Summary of Product Characteristics
last updated on the eMC:
29/09/2009
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 29/09/2009 and displayed until Current
|
Reasons for adding or updating:
|
-
Change to section 9 - Date of first Authorisation/renewal of the Authorisation
-
Removal of Black Triangle
|
| Date of revision of text on the SPC: 28-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Black Triangle has been removed and date of renewal is 28 August 2009
|
|
Updated on 23/09/2009 and displayed until 29/09/2009
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6. 3 - Shelf Life
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 28-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.8 has been changed to add orthostatic hypotension: please see in bold below:-
Transient episodes of
light-headedness, occasionally related to blood pressure changes, also may
occur. Hypotension (including orthostatic hypotension) occurs infrequently, but
in some patients may be severe enough to warrant discontinuation of therapy
Section 6.3 - the shelf-life has changed from 2 years to 15 months.
|
|
Updated on 27/07/2009 and displayed until 23/09/2009
|
Reasons for adding or updating:
|
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 26-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
In section 6.3, the shelf-life has been changed from 2 years to 15 months.
|
|
Updated on 26/09/2008 and displayed until 27/07/2009
|
Reasons for adding or updating:
|
-
Change to section 5.1 - Pharmacodynamic Properties
|
| Date of revision of text on the SPC: 23-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
|
Pharmacotherapeutic
group: Muscle relaxants
ATC
Code: C05AE
01
|
|
Updated on 25/05/2007 and displayed until 26/09/2008
|
Reasons for adding or updating:
|
-
Extra statutory information
|
| Date of revision of text on the SPC: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
| Re-instatement of Black triangle - ommitted in last submission process
|
|
Updated on 21/05/2007 and displayed until 25/05/2007
|
Reasons for adding or updating:
|
-
Correction of spelling/typing errors
|
|
Updated on 17/05/2007 and displayed until 21/05/2007
|
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 4.6 - Pregnancy and Lactation
-
Change to section 4.8 - Undesirable Effects
-
Change to section 4.9 - Overdose
-
Change to section 5.3 - Preclinical Safety Data
-
Change to section 6. 3 - Shelf Life
|
| Date of revision of text on the SPC: 03/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
|
Section 4.2 - Clarification that no specific information is available on use in the elderly or in hepatic or renal impairment.
Addition of statement on use of Rectogesic use following conservative treatment failure.
Section 4.4 - Addition of risk/benefit statement. Addition of information on bleeding associated with heamorrhoids. Addition of presence of lanolin and propylene glycol as excipients. Potential for interference with measurement of catecholamines and vanilmandelic acid in urine. Advice on subjects at risk of postural hypotention.
Section 4.5 - Addition of potential for interactions with acetyl cysteine, heparin and alteplase.
Section 4.6 - Provision of additional advice
Section 4.8 - Provsion of updated side effect data from clinical trials.
Section 4.9 - Provision of additional guidance
Section 5.3 - Provision of additional preclinical data
Section 6.6 - Addition of shelf-life once opened (8 weeks)
|
|
Updated on 06/09/2005 and displayed until 17/05/2007
|
Reasons for adding or updating:
|
-
Addition of Black Triangle
|
|
Updated on 01/06/2005 and displayed until 06/09/2005
|
Reasons for adding or updating:
|
-
New SPC for new product
-
Pending awaiting re-submission
|
|
