Summary of Product Characteristics
last updated on the eMC:
21/12/2011
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 21/12/2011 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 10 date of revision of the text
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| Date of revision of text on the SPC: 12-Jul-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In Section 4.2 The following section has changed to read:
The last doses should, in general, not be given within 4 hours before bedtime in order to prevent disturbances in falling asleep.However, if the effect of the medicinal product wears off too early in the evening, disturbed behaviour may recur. A small evening dose may help to solve this problem.The pros and cons of a small evening dose versus disturbances in falling asleep should be considered.
In Section 4.4 the following wording has been added to the end of the "aggressive or hostile behaviour" section:
...., bearing in mind that upwards or downwards titration may be appropriate . Treatment interruption can be considered.
In Section 10 the revised date is 12th July 2011
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Updated on 24/06/2010 and displayed until 21/12/2011
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Reasons for adding or updating:
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Change to section 1 -Name of the Medicinal product
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Change to section 2 - Qualitative and quantitative composition
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Change to section 3 - Pharmaceutical form
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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 4.6 - Pregnancy and Lactation
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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 4.9 - Overdose
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Change to section 5.3 - Preclinical Safety Data
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Change to section 9 - Date of first Authorisation/renewal of the Authorisation
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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: 03-Feb-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Changes to the SmPC
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Updated on 30/04/2007 and displayed until 24/06/2010
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Reasons for adding or updating:
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New SPC for new product
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SPC Submitted in error
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