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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: 21/07/2011
SPC Aricept Tablets

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 21/07/2011 and displayed until Current
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:
  • Introduction of new pack/pack size
Date of revision of text on the SPC:   12-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Old SPC which was retired in error
Updated on 21/07/2010 and displayed until 27/07/2010
Reasons for adding or updating:
  • Change to section 10 date of revision of the text
  • Change to MA holder contact details
  • SPC Submitted in error
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
Change to address of MA holder
Updated on 28/05/2009 and displayed until 21/07/2010
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:   12-May-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 6.5:

Addition of 14 pack size

Section 10:

Change to 12th May 2009
Updated on 09/04/2009 and displayed until 28/05/2009
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   09-Mar-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
Section 7:
MAH address has been changed

Section 10:
Date of revision has been updated to 9th March 2009
Updated on 13/04/2007 and displayed until 09/04/2009
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6.1 - List of Excipients
  • 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:   01/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2: Information on the quantity of lactose/film coated tablet has been added ie 87.17 mg for 5mg tablet & 174.33 for 10mg tablet

 

Section 4.4:

 

The following sentence has been added: " This medicinal product contains lactose."

 

Two paragraphs of information have been added under the heading of "Mortality in Vascular Dementia Clinical Trials". The first paragraph gives information on mortality rates in 3 separate clinical trials conducted in individuals with probable or possible vascular dementia. The second paragraph gives information on mortality rates in pooled Alzheimer's disease and vascular dementia studies.

 

Section 4.8:

 

Information has been added on the following frequencies in wording above the table: very common, very rare and not known

 

In the table, the following adverse reactions have moved from "common" to "very common": diarhhoea, nausea & headache

 

Section 6.1: "hydroxypropyl cellulose" has changed to "hyprolose"

 

Sectio 9: The Date of last renewal has been added ie 10th January 2007

 

Section 10: This has been updated to 10th January 2007
Updated on 23/08/2006 and displayed until 13/04/2007
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
Date of revision of text on the SPC:   05/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company

Section 2 Reworded but factual information unchanged

Section 3 Minor rewording factual information unchanged

Section 4.2 Posology and method of administration

Addition of paragraph (transferred from section 4.4):

Deletion of: There is no evidence of a rebound effect after abrupt discontinuation of therapy.

Section 4.3 Contraindications 
Deletion of:                  ARICEPT is contraindicated in pregnancy.

Section 4.4 Special warnings and special precautions for use

Deletion of paragraph which has been transferred to section 4.2

Addition of: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.

Section 4.6 Pregnancy and lactation

Pregnancy: section revised

Lactation: Addition of : Donepezil is excreted in the milk of rats.
Section4.7 Effects on ability to drive and use machines Section modified.

Section 5.1 Pharmacodynamic properties

Change of pharmacotherapeutic group to anti-dementia drugs; anticholinesterase; ATC-code N06DA02.

Minor change of wording in second paragraph (which to that)

Section 5.2 Pharmacokinetic properties

Deletion from heading of  'general characteristics'

Change of sentence as shown below in second last paragraph (change in bold): The pharmacokinetics of donepezil has not been formally studied in healthy elderly subjects or in Alzheimer’s or vascular dementia patients.

Section 5.3 Preclinical Safety Data Deletion of the word ‘above’ in the cross references to other sections

Section 6.1 List of excipients Change to layout of section

Section 6.5 Nature and contents of container

Pack sizes added: 7 tablets, 84 tablets 

Change of blister description 

Section 6.6 Section heading updated
Updated on 17/08/2006 and displayed until 23/08/2006
Reasons for adding or updating:
  • Change to section 2 - qualitative and quantitative composition
  • Change to section 3 - pharmaceutical form
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.3 - Contra-indications
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 4.6 - Pregnancy and Lactation
  • Change to section 4.7 - Effects on Ability to Drive and Use Machines
  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 5.3 - Preclinical Safety Data
  • Change to section 6.1 - List of Excipients
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instruction for Use/Handling
  • Change to section 10 (date of (partial) revision of the text
  • Pending awaiting re-submission
Date of revision of text on the SPC:   05/2006
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
  Section 2 Reworded but factual information unchanged
Section 3 Minor rewording factual information unchanged
Section 4.2 Posology and method of administration
Addition of paragraph (transferred from section 4.4):
Deletion of: There is no evidence of a rebound effect after abrupt discontinuation of therapy.
Section 4.3 Contraindications 
Deletion of:                         ARICEPT is contraindicated in pregnancy.
Section 4.4 Special warnings and special precautions for use
Deletion of paragraph which has been transferred to section 4.2
Addition of: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Section 4.6 Pregnancy and lactation
Pregnancy: section revised
Lactation: Addition of : Donepezil is excreted in the milk of rats.
Section4.7 Effects on ability to drive and use machinesSection modified. 
Section 5.1 Pharmacodynamic properties
Change of pharmacotherapeutic group to anti-dementia drugs; anticholinesterase; ATC-code N06DA02.
Minor change of wording in second paragraph (which to that)
 Section 5.2 Pharmacokinetic properties
Deletion from heading of  'general characteristics'
 Change of sentence as shown below in second last paragraph (change in bold) : The pharmacokinetics of donepezil has not been formally studied in healthy elderly subjects or in Alzheimer’s or vascular dementia patients.
Section 5.3 Preclinical Safety Data Deletion of the word ‘above’ in the cross references to other sections
Section 6.1 List of excipients Change to layout of section
 Section 6.5 Nature and contents of containerPack sizes added:  7 tablets, 84 tablets 
 Section 6.5 Nature and contents of container  Change of blister description          

 

 
Updated on 23/04/2002 and displayed until 17/08/2006
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
Updated on 04/04/2002 and displayed until 23/04/2002
Reasons for adding or updating:
  • Change to section 4.5 - Interactions with other Medicaments and other forms of Interaction
  • Change to section 4.8 - Undesirable Effects
  • Change to section 10 (date of (partial) revision of the text
Updated on 29/11/2001 and displayed until 04/04/2002
Reasons for adding or updating:
  • Change to section 4.2 - Posology and Method of Administration
  • Change to section 4.4 - Special Warnings and Precautions for Use
  • Change to section 5.2 - Pharmacokinetic Properties
Updated on 21/08/2001 and displayed until 29/11/2001
Reasons for adding or updating:
  • Change to section 5.1 - Pharmacodynamic Properties
Updated on 22/01/2001 and displayed until 21/08/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 12/07/2000 and displayed until 22/01/2001
Reasons for adding or updating:
  • No reasons supplied
Updated on 24/03/2000 and displayed until 12/07/2000
Reasons for adding or updating:
  • No reasons supplied
Updated on 06/09/1999 and displayed until 24/03/2000
Reasons for adding or updating:
  • No reasons supplied

Active Ingredients/Generics

 
  donepezil hydrochloride