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Recordati Pharmaceuticals Limited
Isis House, 43 Station Road, Henley-on-Thames, Oxfordshire, RG9 1AT, UK
Telephone: +44 (0)1491 576 336
Fax: +44 (0)1491 576 336
WWW: http://www.recordati.com
Medical Information Direct Line: +44 (0)1491 576 336
Medical Information e-mail: medinfo@recordati.co.uk

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: 09/11/2010
SPC Lopresor SR

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 09/11/2010 and displayed until Current
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
Date of revision of text on the SPC:   06-Oct-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
New MAH is:

Recordati Pharmaceuticals Limited

Isis House

43 Station Road

Henley-on-Thames

Oxfordshire

RG9 1AT

UK
Updated on 23/01/2009 and displayed until 09/11/2010
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
  • Transfer of Marketing Authorisation Holder
Date of revision of text on the SPC:   17-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
To include PVC/PE/PVDC/ALU blister pack as an additional pack type for the drug product.
Updated on 01/09/2008 and displayed until 23/01/2009
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   01-Jan-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


·         Section 4.4 (Special warnings and special precautions for use) has been updated to specify that the mention of beta-blockers in this section includes Lopresor.

 

·         Section 4.8 (Undesirable effects) has been reworded to align with the basic prescribing information. Additional information has been added with regards to:

 

Ear and labyrinth disorders.

Respiratory disorders

Reproductive system disorders

 

The following undesirable effect has also been added:

Retroperitoneal fibrosis

 

Information on post-marketing experience has been added as follows:

 

The following adverse reactions have been reported during post-approval use of Lopresor: confusional state, an increase in blood triglycerides and a decrease in high density lipoprotein (HDL). Because these reports are from a population of uncertain size and are subject to confounding factors, it is not possible to reliably estimate their frequency
Updated on 26/06/2007 and displayed until 01/09/2008
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 5.2 - Pharmacokinetic Properties
Date of revision of text on the SPC:   04/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
SECTION 4.4:   
 
Updated to include information on the use of lopresor SR during anaesthesia
 
SECTION 4.8:
 
Updated in line with MedDRA terminology and to include hepatitis, retroperitoneal fibrosis and Peyronie's disease
 
SECTION 4.5 and 5.2:
 
Section 5.2 updated to include information on the role of cytochrome P450 2D6 in the metabolism of metoprolol and section 4.5 updated to add a warning about possible interactions with potent CYP 2D6 inhibitors
Updated on 29/12/2004 and displayed until 26/06/2007
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 01/10/2004 and displayed until 29/12/2004
Reasons for adding or updating:
  • Improved Electronic Presentation
Updated on 25/07/2001 and displayed until 01/10/2004
Reasons for adding or updating:
  • Transferred from eMC version 1
Updated on 02/01/2001 and displayed until 25/07/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 02/01/2001
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  metoprolol tartrate