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sanofi-aventis
1 Onslow Street, Guildford, Surrey, GU1 4YS, UK
Telephone: +44 (0)1483 505 515
Fax: +44 (0)1483 535 432
Medical Information e-mail: uk-medicalinformation@sanofi-aventis.com

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: 28/06/2011
SPC Priadel 200mg & 400mg prolonged release 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 28/06/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
  • Change to section 6.2 - Incompatibilities
  • Change to section 6.1 - List of Excipients
Date of revision of text on the SPC:   22-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
SPC has been updated to bring the format into line with the QRD template and European SPC Guidelines.
Updated on 12/01/2011 and displayed until 28/06/2011
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   19-Nov-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.2 - The text in italic as been added. In the serum levels, -0.8 - 1.5' has been replaced with '0.8 - 12.'

Treatment of acute manic or hypomanic episodes and recurrent depressive disorders: It is likely that a higher than normal Priadel intake may be necessary during an acute phase and divided doses would be required here. As a general rule the monitoring should maintain serum levels at 0.8-1.2 mmol/l until acute symptoms have been controlled. In all other details the described treatment schedule is recommended. The dosage needed may vary from patient to patient. Serum lithium levels should be monitored (see above) and should not exceed 1.5 mmol/L. Once clinical control is achieved, dosage should be reduced to the prophylactic dose.
Updated on 01/09/2010 and displayed until 12/01/2011
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   02-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 - changes to bring in line with core safety information
Updated on 01/08/2010 and displayed until 01/09/2010
Reasons for adding or updating:
  • Change to section 4.3 - Contraindications
  • 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 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic Properties
Date of revision of text on the SPC:   19-Jun-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.3: update in line with Company Core Safety Information and add Brugada syndrome
Section 4.4: update in line with Company Core Safety Information 
Section 4.5: update in line with Company Core Safety Information 
Section 4.6: update in line with Company Core Safety Information 
Section 4.7: update in line with Company Core Safety Information 
Section 4.8: update in line with Company Core Safety Information 
Section 4.9: update in line with Company Core Safety Information 
Section 5.1: update in line with Company Core Safety Information 
Updated on 23/02/2009 and displayed until 01/08/2010
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   27-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 8: Change of PL numbers to: Priadel 04425/0325, Priadel 200mg 04425/0322
Section 9: Change of date to 27th January 2009
Section 10: Change of date to 27th January 2009
Updated on 06/03/2008 and displayed until 23/02/2009
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   11/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Amendment to section 6.5 to reflect containers currently marketed.

Updated on 04/09/2007 and displayed until 06/03/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
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 7: Market Authorisation Holder
Change to sanofi-aventis from Sanofi-synthelabo
Updated on 26/09/2006 and displayed until 04/09/2007
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Date of revision of text on the SPC:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Change to section 6.4 (Special precautions for storage): change to wording regarding storage conditions
Updated on 04/08/2005 and displayed until 26/09/2006
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 24/11/2004 and displayed until 04/08/2005
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 10 (date of (partial) revision of the text
Updated on 17/09/2004 and displayed until 24/11/2004
Reasons for adding or updating:
  • Change to section 4.3 - Contra-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
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 4.8 - Undesirable Effects
  • Change to section 4.9 - Overdose
  • Change to section 10 (date of (partial) revision of the text
Updated on 03/10/2003 and displayed until 17/09/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 16/07/2002 and displayed until 03/10/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 28/08/2001 and displayed until 16/07/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  lithium carbonate