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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: 24/02/2012
SPC Priadel Liquid

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 24/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • 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 9 - Date of first Authorisation/renewal of the Authorisation
Date of revision of text on the SPC:   18-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Type IB to align the SPC with the QRD template and the European SPC Guidelines.
Updated on 07/02/2012 and displayed until 24/02/2012
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • 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 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:   18-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Type IB (A.z) variation to align the SmPC with the QRD template (April 2010) and the European SPC Guidelines (September 2009).

Updated on 01/12/2011 and displayed until 07/02/2012
Reasons for adding or updating:
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 6. 5 - Nature and Contents of Container
Date of revision of text on the SPC:   10-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 5.2 updated with pharmacokinetic data
Section 6.5 - only 150ml is marketed
Updated on 25/03/2011 and displayed until 01/12/2011
Reasons for adding or updating:
  • Change to section 1 -Name of the Medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   10-Mar-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


(changes shown in red)

Section 1.
change in product name

Priadel 520mg/5ml Liquid.

Section 2.
            A clear, colourless, pineapple flavoured, sugar free syrup containing 520mg lithium citrate equivalent to 204mg lithium carbonate per 5ml.

For a full list of excipients see section 6.1

Section 3.

        Syrup
        Clear, colourless, pineapple flavoured, sugar free syrup.

Section 6.5
        Priadel Liquid is supplied in an amber glass bottle fitted with a one-piece polypropylene screw cap. Packs are available in 150ml and 300ml volumes. 
        Priadel Liquid is supplied with a 2.5/5ml double ended spoon.

Updated on 12/01/2011 and displayed until 25/03/2011
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 - to bring in line with core safety sheet
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 21/06/2010 and displayed until 01/08/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.2 - Posology and method of administration
Date of revision of text on the SPC:   18-May-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In Section 2, the amount of lithium carbonate per 5ml which is equivalent to 520mg of lithium citrate has been corrected to 204mg (was 200mg). A statement saying where the full list of excipients can be found has also been added.

In Section 4.2, as a result of the correction to Section 2, there have been consequential changes to dosing amounts in sub-sections 1, 3 and the sub-section titled "elderly"
Updated on 27/05/2009 and displayed until 21/06/2010
Reasons for adding or updating:
  • Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 8: Change to Marketing Authorisation Number to 04425/0354
Section 10: Date of Revision of text: 26th March 2009
Updated on 04/09/2007 and displayed until 27/05/2009
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 27/09/2006 and displayed until 04/09/2007
Reasons for adding or updating:
  • 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:   08/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 9: Change to renewal date
Section 10: Change to date of revision of text
Updated on 17/09/2004 and displayed until 27/09/2006
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 06/06/2003 and displayed until 17/09/2004
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 16/07/2002 and displayed until 06/06/2003
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 20/08/2001 and displayed until 16/07/2002
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder

Active Ingredients/Generics

 
  lithium citrate