Summary of Product Characteristics
last updated on the eMC:
02/05/2012
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 02/05/2012 and displayed until Current
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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: 30-Apr-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Please see changes hightlighted below in red:
4.8. Undesirable effects
There have been reports of decreased bone mineral density, osteopenia, osteoporosis and fractures in patients on long term therapy with phenytoin. The mechanism by which phenytoin affects bone metabolism has not been identified.
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Updated on 19/04/2012 and displayed until 02/05/2012
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Reasons for adding or updating:
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Change of Marketing Authorisation Holder
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| Date of revision of text on the SPC: 30-Mar-2012 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Please note changes below highlighted in red:
7. MARKETING AUTHORISATION HOLDER
Alliance Pharmaceuticals Ltd
Avonbridge House
Bath Road
Chippenham
Wiltshire
SN15 2BB
UK
8. MARKETING AUTHORISATION NUMBER
PL 16853/0129
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Updated on 29/09/2008 and displayed until 19/04/2012
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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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| Date of revision of text on the SPC: 09-Sep-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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The following additonal text added into Sec 4.4
Suicidal ideation and behaviour have been reported in patients treated with anti-epileptic agents in several indications. A meta-analysis of randomised placebo controlled trials of anti-epileptic drugs has also shown a small increased risk of suicidal ideation and behaviour. The mechanism of this risk is not known and the available data do not exclude the possibility of an increased risk for phenytoin.
Therefore, patients should be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. Patients and caregivers of patients) should be advised to seek medical advice should signs of suicidal ideation or behaviours emerge.
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Updated on 12/06/2008 and displayed until 29/09/2008
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Reasons for adding or updating:
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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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