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GlaxoSmithKline Consumer Healthcare
980 Great West Road, Brentford, Middlesex, TW8 9GS
Telephone: +44 (0)20 8047 5000
Medical Information Direct Line: +44 (0)20 8047 2500
Medical Information e-mail: customer.relations@gsk.com
Customer Care direct line: +44 (0)20 8047 2700
Medical Information Fax: +44 (0)20 8047 6860

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 17/10/2011
SPC NiQuitin 2 mg Lozenges

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC. For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 17/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
Date of revision of text on the SPC:   18-Apr-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2 nicotine polacrilex amended to nicotine resinate
Updated on 12/10/2010 and displayed until 17/10/2011
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   30-Sep-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To extend the indications to include ‘harm reduction’ following advice from the CHM, with updates made to sections 4.1 (Therapeutic indications), 4.2 (Posology and method of administration) and 4.6 (Pregnancy and lactation)

Section 4.1 now includes an indication for pregnant and lactating women, and people who wish to cut down with no immediate plans to quit

Section 4.2 now includes directions for use for a reduction in smoking

Updated on 27/08/2009 and displayed until 12/10/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   10-Jul-2009
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Update to section 4.8 to include anaphylactic reactions
Updated on 21/08/2008 and displayed until 27/08/2009
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   17-Sep-2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 4.1 an indication of temporary abstinence has been added, and section 4.2 has been updated with dosing for this indication.
In section 4.8 an additional reference to sleep disturbance has been added.
Updated on 21/09/2007 and displayed until 21/08/2008
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - 'CQ' removed from Trade name
 
Section 4.1 - Indication revised from smoking cessation to smoking cessation (abrupt and gradual)
 
Section 4.2 -  Addtion of directions for use for gradual cessation of smoking.  Revision of warning to stop smoking completely during treatment with NiQuitin to 'make every effort to stop smoking completely' during abrupt cessation of smoking
 
Section 6.5 - Addition of pack sizes of 96,108 and 144
 
Section 8 - Marketing authorisation number changed from 00079/0369 to 00079/0606
 
Section 9 - Date amended from 24 September 2001 to 29/03/2007
 
Section 10 - Date revised to 29/03/2007
Updated on 06/04/2006 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments 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 10 (date of (partial) revision of the text
Updated on 23/12/2003 and displayed until 06/04/2006
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC

Active Ingredients/Generics

 
  nicotine resinate