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Novartis Consumer Health
Novartis Consumer Health UK Ltd, Park View, Riverside Way, Watchmoor Park, Camberley, Surrey, GU15 3YL, UK
Telephone: +44 (0)1276 687300
Fax: +44 (0)1276 687284
Medical Information Direct Line: +44 (0)1403 323 046
Medical Information e-mail: medicalaffairs.uk@novartis.com
Customer Care direct line: +44 (0)1276 687290
Medical Information Fax: +44 (0)1403 324 024

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: 30/03/2012
SPC Nicotinell liquorice 4mg medicated chewing 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 30/03/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   15-Mar-2012
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4

Under sub heading “Stopping smoking”: olanzapine changed to olanzaprine and clozapine changed to clozaprine.

Under new sub heading “ Special warnings about excipients” additional information added:

This medicine contains low dose of extractum glycyrrhizae (liquorice) as a flavour. High and prolonged intake of liquorice may lead to mineralocorticoid effects (pseudoaldosteronism) in the form of electrolyte imbalance (sodium retention and potassium loss) accompanied by hypertension, oedema and suppression of the renin-angiotensin-aldosterone system.

However, individual tolerance varies widely and regular intake of even low amount of liquorice may cause pseudoaldosteronism in the most sensitive individuals (liquorice susceptible individuals).  The possible mineralocorticoid effects due to liquorice have to be taken into consideration in liquorice susceptible patients with cardiovascular diseases and hypertension. Where use of nicotine replacement therapy is recommended the use of other flavoured nicotine medicated chewing-gums (e.g. fruit, mint or classic) may be considered.

 

 

Section 10

Change of date from 14 November 2008 to 16 March 2012
Updated on 16/12/2008 and displayed until 30/03/2012
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 polacrilin