ARICEPT 5 mg film coated tablets
- Name:
ARICEPT 5 mg film coated tablets
- Company:
Pfizer Healthcare Ireland
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may not be renewed (A)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 02/08/18
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Pfizer Healthcare Ireland
Company Products
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 2 August 2018 PIL
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 SmPC
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 SmPC
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 PIL
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 SmPC
Reasons for updating
- New SmPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 14 March 2018 SmPC
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 PIL
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 PIL
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 28 November 2017 SmPC
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 PIL
Reasons for updating
- New PIL for new product
Updated on 3 November 2017 SmPC
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 3 November 2017 PIL
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 2 October 2017 PIL
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 2 October 2017 SmPC
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 SmPC
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 PIL
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 6 February 2013 PIL
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 6 February 2013 SmPC
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 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Updated on 19 August 2011 SmPC
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 10 June 2009 PIL
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 SmPC
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 SmPC
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 PIL
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 3 April 2007 SmPC
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 3 April 2007 PIL
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 SmPC
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 PIL
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 PIL
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Updated on 12 June 2006 SmPC
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 SmPC
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 PIL
Reasons for updating
- Change to section 6.5 - Nature and contents of container
Updated on 5 August 2005 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Updated on 5 August 2005 SmPC
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 SmPC
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 PIL
Reasons for updating
- Change to section 7 - Marketing authorisation holder
Updated on 27 June 2003 SmPC
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 PIL
Reasons for updating
- New SPC for medicines.ie