Summary of Product Characteristics
last updated on the eMC:
11/10/2010
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 11/10/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 20-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4: The third paragraph has been amended as follows: "Dorzolamide contains a sulphonamido group, which also occurs in sulphonamides and although administered topically, is absorbed systemically. Therefore the same types of adverse reactions that are attributable to 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 the 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"
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Updated on 06/01/2010 and displayed until 11/10/2010
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Reasons for adding or updating:
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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| Date of revision of text on the SPC: 18-Dec-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 9 (Date of First Authorisation / Renewal of the Authorisation): Renewal Date updated to 11 November 2009, following MA renewal
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Updated on 07/07/2009 and displayed until 06/01/2010
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 5.3 - Preclinical Safety Data
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Change to section 6.1 - List of Excipients
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Correction of spelling/typing errors
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| Date of revision of text on the SPC: 24-Jun-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The changes made to the SmPC are as follows:
Section 1: Product name now in line with QRD guidance.
Section 2: The statement of active substance has been made clearer.
Section 3: Product description has been clarified.
Section 4.2: User Instructions have been extensively revised
in order to prevent over-tightening of the cap of the bottle and reinforce the proper sealing technique to the patient.
Section 4.4: Clarification that Dorzolamide contains a sulphonamido group. Other minor typographical corrections.
Section 4.6: Includes more detailed information concerning use of product during pregnancy and lactation
Section 4.7: Now states that
no studies on the effects on the ability to drive and use machines have been performed.
S
ection 5.3: Findings in rabbits now included.
Section 6.1: Excipients listed in full.
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Updated on 19/06/2007 and displayed until 07/07/2009
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 25/05/2007 and displayed until 19/06/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 5.1 - Pharmacodynamic Properties
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| 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
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| Information on Paediatric use has been added to sections 4.2, 4.4 and 5.1.
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Updated on 04/05/2006 and displayed until 25/05/2007
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Reasons for adding or updating:
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Change to section 4.2 - Posology and Method of Administration
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 31/07/05 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2: Usage instructions (step 1 - 9) added (previously described in section 6.6).
-Section 4.3: Revised text in paragraph I.
Section 4.4: Contact lens information (last paragraph) revised/clarified.
Section 4.5: A paragraph of text regarding potential interactions for topical/systemic carbonic anhydrase inhibitors has been removed
Section 4.8: Reformatted to MedDRA, body system and prevelance.
Section 5.1: ATC Code added
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Updated on 10/06/2002 and displayed until 04/05/2006
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Reasons for adding or updating:
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Change to section 6. 6 - Instruction for Use/Handling
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Change to section 8 - MA number
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 04/03/2002 and displayed until 10/06/2002
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Change to section 4.8 - Undesirable Effects
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Updated on 16/08/2001 and displayed until 04/03/2002
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Transferred from eMC version 1
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Updated on 18/04/2001 and displayed until 16/08/2001
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Updated on 20/02/2001 and displayed until 18/04/2001
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Updated on 06/09/1999 and displayed until 20/02/2001
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