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 15/02/2010 and displayed until 16/06/2010
|
Reasons for adding or updating:
|
-
Change to section 6. 4 - Special Precautions for Storage
|
| Date of revision of text on the SPC: 05-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
|
Section 6.4: The storage conditions have been amended as follows:
"Keep the bottle in the outer carton, in order to protect from light. This medicinal product does not require any special temperature storage conditions. Keep the bottle in the outer carton in order to protect from light."
|
|
Updated on 12/06/2009 and displayed until 15/02/2010
|
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 4.2 - Posology and method of administration
-
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 4.7 - Effects on Ability to Drive and Use Machines
-
Change to section 5.1 - Pharmacodynamic Properties
-
Change to section 5.3 - Preclinical Safety Data
-
Change to section 6.1 - List of Excipients
-
Change to section 6. 4 - Special Precautions for Storage
|
| Date of revision of text on the SPC: 11-Jun-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 amount of preservative has been quantified. The word 'section' has been included which had previously been omitted inadvertently.
Section 4.2: Extensively revised to provide detailed usage instructions.
Section 4.5: Deletion of the paragraph concerning the theoretical acid-base disturbances associated with dorzolamide.
Section 4.6: Includes more detailed information concerning use of product during pregnancy.
Section 4.7: Now states that no studies on the effects on the ability to drive and use machines have been performed.
Section 5.1: Pharmacotherapeutic group explained. Other minor typographical corrections.
Section 5.3: Preclinical information for each component (dorzolamide and timolol) is now included.
Section 6.1: Excipients listed in full.
Section 6.4: Storage conditions have been amended.
.
|
|
Updated on 07/08/2008 and displayed until 12/06/2009
|
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. Minor changes are also made to the SPC in line with the QRD template.
|
|
Updated on 25/05/2007 and displayed until 07/08/2008
|
Reasons for adding or updating:
|
-
Change to section 4.2 - Posology and method of administration
-
Change to section 4.4 - Special warnings and precautions for Use
-
Change to section 5.1 - Pharmacodynamic Properties
|
| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
|
| Information on paediatric use has been added to sections 4.2, 4.4 and 5.1.
|
|
Updated on 20/06/2003 and displayed until 25/05/2007
|
Reasons for adding or updating:
|
-
Change to section 1 - trade name
-
Change to section 3 - pharmaceutical form
-
Change to section 4.4 - Special Warnings and Precautions for Use
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6. 4 - Special Precautions for Storage
-
SPC Submitted in error
|
|
Updated on 29/07/2002 and displayed until 20/06/2003
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6. 6 - Instruction for Use/Handling
|
|
Updated on 25/07/2002 and displayed until 29/07/2002
|
Reasons for adding or updating:
|
-
Change to section 4.8 - Undesirable Effects
-
Change to section 6. 6 - Instruction for Use/Handling
|
|
Updated on 08/08/2001 and displayed until 25/07/2002
|
Reasons for adding or updating:
|
-
Transferred from eMC version 1
|
|
Updated on 29/05/2001 and displayed until 08/08/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 22/01/2001 and displayed until 29/05/2001
|
Reasons for adding or updating:
|
|
|
|
Updated on 06/09/1999 and displayed until 22/01/2001
|
Reasons for adding or updating:
|
|
|
|
