Summary of Product Characteristics
last updated on the eMC:
23/10/2008
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 23/10/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 15-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Update to section 4.8 Undesirable effects
- Adverse reactions table is updated due to migration to MedDRA system organ classification
- Statement added regarding post-marketing reports of hypersensitivity reactions.
Update to section 10 Date of Revision of the text
- Date of revision updated to July 2008
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Updated on 11/03/2008 and displayed until 23/10/2008
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Reasons for adding or updating:
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Change to section 2 - Qualitative and quantitative composition
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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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Change to section 4.9 - Overdose
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 02/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2 – Include excipient details for lactose
Section 4.4 - Update warning on prolonged use of painkillers for headaches, add reference to lactose.
Section 4.9 – Update information on overdose
Section 6.1 – Update details for the film coat (Macrogel 3000)
Sections 9 and 10 – Update date of renewal and revision of the text
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Updated on 06/09/2005 and displayed until 11/03/2008
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Reasons for adding or updating:
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Removal of Black Triangle
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Updated on 13/07/2005 and displayed until 06/09/2005
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Reasons for adding or updating:
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Change to section 5.1 - Pharmacodynamic Properties
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Updated on 28/09/2004 and displayed until 13/07/2005
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Updated on 28/09/2004 and displayed until 28/09/2004
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Reasons for adding or updating:
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Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
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Pending awaiting re-submission
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Updated on 28/09/2004 and displayed until 28/09/2004
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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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Updated on 28/09/2004 and displayed until 28/09/2004
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Reasons for adding or updating:
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