Efexor XL 37.5 mg hard prolonged release capsules

  • Name:

    Efexor XL 37.5 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: 13/08/19

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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 231 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 13 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 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 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 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 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 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 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 4.4 - 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 11 August 2014 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

Updates to sections 4.4 & 4.5

Updated on 3 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 3 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 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 – Inclusion of text on Drug laboratory test interactions
Section 4.8 – Addition of  ‘dyspnoea’ as an adverse drug reaction

Updated 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 – Inclusion of text on Drug laboratory test interactions
Section 4.8 – Addition of  ‘dyspnoea’ as an adverse drug reaction

Updated on 10 July 2012 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 “Special warnings and precautions for use”

Section 4.5 “Interaction with other medicinal products and other forms of interaction”

Updated on 10 July 2012 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 “Special warnings and precautions for use”

Section 4.5 “Interaction with other medicinal products and other forms of interaction”

Updated on 10 February 2012 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects

Free text change information supplied by the pharmaceutical company

Section 4.8  – Update to qualitative and quantitative description

Updated on 10 February 2012 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

Section 4.8  – Update to qualitative and quantitative description

Updated on 31 August 2011 PIL

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • 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 2 – Update to qualitative and quantitative description

Section 6.4 – Update to storage conditions

Section 6.5 – Inclusion of additional pack sizes

Section 10 – Date of revision

Updated on 31 August 2011 SmPC

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 6.4 - Special precautions for storage
  • 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 2 – Update to qualitative and quantitative description

Section 6.4 – Update to storage conditions

Section 6.5 – Inclusion of additional pack sizes

Section 10 – Date of revision

Updated on 22 August 2011 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Addition of the following text to Section 4.4 Special warnings and precautions for use –
Diabetes
In patients with diabetes, treatment with an SSRI or venlafaxine may alter glycaemic control. Insulin and/or oral antidiabetic dosage may need to be adjusted.

Updated on 22 August 2011 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)

Free text change information supplied by the pharmaceutical company

Addition of the following text to Section 4.4 Special warnings and precautions for use –
Diabetes
In patients with diabetes, treatment with an SSRI or venlafaxine may alter glycaemic control. Insulin and/or oral antidiabetic dosage may need to be adjusted.

Updated on 19 January 2011 SmPC

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • 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 7 - Marketing Authorisation Holder changed
Section 8 - Marketing Authorisation number changed
Section 10 - Date of revision of the text updated

Updated on 19 January 2011 PIL

Reasons for updating

  • Change to section 7 - Marketing authorisation holder
  • Change to section 8 - MA number
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 7 - Marketing Authorisation Holder changed
Section 8 - Marketing Authorisation number changed
Section 10 - Date of revision of the text updated

Updated on 25 February 2009 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • 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 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Section 1: Update to pharmaceutical form

Section 2: Update to pharmaceutical form

Section 3: Update to pharmaceutical form

Section 4: Addition of Treatment of social anxiety disorder and other indications reworded.

Section 4.2: New information and other information reworded.

Section 4.3: Information reworded

Section 4.4: New information and other information reworded.

Section 4.5: New information and other information reworded.

Section 4.6: New information and other information reworded.

Section 4.7: Information reworded

Section 4.8: Additional adverse events added, adverse events deleted, adverse events reformatted to MEDRA.

Section 4.9: New information

Section 5.1: New information and other information reworded.

Section 5.2: New information and other information reworded.

Section 5.3: New information

Updated on 25 February 2009 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • Change to section 2 - Qualitative and quantitative composition
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • 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 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 1: Update to pharmaceutical form

Section 2: Update to pharmaceutical form

Section 3: Update to pharmaceutical form

Section 4: Addition of Treatment of social anxiety disorder and other indications reworded.

Section 4.2: New information and other information reworded.

Section 4.3: Information reworded

Section 4.4: New information and other information reworded.

Section 4.5: New information and other information reworded.

Section 4.6: New information and other information reworded.

Section 4.7: Information reworded

Section 4.8: Additional adverse events added, adverse events deleted, adverse events reformatted to MEDRA.

Section 4.9: New information

Section 5.1: New information and other information reworded.

Section 5.2: New information and other information reworded.

Section 5.3: New information

Updated on 29 October 2008 PIL

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

Free text change information supplied by the pharmaceutical company

Section 4.8

Reinsertion of a paragraph deleted in error:

 

Particularly, the following adverse reactions were observed in pediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis and myalgia.

 

Section 4.9

Reinsertion of paragraph deleted in error:

 

Recommended Treatment

General supportive and symptomatic measures are recommended; cardiac rhythm and vital signs must be monitored.

When there is a risk of aspiration, induction of emesis is not recommended.

Gastric Lavage may be indicated if performed soon after ingestion or in symptomatic patients.

Administration of activated charcoal may also limit drug absorption.

Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.

No specific antidotes for venlafaxine are known.

