Summary of Product Characteristics
last updated on the eMC:
12/09/2008
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 12/09/2008 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 4.4 - 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 4.8 - Undesirable Effects
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Change to section 6. 4 - Special Precautions for Storage
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Change to section 6. 5 - Nature and Contents of Container
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Change to section 2 - Qualitative and quantitative composition
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Change to section 4.3 - Contraindications
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Change to section 4.6 - Pregnancy and Lactation
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Change to section 6.1 - List of Excipients
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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-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 2 – quantitative and qualitative composition
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Addition of information that lactose is an excipient
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Change to section 4.1 – Therapeutic Indications
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‘Drug’ now referred to as ‘medicinal product’ throughout the SPC
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Change to section 4.2 – Posology and |Method of Administration
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Safety statement referring to children under 6 moved to beginning of section 4.2
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Change to section 4.3 – Contra-indications
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Minor text changes
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Change to section 4.4 – Special Warnings and Precautions for Use
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Removal of reference to patients with renal or hepatic inpairtment’
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Change to section 4.5 –Interaction with other medicinal products and other forms of interaction
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Minor text changes
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Change to section 4.6 – Pregnancy and Lactation
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Minor text changes
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Change to section 4.7 - Effects on Ability to Drive and Use Machines
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Minor text changes
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Change to section 4.8 – Undesirable effects
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Change in order of undesirable effects according to frequency of reporting
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Change to section 6.1 – List of Excipients
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Minor text changes
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Change to section 6.4 – Special Precautions for Storage
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Addition of ‘in order to protect from moisture’
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Change to section 6.5 – Nature and Contents of Container
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Addition of ‘silica gel’
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Change to section 10 – Date of revision of the text
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Change to 4th September 2008
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Updated on 04/08/2008 and displayed until 12/09/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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Change to section 10 date of revision of the text
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| Date of revision of text on the SPC: 29-Jul-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 7 – Marketing Authorisation Holder
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Updated to High Wycombe address
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Change to section 10 – Date of revision of the text
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Updated to 29th July 2008
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Updated on 18/07/2007 and displayed until 04/08/2008
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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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Change to section 10 date of revision of the text
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Change to joint SPC covering all presentations
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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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Change to section 4.4 – Special Warnings and Precautions for Use
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Addition of mania/aggression sub-headings & text
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Change to section 4.8 – Undesirable effects
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Major revision to update to 2005 SPC guidance
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Change to section 10 – Date of revision of the text
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Changed to 20th June 2007
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Change to separate SPCs covering individual presentations
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Updated on 12/03/2007 and displayed until 18/07/2007
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Reasons for adding or updating:
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