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Pfizer Healthcare Ireland

9 Riverwalk, National Digital Park, Citywest Business Campus, Dublin 24,
Telephone: +353 1 467 6500
Fax: +353 1 467 6501
Medical Information Direct Line: 1 800 633 363
Medical Information Website: http://www.pfizermedicalinformation.ie
Summary of Product Characteristics last updated on medicines.ie: 03/11/2017
SPC ARICEPT 5 mg film coated tablets

When a pharmaceutical company changes an SPC or PIL, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.

Updated on 03/11/2017 and displayed until Current
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Dec-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated in section 3, tablet description change of ‘embossed’ to ‘debossed’

Updated on 02/10/2017 and displayed until 03/11/2017
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
Date of revision of text on the SPC:   01-Sep-2017
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated in section 3, tablet description change of ‘embossed’ to ‘debossed’

Updated on 16/12/2016 and displayed until 02/10/2017
Reasons for adding or updating:
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.1 - Therapeutic indications
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • 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 4.8 - Undesirable effects
  • Change to section 5.1 - Pharmacodynamic properties
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 6.1 - List of excipients
  • Change to section 6.6 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   01-Dec-2016
Legal Category:   Product subject to medical prescription which may not be renewed (A)

Free-text change information supplied by the pharmaceutical company



The SPC has been updated as Follow:

The SPC has been updated in section 2, 3, 4.1, 4.2, 4.3, 4.4, 4.6, 4.7, 4.8, 5.1, 5.2, 6.1 and 6.6
Updated on 06/02/2013 and displayed until 16/12/2016
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   01-Jan-2013
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



section 4.4 – addition of information regarding Neuroleptic malignant syndrome, detailing signs and symptoms that may require discontinuation of treatment

Section 4.8 – addition of very rare side effect: Neuroleptic malignant syndrome

Updated on 19/08/2011 and displayed until 06/02/2013
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   04-Aug-2011
Legal Category:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company

Addition of Abnormal Dreams and Nightmares to Section 4.8 of the SPC
Updated on 10/06/2009 and displayed until 19/08/2011
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:   Product subject to restricted prescription (C)

Free-text change information supplied by the pharmaceutical company



Section 6.5 – updated to include pack size of 14

Section 10 – Date of revision updated

Updated on 25/02/2009 and displayed until 10/06/2009
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Date of revision of text on the SPC:   02/2009
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

Update to Section 6.5: Nature and contents of the container - Addition of alternative pack size of 112 tablets

Updated on 03/04/2007 and displayed until 25/02/2009
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 5.1 - Pharmacodynamic properties
  • Change to section 6.1 - List of excipients
Date of revision of text on the SPC:   03/2007
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

 
Section 2 Correct quantities of lactose per tablet added.

Section 4.4 Following statement added: This medicinal product contains lactose. Information on Mortality in Vascular Dementia Clinical Trials added.

Section 4.8 Section updated to comply with legislation.

Section 5.1 Response statement updated.

Section 6.1 Hyprolose replaces hydroxypropyl cellulose.

Updated on 21/08/2006 and displayed until 03/04/2007
Reasons for adding or updating:
  • Change to section 3 - Pharmaceutical form
  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 2 - Qualitative and quantitative composition
  • 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 - Special precautions for disposal and other handling
Date of revision of text on the SPC:   06/2006
Legal Category:   prescription only

Free-text change information supplied by the pharmaceutical company

This will be added later
 
 
                                                      
Updated on 12/06/2006 and displayed until 21/08/2006
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 24/01/2006 and displayed until 12/06/2006
Reasons for adding or updating:
  • Change to section 6.5 - Nature and contents of container
Updated on 05/08/2005 and displayed until 24/01/2006
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 29/07/2004 and displayed until 05/08/2005
Reasons for adding or updating:
  • Change to section 7 - Marketing authorisation holder
Updated on 27/06/2003 and displayed until 29/07/2004
Reasons for adding or updating:
  • New SPC for medicines.ie

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Active Ingredients

 
   Donepezil Hydrochloride