Updated on 29 October 2008 SmPC

Reasons for updating

  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Section 4.8

Reinsertion of a paragraph deleted in error:

 

Particularly, the following adverse reactions were observed in pediatric patients: abdominal pain, agitation, dyspepsia, ecchymosis, epistaxis and myalgia.

 

Section 4.9

Reinsertion of paragraph deleted in error:

 

Recommended Treatment

General supportive and symptomatic measures are recommended; cardiac rhythm and vital signs must be monitored.

When there is a risk of aspiration, induction of emesis is not recommended.

Gastric Lavage may be indicated if performed soon after ingestion or in symptomatic patients.

Administration of activated charcoal may also limit drug absorption.

Forced diuresis, dialysis, hemoperfusion and exchange transfusion are unlikely to be of benefit.

No specific antidotes for venlafaxine are known.

Updated on 3 June 2008 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 Special warnings and precautions for use - additional information on Suicide/suicidal thoughts or clinical worsening

 

Section 4.8 Undesirable effects – additional information on Psychiatric disorders and suicide

Updated on 3 June 2008 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 Special warnings and precautions for use - additional information on Suicide/suicidal thoughts or clinical worsening

 

Section 4.8 Undesirable effects – additional information on Psychiatric disorders and suicide

Updated on 8 January 2008 SmPC

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • 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

Section 1 – inclusion of additional strength information

 

Section 2 - inclusion of additional strength information

 

Section 3 - inclusion of additional strength information

 

Section 4.1 – addition of indication for the treatment of panic disorder, with or without agoraphobia

 

Section 4.2 – addition of dosage and Maintenance/Continuation/Extended Treatment instructions for panic disorder, with or without agoraphobia

 

Section 4.3 – reworded

 

Section 4.4 – addition of precaution for concomitant use of (serotonin re-uptake inhibitors/ nefazodone /trazodone/ triptans) and herbal preparations containing St John’s Wort (Hypericum perforatum)

 

Section 4.5 – rewording of MAOI, Imipramine/desipramine, Metoprolol, Cimetidine and Warfarin interaction paragraphs

 

Section 4.6 – rewording of section

 

Section 4.7 - rewording of section

 

Section 4.8 – rewording of adverse events from paediatric clinical trials section

 

Section 4.9 – rewording of section

 

Section 6.5 – addition of 7-day pack for Efexor 37.5mg

 

Section 6.6 - inclusion of additional strength information

 

Section 8 - inclusion of additional strength information

 

Section 9 - inclusion of additional strength information

Updated on 8 January 2008 PIL

Reasons for updating

  • Change to section 1 - Name of medicinal product
  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose
  • Change to section 6.5 - Nature and contents of container
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 8 - MA number
  • Change to section 9 - Date of renewal of authorisation

Free text change information supplied by the pharmaceutical company

Section 1 – inclusion of additional strength information

 

Section 2 - inclusion of additional strength information

 

Section 3 - inclusion of additional strength information

 

Section 4.1 – addition of indication for the treatment of panic disorder, with or without agoraphobia

 

Section 4.2 – addition of dosage and Maintenance/Continuation/Extended Treatment instructions for panic disorder, with or without agoraphobia

 

Section 4.3 – reworded

 

Section 4.4 – addition of precaution for concomitant use of (serotonin re-uptake inhibitors/ nefazodone /trazodone/ triptans) and herbal preparations containing St John’s Wort (Hypericum perforatum)

 

Section 4.5 – rewording of MAOI, Imipramine/desipramine, Metoprolol, Cimetidine and Warfarin interaction paragraphs

 

Section 4.6 – rewording of section

 

Section 4.7 - rewording of section

 

Section 4.8 – rewording of adverse events from paediatric clinical trials section

 

Section 4.9 – rewording of section

 

Section 6.5 – addition of 7-day pack for Efexor 37.5mg

 

Section 6.6 - inclusion of additional strength information

 

Section 8 - inclusion of additional strength information

 

Section 9 - inclusion of additional strength information

Updated on 25 October 2007 SmPC

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose

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

Free text change information supplied by the pharmaceutical company

Section 4.2

Elderly Patients – dosage adjustment statement reworded

 

Section 4.3

Maintenance/Continuation, extended treatment – New information added for General Anxiety Disorder

 

Section 4.4

Precaution added regarding concomitant use of SSRIs and St Johns Wort

 

Section 4.5

MAOI – paragraph reworded

Imipramine/desipramine – paragraph reworded

Metoprolol – paragraph reworded and new information added

Cimetidine – paragraph reworded

Warfarin – paragraph reworded

 

Section 4.6

Section reworded

 

Section 4.7

Section reworded

 

Section 4.8

Adverse events from paediatric clinical trials – paragraph reworded and new information added

 

Section 4.9

Section reworded

Updated on 25 October 2007 PIL

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • 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 4.9 - Overdose

