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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: 04/04/2012
SPC NiQuitin 14 mg transdermal patches.

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 04/04/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   30-Mar-2012
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


List of excipients

Drug Reservoir:

Ethylene Vinyl Acetate Copolymer

Occlusive Backing:

Polyethylene Terephthalate/ Ethylene vinyl acetate

Rate Controlling Membrane:

Polyethylene Film

Contact Adhesive and Protective Layer:

Polyisobutylene Adhesive Laminate B100 and B12 SFN

Protective Layer:

Siliconised Polyester Film

Printing Ink:

White ink
Updated on 14/10/2010 and displayed until 04/04/2012
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:   11-Oct-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.1 changed to include further indications:-

-as an aid to smokers wishing to quit or reduce prior to quitting
-to assist smokers who are unwilling or unable to smoke
-as a safer alternative to smoking for smokers and those around them
-in pregnant and lactating women making a quit attempt

Section 4.2

Directions for use added for gradual cessation, reduction in smoking and temporary abstinence

Restrictions for 9 months use in adults removed, and smokers advised to contact a HCP if they are having difficulty discontinuing patch use.

Resctrictions for 12 weeks use in children removed and adolescents advised to contact a HCP if they are not ready or not able to quit abruptly.

 

Section 4.6 pregnancy and lactation reworded.
Updated on 11/06/2010 and displayed until 14/10/2010
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   07-Jun-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 6.1 - removal of 'sunsharp' from description of printing ink
Updated on 27/08/2009 and displayed until 11/06/2010
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 and photosensitivity
Updated on 18/10/2007 and displayed until 27/08/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • 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 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:   01/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - 'CQ' removed from trade name
Section 4.2 - Advice not to smoke or take any other form of nicotine at the same time has been removed.  Advice not to use beyond 10 weeks replaced with recommendation that patches may be used beyond 10 weeks if needed to stay cigarette free, but additional help and advice should be sought from a healthcare professional if using beyond 9 months.  Recommendation that NiQuitin should only be used with advice from a healthcare professional in 12-17 year olds removed, and replaced with advice to restrict treatment to 12 weeks.
Section 4.3 - Contra-indications to recent myocardial infarction, unstable or worsening angina pectoris, Prinzmetal's angina, severe cardiac arrythmias, or recent cerebrovascular accident have been removed.
Section 4.4 - Precautions relating to the use of NiQuitin beyond 10 weeks, and use with other forms of nicotine have been removed.  Warnings relating to Patients hospitalised for MI, severe dysrhythmia or CVA, diabetes mellitus, allergic reactions, atopic or eczematous dermatitis, contact sensitisation, renal and hepatic impairment, phaechromocytoma and uncontrolled hyperthyroidism have been amended and the need to be used only with medical advice in these conditions has been removed.  Warnings on stopping smoking and transferred dependence have been added.  The section on danger in small children has been revised to include advice on disposal of patches.
Section 4.5 - The list of drugs interactions has been removed.  A warning that nicotine may possibly enhance the haemodynamic effects of adenosine has been added.
Section 4.6 -  The recommendation that NiQuitin should only be used in pregnancy and lactaction on medical advice has been removed.  Further information has been added, including a recommendation to use intermittent dosing products.
Section 4.8 - reformatted
Section 4.9 - section on management of nicotine poisoning has been removed, and replaced with 'management of an overdose'
Section 8 - PL number changed from 00079/0345 to 00079/0366
Section 9 - Date of first authorisation amended from 29th September 2003 to 3 April 2001
Section 10 - updated to 30 January 2007
Updated on 20/10/2004 and displayed until 18/10/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/02/2004 and displayed until 20/10/2004
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