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Bayer plc
Bayer House, Strawberry Hill, Newbury, Berkshire, RG14 1JA
Telephone: +44 (0)1635 563 000
Fax: +44 (0)1635 563 393
WWW: http://www.bayer.co.uk

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: 25/02/2011
SPC Co-Codamol eff.

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 25/02/2011 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:   01-Jan-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 and 4.6

To include warnings for pregnant and lactating mothers who could be ultra-rapid codeine metabolisers, which as a result can increase risk of opioid toxicity.
Updated on 31/03/2010 and displayed until 25/02/2011
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 Legal category
Date of revision of text on the SPC:   23-Feb-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to legal status of product from P to POM at request of MHRA.
Consequential changes to Section 1 (name) and 4.4 (Special warnings) - addition of codeine warnings
Updated on 28/10/2009 and displayed until 31/03/2010
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-May-2008
Legal Category:   P
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change in manufacturing process

Section 6.3 (Shelf Life) from 36 months to 24 months

Section 10 (Date of last revision) changed
Updated on 18/09/2006 and displayed until 28/10/2009
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  paracetamol
  codeine phosphate hemihydrate