Summary of Product Characteristics
last updated on the eMC:
02/11/2010
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 02/11/2010 and displayed until Current
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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 4.1 - Therapeutic indications
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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 5.2 - Pharmacokinetic Properties
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Change to section 6.1 - List of Excipients
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Change to section 6. 3 - Shelf Life
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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: 20-Sep-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| The name of the product has changed from Frumil to Frumil 40 mg/5 mg Tablets and from Frumil LS to Frumil LS 20 mg/2.5 mg Tablets, which has resulted in a change to a number of SPC sections.
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Updated on 17/08/2010 and displayed until 02/11/2010
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Reasons for adding or updating:
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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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| Date of revision of text on the SPC: 27-Jul-2010 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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Change to section 4.8- undesirable effects to bring the SPC in line with the CCDS- to add two new undesirable effects. The following text has been added: Stevens-Johnson Syndrome, toxic epidermal necrolysis.
Section 10: revision date changed to 27/07/2010
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Updated on 01/12/2009 and displayed until 17/08/2010
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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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| Date of revision of text on the SPC: 26-Oct-2009 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Type II variation to add a precaution regarding concomitant treatment with risperidone to section 4.4 (special warnings) of the SPC in line with the Company Core Safety Information (CCSI). Hence also subsequent change to section 4.5:
4.4: Concomitant use with risperidone- the following text has been added under this section;
In risperidone placebo-controlled trials in elderly patients with dementia, a higher incidence of mortality was observed in patients treated with furosemide plus risperidone (7.3%; mean age 89 years, range 75-97 years) when compared to patients treated with risperidone alone (3.1%; mean age 84 years, range 70-96 years) or furosemide alone (4.1%; mean age 80 years, range 67-90 years). Concomitant use of risperidone with other diuretics (mainly thiazide diuretics used in low dose) was not associated with similar findings.
No pathophysiological mechanism has been identified to explain this finding, and no consistent pattern for cause of death observed. Nevertheless, caution should be exercised and the risks and benefits of this combination or co-treatment with other potent diuretics should be considered prior to the decision to use. There was no increased incidence of mortality among patients taking other diuretics as concomitant treatment with risperidone. Irrespective of treatment, dehydration was an overall risk factor for mortality and should therefore be avoided in elderly patients with dementia (see section 4.3 Contraindications).
4.5: The following text has been added under this section;
Risperidone: Caution should be exercised and the risks and benefits of the combination or co-treatment with furosemide or with other potent diuretics should be considered prior to the decision to use. See section 4.4 Special warnings and precautions for use regarding increased mortality in elderly patients with dementia concomitantly receiving risperidone.
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Updated on 11/09/2008 and displayed until 01/12/2009
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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: 18-Jun-2008 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| In section 4.8 (undesirable effects): Addition of hepatic encephalopathy and bullous pemphigoid as side effects.
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Updated on 18/09/2007 and displayed until 11/09/2008
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 12/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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| Section 7 (Market Authorisation Holder): change to sanofi-aventis.
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Updated on 22/08/2006 and displayed until 18/09/2007
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Reasons for adding or updating:
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Change to section 7 - Marketing Authorisation Holder
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| Date of revision of text on the SPC: 06/2006 |
| Legal Category: POM |
| Black Triangle (CHM):
NO |
Free-text change information supplied by the pharmaceutical company
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There has been a change of MA holder.
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Updated on 20/09/2005 and displayed until 22/08/2006
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Reasons for adding or updating:
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Change from BAN to rINN
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Change to section 10 (date of (partial) revision of the text
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Updated on 03/10/2003 and displayed until 20/09/2005
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Reasons for adding or updating:
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Improved Electronic Presentation
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Updated on 28/08/2001 and displayed until 03/10/2003
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Reasons for adding or updating:
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Transferred from eMC version 1
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