

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use

Free text change information supplied by the pharmaceutical company

Section 4.4 Addition of warning to reduce or discontinue dose if there is a clinically significant increase in cardiovascular or other effects attributable to nicotine in patients hospitalised for MI etc.

Updated on 10 March 2014 SmPC

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

Section 4.4 Addition of warning to reduce or discontinue dose if there is a clinically significant increase in cardiovascular or other effects attributable to nicotine in patients hospitalised for MI etc.

Updated on 25 June 2013 PIL

Reasons for updating

  • Change to section 4.9 - Overdose

Free text change information supplied by the pharmaceutical company

Formatting changes and typographical error amendments in Section 4.9

Updated on 25 June 2013 SmPC

Reasons for updating

  • Change to section 4.9 - Overdose

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Formatting changes and typographical error amendments in Section 4.9

Updated on 26 April 2013 SmPC

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

Update to section 4.5 - Addition of the following text: Healthcare professionals are reminded that smoking cessation itself may require the adjustment of some drug therapy.

Updated on 26 April 2013 PIL

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

Update to section 4.5 - Addition of the following text: Healthcare professionals are reminded that smoking cessation itself may require the adjustment of some drug therapy.

Updated on 22 December 2010 SmPC

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 PIL

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 4 August 2010 PIL

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 4 August 2010 SmPC

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 13 July 2009 SmPC

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 6.1 - replacement of an excipient with a comparable excipient
Section 10 - Updated date of revision

Updated on 13 July 2009 PIL

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 6.1 - replacement of an excipient with a comparable excipient
Section 10 - Updated date of revision

Updated on 19 August 2008 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 19 August 2008 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 1 November 2007 SmPC

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 1 November 2007 PIL

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 SmPC

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

Due to the extento of changes please follow the link below:
 
 

Updated on 16 July 2007 PIL

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

Due to the extento of changes please follow the link below:
 
 

Updated on 21 June 2007 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale

Updated on 21 June 2007 PIL

Reasons for updating

  • New SPC for medicines.ie