ARICEPT 10 mg film coated tablets
*Company:
Pfizer Healthcare IrelandStatus:
No Recent UpdateLegal 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
Updated on 29 February 2024
File name
Reg SPC AR 28_2 10mg IE clean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.8 - Undesirable effects
- Change to section 10 - Date of revision of the text
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 17 January 2023
File name
RegSPCAR28110mgIEclean.pdf
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- 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
- 4.2 Posology and method of administration- additiona of text to method of adminstration
- 4.8 Undesirable effects- Addition of Libido increased, Hypersexuality to Psychiatric disorders and addition of Pleurothotonus (Pisa syndrome) to nervous system disorders.
Updated on 16 November 2022
File name
Reg SPC AR 27_0 10mg IE clean.pdf
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.8 - Undesirable effects
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 03 November 2022
File name
IE PIL 27_1.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 23 January 2020
File name
DEC202003778_Reg PIL AR 24_1 IE clean.pdf
Reasons for updating
- Removal/change of distributor
Updated on 02 August 2018
File name
Reg PIL AR 23_0 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 19 July 2018
File name
Reg SPC AR 26_0 10mg 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 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 18 May 2018
File name
Reg_SPC_AR_26_0_10mg_IE_clean.docx
Reasons for updating
- New SPC for new product
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 18 May 2018
File name
Reg_SPC_AR_26_0_10mg_IE_clean.docx
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 18 May 2018
File name
Reg_SPC_AR_26_0_10mg_IE_clean.docx
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 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 in section 6.3 and 6.5.
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:
Updated on 27 November 2017
File name
PIL_8783_810.pdf
Reasons for updating
- New PIL for new product
Updated on 27 November 2017
Reasons for updating
- Correction of spelling/typing errors
- Change to section 6 - what the product looks like and pack contents
- Change to section 6 - date of revision
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
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
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 6.6Updated on 15 December 2016
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - pregnancy, breast feeding and fertility
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
- Improved presentation of PIL
Updated on 08 October 2014
Reasons for updating
- Change of manufacturer
- Change to date of revision
Updated on 06 February 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Legal category:Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 31 January 2013
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 16 August 2011
Reasons for updating
- Change to side-effects
- Change to date of revision
Updated on 19 November 2008
Reasons for updating
- Change due to user-testing of patient information
Updated on 05 April 2007
Reasons for updating
- Change of active ingredient
- Change of inactive ingredient
Updated on 21 August 2006
Reasons for updating
- Improved electronic presentation
Updated on 05 August 2005
Reasons for updating
- Change of licence holder
Updated on 14 September 2004
Reasons for updating
- New PIL for medicines.ie