Summary of Product Characteristics
last updated on the eMC:
23/03/2011
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 23/03/2011 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 6.1 - List of Excipients
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| Date of revision of text on the SPC: 01-Mar-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.8 (undesirable effects) in the Cardiovascular section, orthostatic hypotension has replaced orthostatic hypertension.
Section 6.1 (list of excipients). Citric Acid Monohydrate, Methyl Hydroxybenzoate, Propyl Hydroxybenzoate, Propylene Glycol, Vanillin and Purified Water now use Ph. Eur as the reference standard rather than the BP.
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Updated on 11/01/2010 and displayed until 23/03/2011
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 07-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.8 (undesirable effects) Additions: Serum uric acid levels may rise during treatment with Amiloride and acute attacks of gout may be precipitated.
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Updated on 21/09/2009 and displayed until 11/01/2010
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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: 07-Aug-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.8: Additions: Serum uric acid levels may rise during treatment with Amiloride and acute attacks of gout may be precipitated.
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Updated on 02/08/2007 and displayed until 21/09/2009
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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: 07/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.5: CHlorthiazide amended to chlorpropramide. Additional paragraph re: diuretics
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Updated on 25/09/2002 and displayed until 02/08/2007
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Reasons for adding or updating:
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