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SANOFI

Citywest Business Campus, Dublin 24, Ireland
Telephone: +353 1 4035600
Fax: +353 1 4035687
Medical Information e-mail: iemedinfo@sanofi.com
Summary of Product Characteristics last updated on medicines.ie: 12/10/2017
SPC Nozinan 25mg/ml Solution for Injection/Infusion

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 12/10/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 10 - Date of revision of the text
Date of revision of text on the SPC:   09-Oct-2017
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



4.5 added:-

There is a possible pharmacokinetic interaction between inhibitors of CYP2D6, such as phenothiazines, and CYP2D6 substrates.

Updated on 15/03/2017 and displayed until 12/10/2017
Reasons for adding or updating:
  • 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:   30-Dec-2016
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

TII Update to product info (SPC only) with Levomepromazine CCSI v1.
Updated on 02/06/2016 and displayed until 15/03/2017
Reasons for adding or updating:
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to Section 4.8 – Undesirable effects - how to report a side effect
Date of revision of text on the SPC:   19-May-2016
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Section 4.6

Fertility, Ppregnancy and lactation

 

Pregnancy

In humans, the teratogenic risk of levomepromazine has not been evaluated. Different prospective epidemiological studies conducted with other phenothiazines have yielded contradictory results regarding teratogenic risk. Nozinan is not recommended during pregnancy and in women of childbearing potential not using contraception.

 

 

Breast-feeding

Levomepromazine is excreted in breast milk in low amounts in human milk. A risk to the suckling child cannot be excluded.

 

Fertility

 

In humans, because of the interaction with dopamine receptors, levomepromazine may cause hyperprolactinaemia which can be associated with impaired fertility in women. Some data suggest that levomepromazine treatment is associated with impaired fertility in men.



Reporting of suspected adverse reactions

Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions preferably through the online reporting option accessible from the IMB homepage. A downloadable report form is also accessible from the IMB website, which may be completed manually and submitted to the IMB via ‘freepost’, in addition to the traditional post-paid ‘yellow card’ option.

FREEPOSTHPRA

Pharmacovigilance, Section

Irish Medicines Board

Kevin O’Malley House

Earlsfort Centre

Earlsfort Terrace, IRL -

Dublin 2;

Tel: +353 1 6764971

Fax: +353 1 6762517Website: www.hpraimb.ie;

Updated on 06/01/2014 and displayed until 02/06/2016
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:   12-Dec-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Type II C.1.4 to update the SPC sections 4.4 & 4.8 to reflect the updated Levomepromazine GLU version 8 & 9.

Updated on 22/11/2013 and displayed until 06/01/2014
Reasons for adding or updating:
  • Change to section 6.3 - Shelf life
Date of revision of text on the SPC:   15-Nov-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Type IAIN B.II.f.1.a.1 variation to reduce the shelf life of the finished product from 60 months to 36 months without change of the storage conditions (below 25°C protect from light).
Updated on 09/08/2013 and displayed until 22/11/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   02-Aug-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Type 1B No. A.2 b to update the product name to Nozinan 25mg/ml Solution for Injection/Infusion, in line with the standard terms.
Updated on 30/05/2013 and displayed until 09/08/2013
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 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
Date of revision of text on the SPC:   22-May-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Type II variation to update the SPC and PL to reflect the changes in the recent PSUR submission (CRN 2104815).
Updated on 01/02/2010 and displayed until 30/05/2013
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:   01-Jan-2010
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Information relating to hyperglycaemia
Updated on 18/03/2009 and displayed until 01/02/2010
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 4.8 - Undesirable effects
Date of revision of text on the SPC:   03/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update Sections 4.3, 4.4, 4.5, 4.8 of SPC
Updated on 13/05/2008 and displayed until 18/03/2009
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 07/04/2008 and displayed until 13/05/2008
Reasons for adding or updating:
  • 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:   04/2008
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update Section 6.5 of SPC Nature and Contents of Container
Updated on 13/08/2007 and displayed until 07/04/2008
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 21/05/2007 and displayed until 13/08/2007
Reasons for adding or updating:
  • Correction of spelling/typing errors
Updated on 13/11/2006 and displayed until 21/05/2007
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
  • Change to section 9 - Date of renewal of authorisation
Date of revision of text on the SPC:   11/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update Section 7 - Change MAH to sanofi-aventis Ireland Ltd.
Update Section 10 - Change date of revision.
 
Updated on 20/06/2006 and displayed until 13/11/2006
Reasons for adding or updating:
  • Improved electronic presentation
Updated on 02/12/2005 and displayed until 20/06/2006
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
Updated on 11/05/2005 and displayed until 02/12/2005
Reasons for adding or updating:
  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • 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 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text
Updated on 10/06/2003 and displayed until 11/05/2005
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   levomepromazine hydrochloride