Free text change information supplied by the pharmaceutical company

Section 4.2

Elderly Patients – dosage adjustment statement reworded

 

Section 4.3

Maintenance/Continuation, extended treatment – New information added for General Anxiety Disorder

 

Section 4.4

Precaution added regarding concomitant use of SSRIs and St Johns Wort

 

Section 4.5

MAOI – paragraph reworded

Imipramine/desipramine – paragraph reworded

Metoprolol – paragraph reworded and new information added

Cimetidine – paragraph reworded

Warfarin – paragraph reworded

 

Section 4.6

Section reworded

 

Section 4.7

Section reworded

 

Section 4.8

Adverse events from paediatric clinical trials – paragraph reworded and new information added

 

Section 4.9

Section reworded

Updated on 4 January 2007 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)

Free text change information supplied by the pharmaceutical company

Section 4.4 - change of final word of paragraph 3 from depression to aggression

Updated on 4 January 2007 PIL

Reasons for updating

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

Free text change information supplied by the pharmaceutical company

Section 4.4 - change of final word of paragraph 3 from depression to aggression

Updated on 4 September 2006 PIL

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • Change to section 10 - Date of revision of the text

Free text change information supplied by the pharmaceutical company

Present

Proposed

4.2    Posology and Method of Administration

 

Patients with Renal or Hepatic Impairment:

 

For patients with mild renal impairment (GFR > 30ml/minute) or mild hepatic impairment, no change in dosage is necessary.

 

For patients with moderate renal impairment (GFR 10-30ml/minute) or moderate hepatic impairment, the dose should be reduced by 50%.  For patients requiring a lower daily dose than 75mg, treatment may be provided with Efexor Tablets.

 

Insufficient data are available to support the use of Efexor XL in patients with severe renal impairment (GFR < 10ml/minute) or severe hepatic impairment.

4.2     Posology and Method of Administration

 

Patients with Renal or Hepatic Impairment:

 

For patients with mild renal impairment (GFR > 30ml/minute), no change in dosage is necessary.  For patients with moderate renal impairment (GFR 10-30ml/minute) the dose should be reduced by 50%.

 

For patients with mild to moderate hepatic impairment (PT < 18 seconds), the dose should be reduced by 50%.  Reductions of more than 50% may be appropriate for some patients. For patients requiring a lower daily dose than 75mg, treatment may be provided with Efexor Tablets.

 

Insufficient data are available to support the use of Efexor XL in patients with severe renal impairment (GFR < 10ml/minute) or severe hepatic impairment.

4.4    Special Warnings and Special Precautions For Use

 

2.      Activation of mania or hypomania has been reported rarely in patients who have received antidepressants, including venlafaxine.  As with all antidepressants, Efexor should be used with caution in patients with a history of mania.

4.4     Special Warnings and Precautions For Use

 

2.        Activation of mania or hypomania has been reported rarely in patients who have received antidepressants, including venlafaxine.  As with all antidepressants, Efexor should be used with caution in patients with a history or family history of bipolar disorder.

4.4    Special Warnings and Special Precautions For Use

 

2.      Activation of mania

 

3.      Venlafaxine has not been evaluated

 

4.      Efexor XL should be introduced…

 

5.      Dose-related increases in blood…

 

6.      Due to the possibility of…

 

7.      When considering the…

 

8.      Increases in heart rate…

 

9.      Dosage should be reduced…

 

10.     Postural hypotension has…

 

11.     Hyponatraemia (usually in…

 

12.     Mydriasis has been…

 

13.     There have been reports…

 

14.     Clinically relevant increases…

 

15.     The safety and efficacy…

 

16.     As with SSRIs…

 

17.     Discontinuation effects…

 

18.     Use in children…

4.4     Special Warnings and Precautions For Use

 

2.        Activation of mania

 

3.       Aggression may occur in a small proportion of patients who have received antidepressants including venlafaxine treatment, dose reduction or discontinuation.  As with other antidepressants, venlafaxine should be used cautiously in patients with a history of depression

 

4.       Venlafaxine has not been evaluated…

 

5.       Efexor XL should be introduced…

 

6.       Dose-related increases in blood…

 

7.       Due to the possibility of…

 

8.       When considering the…

 

9.       Increases in heart rate…

 

10.     Dosage should be reduced…

 

11.     Postural hypotension has…

 

12.     Hyponatraemia (usually in…

 

13.     Mydriasis has been…

 

14.     There have been reports…

 

15.     Clinically relevant increases…

 

16.     The safety and efficacy…

 

17.     As with SSRIs…

 

18.     Discontinuation effects…

 

19.     Use in children…

4.4    Special Warnings and Special Precautions For Use

 

5.      Dose-related increases in blood pressure have been reported particularly in patients receiving daily doses greater than 200mg.  Measurement of blood pressure is therefore recommended for patients receiving venlafaxine.  The presence of treated hypertension or elevated blood pressure at baseline did not seem to predispose patients to further increases during venlafaxine therapy.

