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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
Summary of Product Characteristics last updated on medicines.ie: 19/08/2011
SPC ARICEPT TABLETS 5MG, 10MG

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 19/08/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable effects
Date of revision of text on the SPC:   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