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Norgine Limited

Norgine House, Widewater Place, Moorhall Road, Harefield, Middlesex, UB9 6NS
Telephone: +44 (0)1895 826 600
Fax: +44 (0)1895 825 865
E-mail:
Medical Information e-mail: medinfo@norgine.com

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Summary of Product Characteristics last updated on the eMC: 01/09/2011
SPC CAMCOLIT 250

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 01/09/2011 and displayed until Current
Reasons for adding or updating:
  • Correction of spelling/typing errors
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

None provided
Updated on 02/12/2010 and displayed until 01/09/2011
Reasons for adding or updating:
  • Improved Electronic Presentation
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

None provided
Updated on 12/10/2010 and displayed until 02/12/2010
Reasons for adding or updating:
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.4 - Special warnings and precautions for Use
Date of revision of text on the SPC:   01-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

SmPc change to 4.2, 4.3 & 4.4
Updated on 09/01/2009 and displayed until 12/10/2010
Reasons for adding or updating:
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
Date of revision of text on the SPC:   01-Jan-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company



As lithium may cause disturbances of the CNS, patients should be warned of the possible hazards when driving or operating machinery.  

Updated on 03/10/2006 and displayed until 09/01/2009
Reasons for adding or updating:
  • 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 4.8 - Undesirable Effects
  • 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 4.4:

Caution in patients with cardiovascular disease or family history of QT prolongation.

Avoid concomitant antipsychotics.

Caution is advised in patients with cardiovascular disease or family history of QT prolongation.

Concomitant administration of antipsychotics should be avoided.

Section 4.5:    

Interactions may occur with concomitant QT interval prolonging drugs.

Interactions may occur with drugs which cause electrolyte imbalance.

Use with concomitant QT prolonging drugs (e.g. Class IA and III antiarrhythmics, arsenic trioxide, dolasetron mesylate, mefloquine, IV erythromycin) is not recommended. 

Use with drugs causing electrolyte imbalance is not recommended.

Section 4.8:

Cardiovascular effects of lithium are rare and often benign. Reported effects are ventricular arrhythmia ventricular fibrillation, ventricular tachycardia (rare), oedema, and sinus node dysfunction.  Any signs of cardiac disturbance e.g. syncope, heart rhythm or rate disturbances should be investigated further. QT interval prolongation, sudden unexplained death, cardiac arrest, Torsade de pointes.

Cardiovascular effects of lithium are rare and often benign.  Reported effects are arrhythmia, oedema and sinus node dysfunction.  QT interval prolongation, ventricular arrhythmias – ventricular fibrillation, ventricular tachycardia (rare), sudden unexplained death, cardiac arrest and Torsade de pointes have been reported,  Any signs of cardiac disturbance e.g. syncope, heart rhythm or rate disturbances should be investigated further.
 
Section 10:  23 August 2006
 
Updated on 16/05/2005 and displayed until 03/10/2006
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/05/2005 and displayed until 16/05/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/05/2005 and displayed until 11/05/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 11/05/2005 and displayed until 11/05/2005
Reasons for adding or updating:
  • Change to section 1 - trade name
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 10 (date of (partial) revision of the text
Updated on 22/09/2003 and displayed until 11/05/2005
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 26/09/2002 and displayed until 22/09/2003
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 13/08/2001 and displayed until 26/09/2002
Reasons for adding or updating:
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 06/09/1999 and displayed until 13/08/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
   lithium carbonate