NiQuitin 7mg/24hrs transdermal patches

  • Name:

    NiQuitin 7mg/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: 31/07/19

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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 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 31 July 2019 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 31 July 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

Free text change information supplied by the pharmaceutical company

Update to MAH address 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 9 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 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 1186/11/1

Revision - January 2016

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 1186/11/1

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 14 February 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 nicotine dose if there is a clinically significant increase in cardiovascular or other effects.

Updated on 14 February 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 nicotine dose if there is a clinically significant increase in cardiovascular or other effects.

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 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 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 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.

The sentence “NiQuitin is not recommended for use in children under 12 years of age” was also added.

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 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.

The sentence “NiQuitin is not recommended for use in children under 12 years of age” was also added.

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 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 also photosenesitivity has been included here as an undesirable effect.
  • For Immune System Disorders anaphylaxis reactions has been added as a very rare undesiarable 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 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 also photosenesitivity has been included here as an undesirable effect.
  • For Immune System Disorders anaphylaxis reactions has been added as a very rare undesiarable 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 6 July 2010 SmPC

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 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • 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 4.2 Posology and method of administration text saying, “Any smoking is very likely to lead to relapse. Therefore users must not smoke during a cessation attempt. No other form of nicotine should be taken at the same time.”, has been removed and replaced by “every effort should be made to stop smoking during treatment with NiQuitin”. The subheading “Adults (including the elderly)” has been replaced by “Adults (18 years and over)”
  • The dose and duration steps have now been tabulated. Text saying “it should not extend beyond ten weeks.” Has been replaced by text detailing how long the treatment could be continued for if a patient is not cigarette free. In the beginning of the next paragraph the opening word “However” has been removed. The subheading “Children” has been replaced by “Adolescents and Children” the text underneath this has been removed and replaced by text outlining the dosing schedule for adolescents (12 to 17 years) and a sentence saying it is not recommended for children under 12 years of age.

  • In section 4.3( Contraindications), the opening part of the first sentence has been removed up to the word “hypersensitivity” in addition the phrase following this (“to the system”) has also been removed. The sentence saying that Niquitin should not be used in children has had the suffix “under 12” added to it. The paragraph detailing that Niquitin should not be used in people with heart problems including unstable angina pectoris has been removed.

 

  • In section 4.4 (Special warnings and precautions for use) all of the text , including the subheadings has been replaced. An opening sentence is now present detailing the fact that the risks of cigarette smoke in virtually all cases outweigh the risks of NRT. Following this 5 paragraphs have been added detailing special warning and precautions for use in certain groups and cases (i.e. patients hospitalised for MI, severe dysryhthmia, or CVA, Diabetes Mellitus, Allergic reactions, Atopic or eczematous dermatitis, Contact sensitisation) following these groups and cases further reasoning behind the precautions is given and also what should be done if certain symptoms are observed. The next paragraph then lists two cases where an appropriate healthcare professional should perform a risk benefit assessment (renal and hepatic impairment and Phaeochromocytoma and  uncontrolled hyperthyroidism) and the reasoning why this should be performed.  After this four paragraphs have been added listing further cases where precautions and special warnings are needed (i.e. Danger in small children, Stopping smoking, Transferred dependence and Safety on handling) reasons why these special warning and precautions are needed are given in each paragraph.
  • In section 4.5 (Interactions with other Medicinal Products and other forms of Interaction) the text below it has been removed and replaced by “No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.”
  • In section 4.6 (Pregnancy and lactation), all of the text underneath this has been removed and replaced by a subheading for “Pregnancy” below this details of the harm of smoking during pregnancy is given and advice that ideally smoking cessation should be done without  NRT, following this details of when NRT should be used during pregnancy is given and also information on when it is best to use NRT during pregnancy and also advice that intermittent dosing products should be used where possible and that a patch, if being used, should be taken off before going to bed. Another subheading has also been added for “Lactation” and text detailing that the amount of nicotine that an infant would be exposed to if a mother is using NRT is less than that of second hand smoke. Advice that intermittent products may be more beneficial is also given.
  • In section 4.7 (Effects on ability to drive and use machines), an additional sentence has been added saying “However, users of nicotine replacement products should be aware that smoking cessation can cause behavioural changes.”
  • In section 4.8 (undesirable effects), the opening three paragraphs have been replaced by text detailing that NRT can cause adverse effects similar to nicotine administered in other forms, and that some of these effects are dose dependent, and also that at the recommended dose no serious adverse events have been reported . warning on adverse effects due to excessive use of Niquitin has been added. Information on symptoms someone may suffer when giving up smoking is also given and states that these symptoms may be withdrawal symptoms from smoking. A sentence has then been added saying that what is below it is the undesirable effects reported in clinical trials and in post-marketing. Another sentence has been added saying application site reactions are the most frequent. In the undesirable adverse effect that are listed anywhere where “NOS “is found it has been removed. Also under General disorders and Administration Site conditions a * has been placed after common effect “pain”.

