Summary of Product Characteristics
last updated on the eMC:
04/04/2012
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 04/04/2012 and displayed until Current
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Reasons for adding or updating:
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Change to section 4.1 - Therapeutic indications
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Change to section 4.2 - Posology and method of administration
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Change to section 4.3 - Contraindications
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Change to section 4.4 - Special warnings and precautions for Use
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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 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.1 Therapeutic indications – CHF indication added▼
Section 4.2 Posology and method of administration – CHF administration added, Renal impairment administration updated
Section 4.3 Contraindications – Patients with severe renal insufficiency updated, ACE inhibitor updated
Section 4.4 Special warnings and precautions for use – ACE inhibitors and ARB risk of hyperkalaemia added
Section 4.5 Interaction with other medicinal products and other forms of interaction – ACE inhibitors and ARB risk of hyperkalaemia added
Section 4.7 Undesirable effects – Updated
Section 5.1 Pharmacodynamic properties
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Updated on 19/11/2009 and displayed until 04/04/2012
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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 10 date of revision of the text
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| Date of revision of text on the SPC: 01-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 2: addition of lactose monohydrate details
Section 10: date of revision
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Updated on 01/10/2007 and displayed until 19/11/2009
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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: 04/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.8 – Addition of a paragraph to provide further explanation as to the genesis of adverse events (i.e., from EPHESUS or from post marketing surveillance).
Reordering of some of the undesirable effects including with NO change to the information:
i) Infections and infestations
ii) Metabolism and nutrition disorders
iii) Cardiac disorders
iv) Vascular disorders
v) Gastrointestinal disorders
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Updated on 31/08/2006 and displayed until 01/10/2007
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Reasons for adding or updating:
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Addition of Black Triangle
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| Date of revision of text on the SPC: 05/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
YES |
Free-text change information supplied by the pharmaceutical company
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| Section 1: addition of black triangle
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Updated on 21/09/2005 and displayed until 31/08/2006
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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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