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McNeil Products Ltd
Foundation Park, Roxborough Way, Maidenhead, Berks, SL6 3UG
Medical Information Direct Line: 01344 864042
Medical Information e-mail: medinfo@its.jnj.com

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: 13/02/2012
SPC Nicorette Freshmint 4mg Gum

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 13/02/2012 and displayed until Current
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 4.3 - Contraindications
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   31-Jan-2012
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Nature of change:

o   To update the therapeutic indication following approval of identical indication for Nicorette Inhalator. SPC sections 4.1 (Therapeutic indications), 4.2 (Posology and method of administration), 4.3 (Contraindications), 4.6 (Pregnancy and lactation) and 5.1 (Pharmacodynamic properties), the PIL and labelling were updated consequentially. Additionally, section 6.6 (Special precautions for disposal) was updated with ‘Dispose of Nicorette Gum sensibly. Any unused product or waste material should be disposed of in accordance with local requirements’ in line with current SPC guidelines
Updated on 15/06/2010 and displayed until 13/02/2012
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   04-Jun-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The reason for change is a change to shelf life of the product to 3 years.
Updated on 28/02/2008 and displayed until 15/06/2010
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