Summary of Product Characteristics
last updated on the eMC:
12/02/2010
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 12/02/2010 and displayed until Current
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Reasons for adding or updating:
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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 4.6 - Pregnancy and Lactation
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Change to section 5.1 - Pharmacodynamic Properties
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| Date of revision of text on the SPC: 01-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 4.3 Contraindications – addition of hypersensitivity
Section 4.4 Special Warnings – addition of fluid and electrolyte balance, angina pectoris, thrombocytopenia, pericardial effusion, galactose intolerance warning.
Section 4.5 Interactions – addition of guanethidine
Section 4.6 Pregnancy – information updated
Section 5.1 Pharmacodynamic properties – Addition of ATC code
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Updated on 22/01/2008 and displayed until 12/02/2010
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Reasons for adding or updating:
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Change to section 4.2 - Posology and method of administration
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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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| Date of revision of text on the SPC: 01/2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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4.2 (posology and method of administration) BAN to INN change - Chlorthalidone to Chlortalidone and Frusemide to Furosemide
4.4 (Special warnings) BAN to INN change – bethanidine to betanidine
4.5 (Interactions) BAN to INN change – bethanidine to betanidine
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Updated on 16/07/2007 and displayed until 22/01/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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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 7 MA Holder address amended from Milton Keynes to Sandwich
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Updated on 28/09/2004 and displayed until 16/07/2007
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Reasons for adding or updating:
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Addition of joint SPC covering all presentations
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Updated on 25/09/2002 and displayed until 28/09/2004
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Reasons for adding or updating:
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Change to section 9 - Date of Renewal of Authorisation
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Updated on 24/08/2001 and displayed until 25/09/2002
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 (date of (partial) revision of the text
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Updated on 23/08/2001 and displayed until 24/08/2001
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 18/07/2001 and displayed until 23/08/2001
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Reasons for adding or updating:
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Transferred from eMC version 1
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Updated on 18/08/2000 and displayed until 18/07/2001
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Updated on 25/05/2000 and displayed until 18/08/2000
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Updated on 06/09/1999 and displayed until 25/05/2000
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