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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 2 mg Mint Lozenge

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 19/01/2010 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 01/07/2008 and displayed until 19/01/2010
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Apr-2008
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.5 "a polypropylene tablet container with an attached cap containing 24 lozenges in packs of 24, 48 and 72" has been added
Updated on 18/10/2007 and displayed until 01/07/2008
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 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • 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
 

Section1 - "CQ" removed from trade name

Section 4.1 - Indication for smoking cessation (abrupt and gradual) added

Section 4.2  - Recommendation to not use product for more than 6 months replaced with recommendation to seek advice from a healthcare professional if used beyond 9 months.  Directions for use for gradual cessation of smoking added. Addition of directions for use in adolescents and children.

Section 4.3 - Removal of contra-indications for people with phenylketonuria, unstable or worsening angina pectoris, Prinzmetals angina or cardiac arrhythmias and those who have recently suffered a myocardial infarcation or cerebrovascular accident.  Contraindication in under 18's amended to under 12's.

Section 4.4  - Addition of sections 'Patients hospitalised for MI, sever dysrhythmia or CVA', 'Allergic reactions','Stopping smoking' and 'Transferred dependence'.  Removal of warning not to use other nicotine containing products at the same time as NiQuitin.  Removal of precuation in stable cardiovascular disease.

Section 4.5 Removal of all drug interactions with addition of warning the nicotine may enhance the haemodynamic effects of adenosine.

Section 4.6 - Removal of advice that a medical assessment of the risk/benefit ration must be made before using NiQuitin.  Advice that intermittent dosing products are preferred added, and recommendation that NRT should ideally be used for only 2-3 months.

Section 4.8 - reformatted

Section 4.9 - management of overdose changed to remove induction of vomiting or gastric lavage.

Section 6.5 - Addition of pack sizes 96,108 and 144

Section 8 -  MA number changed from 00079/0373 to  00079/0369

Section 9 - Date changed from April 2002 to 29/03/2007

Section 10 - Date changed from April 2005 to 29/03/2007
Updated on 12/05/2005 and displayed until 18/10/2007
Reasons for adding or updating:
  • Change from BAN to rINN
  • Improved Electronic Presentation
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 20/10/2004 and displayed until 12/05/2005
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 23/12/2003 and displayed until 20/10/2004
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 12/12/2003 and displayed until 23/12/2003
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 11/12/2003 and displayed until 12/12/2003
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