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Eisai Ltd
European Knowledge Centre, Mosquito Way, Hatfield, Hertfordshire, AL10 9SN
Telephone: +44 (0)845 676 1400
Fax: +44 (0)845 676 1486
WWW: http://www.eisai.co.uk
Medical Information e-mail: Lmedinfo@eisai.net
Out of Hours Telephone: +44 (0)845 676 1400

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?
Summary of Product Characteristics last updated on the eMC: 09/02/2012
SPC Aricept Evess

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 09/02/2012 and displayed until Current
Reasons for adding or updating:
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Jan-2012
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
In section 6.5 wording or PVC/PE/PVdC/Aluminium foil added to the blister contents.
Updated on 21/07/2011 and displayed until 09/02/2012
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Date of revision of text on the SPC:   28-Jun-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Addition of nightmares and abnormal dreams to Section 4.8
Updated on 27/07/2010 and displayed until 21/07/2011
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to MA holder contact details
Date of revision of text on the SPC:   03-Jul-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Eisai address details updated
Updated on 15/04/2010 and displayed until 27/07/2010
Reasons for adding or updating:
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   26-Mar-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
The date of last renewal and date of revision of text has been amended to 26th March 2010
Updated on 21/12/2007 and displayed until 15/04/2010
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
Section 4.4 Special warnings and special precautions for use
 
Addition of:

 Mortality in Vascular Dementia Clinical Trials

Three clinical trials of 6 months duration were conducted studying individuals meeting the NINDS-AIREN criteria for probable or possible vascular dementia (VaD). The NINDS-AIREN criteria are designed to identify patients whose dementia appears to be due solely to vascular causes and to exclude patients with Alzheimer’s disease.  In the first study, the mortality rates were 2/198 (1.0%) on donepezil hydrochloride 5 mg, 5/206 (2.4%) on donepezil hydrochloride 10 mg and 7/199 (3.5%) on placebo.  In the second study, the mortality rates were 4/208 (1.9%) on donepezil hydrochloride 5 mg, 3/215 (1.4%) on donepezil hydrochloride 10 mg and 1/193 (0.5%) on placebo.  In the third study, the mortality rates were 11/648 (1.7%) on donepezil hydrochloride 5 mg and 0/326 (0%) on placebo.  The mortality rate for the three VaD studies combined in the donepezil hydrochloride group (1.7%) was numerically higher than in the placebo group (1.1%), however, this difference was not statistically significant.  The majority of deaths in patients taking either donepezil hydrochloride or placebo appear to result from various vascular related causes, which could be expected in this elderly population with underlying vascular disease.  An analysis of all serious non-fatal and fatal vascular events showed no difference in the rate of occurrence in the donepezil hydrochloride group relative to placebo.

 In pooled Alzheimer’s disease studies (n=4146), and when these Alzheimer’s disease studies were pooled with other dementia studies including the vascular dementia studies (total n=6888), the mortality rate in the placebo groups numerically exceeded that in the donepezil hydrochloride groups

 

Section 4.8 Undesirable effects

Addition of category

very common (> 1/10)

Addition of

 very rare (< 1/10000) and not known (cannot be estimated from available data).

 Moved from common to very common

Diarrhoea, nausea, headache 

Section 10 Date of revision of the text

            9th September 2007
Updated on 20/09/2007 and displayed until 21/12/2007
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   05/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 Section 6.3 - Shelf life
Shelf life was extended to 3 years
 
Section 10 - Date of revision of the text
This was changed to 18 May 2007
Updated on 22/01/2007 and displayed until 20/09/2007
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  donepezil hydrochloride