ARICEPT 5 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 17 January 2023
File name
RegSPCAR2815mgIEClean.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 5mg 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_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 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 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 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:
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
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 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 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 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 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 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 6.6Updated 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 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 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
Updated on 19 August 2011
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
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 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 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 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 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 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 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
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
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
Legal category:Product subject to medical prescription which may not be renewed (A)
Updated on 27 June 2003
Reasons for updating
- New SPC for medicines.ie