Summary of Product Characteristics
last updated on the eMC:
23/03/2011
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 23/03/2011 and displayed until Current
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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 4.5 - Interaction with other medicinal products and other forms of interaction
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Change to section 4.9 - Overdose
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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: 22-Feb-2011 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| - To update section 4.4 (Special warnings) of the SPC in line with the brand leader Amitriptyline Hydrochloride, and Martindale, by including the risk of suicidal thoughts and behaviour at the start of treatment.
- To update section 4.5 (Interactions) of the SPC adding "Antifungals: Increased serum concentrations have occurred in patients also taking fluconazole. Serious adverse effects have been reported due to increased amitriptyline plasma concentration." This brings the section in line with the current literature in Martindale and Stockleys.
- To update section 4.9 of the SPC (Overdose) in line with the CCSI.
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Updated on 22/09/2010 and displayed until 23/03/2011
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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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| Date of revision of text on the SPC: |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| None provided |
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