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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 Panadol Ultra

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 4.4 - Special warnings and precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
Date of revision of text on the SPC:   21-Jun-2011
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Sections 4.4 and 4.6 updated to include advice on potential risks to a breastfeeding child from maternal consumption of codeine
Updated on 16/04/2010 and displayed until 17/10/2011
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   26-Mar-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to section 4.8
Updated on 28/01/2010 and displayed until 16/04/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   15-Jan-2010
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Sections 4.1 and 4.4 updated in response to the request by the MHRA to amend to reflect recent advice from the CHM regarding OTC medicines containing codeine.
Updated on 15/06/2007 and displayed until 28/01/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   01/2006
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - Addition of codeine addiction warnings to leaflet and label
Section 4.8 - Addition of warnings regarding prolonged use of codeine and painkillers
Section 4.9 - Addition of generic overdose statements for paracetamol and codeine
Section 6.1 - Amendment of excipients in line with EU directive
Updated on 17/05/2005 and displayed until 15/06/2007
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
  codeine phosphate hemihydrate