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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: 03/01/2012
SPC Nozinan 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 03/01/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and Lactation
  • 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:   06-Dec-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To update section 4.6 and 4.8 of the SPC and leaflet with information on the use of conventional and atypical antipsychotics during pregnancy and the risk of abnormal muscle movements and withdrawal symptoms in newborns.
Updated on 16/02/2011 and displayed until 03/01/2012
Reasons for adding or updating:
  • Change to section 4.1 - Therapeutic indications
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   03-Feb-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


4.1       Therapeutic indications

 

Nozinan is a neuroleptic with indications in psychiatry and general medicine, particularly in terminal illness.  Clinically it is more sedative and more potent than chlorpromazine in the management of psychotic conditions and in the relief of severe chronic pain.

 

Psychiatry

As an alternative to chlorpromazine in schizophrenia especially when it is desirable to reduce psychomotor activity.

 

General medicine – Terminal illness

Adjunct therapy in the relief of pain and the accompanying distress. delirium, agitation, restlessness and confusion associated with pain in the terminal phase.
Updated on 27/04/2010 and displayed until 16/02/2011
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:   26-Jan-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 4.4 - addition of warning re risk of increaed mortality in elderly patients with dementia

Section 4.4 - addition of risk of VTE
Updated on 22/01/2010 and displayed until 27/04/2010
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 6.1 - List of Excipients
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   17-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 2: Rephrased from "Levomepromazine maleate INN (methotrimeprazine maleate BAN) 25mg per   tablet." to "Levomepromazine maleate 25mg per tablet. For excipients, see 6.1."

Section 3: Added detail about tablet: "Circular, grey-white or cream biconvex uncoated tablet. One face with Nozinan around a central 25 and a breakline on the reverse."

Section 5.1: Added the following: " ATC Code: NO5AA02. Pharmacotherapeutic group: Antipsychotics."

Section 6.1 "sodium lauryl sulphate" changed to "Sodium lauryl sulfate"

Date of revision changed to 17/11/09.
Updated on 28/06/2006 and displayed until 22/01/2010
Reasons for adding or updating:
  • Change to section 6. 4 - Special Precautions for Storage
Updated on 04/08/2005 and displayed until 28/06/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 9 - Date of Renewal of Authorisation
Updated on 24/03/2004 and displayed until 04/08/2005
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 17/12/2003 and displayed until 24/03/2004
Reasons for adding or updating:
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
Updated on 20/08/2001 and displayed until 17/12/2003
Reasons for adding or updating:
  • Addition of separate SPCs covering individual presentations

Active Ingredients/Generics

 
  levomepromazine maleate