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Sovereign Medical

Sovereign House , Miles Gray Road , Basildon , Essex , SS14 3FR
Telephone: +44 (0)1268 535 200
Fax: +44 (0)1268 535 299
Medical Information Direct Line: +44 (0)1268 823 049
Medical Information e-mail: medinfo@amdipharm.com
Medical Information Fax: +44 (0)1268 535 287

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: 29/04/2008
SPC Efcortesol Injection

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 29/04/2008 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   01-Apr-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


To include early psychiatric side-effects associated with corticosteroids in sections 4.4 (Special warnings) and 4.8 (Undesirable effects) of the SPC.
Updated on 18/09/2007 and displayed until 29/04/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to Section 4.2
The following text has been added: test
Updated on 14/09/2006 and displayed until 18/09/2007
Reasons for adding or updating:
  • 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
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   02/2005
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 Special warnings and precautions for use
Addition of the following text:
Corticosteroids should NOT be used in the treatment of cerebral oedema associated with acute head injury or cerebrovascular accident, as they are unlikely to be of benefit and may even be harmful.

Section 4.5 Interaction with other medicinal products and other forms of interaction
The word "phenobarbitone" has been changed to " phenobarbital" in the following paragraph: Drug interactions: rifampicin, rifabutin, carbamazepine, phenobarbital, phenytoin, primidone, ephedrine and aminoglutethimide enhance the metabolism of corticosteroids and its therapeutic effects may be reduced.

10. Date of revision of the text
February 2004 February 2005

 
Updated on 27/09/2004 and displayed until 14/09/2006
Reasons for adding or updating:
  • Change to separate SPCs covering individual presentations
Updated on 01/10/2002 and displayed until 27/09/2004
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

 
  hydrocortisone