4.4     Special Warnings and Precautions For Use

 

6.       Dose-related increases in blood pressure have been reported particularly in patients receiving daily doses greater than 200mg.  Cases of elevated blood pressure requiring immediate treatment have been reported in post marketing experience.  Measurement of blood pressure is therefore recommended for patients receiving venlafaxine.  Pre­‑existing hypertension should be controlled before treatment with venlafaxine.  The presence of treated hypertension or elevated blood pressure at baseline did not seem to predispose patients to further increases during venlafaxine therapy.

4.4    Special Warnings and Special Precautions For Use

 

12.     Mydriasis has been reported in association with venlafaxine; therefore patients with raised intraocular pressure or at a risk of narrow angle glaucoma should be monitored closely.

4.4     Special Warnings and Precautions For Use

 

13.     Mydriasis has been reported in association with venlafaxine; therefore patients with raised intraocular pressure or at a risk of narrow angle glaucoma (angle closure glaucoma) should be monitored closely.

4.4    Special Warnings and Special Precautions For Use

 

13.     There have been reports of cutaneous bleeding abnormalities, such as ecchymosis and purpura, with serotonin-reuptake inhibitors (SSRIs).  Other bleeding manifestations (e.g. gastrointestinal bleeding and mucous membrane bleeding) have been reported.  Caution is advised in patients predisposed to bleeding due to factors such as age, underlying medical conditions or concomitant medications.

4.4     Special Warnings and Precautions For Use

 

14.     Drugs that inhibit serotonin uptake may lead to abnormalities of platelet aggregation. The risk of cutaneous and mucous membrane bleeding may be increased in patients taking venlafaxine. Bleeding abnormalities, such as ecchymosis and purpura have been reported, as have other bleeding manifestations (e.g. gastrointestinal bleeding and mucous membrane bleeding).  Caution is advised in patients predisposed to bleeding.

 

4.5    Interactions with Other Medicinal Products and Other Forms of Interaction

 

Imipramine/desipramine:

 

Haloperidol:

4.5     Interactions with Other Medicinal Products and Other Forms of Interaction

 

Imipramine/desipramine:

 

Ketoconazole: A pharmacokinetic study with ketoconazole in extensive (EM) and poor metabolizers (PM) of CYP2D6 resulted in higher plasma concentrations of both venlafaxine and ODV in most subjects following administration of ketoconazole.  Venlafaxine Cmax increased by 26% in EM subjects and 48% in PM subjects.  Cmax values for ODV increased by 14% and 29% in EM and PM subjects respectively.  Venlafaxine AUC increased by 21% in EM subjects and 70% in PM subjects.  AUC values of ODV increased by 23% and 141% in EM and PM subjects, respectively.

 

Haloperidol:

4.5    Interactions with Other Medicinal Products and Other Forms of Interaction

 

Imipramine/desipramine:

 

Haloperidol:

4.5     Interactions with Other Medicinal Products and Other Forms of Interaction

 

Imipramine/desipramine:

 

Ketoconazole: …

 

Metoprolol: In a pharmacokinetic interaction study for both venlafaxine and metoprolol, the plasma concentration of metoprolol increased by approximately 30 ‑ 40% without altering the plasma concentrations of its active metabolite, a‑hydroxymetoprolol.  Metoprolol did not alter the pharmacokinetic profile of venlafaxine or its active metabolite, O‑desmethylvenlafaxine.

 

Haloperidol:

4.5    Interactions with Other Medicinal Products and Other Forms of Interaction

 

Studies indicate that venlafaxine is a relatively weak inhibitor of CYP2D6. Venlafaxine did not inhibit CYP1A2, CYP2C9 or CYP3A4.  This was confirmed by in vivo studies with the following drugs: alprazolam (CYP3A4), caffeine (CYP1A2), carbamazepine, diazepam (CYP3A4 and CYP2C19).

4.5     Interactions with Other Medicinal Products and Other Forms of Interaction

 

Studies indicate that venlafaxine is a relatively weak inhibitor of CYP2D6. Venlafaxine did not inhibit CYP1A2, CYP2C9 or CYP3A4.  This was confirmed by in vivo studies with the following drugs: alprazolam (CYP3A4), caffeine (CYP1A2), carbamazepine (CYP3A4), diazepam (CYP3A4 and CYP2C19) and tolbutamide (CYP2C9).

4.8              Undesirable Effects

 

Neurological disorders  - Very common: dizziness, dry mouth, insomnia, nervousness, somnolence; Common: abnormal dreams, agitation, anxiety, confusion, hypertonia, paraesthesia, tremor; Uncommon: apathy, hallucinations, myoclonus; Rare:  ataxia and disorders of balance and coordination, speech disorders including dysarthria, mania or hypomania (see section 4.4), neuroleptic malignant syndrome-like effects, seizures (see section 4.4), serotonergic syndrome; Very rare: delirium, extrapyramidal disorders including dyskinesia and dystonia, tardive dyskinesia.

4.8              Undesirable Effects

 

Neurological disorders  - Very common: dizziness, dry mouth, insomnia, nervousness, somnolence; Common: abnormal dreams, agitation, anxiety, confusion, hypertonia, paraesthesia, tremor; Uncommon: apathy, hallucinations, myoclonus; Rare:  akathisia, ataxia and disorders of balance and coordination, speech disorders including dysarthria, mania or hypomania (see section 4.4), neuroleptic malignant syndrome-like effects, seizures (see section 4.4), serotonergic syndrome; Very rare: delirium, extrapyramidal disorders including dyskinesia and dystonia, tardive dyskinesia.

4.8        Undesirable Effects

 

Skin and subcutaneous tissue disorders -Very common: sweating (including night sweats); Common: pruritus, rash; Uncommon: angioedema, maculopapular eruptions, urticaria, photosensitivity reactions, alopecia; Rare: erythema multiforme, Stevens Johnson syndrome.

4.8           Undesirable Effects

 

Skin and subcutaneous tissue disorders -Very common: sweating (including night sweats); Uncommon: rash, angioedema, maculopapular eruptions, photosensitivity reactions, alopecia; Rare: erythema multiforme, Stevens Johnson syndrome, pruritus, urticaria.

4.8        Undesirable Effects

 

Special senses - Common:  abnormal vision/ accommodation, mydriasis, tinnitus; Uncommon:  altered taste sensation.

4.8           Undesirable Effects

 

Special senses - Common:  abnormal vision/ accommodation, mydriasis; Uncommon:  altered taste sensation, tinnitus; Very rare: Narrow Angle glaucoma.

4.9    Overdose

 

Electrocardiogram changes (e.g. prolongation of QT interval, bundle branch block, QRS prolongation), sinus and ventricular tachycardia, bradycardia and seizures, hypotension and changes in level of consciousness have been reported in association with overdosage of venlafaxine usually when in combination with alcohol and/or other CNS drugs.

4.9    Overdose

 

Electrocardiogram changes (e.g. prolongation of QT interval, bundle branch block, QRS prolongation), sinus and ventricular tachycardia, bradycardia and seizures, hypotension and changes in level of consciousness (ranging from somnolence to coma) have been reported in association with overdosage of venlafaxine usually when in combination with alcohol and/or other CNS drugs.

5.2    Pharmacokinetic Properties

 

The half lives of venlafaxine…

 

Administration of Efexor XL…

5.2    Pharmacokinetic Properties

 

The half lives of venlafaxine…

 

A clinical study demonstrated that in hepatically impaired patients the mean plasma half-life of venlafaxine is approximately doubled (see Section 4.2)

 

Administration of Efexor XL…

5.3    Preclinical Safety Data

 

Reduced fertility was observed in a study in which both male and female rats were exposed to the major metabolite of venlafaxine (ODV).  This exposure was approximately 2 to 3 times that of a human dose of 225mg/day.

5.3    Preclinical Safety Data

 

Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses of up to 8 times the maximum recommended human daily dose on a mg/kg basis, or up to 2 times on a mg/m2 basis.  Reduced fertility was observed in a study in which both male and female rats were exposed to the major metabolite of venlafaxine (ODV).  This ODV exposure was approximately 2 to 3 times that of a human dose of 225mg/day.

Updated on 4 September 2006 SmPC

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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 5.3 - Preclinical safety data
  • 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

Present

Proposed

4.2    Posology and Method of Administration

 

Patients with Renal or Hepatic Impairment:

 

For patients with mild renal impairment (GFR > 30ml/minute) or mild hepatic impairment, no change in dosage is necessary.

 

For patients with moderate renal impairment (GFR 10-30ml/minute) or moderate hepatic impairment, the dose should be reduced by 50%.  For patients requiring a lower daily dose than 75mg, treatment may be provided with Efexor Tablets.

 

Insufficient data are available to support the use of Efexor XL in patients with severe renal impairment (GFR < 10ml/minute) or severe hepatic impairment.

4.2     Posology and Method of Administration

 

Patients with Renal or Hepatic Impairment:

 

For patients with mild renal impairment (GFR > 30ml/minute), no change in dosage is necessary.  For patients with moderate renal impairment (GFR 10-30ml/minute) the dose should be reduced by 50%.

 

For patients with mild to moderate hepatic impairment (PT < 18 seconds), the dose should be reduced by 50%.  Reductions of more than 50% may be appropriate for some patients. For patients requiring a lower daily dose than 75mg, treatment may be provided with Efexor Tablets.

 

Insufficient data are available to support the use of Efexor XL in patients with severe renal impairment (GFR < 10ml/minute) or severe hepatic impairment.

