Summary of Product Characteristics
last updated on the eMC:
21/06/2010
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 21/06/2010 and displayed until Current
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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 4.6 - Pregnancy and Lactation
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Change to section 4.8 - Undesirable Effects
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Change to section 5.3 - Preclinical Safety Data
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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: 10-Jun-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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In section 4.2 (Posology and method of administration) title Children has changed to Pediatric population
In section 4.4 (Special warnings and precautions for use) insertion of one sentence ' Entacapone therapy should be administered cautiously to patients with ischemic heart disease.'
and
For patients..........weight decrease. Prolonged or peristent diarrhoea, the drug should be discontinued and appropriate medical therapy and investigations considered.
In section 4.6 (Pregnancy and lactation) has changed to Fertility, pregnancy and lactation
In section 4.8 (Undesirable effects) addition of Cardiac disorders** section and below an additional paragraph to cover ** The incidence.........receiving entacapone.
In section 5.3 (Preclinical safety data) the first word has changed from Preclinical data to Non-clinical data.
In section 10 (Date of Revision of the Text) is 10 June 2010
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Updated on 20/04/2009 and displayed until 21/06/2010
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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: 03-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The product licence has been renewed, so the SPC has been updated
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Updated on 22/05/2007 and displayed until 20/04/2009
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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 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Change to section 6. 6 - Instructions for use, handling and disposal
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| Date of revision of text on the SPC: 05/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.2 (Posology and method of administration) Change to the order of the the paragraphs
Section 4.4 (Special warnings and precautions for use) the addition of a new paragraph at the end of the section
Section 4.7 (Effects on ability to drive and use machines) Addition of the first sentence
Section 4.8 (Undesirable effects) Change of order in the table and the addition of a sentence to the paragraph directly under the table
Section 6.6 (Instructions for use, handling and disposal) The heading has been changed to Special precautions for disposal
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Updated on 21/05/2007 and displayed until 22/05/2007
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Reasons for adding or updating:
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Change to section 4.4 - Special warnings and precautions for Use
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Change to section 4.8 - Undesirable Effects
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| Date of revision of text on the SPC: 02/2007 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Section 4.4 (Special earnings and precautions for use) - 'For patients who experience progressive anorexia, asthenia and weight decrease within a relatively short period of time, a general medical evaluation including liver function should be considered.' has been added.
Section 4.8 (Undesirable effects) - The following have been added to this section; Colitis. Skin, hair, beard and nail discolourations. Hepatitis with mainly cholestatic features.
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Updated on 29/11/2006 and displayed until 21/05/2007
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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: 04/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Omitted brackets have been included at the end of section 4.8
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Updated on 06/11/2006 and displayed until 29/11/2006
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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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| Date of revision of text on the SPC: 04/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 10 Date of revision of the text
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Updated on 08/04/2005 and displayed until 06/11/2006
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 04/04/2005 and displayed until 08/04/2005
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Reasons for adding or updating:
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Correction of spelling/typing errors
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Updated on 24/03/2005 and displayed until 04/04/2005
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Reasons for adding or updating:
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Change to section 4.8 - Undesirable Effects
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Updated on 08/12/2003 and displayed until 24/03/2005
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Reasons for adding or updating:
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Change to section 4.3 - Contra-indications
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.8 - Undesirable Effects
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Change to section 5.1 - Pharmacodynamic Properties
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Change to section 9 - Date of Renewal of Authorisation
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Change to section 10 (date of (partial) revision of the text
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Updated on 22/10/2002 and displayed until 08/12/2003
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Reasons for adding or updating:
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Change to section 4.4 - Special Warnings and Precautions for Use
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Change to section 4.8 - Undesirable Effects
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Updated on 25/06/2002 and displayed until 22/10/2002
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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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