Skip to content
SPC Logo

TOVIAZ 4 mg prolonged-release tablets & TOVIAZ 8 mg prolonged-release tablets

Last Updated on eMC 12-Oct-2017 View document  | Pfizer Limited Contact details

When a pharmaceutical company changes an SPC or PIL, a new version is published on the eMC.  For each version, we show the dates it was published on the eMC and the reasons for change.

Updated on 12-Oct-2017 and displayed until Current

Reasons for adding or updating:

  • Change to section 4.6 - Fertility, pregnancy and lactation
  • Change to section 5.3 - Preclinical safety data

Date of revision of text on the SPC: 01-Sep-2017

Legal Category:POM

Black Triangle (CHM): NO

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 08-Aug-2016 and displayed until 12-Oct-2017

Reasons for adding or updating:

  • 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 - Fertility, 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 - Marketing authorisation number(s)
  • Change to section 2 - Qualitative and quantitative composition

Date of revision of text on the SPC: 01-Aug-2016

Legal Category:POM

Black Triangle (CHM): NO

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 23-Oct-2014 and displayed until 08-Aug-2016

Reasons for adding or updating:

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

Date of revision of text on the SPC: 01-Oct-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

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

Updated on 19-Oct-2012 and displayed until 23-Oct-2014

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 01-Oct-2012

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Change to section 6.5 to add 30 tablet blister pack)

Updated on 28-Mar-2012 and displayed until 19-Oct-2012

Reasons for adding or 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 4.3 - 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 6.1 - List of Excipients
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 9 - Date of first Authorisation/renewal of the Authorisation
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Mar-2012

Legal Category:POM

Black Triangle (CHM): NO

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 09-Mar-2012 and displayed until 28-Mar-2012

Reasons for adding or updating:

  • Removal of Black Triangle

Date of revision of text on the SPC: 01-Oct-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



SPC inverted black triangle symbol next to the product name has been deleted.

Updated on 01-Nov-2011 and displayed until 09-Mar-2012

Reasons for adding or updating:

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

Date of revision of text on the SPC: 01-Oct-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

SmPC Section 4.4 updated to include an angioedema warning.

Updated on 04-Apr-2011 and displayed until 01-Nov-2011

Reasons for adding or 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

Date of revision of text on the SPC: 01-Mar-2011

Legal Category:POM

Black Triangle (CHM): YES

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 and EMA website address has been amended.

Updated on 16-Feb-2011 and displayed until 04-Apr-2011

Reasons for adding or updating:

  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 14-Jan-2011

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

SmPC (Section 4.8) to add the undesirable effects urticaria and pruritus


Updated on 03-Nov-2010 and displayed until 16-Feb-2011

Reasons for adding or updating:

  • Change to section 4.5 - Interaction with other medicinal products and other forms of interaction

Date of revision of text on the SPC: 25-Oct-2010

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

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 12-Jul-2010 and displayed until 03-Nov-2010

Reasons for adding or updating:

  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects

Date of revision of text on the SPC: 01-Jun-2010

Legal Category:POM

Black Triangle (CHM): YES

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 21-Jul-2009 and displayed until 12-Jul-2010

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 01-Jul-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:



Addition of a 100 pack size

Updated on 16-Mar-2009 and displayed until 21-Jul-2009

Reasons for adding or updating:

  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 01-Feb-2009

Legal Category:POM

Black Triangle (CHM): YES

Free-text change information supplied by the pharmaceutical company:

Date of revision updated

Updated on 22-Jan-2009 and displayed until 16-Mar-2009

Reasons for adding or updating:

  • Change to section 6. 5 - Nature and Contents of Container

Date of revision of text on the SPC: 01-Nov-2008

Legal Category:POM

Black Triangle (CHM): YES

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 17-Jun-2008 and displayed until 22-Jan-2009

Reasons for adding or updating:

  • New SPC for new product

Legal Category:POM

Black Triangle (CHM): NO

Company contact details

Pfizer Limited

Company image
Address

Ramsgate Road, Sandwich, Kent, CT13 9NJ

Fax

+44 (0)1304 656 221

Telephone

+44 (0)1304 616 161

Medical Information Website

Before you contact this company: often several companies will market medicines with the same active ingredient. Please check that this is the correct company before contacting them. Why?

Active ingredients

fesoterodine fumarate

Legal categories

POM - Prescription Only Medicine

This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue