Efexor XL 75 mg hard prolonged release capsules
*Company:
Upjohn EESVStatus:
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 27 July 2023
File name
ie-pl-se0936 - clean MT LENC-CLEAN PRAC.pdf
Reasons for updating
- Change to section 2 - what you need to know - warnings and precautions
- Change to section 2 - interactions with other medicines, food or drink
- Change to section 3 - overdose, missed or forgotten doses
- Change to section 6 - manufacturer
- Change to section 6 - date of revision
Updated on 27 July 2023
File name
ie-smpc-se0936- 75mg-PRAC-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 4.9 - Overdose
- 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 14 July 2023
File name
Patient Information Leaflet - 002896904 clean MT LENC.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 24 August 2022
File name
DEC202209897-V_Reg SPC EF 75mg 23_1 IE - clean.pdf
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
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 7 - Pfizer Healthcare Ireland changed to Viatris Healthcare Limited as the MAH, with updated address
Section 8 - updated with new PA number for Viatris Healthcare Limited
Updated on 24 August 2022
File name
DEC202209897-V_Reg PIL EF 22_1 IE - clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - date of revision
Updated on 03 March 2022
File name
DEC202112459-V_Reg PIL EF 20_1 IE - clean.pdf
Reasons for updating
- Change to Section 1 - what the product is
- Change to section 2 - excipient warnings
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
Updated on 29 April 2021
File name
Reg PIL EF 19_3 IE -Clean.pdf
Reasons for updating
- Change to section 6 - date of revision
Updated on 06 April 2021
File name
DEC202104643-V_Reg SPC EF 75mg 21_2 IE Clean.pdf
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 06 April 2021
File name
DEC202104643-V_Reg PIL EF 19_2 IE Clean.pdf
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 06 October 2020
File name
DEC202048365-V_Reg SPC EF 75mg 20_1 IE Clean.pdf
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 06 October 2020
File name
DEC202048365-V_Reg PIL EF 16_1 IE Clean.pdf
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 08 July 2020
File name
Reg PIL EF 15_0 IE Clean.pdf
Reasons for updating
- Change to section 6 - marketing authorisation holder
Updated on 21 February 2020
File name
DEC202011241_Reg SPC EF 75mg 19_1 IE - Clean.pdf
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
|
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
File name
DEC202011241_Reg PIL EF 14_1 IE -Clean.pdf
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 6 - date of revision
Updated on 14 August 2019
File name
DEC201939401_Reg PIL EF 13_0 IE Clean .pdf
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
File name
DEC201939401_Reg SPC EF 75mg 18_0 IE Clean.pdf
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
File name
Reg SPC EF 75mg 17_0 IE.pdf
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
File name
Reg_SPC_EF_75mg_17_0_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 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
File name
Reg PIL EF 12_1 IE_clean.pdf
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
File name
Reg_SPC_EF_75mg_16_1_IE_clean.docx
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 09 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 09 March 2018
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 09 March 2018
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 08 July 2016
File name
PIL_9968_945.pdf
Reasons for updating
- New PIL for new product
Updated on 24 June 2016
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 24 June 2016
Reasons for updating
- Change to section 4.8 - Undesirable effects
Free text change information supplied by the pharmaceutical company
Updated on 09 February 2016
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 09 February 2016
Reasons for updating
- Change to section 9 - Date of renewal of authorisation
Free text change information supplied by the pharmaceutical company
Updated on 01 February 2016
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 01 February 2016
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
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
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
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
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 02 October 2013
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 02 October 2013
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 07 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 07 February 2013
Reasons for updating
- New individual SPC (was previously included in combined SPC)