 

  • In section 4.9 (Overdose), the opening two paragraphs detailing signs and symptoms of overdose and effects of applying or swallowing simultaneously several NiQuitin systems has been removed and replaced by text detailing the symptoms (including minimum lethal dose of nicotine) and also the management of an overdose. The subheading “Overdose from Ingestion” and the text below it has been removed. The subheading “Management of Nicotine Poisoning” and the text below it have also been removed.
  • In section 5.3 (Preclinical safety data) the second paragraph detailing comparison of systemic exposure needed to elicit adverse effects from preclinical data and the favourable risk benefit analysis has been removed. The sentence detailing when NiQuitin should be used in pregnancy has also been removed.
  • In section 6.1 (List of exipients), Polyisobutylene 1200000 and 35000 has been replaced with Polyisobutylene B100 and B12 SFN
  • In section 6.5 (Nature and contents of container), the wording has been reorganised to read “Each patch is contained in a laminate sachet. 7 or 14 patches in a carton.”  Also the text “Not all pack sizes will be marketed.” has been added.

 

  • In section 9 (Date of first authorisation/renewal of authorisation) September 2003 has been replaced by September 2008
  • In section 10 (Date of revision of the text) has been replaced from April 2007 to September 2009

Updated on 6 July 2010 PIL

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 4.9 - Overdose
  • Change to section 5.3 - Preclinical safety data
  • Change to section 6.1 - List of excipients
  • Change to section 6.5 - Nature and contents of container
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

  • In section 4.2 Posology and method of administration text saying, “Any smoking is very likely to lead to relapse. Therefore users must not smoke during a cessation attempt. No other form of nicotine should be taken at the same time.”, has been removed and replaced by “every effort should be made to stop smoking during treatment with NiQuitin”. The subheading “Adults (including the elderly)” has been replaced by “Adults (18 years and over)”
  • The dose and duration steps have now been tabulated. Text saying “it should not extend beyond ten weeks.” Has been replaced by text detailing how long the treatment could be continued for if a patient is not cigarette free. In the beginning of the next paragraph the opening word “However” has been removed. The subheading “Children” has been replaced by “Adolescents and Children” the text underneath this has been removed and replaced by text outlining the dosing schedule for adolescents (12 to 17 years) and a sentence saying it is not recommended for children under 12 years of age.

  • In section 4.3( Contraindications), the opening part of the first sentence has been removed up to the word “hypersensitivity” in addition the phrase following this (“to the system”) has also been removed. The sentence saying that Niquitin should not be used in children has had the suffix “under 12” added to it. The paragraph detailing that Niquitin should not be used in people with heart problems including unstable angina pectoris has been removed.

