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Section 1
Addition of word ‘compressed’.
Section 2
Addition of Excipients(s): aspartame (0.01 g), maltitol (0.9 g) and sodium (9.8 mg).
For a full list of excipients, see section 6.1
Section 4.1
Paragraph 1: Deletion of words ‘Nicotinell treatment is indicated for the .....’
Paragraph 2: Patient counselling and support...’ replaces ‘advice and support...’
Section 4.2
Adults & Elderly
Paragraph 2: Words changed from: ‘...medium nicotine dependency’ to ‘..low to moderate nicotine dependency’.
Paragraph 3: Addition of words: ‘or very strong’ after ‘strong’ and ‘nicotine dependency’.
Paragraph 5: Clarification of high dose form as 2mg lozenge and low dose form as 1mg lozenges.
New paragraph added:
Patients who have been using oral nicotine replacement therapy beyond 9 months are advised to seek additional help and information from health care professionals.
Paragraph regarding use of acidic beverages has been moved from Children and adolescents (<18 years) section to section called Directions for use.
Deletion of paragraph: Nicotinell Mint 1 mg lozenge is sugar-free.
Section 4.3
Change of wording from ‘Hypersensitivity to any excipients of the lozenge’ to ‘Hypersensitivity to nicotine or to any of the excipients’.
Section 4.4
New Heading added: Special warnings about excipients and related warnings grouped underneath.
Paragraph added:
Nicotinell lozenges contain sweeteners, including aspartame and maltitol.
Addition of words ‘a source of frustose’ added after ...’contains aspartame (E951)...’
Section 4.5
‘olanzapine’ moved from list in paragraph 3 to list in paragraph 2.
Paragraph 4: Deletion of word ‘reduction’ between words ‘heart rate’ and ‘and reduced’.
Section 4.7
Wording added: ‘one should take into consideration that’ between ‘nevertheless’ and ‘smoking cessation’
Section 4.8
Paragraph 1: Addition of: ‘Non dose-dependent adverse reactions are as follows: hypersensitivity, angioneurotic oedema and anaphylactic reactions.’
Paragraph 3: Last sentence changed from :
‘Those with a tendency to indigestion may suffer initially from slight dyspepsia or heartburn.’ to ‘Those who are prone to indigestion may suffer initially from minor degrees of dyspepsia or heartburn; slower sucking will usually overcome this problem.‘
Addition of paragraph: ‘Increased frequency of aphthous ulcer may occur after abstinence from smoking.’
New paragraph: Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as : very common (≥1/10), common (≥1/100) to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10,000, <1/1,000) or very rare (<1/10,000).
Addition of : Immune system disorders: Rare: hypersensitivity, angioneurotic oedema and anaphylactic reactions.
Section 4.9
Treatment of overdose:
‘Treatment of overdose should be immediate as symptoms may develop rapidly. Emesis is usually spontaneous. Administration of oral activated charcoal and gastric lavage should be considered as soon as possible and within 1 hour of ingestion. Monitor vital signs and treat symptomatically.’
Replaces :
‘In the event of overdosage, vomiting should be induced with syrup of ipecac or gastric lavage carried out (wide bore tube). A suspension of activated charcoal should then be passed through the tube and left in the stomach. Artificial respiration with oxygen should be instituted if needed and continued for as long as necessary. Other therapy, including treatment of shock, is purely symptomatic.’
Section 5.2
Paragraph 3: (2-)3 1/kg has changed to 2-3 1/kg.
Paragraph 4: The words’..concomitant drugs...’ has been replaced with ‘...concomitant medicinal products..’.
Section 5.3
Paragraph 1:
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 6.4
Deletion of words ‘Store in the original package’.
Section 9
Date of first authorisation: 20 July 1999. Date of last renewal:16 December 2008
Replaces : 20 July 1999
Section 10
Date changed from 10 January 2008 to 19 November 2010
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