Efexor XL 75 mg hard prolonged release capsules
- Name:
Efexor XL 75 mg hard prolonged release capsules
- 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: 06/04/21
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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 6 April 2021 SPC
Reasons for updating
- 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
- Change to Section 4.8 – Undesirable effects - how to report a side effect
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC has been updated as follows:
Update to sections 4.4, 4.6 and 4.8 of the SmPC in line with the PRAC recommendation regarding Postpartum haemorrhage. Also ADR reporting details have been updated in section 4.8 of SmPC.
Updated on 6 April 2021 PIL
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
Updated on 6 October 2020 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.8 - Undesirable effects
- Change to section 5.1 - Pharmacodynamic properties
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
SPC has been updated as follows:
Information regarding discontinuation of treatment with Venlafaxine has been updated in following sections.
Section 4.2 Posology and method of administration.
Section 4.4 Special warnings and precautions for use.
Section 4.8 Undesirable effects
Section 5.1 Pharmacodynamic properties
Updated on 6 October 2020 PIL
Reasons for updating
- Change to section 1 - what the product is used for
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 4 - how to report a side effect
- Change to section 6 - date of revision
Updated on 8 July 2020 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 21 February 2020 SPC
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
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The SPC: Updated as follows, Section 4.8 has been updated with the addition of adverse drug reaction (ADR) ‘takotsubo cardiomyopathy’ to Section 4.8 “Undesirable effects” of the venlafaxine hydrochloride Summary of Product Characteristics (SmPC) in line with the company Core Data Sheet (CDS) for the above products. PIL has been updated accrodingly. |
Updated on 21 February 2020 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 August 2019 PIL
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 6 - date of revision
Updated on 13 August 2019 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 27 November 2018 SPC
Reasons for updating
- Improved presentation of SPC
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Improved presentation of SPC uploaded
Updated on 28 August 2018 SPC
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 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 as follows:
Section 4.4 – update to include reference to amphetamines
Section 4.5 – update to include reference to amphetamines
Section 10 – update Date of Revision of text 10 07/2018
Updated on 16 July 2018 PIL
Reasons for updating
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 6 - date of revision
Updated on 29 May 2018 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
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 follows:
Section 4.5 updated to included details of interaction with cytochrome P450 and oral contraceptives.
Updated on 9 March 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may not be renewed (A)
Updated on 9 March 2018 SPC
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- 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 as follows:
Section 5.1 updated with a new section ‘Cardiac electrophysiology’ to include detail of QT interval prolongation.
Section 4.4 updated to cross reference Section 5.1.
Section 4.9 updated to cross reference Section 5.1.
Section 5.1 – b.i.d. updated to ‘twice daily’.
Section 10 – Date of Revision of text updated to reflect approval date (03/2018). Ref number also updated.Updated on 9 March 2018 PIL
Reasons for updating
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.9 - Overdose
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Free text change information supplied by the pharmaceutical company
The SPC has been updated as follows:
Section 5.1 updated with a new section ‘Cardiac electrophysiology’ to include detail of QT interval prolongation.
Section 4.4 updated to cross reference Section 5.1.
Section 4.9 updated to cross reference Section 5.1.
Section 5.1 – b.i.d. updated to ‘twice daily’.
Section 10 – Date of Revision of text updated to reflect approval date (03/2018). Ref number also updated.Updated on 8 July 2016 PIL
Reasons for updating
- New PIL for new product
Updated on 24 June 2016 PIL
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Updated on 24 June 2016 SPC
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 9 February 2016 SPC
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updated on 9 February 2016 PIL
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
Updated on 1 February 2016 SPC
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- 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
QRD updates to most sections of the SPC
Section 4.6 - Addition of text on Fertility
Section 4.8 – Addition of reporting of side effectsUpdated on 1 February 2016 PIL
Reasons for updating
- Change to section 4.6 - Pregnancy and lactation
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
QRD updates to most sections of the SPC
Section 4.6 - Addition of text on Fertility
Section 4.8 – Addition of reporting of side effectsUpdated on 26 January 2015 SPC
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
Update to section 6.5 – Nature and contents of Container.
- Removal of PVC/Aclar/Aluminium foil from this section.
Update section 10 - Date of revision of text to January 2015.
Updated on 26 January 2015 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
Update to section 6.5 – Nature and contents of Container.
- Removal of PVC/Aclar/Aluminium foil from this section.
Update section 10 - Date of revision of text to January 2015.
Updated on 11 August 2014 SPC
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.4 - Special warnings and precautions for use
Legal category: Product subject to medical prescription which may not be renewed (A)
Free text change information supplied by the pharmaceutical company
Updates to sections 4.4 & 4.5
Updated on 11 August 2014 PIL
Reasons for updating
- Change to section 4.5 - Interaction with other medicinal products and other forms of interaction
- Change to section 4.4 - Special warnings and precautions for use
Free text change information supplied by the pharmaceutical company
Updates to sections 4.4 & 4.5
Updated on 2 October 2013 SPC
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
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 – Update to wording on Serotonin syndrome and abnormal bleeding
Section 4.5 - Update to wording on Serotonin syndrome
Updated on 2 October 2013 PIL
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
Free text change information supplied by the pharmaceutical company
Section 4.4 – Update to wording on Serotonin syndrome and abnormal bleeding
Section 4.5 - Update to wording on Serotonin syndrome
Updated on 7 February 2013 PIL
Reasons for updating
- New individual SPC (was previously included in combined SPC)
Free text change information supplied by the pharmaceutical company
Updated on 7 February 2013 SPC
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)