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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: 23/02/2012
SPC CAMCOLIT 400

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 23/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 3 - Shelf Life
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   16-Aug-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Transcription error in the SPC - inadvertent use of 250mg strength excipient and shelf life.
Other typographical errors corrected
Updated on 12/10/2010 and displayed until 23/02/2012
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

changes to smpc, section: 4.2, 4.3 & 4.4
Updated on 19/01/2009 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 03/11/2006 and displayed until 19/01/2009
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:    

25th January 2005 23 August 2006

Updated on 31/10/2006 and displayed until 03/11/2006
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:   09/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 4.4:

Elderly patients are particularly liable to lithium toxicity.

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

Exacerbation of psoriasis may occur.

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:

Date approved: 28 September 2006

Updated on 29/09/2006 and displayed until 31/10/2006
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

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.

 

            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.

 

 

            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.

 

            10.

25th January 2005 23 August 2006

Updated on 11/05/2005 and displayed until 29/09/2006
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 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