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Napp Pharmaceuticals Limited
Cambridge Science Park, Milton Road, Cambridge, Cambridgeshire, CB4 0GW
Telephone: +44 (0)1223 424 444
Fax: +44 (0)1223 424 441
WWW: http://www.napp.co.uk
Medical Information Fax: +44 (0)1223 424 912

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: 24/09/2009
SPC Remedeine and Remedeine forte tablets

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 24/09/2009 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   28-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Changed the date of revision of the text (previous error)
Updated on 02/07/2009 and displayed until 24/09/2009
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   28-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
MA Renewal
Updated on 06/09/2007 and displayed until 02/07/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5 Nature and Contents of Container now reads:
 
REMEDEINE tablets are available in polyethylene containers with polypropylene lids containing 56 or 112 tablets.
REMEDEINE FORTE tablets are available in ployehtylene containers with polypropylene lids containing 56 tablets.
 
Updated on 02/03/2007 and displayed until 06/09/2007
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 10 date of revision of the text
Date of revision of text on the SPC:   10/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 Risk benefit statement added
 
Section 4.8 Regular prolonged use of DHC leading to tolerance and addiction statement added. painkiller and headaches statement added.
 
 
Updated on 23/03/2006 and displayed until 02/03/2007
Reasons for adding or updating:
  • Change to section 10 (date of (partial) revision of the text
  • Change to section 4.9 - Overdose
Updated on 20/03/2006 and displayed until 23/03/2006
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 14/09/2004 and displayed until 20/03/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 (date of (partial) revision of the text
Updated on 28/08/2001 and displayed until 14/09/2004
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 20/10/2000 and displayed until 28/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 20/10/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  paracetamol
  dihydrocodeine tartrate