Summary of Product Characteristics
last updated on the eMC:
14/05/2010
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 14/05/2010 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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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: 01-May-2010 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.5 (Interaction with other medicinal products and other forms of interaction) : the text has changed from "None known" to "Adios can theoretically have an effect on anticoagulant treatments. Closer monitoring of such patients by their doctor/clinic is advised if they take Adios."
In section 10 (Date of Revision of the Text) : the date has changed to "May 2010"
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Updated on 10/06/2008 and displayed until 14/05/2010
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Reasons for adding or updating:
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Change to section 10 date of revision of the text
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 6. 5 - Nature and Contents of Container
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| Date of revision of text on the SPC: 01-Apr-2008 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.4 (Special warnings and precautions for use), the following text has been added: "Because it contains lactose and sucrose, patients with rare hereditary problems of galactose or fructose intolerance, glucose-galactose malabsorption, the Lapp lactase deficiency or sucrose-isomaltase insufficiency should not take this medicine".
In section 6.5 (Nature and contents of container), the following text has been removed: "This is supplied as an original pack (OP)".
In section 10 (Date of revision of the text), the date has changed to "1 April 2008".
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Updated on 24/07/2007 and displayed until 10/06/2008
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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: 05/2007 |
| Legal Category: GSL |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 9: "Renewal of the Authorisation" date has changed to 11 May 2007.
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Updated on 26/01/2007 and displayed until 24/07/2007
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Reasons for adding or updating:
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New SPC for eMC ie an SPC for an existing product, but one that is new for the eMC
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