Britannia Pharmaceuticals Limited

Park View House, 65 London Road, Newbury, Berkshire, RG14 1JN
Telephone: +44 (0) 1635 568 400
Fax: +44 (0) 1635 568 401
WWW: http://www.britannia-pharm.co.uk/
Medical Information Direct Line: +44 (0)870 851 0207
Medical Information e-mail: enquiries@medinformation.co.uk

Summary of Product Characteristics last updated on the eMC: 15/09/2010
SPC BritLofex Tablets 0.2mg

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 15/09/2010 and displayed until Current
Reasons for adding or updating:
  • Change to MA holder contact details
Date of revision of text on the SPC:   29-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Address change for marketing authorisation holder, Britannia Pharmaceuticals Ltd from Brighton Road to Park View House
Updated on 04/09/2009 and displayed until 15/09/2010
Reasons for adding or updating:
  • Improved Electronic Presentation
Date of revision of text on the SPC:   01-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

None provided
Updated on 19/09/2006 and displayed until 04/09/2009
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
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

There have been changes to the dosage of this medication in the following section:

 

-             Posology and Method of Administration:

 

The initial dose has been changed from “one 0.2mg tablet twice daily” to “0.8mg per day in divided doses”. The increments per day have changed from “0.2-0.4mg/day” to “0.4 to 0.8mg per day”. The maximum dose remains the same at 2.4mg/day.

Updated on 04/02/2005 and displayed until 19/09/2006
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 23/09/2004 and displayed until 04/02/2005
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 23/09/2004 and displayed until 23/09/2004
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 23/09/2004 and displayed until 23/09/2004
Reasons for adding or updating:
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 13/06/2003 and displayed until 23/09/2004
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic Indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
Updated on 11/06/2003 and displayed until 13/06/2003
Reasons for adding or updating:
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.8 - Undesirable Effects
Updated on 24/08/2001 and displayed until 11/06/2003
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 21/08/2001 and displayed until 24/08/2001
Reasons for adding or updating:
  • Change from datasheet to SPC

Active Ingredients/Generics

 
   lofexidine hydrochloride