Efexor XL 75 mg hard prolonged release capsules

  • Name:

    Efexor XL 75 mg hard prolonged release capsules

  • Company:
    info
  • Active Ingredients:

    venlafaxine hydrochloride

  • Legal Category:

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

Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 14/08/19

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Summary of Product Characteristics last updated on medicines.ie: 13/8/2019

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Pfizer Healthcare Ireland

Pfizer Healthcare Ireland

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1 - 0 of 227 items.Total: Infinity pages

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 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 SmPC

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 SmPC

Reasons for updating

  • Improved presentation of SmPC

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 SmPC

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 SmPC

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 SmPC

Reasons for updating

  • New SmPC for new product

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

Updated on 9 March 2018 SmPC

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

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

Updated on 24 June 2016 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

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

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

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 9 February 2016 SmPC

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 1 February 2016 SmPC

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 effects

Updated 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 effects

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 26 January 2015 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

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 SmPC

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 SmPC

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

None provided

Updated on 7 February 2013 SmPC

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