Summary of Product Characteristics
last updated on the eMC:
28/08/2008
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 28/08/2008 and displayed until Current
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Reasons for adding or updating:
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Change to section 6.1 - List of Excipients
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Change to section 6. 5 - Nature and Contents of Container
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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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| 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 "Keep medicines away from children. Because it contains glucose monohydrate, patients with rare glucose-galactose malabsorption should not take this medicine."
In section 6.1 (List of excipients): "Dextrose Monohydrate" has been replaced with "Glucose Monohydrate"
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 "April 2008"
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Updated on 30/01/2007 and displayed until 28/08/2008
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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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