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Efexor XL 150 mg hard prolonged release capsules *
Pharmacy Only: Prescription

  • Company:

    Upjohn EESV

  • Status:

    No Recent Update

  • Legal Category:

    Product subject to medical prescription which may not be renewed (A)

  • Active Ingredient(s):

    Venlafaxine Hydrochloride

    *Additional information is available within the SPC or upon request to the company

Updated on 24 August 2022

File name

63062803c5fbd.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

630627f0e0129.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder
  • Change to section 6 - date of revision

Updated on 23 September 2021

File name

DEC202112459-V_Reg SPC EF 150mg 24_1 IE - clean_1632401261.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)

Free text change information supplied by the pharmaceutical company

The SPC has been updated as follows: Section 4.4 Special Warnings and precautions for use – addition of sodium warning.

Updated on 23 September 2021

File name

DEC202112459-V_Reg PIL EF 20_1 IE - clean_1632401224.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_1619701954.pdf

Reasons for updating

  • Change to section 6 - date of revision

Updated on 06 April 2021

File name

DEC202104643-V_Reg SPC EF 150mg 23_2 IE Clean_1617699311.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_1617699063.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 150mg 20_1 IE Clean_1601966816.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_1601966750.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_1594218281.pdf

Reasons for updating

  • Change to section 6 - marketing authorisation holder

Updated on 21 February 2020

File name

DEC202011241_Reg SPC EF 150mg 19_1 IE- Clean_1582281472.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_1582281416.pdf

Reasons for updating

  • Change to section 4 - possible side effects
  • Change to section 6 - date of revision

Updated on 13 August 2019

File name

DEC201939401_Reg PIL EF 13_0 IE Clean _1565710873.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 150mg 18_0 IE Clean_1565710911.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 150mg 17_0 IE_1543329370.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 27 November 2018

File name

Reg SPC EF 150mg 17_0 IE_1543329368.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_150mg_17_0_IE_clean_1535449172.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_SPC_EF_150mg_17_0_IE_clean.docx

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 30 May 2018

File name

Reg_SPC_EF_150mg_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 08 July 2016

File name

PIL_9968_945.pdf

Reasons for updating

  • New PIL for new product

Updated on 08 July 2016

Reasons for updating

  • Correction of spelling/typing errors

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

Re-assignment of frequency categories for the adverse drug reactions (ADRs) in Section 4.8

Updated on 23 June 2016

Reasons for updating

  • Change to side-effects
  • Change to date of revision

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

lease find attached an updated SPC for Efexor XL 37.5mg, 75mg and 150mg Capsules , the update is to add the ‘Date of last renewal’ to section 9 of the SPC and a change to the regulatory ref number from 12_0 to 12_1.

Updated on 01 February 2016

Reasons for updating

  • Change to section 4.4 - Special warnings and precautions for use
  • Change to section 4.6 - Pregnancy and lactation

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 effects

Updated on 29 January 2016

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to instructions about missed dose
  • Change to storage instructions
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to date of revision
  • Change to improve clarity and readability

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

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 21 January 2015

Reasons for updating

  • Change to date of revision
  • Addition of manufacturer

Updated on 11 August 2014

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

Updates to sections 4.4 & 4.5

Updated on 06 August 2014

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to drug interactions
  • Change to date of revision

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 27 September 2013

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

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

None provided

Updated on 04 February 2013

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 04 July 2012

Reasons for updating

  • Change to drug interactions
  • Change to date of revision

Updated on 09 March 2012

Reasons for updating

  • Correction of spelling/typing errors

Updated on 08 February 2012

Reasons for updating

  • Change to side-effects
  • Change to date of revision

Updated on 26 August 2011

Reasons for updating

  • Change to storage instructions
  • Change to date of revision
  • Change due to harmonisation of PIL
  • Introduction of new pack/pack size

Updated on 16 August 2011

Reasons for updating

  • Change of manufacturer
  • Change to warnings or special precautions for use
  • Change to date of revision

Updated on 13 January 2011

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation

Updated on 25 February 2009

Reasons for updating

  • Change due to harmonisation of patient information leaflet

Updated on 03 June 2008

Reasons for updating

  • Change to warnings or special precautions for use

Updated on 08 January 2008

Reasons for updating

  • Change to, or new use for medicine
  • Change to warnings or special precautions for use
  • Addition of joint PIL covering all presentations
  • Change to dosage and administration

Updated on 25 October 2007

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to storage instructions

Updated on 20 February 2007

Reasons for updating

  • Correction of spelling/typing errors

Updated on 11 September 2006

Reasons for updating

  • Improved electronic presentation
  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Correction of spelling/typing errors
  • Change to date of revision
  • Change to instructions about overdose
  • Change to storage instructions

Updated on 29 June 2006

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to date of revision

Updated on 27 June 2005

Reasons for updating

  • New PIL for medicines.ie