NiQuitin 21mg/24hrs transdermal patches

  • Name:

    NiQuitin 21mg/24hrs transdermal patches

  • 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: 21/8/2019

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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 21 August 2019 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

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 10 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

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 17 February 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 1186/18/3

Revision - January 2016

Updated on 17 February 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 1186/18/3

Revision - January 2016

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 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 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 15 June 2011 PIL

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 15 June 2011 SmPC

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 11 April 2011 SmPC

Reasons for updating

  • Correction of spelling/typing errors

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

In Section 5.1, wording changed.

Updated on 11 April 2011 PIL

Reasons for updating

  • Correction of spelling/typing errors

Free text change information supplied by the pharmaceutical company

In Section 5.1, wording changed.

Updated on 21 December 2010 SmPC

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 PIL

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 4 August 2010 PIL

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 4 August 2010 SmPC

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 5 July 2010 PIL

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

In section 4.2 (Posology and method of administration), the text "

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 5 July 2010 SmPC

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

In section 4.2 (Posology and method of administration), the text "

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 SmPC

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 PIL

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 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 19 August 2008 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 11 June 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

Name change: Removal of 'CQ' from product name

Updated on 11 June 2007 PIL

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 3 November 2005 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Updated on 3 November 2005 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category: Supply through general sale

Updated on 6 September 2004 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

Updated on 6 September 2004 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

Updated on 26 June 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale

Updated on 26 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie