Summary of Product Characteristics
last updated on the eMC:
12/05/2010
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 12/05/2010 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 2 - Qualitative and quantitative composition
-
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
|
| Date of revision of text on the SPC: 19-Apr-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 2 has been updated to include information on Lactose
Section 4.4:
· addition of a warning on rhabdomyolysis (in cases when Erymax is used concomitantly with HMG-CoA reductase inhibitors),
· addition of a warning on the risk to develop congenital syphilis for infants born to women treated during pregnancy with oral erythromycin.
· The warning on impaired hepatic patients has been expanded to also include patients who are taking concomitant potentially hepatotoxic agents.
· A statement on the potential interaction with the determination of urinary catecholamines/17-hydroxycorticosteroids has been moved from section 4.5 to section 4.4.
Section 4.5:
There is no new information added to the Interactions section, however to improve readability for the prescriber the section has been split into two parts: “Cytochrome P450 interactions” followed by “Other interactions”. The current information regarding HMG-CoA reductase inhibitors has been moved to the top of the “Other interactions” part of the section.
Section 4.8
has been updated to include erythema multiforme and toxic epidermal necrolysis and to expand to the information already present regarding hepatic dysfunction with additional relevant safety information.
Section 4.9: hearing loss has been added to the Overdose section.
Section 5.1 to add the ATC code
|
|
Updated on 14/04/2010 and displayed until 12/05/2010
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 8 - MARKETING AUTHORISATION NUMBER(S)
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 22-Mar-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Sections 7, 8, 9 and 10 of the SmPC have been updated as follows:
Section 7: Marketing Authorisation Holder has been changed to Cephalon UK Limited, 1 Albany Place, Hyde Way, Welwyn Garden City, Hertfordshire
Section 8: Marketing Authorisation Number(s) has been changed from PL 21799/0010 to PL 16260/0024
Section 9: Date of First Authorisation/Renewal of the Authorisation
Section 10: Date of Revision of Text
|
|
Updated on 28/01/2009 and displayed until 14/04/2010
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contraindications
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| Date of revision of text on the SPC: 21-Jan-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Section 4.3 of the SmPC has been updated to contraindicate concomitant use with simvastatin, tolterodine, mizolastine and amisulpride
Section 4.5 has been updated to cross refer to the contraindications for mizolastine and amisulpride (the warnings for mizolastine, simvastatin and tolterodine have been removed from the paragraph on interactions and added to the paragraph in contraindications). The following warning has also been added:
“Concomitant use with simvastatin is contraindicated due to the risk of myopathy and rhabdomyolysis whilst concomitant use with tolterodine is contraindicated due to increased risk of overdose.”
The following warning regarding simvastatin use has also been added:
“It is recommended that therapy with simvastatin is suspended during the course of treatment
|
|
Updated on 09/09/2008 and displayed until 28/01/2009
|
Reasons for adding or updating:
|
-
Change to section 6.1 - List of Excipients
|
| Date of revision of text on the SPC: 02-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Alteration of Section 6.1 with the inclusion of the 4 excipients under the heading printing ink.
|
|
Updated on 21/08/2008 and displayed until 09/09/2008
|
Reasons for adding or updating:
|
-
Change to MA holder contact details
|
| Date of revision of text on the SPC: 04-Oct-2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| The change of MAH address from The Magdalen Centre, Oxford Science Park, Oxford OX4 4GA to 1 Albany Place Hyde Way, Welwyn Garden City, Hertfordshire, AL7 3BT
1
|
|
Updated on 13/06/2007 and displayed until 21/08/2008
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
|
| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Section 7 - Marketing Authorisation Holder
changed from:
Zeneus Pharma Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
to:
Cephalon Limited
The Magdalen Centre
Oxford Science Park
Oxford
OX4 4GA
United Kingdom
|
|
Updated on 15/09/2005 and displayed until 13/06/2007
|
Reasons for adding or updating:
|
-
Change to section 4.3 - Contra-indications
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 28/05/2004 and displayed until 15/09/2005
|
Reasons for adding or updating:
|
-
Company name change or merger
|
|
Updated on 21/07/2001 and displayed until 28/05/2004
|
Reasons for adding or updating:
|
-
Change to section 7 - Marketing Authorisation Holder
-
Change to section 10 (date of (partial) revision of the text
|
|
Updated on 18/01/2000 and displayed until 21/07/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 18/01/2000
|
Reasons for adding or updating:
|
|
|
|
