Nicotinell Fruit 4mg Medicated Chewing-Gums

Update to excipient warnings

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

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

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.

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

Section 6.5

Addition of 120 pieces

Section 10

Date change from May 2009 to 28 January 2010

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’.

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.