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Toviaz Prolonged-Release Tablets 4mg & 8mg

*
Pharmacy Only: Prescription

  • Company:

    Pfizer Healthcare Ireland

  • Status:

    No Recent Update

  • Legal Category:

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

  • Active Ingredient(s):

    Fesoterodine Fumarate

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

Updated on 14 February 2023

File name

Adv SPC TV 21_0 IE-clean.pdf

Reasons for updating

  • Document format updated

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

Updated on 18 September 2020

File name

Adv SPC TV 21_0 IE-clean.pdf

Reasons for updating

  • 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)

Updated on 18 September 2020

File name

Adv PIL TV 19_0 IE-clean.pdf

Reasons for updating

  • Change to section 4 - how to report a side effect

Updated on 15 November 2019

File name

DEC201963752_Adv PIL TV 18_0 UK IE-clean.pdf

Reasons for updating

  • Change to section 6 - date of revision
  • Change to other sources of information section

Updated on 23 July 2019

File name

DEC201939070_Adv PIL TV 17_0 UK IE - clean.pdf

Reasons for updating

  • Change to section 6 - manufacturer
  • Change to section 6 - date of revision

Updated on 23 July 2019

File name

DEC201939070_Adv SPC TV 20_0 UK IE-clean.pdf

Reasons for updating

  • Change to section 9 - Date of first authorisation/renewal of the authorisation
  • 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 9 - Date of latest renewal: updated to 15 March 2012

Section 10: date of revision: updated in line with approval date - 07/2019

Updated on 03 August 2018

File name

Adv PIL TV 16_0 UK IE - clean.pdf

Reasons for updating

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

Updated on 03 August 2018

File name

Adv SPC TV 19_0 UK IE-clean.pdf

Reasons for updating

  • Change to section 7 - Marketing authorisation holder

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: SPC section 7:

Marketing authorisation holder change to Pfizer EEIG.

Updated on 12 October 2017

File name

PIL_13644_659.pdf

Reasons for updating

  • New PIL for new product

Updated on 12 October 2017

Reasons for updating

  • New SPC for new product

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

Updated on 12 October 2017

Reasons for updating

  • Change to section 4.6 - Pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

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

Free text change information supplied by the pharmaceutical company

update sections 4.6  and 5.3 of the Toviaz SPC in accordance with the corrected information in the Non-Clinical Overview

Updated on 12 October 2017

Reasons for updating

  • Change to section 4 - how to report a side effect
  • Change to section 6 - date of revision
  • Improved presentation of PIL

Updated on 08 August 2016

Reasons for updating

  • 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 4.4 - 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 5.1 - Pharmacodynamic properties
  • Change to section 5.4 - Radiation dosimetry
  • Change to section 8 - MA number

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 2, 3, 4.1, 4.2, 4.4, 4.5, 4.6, 4.8, 5.4, 8, aligned with the QRD template (v 9.1) and minor editorial changes.

Section 5.1 under Cardiac electrophysiology has also been corrected as follows: 8 mg has been revised to 28 mg

Updated on 05 August 2016

Reasons for updating

  • Change to date of revision
  • Improved electronic presentation

Updated on 03 July 2015

Reasons for updating

  • Change to date of revision
  • Change to MA holder contact details

Updated on 23 October 2014

Reasons for updating

  • Change to section 10 - Date of revision of the text
  • Improved electronic presentation

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

Free text change information supplied by the pharmaceutical company

The SPC is updated with the revision date and correction of minor typos

Updated on 01 October 2014

Reasons for updating

  • Change to MA holder contact details
  • Change to date of revision

Updated on 24 October 2013

Reasons for updating

  • Change to section 11 - Dosimetry

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 11

Updated on 30 October 2012

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Change to section 6.5 to add 30 tablet blister pack

