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Acorus Therapeutics Limited
Office Village, Chester Business Park, Chester, CH4 9QZ, UK
Telephone: +44 (0)1244 625 150
Fax: +44 (0)1244 625 151
WWW: http://www.ispharma.plc.uk
Medical Information Direct Line: +44 (0)1244 625 152
Medical Information e-mail: enquiries@ispharma.plc.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: 23/04/2009
SPC Mysoline 250mg 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 23/04/2009 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   01-Apr-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Update to drug interactions and foetal effects.
Requested safety update relating to anti-epileptics and suicidal thoughts. 
Updated on 11/09/2006 and displayed until 23/04/2009
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   07/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.1: Change in excipient description from Calcium carboxymethylcellulose U.S.N.F. to Carmellose calcium Ph. Eur
Updated on 04/05/2006 and displayed until 11/09/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   04/05/06
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.8 (Undesirable effects) 'Elevations in hepatic enzymes, including gamma-glutamyl transferase (gamma GT) and alkaline phosphatase' has been added to the table of undesirable effects.
Updated on 22/09/2005 and displayed until 04/05/2006
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

 
  primidone