eMC Medicine Guides  
The electronic Medicines Compendium (eMC) contains information about UK licensed medicines.
go to eMC homepage
Search for:  
  Advanced Search

Astellas Pharma Ltd
3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH
Telephone: +44 (0)1784 419615
Fax: +44 (0)1784 419583
Medical Information Direct Line: 0800 783 5018
Medical Information e-mail: medinfo@gb.astellas.com

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: 12/10/2011
SPC Vesicare 5mg & 10mg film-coated 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 12/10/2011 and displayed until Current
Reasons for adding or updating:
  • Change to section 4.4 - Special warnings and precautions for Use
  • 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:   08-Sep-2011
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.4 Special Warnings and Precautions For Use

 

Addition of text:

‘Angioedema with airway obstruction has been reported in some patients on Solifenacin succinate. If Angioedema occurs, Solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.’

 

Section 4.8 Undesirable Effects

 

Side Effects ‘Dizziness, Headaches, Vomiting, Pruritus and Rash’ have been moved from Very Rare (< 1/10,000) to Rare (> 1/10000, < 1/1000) in the undesirable effects table.

Angioedema has been added as a side effect listed under ‘very rare <1/10,000’

The Undesirable effects table, has been re-formatted. The formatting change is to add a new column headed ‘Not known (cannot be estimated from the available data) to the undesirable effects table.

 

Section 10

Date Of Revision Of Text
Updated on 18/04/2011 and displayed until 12/10/2011
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   13-Dec-2010
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


In section 7 the address of the MAH, Astellas Pharma Ltd., has been updated following a move to new premises.  This entails the address changing from Lovett House, Lovett Road, Staines, TW18 3AZ, United Kingdom to 3rd Floor, Future House, The Glanty, Egham, Surrey, TW20 9AH, United Kingdom.

 

In section 10 the last revision date of the text has been revised to correspond with this move to new premises as detailed in Section 7.  This date is updated to 13th December 2010.
Updated on 16/03/2010 and displayed until 18/04/2011
Reasons for adding or updating:
  • Correction of spelling/typing errors
Date of revision of text on the SPC:   23-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
None provided
Updated on 26/01/2010 and displayed until 16/03/2010
Reasons for adding or updating:
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 10 date of revision of the text
Date of revision of text on the SPC:   23-Nov-2009
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 4.8

 

 "Confusional state" has been added as a very rare side effect under Psychiatric disorders, and "erythema multiforme" has been added as a very rare side effect under Skin and subcutaneous tissue disorders.  The text has been added underneath the table with regards to QT prolongation and Torsade de Pointes.  Asterisks have been added to the table.

 

MedDRA system organ class

Very common ≥1/10

Common

>1/100, <1/10

Uncommon

>1/1000, <1/100

Rare

> 1/10000, <1/1000

Very rare

<1/10,000, not known (cannot be estimated from the available data)

Infections and infestations

 

 

Urinary tract infection

Cystitis

 

 

Psychiatric disorders

 

 

 

 

Hallucinations*

Confusional state*

Nervous system disorders

 

 

Somnolence

Dysgeusia

 

Dizziness*, Headache*

Eye disorders

 

Blurred vision

Dry eyes

 

 

Respiratory, thoracic and mediastinal disorders

 

 

Nasal dryness

 

 

Gastrointestinal disorders

Dry mouth

Constipation
Nausea
Dyspepsia
Abdominal pain

Gastro-oesophageal reflux diseases

Dry throat

Colonic obstruction

Faecal impaction

Vomiting*

Skin and subcutaneous tissue disorders

 

 

Dry skin

 

Erythema multiforme* , Pruritus*, Rash*, Urticaria*

Renal and urinary disorders

 

 

Difficulty in micturition

Urinary retention

 

General disorders and administration site conditions

 

 

Fatigue Peripheral oedema

 

 

 

*observed post-marketing

 

QT prolongation and Torsade de Pointes have been reported in association with solifenacin use in worldwide postmarketing experience. Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of solifenacin in their causation cannot be reliably determined.

 

 

Section 6.3

Addition of bottle presentation (Please note that the bottle is not being marketed in the UK)

Section 6.5

Addition of 200 pack size (Please note that the 200 pack size is not being marketed in the UK)

Addition of bottle presentation (Please note that the bottle is not being marketed in the UK)

 
Updated on 23/09/2008 and displayed until 26/01/2010
Reasons for adding or updating:
  • Change to section 4.9 - Overdose
  • Change to section 5.2 - Pharmacokinetic Properties
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 4.4 - Special warnings and precautions for Use
  • Change to section 4.8 - Undesirable Effects
  • Change to section 6. 6 - Instructions for use, handling and disposal
Date of revision of text on the SPC:   10-Sep-2008
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company


Section 2         QUALITATIVE AND QUANTITATIVE COMPOSITION

 

The following has been added:

 

Excipients: lactose monohydrate 107.5mg (5mg), 102.5mg (10mg)

 

 

Section 4.4      Special warnings and precautions for use

 

The heading has been updated.



4.8       Undesirable effects

The table in this section has been updated.

 

4.9              Overdose

 

The first two paragraphs of this section have been updated to read as follows:

 

Overdosage with solifenacin succinate can potentially result in severe anticholinergic effects.  The highest dose of solifenacin succinate accidentally given to a single patient was 280 mg in a 5 hour period, resulting in mental status changes not requiring hospitalisation.

In the event of overdose with    solifenacin succinate, the patient should be treated with activated charcoal.  Gastric lavage is useful if performed within 1 hour, but vomiting should not be induced.

 

5.2       Pharmacokinetic properties

Grammatical error corrections have been made in the last two paragraphs.

 

6.6       Special precautions for disposal

 

The heading has been updated.
Updated on 11/01/2008 and displayed until 23/09/2008
Reasons for adding or updating:
  • Removal of Black Triangle
Date of revision of text on the SPC:   12/2007
Legal Category:   POM
Black Triangle (CHM):   NO

Free-text change information supplied by the pharmaceutical company
 
The Black Triangle has been removed.
Updated on 06/01/2006 and displayed until 11/01/2008
Reasons for adding or updating:
  • Change to section 7 - Marketing Authorisation Holder
  • Change to section 10 (date of (partial) revision of the text
Updated on 18/07/2005 and displayed until 06/01/2006
Reasons for adding or updating:
  • Change to section 6. 3 - Shelf Life
  • Change to section 6. 5 - Nature and Contents of Container
Updated on 25/08/2004 and displayed until 18/07/2005
Reasons for adding or updating:
  • New SPC for new product

Active Ingredients/Generics

 
  solifenacin succinate