Summary of Product Characteristics
last updated on the eMC:
16/06/2010
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 16/06/2010 and displayed until Current
|
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: 09-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 4.4: Under the subsection "Immunology and Hypersensitivity" the sentence concerning the types of adverse reactions found with systemic administration of sulphonamides has been amended as follows:
"Therefore, the same types of adverse reactions found with systemic administration of sulphonamides may occur with topical administration, including severe reactions such as Stevens-Johnson syndrome and toxic epidermal necrolysis. If signs of serious reactions or hypersensitivity occur, discontinue use of this preparation."
Section 4.8: Under the sub-heading "Skin and subcutaneous tissue disorders" the following rare side effects have been added "Stevens-Johnson syndrome, toxic epidermal necrolysis"
|
|
Updated on 09/03/2009 and displayed until 16/06/2010
|
Reasons for adding or updating:
|
-
Change to section 1 -Name of the Medicinal product
-
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 6. 6 - Instructions for use, handling and disposal
-
Change to section 10 date of revision of the text
|
| Date of revision of text on the SPC: 27-Feb-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 1: Product name now in line with QRD guidance
Section 2: The word 'section' has been included which had inadvertently been omitted previously
Section 4.4: Minor typographical correction within the sub-section 'Hepatic Impairment'
Section 4.5:
Deletion of the paragraph concerning the theoretical acid-base disturbances associated with dorzolamide
Section 4.8: Minor typographical corrections to system organ class headings
Section 6.6: Correction to the name of the section in line with QRD guidance
Section 10: Renewal date updated
|
|
Updated on 07/08/2008 and displayed until 09/03/2009
|
Reasons for adding or updating:
|
-
Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
|
| Date of revision of text on the SPC: 31-May-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Update to section 4.5 (interactions) of the SPC with information regarding drug interaction of timolol maleate with CYP2D6 inhibitors. Update to section 4.2 (posology and administration), 4.4 (Special warning and precautions for use) and 5.1 (pharmacodynamic properties) of the SPC regarding paediatrics that has already been approved for Cosopt. Minor changes are also made to the SPC in line with the QRD template.
|
|
Updated on 22/11/2006 and displayed until 07/08/2008
|
Reasons for adding or updating:
|
|
|
|