4.4    Special Warnings and Special Precautions For Use

 

2.      Activation of mania or hypomania has been reported rarely in patients who have received antidepressants, including venlafaxine.  As with all antidepressants, Efexor should be used with caution in patients with a history of mania.

4.4     Special Warnings and Precautions For Use

 

2.        Activation of mania or hypomania has been reported rarely in patients who have received antidepressants, including venlafaxine.  As with all antidepressants, Efexor should be used with caution in patients with a history or family history of bipolar disorder.

4.4    Special Warnings and Special Precautions For Use

 

2.      Activation of mania

 

3.      Venlafaxine has not been evaluated

 

4.      Efexor XL should be introduced…

 

5.      Dose-related increases in blood…

 

6.      Due to the possibility of…

 

7.      When considering the…

 

8.      Increases in heart rate…

 

9.      Dosage should be reduced…

 

10.     Postural hypotension has…

 

11.     Hyponatraemia (usually in…

 

12.     Mydriasis has been…

 

13.     There have been reports…

 

14.     Clinically relevant increases…

 

15.     The safety and efficacy…

 

16.     As with SSRIs…

 

17.     Discontinuation effects…

 

18.     Use in children…

4.4     Special Warnings and Precautions For Use

 

2.        Activation of mania

 

3.       Aggression may occur in a small proportion of patients who have received antidepressants including venlafaxine treatment, dose reduction or discontinuation.  As with other antidepressants, venlafaxine should be used cautiously in patients with a history of depression

 

4.       Venlafaxine has not been evaluated…

 

5.       Efexor XL should be introduced…

 

6.       Dose-related increases in blood…

 

7.       Due to the possibility of…

 

8.       When considering the…

 

9.       Increases in heart rate…

 

10.     Dosage should be reduced…

 

11.     Postural hypotension has…

 

12.     Hyponatraemia (usually in…

 

13.     Mydriasis has been…

 

14.     There have been reports…

 

15.     Clinically relevant increases…

 

16.     The safety and efficacy…

 

17.     As with SSRIs…

 

18.     Discontinuation effects…

 

19.     Use in children…

4.4    Special Warnings and Special Precautions For Use

 

5.      Dose-related increases in blood pressure have been reported particularly in patients receiving daily doses greater than 200mg.  Measurement of blood pressure is therefore recommended for patients receiving venlafaxine.  The presence of treated hypertension or elevated blood pressure at baseline did not seem to predispose patients to further increases during venlafaxine therapy.

4.4     Special Warnings and Precautions For Use

 

6.       Dose-related increases in blood pressure have been reported particularly in patients receiving daily doses greater than 200mg.  Cases of elevated blood pressure requiring immediate treatment have been reported in post marketing experience.  Measurement of blood pressure is therefore recommended for patients receiving venlafaxine.  Pre­‑existing hypertension should be controlled before treatment with venlafaxine.  The presence of treated hypertension or elevated blood pressure at baseline did not seem to predispose patients to further increases during venlafaxine therapy.

4.4    Special Warnings and Special Precautions For Use

 

12.     Mydriasis has been reported in association with venlafaxine; therefore patients with raised intraocular pressure or at a risk of narrow angle glaucoma should be monitored closely.

4.4     Special Warnings and Precautions For Use

 

13.     Mydriasis has been reported in association with venlafaxine; therefore patients with raised intraocular pressure or at a risk of narrow angle glaucoma (angle closure glaucoma) should be monitored closely.

4.4    Special Warnings and Special Precautions For Use

 

13.     There have been reports of cutaneous bleeding abnormalities, such as ecchymosis and purpura, with serotonin-reuptake inhibitors (SSRIs).  Other bleeding manifestations (e.g. gastrointestinal bleeding and mucous membrane bleeding) have been reported.  Caution is advised in patients predisposed to bleeding due to factors such as age, underlying medical conditions or concomitant medications.

4.4     Special Warnings and Precautions For Use

 

14.     Drugs that inhibit serotonin uptake may lead to abnormalities of platelet aggregation. The risk of cutaneous and mucous membrane bleeding may be increased in patients taking venlafaxine. Bleeding abnormalities, such as ecchymosis and purpura have been reported, as have other bleeding manifestations (e.g. gastrointestinal bleeding and mucous membrane bleeding).  Caution is advised in patients predisposed to bleeding.

 

4.5    Interactions with Other Medicinal Products and Other Forms of Interaction

 

Imipramine/desipramine:

 

Haloperidol:

4.5     Interactions with Other Medicinal Products and Other Forms of Interaction

 

Imipramine/desipramine:

 

Ketoconazole: A pharmacokinetic study with ketoconazole in extensive (EM) and poor metabolizers (PM) of CYP2D6 resulted in higher plasma concentrations of both venlafaxine and ODV in most subjects following administration of ketoconazole.  Venlafaxine Cmax increased by 26% in EM subjects and 48% in PM subjects.  Cmax values for ODV increased by 14% and 29% in EM and PM subjects respectively.  Venlafaxine AUC increased by 21% in EM subjects and 70% in PM subjects.  AUC values of ODV increased by 23% and 141% in EM and PM subjects, respectively.

 

Haloperidol:

4.5    Interactions with Other Medicinal Products and Other Forms of Interaction

 

Imipramine/desipramine:

 

Haloperidol:

4.5     Interactions with Other Medicinal Products and Other Forms of Interaction

 

Imipramine/desipramine:

 

Ketoconazole: …

 

Metoprolol: In a pharmacokinetic interaction study for both venlafaxine and metoprolol, the plasma concentration of metoprolol increased by approximately 30 ‑ 40% without altering the plasma concentrations of its active metabolite, a‑hydroxymetoprolol.  Metoprolol did not alter the pharmacokinetic profile of venlafaxine or its active metabolite, O‑desmethylvenlafaxine.

 

Haloperidol:

4.5    Interactions with Other Medicinal Products and Other Forms of Interaction

 

Studies indicate that venlafaxine is a relatively weak inhibitor of CYP2D6. Venlafaxine did not inhibit CYP1A2, CYP2C9 or CYP3A4.  This was confirmed by in vivo studies with the following drugs: alprazolam (CYP3A4), caffeine (CYP1A2), carbamazepine, diazepam (CYP3A4 and CYP2C19).

4.5     Interactions with Other Medicinal Products and Other Forms of Interaction

 

Studies indicate that venlafaxine is a relatively weak inhibitor of CYP2D6. Venlafaxine did not inhibit CYP1A2, CYP2C9 or CYP3A4.  This was confirmed by in vivo studies with the following drugs: alprazolam (CYP3A4), caffeine (CYP1A2), carbamazepine (CYP3A4), diazepam (CYP3A4 and CYP2C19) and tolbutamide (CYP2C9).

4.8              Undesirable Effects

 

Neurological disorders  - Very common: dizziness, dry mouth, insomnia, nervousness, somnolence; Common: abnormal dreams, agitation, anxiety, confusion, hypertonia, paraesthesia, tremor; Uncommon: apathy, hallucinations, myoclonus; Rare:  ataxia and disorders of balance and coordination, speech disorders including dysarthria, mania or hypomania (see section 4.4), neuroleptic malignant syndrome-like effects, seizures (see section 4.4), serotonergic syndrome; Very rare: delirium, extrapyramidal disorders including dyskinesia and dystonia, tardive dyskinesia.

4.8              Undesirable Effects

 

Neurological disorders  - Very common: dizziness, dry mouth, insomnia, nervousness, somnolence; Common: abnormal dreams, agitation, anxiety, confusion, hypertonia, paraesthesia, tremor; Uncommon: apathy, hallucinations, myoclonus; Rare:  akathisia, ataxia and disorders of balance and coordination, speech disorders including dysarthria, mania or hypomania (see section 4.4), neuroleptic malignant syndrome-like effects, seizures (see section 4.4), serotonergic syndrome; Very rare: delirium, extrapyramidal disorders including dyskinesia and dystonia, tardive dyskinesia.

4.8        Undesirable Effects

 

Skin and subcutaneous tissue disorders -Very common: sweating (including night sweats); Common: pruritus, rash; Uncommon: angioedema, maculopapular eruptions, urticaria, photosensitivity reactions, alopecia; Rare: erythema multiforme, Stevens Johnson syndrome.

4.8           Undesirable Effects

 

Skin and subcutaneous tissue disorders -Very common: sweating (including night sweats); Uncommon: rash, angioedema, maculopapular eruptions, photosensitivity reactions, alopecia; Rare: erythema multiforme, Stevens Johnson syndrome, pruritus, urticaria.

4.8        Undesirable Effects

 

Special senses - Common:  abnormal vision/ accommodation, mydriasis, tinnitus; Uncommon:  altered taste sensation.

4.8           Undesirable Effects

 

Special senses - Common:  abnormal vision/ accommodation, mydriasis; Uncommon:  altered taste sensation, tinnitus; Very rare: Narrow Angle glaucoma.

4.9    Overdose

 

Electrocardiogram changes (e.g. prolongation of QT interval, bundle branch block, QRS prolongation), sinus and ventricular tachycardia, bradycardia and seizures, hypotension and changes in level of consciousness have been reported in association with overdosage of venlafaxine usually when in combination with alcohol and/or other CNS drugs.

4.9    Overdose

 

Electrocardiogram changes (e.g. prolongation of QT interval, bundle branch block, QRS prolongation), sinus and ventricular tachycardia, bradycardia and seizures, hypotension and changes in level of consciousness (ranging from somnolence to coma) have been reported in association with overdosage of venlafaxine usually when in combination with alcohol and/or other CNS drugs.

