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 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: 01-Mar-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| · the additional warning "Use with caution in patients with myasthenia gravis, non-specific ulcerative colitis, diverticulitis, fresh intestinal anastamoses" to section 4.4 of the SPC.
· section 4.5 of the SPC to include interactions with fluoroquinolones, anticholinesterases, licorice and neuromuscular blockers.
· section 4.8 of the SPC to include undesirable effects: blood and lymphatic system disorders - alteration in lipid levels, leukemoid reactions; ophthalmic - chorioretinopathy; dermatological - dermatitis and toxic epidermal necrolysis.
|
|
Updated on 04/04/2008 and displayed until 29/09/2009
|
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: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Updated sections 4.4 & 4.8 to include early psychiatric effects associated with corticosteroids
|
|
Updated on 31/03/2008 and displayed until 04/04/2008
|
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: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
Changes to sections 4.4 and 4.8 of SPC to include early psychiatirc effects associated with corticosteroids.
|
|
Updated on 15/09/2005 and displayed until 31/03/2008
|
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 25/06/2003 and displayed until 15/09/2005
|
Reasons for adding or updating:
|
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
-
Change to section 4.8 - Undesirable Effects
|
|
Updated on 02/07/2001 and displayed until 25/06/2003
|
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 06/09/1999 and displayed until 02/07/2001
|
Reasons for adding or updating:
|
|
|
|