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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 Clear 21 mg.

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 17/10/2011 and displayed until 04/04/2012
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
Date of revision of text on the SPC:   21-Dec-2010
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 addition of the name NiQuitin Pre-Quit Clear 21mg Patch
Updated on 21/10/2010 and displayed until 17/10/2011
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:   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 27/08/2009 and displayed until 21/10/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   06-Aug-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 21/09/2007 and displayed until 27/08/2009
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03/2007
Legal Category:   GSL
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 1 - 'CQ' removed from trade name
 
Section 4.4 - 'Safety on handling' section added
 
Section 10 - revision date updated to March 2007
Updated on 09/12/2005 and displayed until 21/09/2007
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/12/2003 and displayed until 09/12/2005
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