5.2    Pharmacokinetic Properties

 

The half lives of venlafaxine…

 

Administration of Efexor XL…

5.2    Pharmacokinetic Properties

 

The half lives of venlafaxine…

 

A clinical study demonstrated that in hepatically impaired patients the mean plasma half-life of venlafaxine is approximately doubled (see Section 4.2)

 

Administration of Efexor XL…

5.3    Preclinical Safety Data

 

Reduced fertility was observed in a study in which both male and female rats were exposed to the major metabolite of venlafaxine (ODV).  This exposure was approximately 2 to 3 times that of a human dose of 225mg/day.

5.3    Preclinical Safety Data

 

Reproduction and fertility studies in rats showed no effects on male or female fertility at oral doses of up to 8 times the maximum recommended human daily dose on a mg/kg basis, or up to 2 times on a mg/m2 basis.  Reduced fertility was observed in a study in which both male and female rats were exposed to the major metabolite of venlafaxine (ODV).  This ODV exposure was approximately 2 to 3 times that of a human dose of 225mg/day.

Updated on 27 June 2006 SmPC

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

.

The following highlighted sections have been changed

 

4.3  Contra-indications

 

1. Known hypersensitivity to venlafaxine or any other component of the product.

 

2.  Concomitant use of venlafaxine with monoamine oxidase inhibitors (See Interactions with other Medicaments and Other Forms of Interactions).

 

3.   Efexor should not be used in children and adolescents under the age of 18 years with Major Depressive Disorder. (see section 4.8, Undesirable Effects)

 

4.4  Special Warnings and Special Precautions for Use

 

17. Use in children and adolescents under 18 years of age: Efexor should not be used in the treatment of children and adolescents under the age of 18 years.  Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.  If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.

 

 

4.8  Undesirable Effects

 

Adverse events from paediatric clinical trials:

 

In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (ages 6 to 17) was similar to that seen for adults.  As with adults, decreased appetite, weight loss, increased blood pressure and increased serum cholesterol were observed.  In paediatric MDD clinical trials the following adverse events were reported at a frequency of at least 2% of patients and occurred at a rate of at least twice that of placebo: abdominal pain, chest pain, tachycardia, anorexia, weight loss, constipation, dyspepsia, nausea, ecchymosis, epistaxis, mydriasis, myalgia, dizziness, emotional lability, tremor, hostility and suicidal ideation.

Updated on 27 June 2006 PIL

Reasons for updating

  • Change to section 4.3 - Contraindications
  • 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

.

The following highlighted sections have been changed

 

4.3  Contra-indications

 

1. Known hypersensitivity to venlafaxine or any other component of the product.

 

2.  Concomitant use of venlafaxine with monoamine oxidase inhibitors (See Interactions with other Medicaments and Other Forms of Interactions).

 

3.   Efexor should not be used in children and adolescents under the age of 18 years with Major Depressive Disorder. (see section 4.8, Undesirable Effects)

 

4.4  Special Warnings and Special Precautions for Use

 

17. Use in children and adolescents under 18 years of age: Efexor should not be used in the treatment of children and adolescents under the age of 18 years.  Suicide-related behaviours (suicide attempt and suicidal thoughts), and hostility (predominantly aggression, oppositional behaviour and anger) were more frequently observed in clinical trials among children and adolescents treated with antidepressants compared to those treated with placebo.  If, based on clinical need, a decision to treat is nevertheless taken, the patient should be carefully monitored for the appearance of suicidal symptoms. In addition, long-term safety data in children and adolescents concerning growth, maturation and cognitive and behavioural development are lacking.

 

 

4.8  Undesirable Effects

 

Adverse events from paediatric clinical trials:

 

In general, the adverse reaction profile of venlafaxine (in placebo-controlled clinical trials) in children and adolescents (ages 6 to 17) was similar to that seen for adults.  As with adults, decreased appetite, weight loss, increased blood pressure and increased serum cholesterol were observed.  In paediatric MDD clinical trials the following adverse events were reported at a frequency of at least 2% of patients and occurred at a rate of at least twice that of placebo: abdominal pain, chest pain, tachycardia, anorexia, weight loss, constipation, dyspepsia, nausea, ecchymosis, epistaxis, mydriasis, myalgia, dizziness, emotional lability, tremor, hostility and suicidal ideation.

Updated on 24 February 2005 SmPC

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • 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 24 February 2005 PIL

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 5.2 - Pharmacokinetic properties
  • Change to section 10 - Date of revision of the text

Updated on 26 February 2004 SmPC

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

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

Updated on 26 February 2004 PIL

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.3 - Contraindications
  • Change to section 4.8 - Undesirable effects

Updated on 14 November 2003 SmPC

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • 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 November 2003 PIL

Reasons for updating

  • 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 4.5 - Interaction with other medicinal products and other forms of interaction
  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 4.8 - Undesirable effects
  • Change to section 4.9 - Overdose
  • Change to section 10 - Date of revision of the text

Updated on 19 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 19 June 2003 PIL

Reasons for updating

  • New SPC for medicines.ie