Updated on 18 October 2012

Reasons for updating

  • Introduction of new pack/pack size

Updated on 28 March 2012

Reasons for updating

  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.1 - Therapeutic indications
  • 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 3 - Pharmaceutical form
  • 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 6.1 - List of excipients
  • Change to section 6.4 - Special precautions for storage
  • Change to section 6.6 - Special precautions for disposal and other handling
  • Change to section 9 - Date of renewal of authorisation
  • Change to section 10 - Date of revision of the text
  • Change to section 4.2 - Posology and method of administration

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

Free text change information supplied by the pharmaceutical company

SPC Changes to Sections 2, 3, 4.1, 4.2, 4.3, 4.4, 4.5, 4.6,4.7,4.8, 4.9, 5.1, 5.2, 5.3, 6.1, 6.4, 6.6, 9 & 10

Updated on 27 March 2012

Reasons for updating

  • Change to warnings or special precautions for use
  • Change of contraindications
  • Change to side-effects
  • Change to drug interactions
  • Change to information about pregnancy or lactation
  • Change to how the medicine works
  • Change to further information section
  • Change to date of revision
  • Change to improve clarity and readability
  • Change of special precautions for disposal

Updated on 01 November 2011

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

SmPC Section 4.4 updated to include an angioedema warning.

Updated on 28 October 2011

Reasons for updating

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

Updated on 04 April 2011

Reasons for updating

  • Change to section 4.2 - Posology and method of administration
  • 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 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 4.2: Deletion of sentence: During concomitant administration of a moderate CYP3A4 inhibitor, a dose increase to 8 mg should be preceded by an evaluation of the individual response and tolerability (see sections 4.4 and 4.5).”

Change to posology table footnote for moderate CYP3A4 inhibitors.



Section 4.5:

Metoclopromide spelling amended to metoclopramide

saquinivir spelling amended to saquinovir

Replacement text included on use with moderate and weak CYP3A4 inhibitors.



Section 4.8

The following events have been added

uncommon: palpitations, blurred vision

rare: angioedema, confusional state



Section 10: Revision date updated

EMA website address has been amended.

Updated on 01 April 2011

Reasons for updating

  • Change to side-effects
  • Change to drug interactions
  • Change to further information section
  • Change to date of revision

Updated on 24 February 2011

Reasons for updating

  • Change to further information section

Updated on 16 February 2011

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

SmPC (SPC Section 4.8 – Addition of urticaria and pruritus as undesirable effects)

Updated on 19 November 2010

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 

Changes to section 4.5 

"A clinical study in healthy volunteers has shown that fesoterodine 8 mg  once daily has no significant effect on the pharmacokinetics or the anticoagulant activity of a single dose of warfarin".

 

Updated on 09 July 2010

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

Update to section 4.4 to provide example of patients at risk of urinary retention (BPH) and section 4.8 to add further information about urinary retention and add the uncommon side effect of gastroesophageal reflux.

Updated on 09 July 2010

Reasons for updating

  • Change to warnings or special precautions for use
  • Change to side-effects

Updated on 22 July 2009

Reasons for updating

  • Change to section 6.5 - Nature and contents of container

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

Free text change information supplied by the pharmaceutical company

Addition of a 100 pack size

Updated on 17 July 2009

Reasons for updating

  • Introduction of new pack/pack size

Updated on 02 April 2009

Reasons for updating

  • Improved electronic presentation

Updated on 16 March 2009

Reasons for updating

  • Addition of marketing authorisation holder

Updated on 11 March 2009

Reasons for updating

  • 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


    Date of revision updated

Updated on 21 January 2009

Reasons for updating

  • Change to date of revision
  • Introduction of new pack/pack size

Updated on 20 January 2009

Reasons for updating

  • Change to section 6.5 - Nature and contents of container
  • Change to section 8 - MA number

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

Free text change information supplied by the pharmaceutical company

Section 6.5 - New text added:

'In addition, TOVIAZ 4 mg and 8mg tablets are also packed in HDPE bottles containing 30 or 90 tablets.'



Section 8 - Text changed:

EU/1/07/386/001-012

to:

EU/1/07/386/001-016

Updated on 01 September 2008

Reasons for updating

  • New PIL for new product

Updated on 28 August 2008

Reasons for updating

  • New SPC for medicines.ie

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