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Pfizer Limited
Ramsgate Road, Sandwich, Kent, CT13 9NJ
Telephone: +44 (0)1304 616 161
Fax: +44 (0)1304 656 221

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?
Summary of Product Characteristics last updated on the eMC: 28/03/2012
SPC TOVIAZ 4 mg prolonged-release tablets & TOVIAZ 8 mg prolonged-release tablets

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 28/03/2012 and displayed until Current
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 09/03/2012 and displayed until 28/03/2012
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 01/11/2011 and displayed until 09/03/2012
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 04/04/2011 and displayed until 01/11/2011
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 16/02/2011 and displayed until 04/04/2011
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 03/11/2010 and displayed until 16/02/2011
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 12/07/2010 and displayed until 03/11/2010
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 21/07/2009 and displayed until 12/07/2010
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 16/03/2009 and displayed until 21/07/2009
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 22/01/2009 and displayed until 16/03/2009
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 17/06/2008 and displayed until 22/01/2009
Reasons for adding or updating:
  • New SPC for new product
Date of revision of text on the SPC:  
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided

Active Ingredients/Generics

 
  fesoterodine fumarate