 

  • In section 4.4 (Special warnings and precautions for use) all of the text , including the subheadings has been replaced. An opening sentence is now present detailing the fact that the risks of cigarette smoke in virtually all cases outweigh the risks of NRT. Following this 5 paragraphs have been added detailing special warning and precautions for use in certain groups and cases (i.e. patients hospitalised for MI, severe dysryhthmia, or CVA, Diabetes Mellitus, Allergic reactions, Atopic or eczematous dermatitis, Contact sensitisation) following these groups and cases further reasoning behind the precautions is given and also what should be done if certain symptoms are observed. The next paragraph then lists two cases where an appropriate healthcare professional should perform a risk benefit assessment (renal and hepatic impairment and Phaeochromocytoma and  uncontrolled hyperthyroidism) and the reasoning why this should be performed.  After this four paragraphs have been added listing further cases where precautions and special warnings are needed (i.e. Danger in small children, Stopping smoking, Transferred dependence and Safety on handling) reasons why these special warning and precautions are needed are given in each paragraph.
  • In section 4.5 (Interactions with other Medicinal Products and other forms of Interaction) the text below it has been removed and replaced by “No clinically relevant interactions between nicotine replacement therapy and other drugs has definitely been established, however nicotine may possibly enhance the haemodynamic effects of adenosine.”
  • In section 4.6 (Pregnancy and lactation), all of the text underneath this has been removed and replaced by a subheading for “Pregnancy” below this details of the harm of smoking during pregnancy is given and advice that ideally smoking cessation should be done without  NRT, following this details of when NRT should be used during pregnancy is given and also information on when it is best to use NRT during pregnancy and also advice that intermittent dosing products should be used where possible and that a patch, if being used, should be taken off before going to bed. Another subheading has also been added for “Lactation” and text detailing that the amount of nicotine that an infant would be exposed to if a mother is using NRT is less than that of second hand smoke. Advice that intermittent products may be more beneficial is also given.
  • In section 4.7 (Effects on ability to drive and use machines), an additional sentence has been added saying “However, users of nicotine replacement products should be aware that smoking cessation can cause behavioural changes.”
  • In section 4.8 (undesirable effects), the opening three paragraphs have been replaced by text detailing that NRT can cause adverse effects similar to nicotine administered in other forms, and that some of these effects are dose dependent, and also that at the recommended dose no serious adverse events have been reported . warning on adverse effects due to excessive use of Niquitin has been added. Information on symptoms someone may suffer when giving up smoking is also given and states that these symptoms may be withdrawal symptoms from smoking. A sentence has then been added saying that what is below it is the undesirable effects reported in clinical trials and in post-marketing. Another sentence has been added saying application site reactions are the most frequent. In the undesirable adverse effect that are listed anywhere where “NOS “is found it has been removed. Also under General disorders and Administration Site conditions a * has been placed after common effect “pain”.

 

  • In section 4.9 (Overdose), the opening two paragraphs detailing signs and symptoms of overdose and effects of applying or swallowing simultaneously several NiQuitin systems has been removed and replaced by text detailing the symptoms (including minimum lethal dose of nicotine) and also the management of an overdose. The subheading “Overdose from Ingestion” and the text below it has been removed. The subheading “Management of Nicotine Poisoning” and the text below it have also been removed.
  • In section 5.3 (Preclinical safety data) the second paragraph detailing comparison of systemic exposure needed to elicit adverse effects from preclinical data and the favourable risk benefit analysis has been removed. The sentence detailing when NiQuitin should be used in pregnancy has also been removed.
  • In section 6.1 (List of exipients), Polyisobutylene 1200000 and 35000 has been replaced with Polyisobutylene B100 and B12 SFN
  • In section 6.5 (Nature and contents of container), the wording has been reorganised to read “Each patch is contained in a laminate sachet. 7 or 14 patches in a carton.”  Also the text “Not all pack sizes will be marketed.” has been added.

 

  • In section 9 (Date of first authorisation/renewal of authorisation) September 2003 has been replaced by September 2008
  • In section 10 (Date of revision of the text) has been replaced from April 2007 to September 2009

Updated on 9 August 2004 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 9 August 2004 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 9 February 2004 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product

Legal category: Supply through general sale

Updated on 9 February 2004 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product

Updated on 19 August 2003 SmPC

Reasons for updating

  • Improved electronic presentation

Legal category: Supply through general sale

Updated on 19 August 2003 PIL

Reasons for updating

  • Improved electronic presentation

Updated on 4 July 2003 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale

Updated on 4 July 2003 PIL

Reasons for updating

  • New SPC for medicines.ie