Summary of Product Characteristics
last updated on the eMC:
08/11/2010
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 08/11/2010 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
|
The new MAH is:
Recordati Pharmaceuticals Limited
Isis House
43 Station Road
Henley-on-Thames
Oxfordshire
RG9 1AT
UK
|
|
Updated on 01/09/2008 and displayed until 08/11/2010
|
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
-
Transfer of Marketing Authorisation Holder
|
| 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 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 2D^ inhibitors
|
|
Updated on 01/10/2004 and displayed until 26/06/2007
|
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 06/09/1999 and displayed until 25/07/2001
|
Reasons for adding or updating:
|
|
|
|
