|
Section 1
Addition of word ‘compressed’.
Section 2
Addition of excipient sodium (9.8 mg). Full list of excipients in section 6.1.
Section 4.1
Paragraph 1: Deletion of ‘Nicotinell treatment is indicated for the... ‘
New paragraph: The 2mg strength is used when severe withdrawal symptoms are experienced.
Paragraph 2: ‘Patient counselling support’ replaces ‘advice and support’.
Section 4.2
Clarification of high dose form as 2mg lozenge and low dose form as 1 mg lozenge.
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
Special warnings about excipients
Paragraph 2: E965 added after ‘contains aspartame’.
Paragraph 3: ‘a source of fructose’ has been added after ‘(E965).’
Paragraph 5: Word change from ‘have’ to ‘experience’.
Section 4.5
‘olanzapine’ moved from list in paragraph 3 to list in paragraph 2.
Section 4.7
Wording added: ‘one should take into consideration that’ between ‘nevertheless’ and ‘smoking cessation’.
Section 4.8
Addition of sentence: 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; ‘
Addition of paragraph: ‘Increased frequency of aphthous ulcer may occur after abstinence from smoking.’
Addition of paragraph: Adverse reactions are listed below, by system organ class and frequency. Frequencies are defined as: very common (³1/10), common (³1/100 to <1/10), uncommon (³1/1,000 to <1/100), rare (³1/10,000, <1/1,000) or very rare (<1/10,000).
Section 4.9
Treatment of overdosage: ‘Treatment of overdose should be immediate as symptoms may develop rapidly’ replaces ‘Following overdose, symptoms may be rapid particularly in children’.
Section 5.2
Paragraph 3 : (2-)3 1/kg changed to 2-3 1/kg.
Section 6.4
Words deleted: ‘Store in the original package’.
Section 9
Dates changed from 31 July 2002 / 2 April 2004 to Date of first authorisation: 31 July 2002. Date of last renewal: 16 December 2008.
Section 10
Date changed from 10 January 2008 to 19 November 2010.
|
