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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: 29/03/2011
SPC NiQuitin 4 mg Mint Lozenges / NiQuitin Pre-Quit 4 mg Mint 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 29/03/2011 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:   23-Mar-2011
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 2 to amend active ingredient from nicotine polacrilex to nicotine resinate
Updated on 12/10/2010 and displayed until 29/03/2011
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 for smokers who wish to cut down with no immediate plans to quit

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 17/04/2009 and displayed until 27/08/2009
Reasons for adding or updating:
  • New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
Date of revision of text on the SPC:  
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  nicotine resinate