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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: 17/10/2011
SPC Night Nurse

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 17/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   11-Nov-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



Section 4.2 Addition of warnings:

Maximum duration of continued use without medical advice: 3 days

Do not exceed the stated dose

Allow 4 hours between taking other paracetamol containing products and Night Nurse

Not to be taken with other cough, cold and antihistamine containing products
Updated on 25/06/2009 and displayed until 17/10/2011
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   03-Mar-2009
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

In section 4.4, the alcohol levels have been amended.
Updated on 07/01/2008 and displayed until 25/06/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   12/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 Addition of special leaflet warnings regarding alcohol, glucose and sodium.
 
Section 6.1 Removal of sodium benzoate from excipients.  Addtion of ascorbic acid and disodium edentate.  Sodium citrate replaces sodium acid citrate.
 
Section 10 Date amended to December 2007
Updated on 25/10/2007 and displayed until 07/01/2008
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:   08/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4 Addition of "Patients with rare glucose-galactose malabsorption should not take this medicine."
Section 10 Updated
Updated on 23/08/2007 and displayed until 25/10/2007
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:   08/2007
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Change to Section 6.5 - Addition of PET bottles as an additional type of immediate packaging.
Change to Section 10 - to update date of revision of text
Updated on 21/08/2007 and displayed until 23/08/2007
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

 
   paracetamol
   promethazine hydrochloride
   dextromethorphan hydrobromide