Nicotinell Fruit 4mg Medicated Chewing-Gums

  • Name:

    Nicotinell Fruit 4mg Medicated Chewing-Gums

  • Company:
    info
  • Active Ingredients:

    Nicotine-polacrilin

  • Legal Category:

    Supply through general sale

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 01/11/16

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Summary of Product Characteristics last updated on medicines.ie: 17/1/2020

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GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

GlaxoSmithKline Consumer Healthcare (Ireland) Ltd

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Medicine Name Nicotinell Cool Mint 2mg medicated chewing gum Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Cool Mint 4mg medicated chewing gum Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Fruit 2mg medicated chewing-gums Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Fruit 4mg Medicated Chewing-Gums Active Ingredients Nicotine-polacrilin
Medicine Name Nicotinell Mint 1mg Compressed Lozenges Active Ingredients nicotine bitartrate dihydrate
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Medicine Name Nicotinell TTS 10, 7 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Nicotinell TTS 20, 14 mg/24 hour Transdermal Patch Active Ingredients Nicotine
Medicine Name Nicotinell TTS 30, 21 mg/24 hour Transdermal Patch Active Ingredients Nicotine
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1 - 0 of 53 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 17 January 2020 SmPC

Reasons for updating

  • Change to section 6.3 - Shelf life

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Shelf Life extended from 24 months to 30 months following replacement of primary packaing blister with new child-resistant senior-friendly blister packaging.

Updated on 1 May 2018 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 1 November 2016 PIL

Reasons for updating

  • New PIL for new product

Updated on 1 November 2016 PIL

Reasons for updating

  • Improved presentation of PIL

Updated on 27 October 2016 PIL

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - marketing authorisation number

Updated on 3 October 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

Sections 7, 8 & 10 updated following Change of Ownership approval

Updated on 3 October 2016 SmPC

Reasons for updating

  • New SmPC for new product

Legal category: Supply through general sale

Updated on 3 May 2016 PIL

Reasons for updating

  • New PIL for medicines.ie

Updated on 4 September 2015 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
  • Change to section 10 - Date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 2

“with known effect”

Section 4.2

Subheadings added and method of administration information put into separate subsection

Section 4.3

“listed in section 6.1” added

Section 4.8


Adverse events tabulated and adverse events reporting statement added


Section 10

From 18 August 2014 to 24 June 2015

Updated on 2 September 2014 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

SPC Update – Nicotinell Fruit 4mg medicated chewing-gum – 18 August 2014   

 

 

Section 7

 

Address changed to Camberley.

 

Section 10

 

Change of date from 20 January 2012 to 18 August 2014.

 

 

 

Updated on 22 March 2012 SmPC

Reasons for updating

  • 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

Section 9

Date of last renewal changed from 25 May 2005 to 20 January 2012-03-16

 

Section 10

Change of date from 28 January 2010 to 20 January 2012

Updated on 11 May 2010 SmPC

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • 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 6.5

Addition of 120 pieces

 

Section 10

Date change from May 2009 to 28 January 2010

Updated on 30 July 2009 SmPC

Reasons for updating

  • Change to section 4.1 - Therapeutic indications
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 - 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 6.6 - Special precautions for disposal and other handling

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company



Nicotinell Fruit 4mg gum – changes to SPC (25 May 2009)

 

Section 2

Addition of: Excipient(s): sorbital (0.2g), sodium (11.52mg) and butylhydroxytoluene (E321).

 

Section 4.1

Words ‘Nicotinell treatment is indicated for the’ have been deleted.

‘Patient counselling and support normally improve the success rate’ has replaced ‘Advice and support normally improve the success rate’.

 

Section 4.2

Following paragraph :  If an adverse event occurs with the use of the high dose form (4 mg medicated chewing-gum), use of the low dose form (2 mg medicated chewing-gum) should be considered.  Replaces: If an adverse event is noted when high dose forms are initiated, this should be replaced by the lower dosage form.

 

New paragraph:  The initial dosage should be individualised on the basis of the patients nicotine dependence.

 

Deletion of paragraph:  Nicotinell gum is sugar free.

 

Section 4.3

Words ‘to nicotine’ added to hypersensitivity to any of the excipients.

 

Section 4.4

‘People having problems with the joint of the jawbone and …..’ added before ‘denture wearers may experience…..’.

 

Paragraph beginning Nicotinell Fruit 4mg has addition of words ‘contains sweeteners, including Sorbitol’.

 

Paragraph beginning Nicotinell Fruit 4mg has addition of words ‘contains sweeteners, including Sorbitol’.

 

New paragraph: ‘The gum base contains butylhydroxytoluene (E321) which may cause local irritation to mucous membranes’.

 

Section 4.5

Paragraph beginning ‘Smoking may lead to reduced….. words ‘reduction and’ have been deleted.

 

Section 4.6

Title change from ‘Use during pregnancy and lactation’ to ‘Pregnancy and lactation’.

 

Section 4.8

Addition of:  Non dose-dependent adverse reactions are as follows:  jaw muscle ache, erythema, urticaria, hypersensitivity, angioneurotic oedema and anaphylactic reactions.

 

New paragraph:  Excessive swallowing of nicotine which is released in the saliva may, at first, cause hiccups.  Those who are prone to indigestion may suffer initially from minor degrees of hyspepsia or heartburn:  slower chewing will usually overcome this problem.  Excessive consumption of nicotine gums by subjects who have not been in the habit of inhaling tobacco smoke, could possibly lead to nausea, faintness and headache.  Increased frequency of aphthous ulcer may occur after abstinence from smoking.

 

Common (>1/100)

Gastrointestinal disorders.  New: flatulence, dyspepsia, salivary hypersecretion, stomatitis, oral pain, or pharyngolaryngeal pain. 

Deleted from list: indigestion, heartburn, increased salivation, irritation or sore mouth or throat.

 

Uncommon (>1/1000, >1/100)

Cardiac disorders:  ‘Rare, atrial arrhythmia’ replaces ‘cardiac arrhythmias (eg atrial fibrillation)’.

 

New paragraph:  ‘Cold sores may develop in connection with smoking cessation, but any relation with the nicotine treatment is unclear’.

 

New paragraph: ‘The patient may still experience nicotine dependence after smoking cessation’.

 

Section 4.9

‘Treatment of overdose should be immediate as symptoms may develop rapidly’ replaces ‘Following overdose, symptoms may be rapid particularly in children.’

 

 

Section 5.3

New paragraph: ‘Nicotine was positive in some in vitro genotoxicity tests but there are also negative results with the same test systems’. Replaces: ‘No definite conclusion can be drawn on the genotoxic activity of nicotine in vitro’.

 

Section 6.1

Addition of E321 after butylhydroxytoluene

Addition of E422 after Glycerol

Addition of E967 after Xylitol

 

Section 6.6

‘Used Nicotinell medicated chewing-gum should be disposed of with care’, replaces, ‘No special requirements’.

 

 

Updated on 17 July 2009 SmPC

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Change to section 6.5 - Nature and contents of container

Legal category: Supply through general sale

Free text change information supplied by the pharmaceutical company

Section 6.5       Addition of box containing 204 pieces of gum.

Section 10.       Date of revision of the text changed from 23 February 2007 to May 2009.

Updated on 15 July 2008 SmPC

Reasons for updating

  • New SPC for medicines.ie

Legal category: Supply through general sale