ARICEPT 5 mg film coated tablets *

  • Company:

    Pfizer Healthcare Ireland
  • Status:

    No Recent Update
  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)
  • Active Ingredient(s):

    *Additional information is available within the SPC or upon request to the company

When a pharmaceutical company changes any document, 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 23 January 2020

File name

DEC202003778_Reg PIL AR 24_1 IE clean_1579767962.pdf

Reasons for updating

  • Removal/change of distributor

Updated on 02 August 2018

File name

Reg PIL AR 23_0 IE-clean_1533206985.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to other sources of information section

Updated on 19 July 2018

File name

Reg_SPC_AR_26_0_5mg_IE_clean.pdf

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.5 - Nature and contents of container

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 2 and 6.5 together with editorial in other sections

Updated on 22 May 2018

File name

Reg_SPC_AR_26_0_5mg_IE_clean.docx

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.8 – Undesirable effects - how to report a side effect
  • Change to section 4.9 - Overdose
  • 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 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container
  • Change to section 7 - Marketing authorisation holder
  • Change to section 10 - Date of revision of the text

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 2 and 6.5 together with editorial in other sections

Updated on 18 May 2018

File name

Reg PIL AR 22_1 IE-clean.pdf

Reasons for updating

  • Change to section 3 - how to take/use
  • Change to section 4 - possible side effects
  • Change to section 6 - what the product contains
  • Change to section 6 - what the product looks like and pack contents
  • Change to other sources of information section

Updated on 14 March 2018

Reasons for updating

  • New SPC for new product

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 14 March 2018

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

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 6.3 and 6.5.

Updated on 14 March 2018

Reasons for updating

  • Change to section 6.3 - Shelf life
  • Change to section 6.5 - Nature and contents of container

Free text change information supplied by the pharmaceutical company

The SPC has been updated as Follow:
The SPC has been updated in section 6.3 and 6.5.

Updated on 28 November 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form

Free text change information supplied by the pharmaceutical company

The SPC has been updated as Follow:

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

Updated on 28 November 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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 3, tablet description change of ‘embossed’ to ‘debossed’

Updated on 27 November 2017

File name

PIL_8783_810.pdf

Reasons for updating

  • New PIL for new product

Updated on 03 November 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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 03 November 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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 October 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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 October 2017

Reasons for updating

  • Change to section 3 - Pharmaceutical form

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 December 2016

Reasons for 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

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 16 December 2016

Reasons for 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

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 February 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

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 06 February 2013

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

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 August 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Addition of Abnormal Dreams and Nightmares to Section 4.8 of the SPC

Updated on 19 August 2011

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Legal category:Product subject to medical prescription which may not be renewed (A)

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 June 2009

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

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 10 June 2009

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 10 - Date of revision of the text

Legal category:Product subject to medical prescription which may not be renewed (A)

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 February 2009

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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 25 February 2009

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

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 April 2007

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

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 03 April 2007

Reasons for 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

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 August 2006

Reasons for 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

Legal category:Product subject to medical prescription which may not be renewed (A)

Free text change information supplied by the pharmaceutical company

This will be added later
 
 
                                                      

Updated on 21 August 2006

Reasons for 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

Free text change information supplied by the pharmaceutical company

This will be added later
 
 
                                                      

Updated on 12 June 2006

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 12 June 2006

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Updated on 24 January 2006

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 24 January 2006

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

Updated on 05 August 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 05 August 2005

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Updated on 29 July 2004

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Legal category:Product subject to medical prescription which may not be renewed (A)

Updated on 29 July 2004

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

Updated on 27 June 2003

Reasons for updating

  • New SPC for medicines.ie

Legal category:Product subject to medical prescription which may not be renewed (A)