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Versatis 5% Medicated Plaster

Last Updated on eMC 27-Apr-2015 View document  | Grunenthal Ltd Contact details

Versions

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 27-Apr-2015 and displayed until Current

Reasons for adding or updating:

  • Correction of spelling/typing errors

Date of revision of text on the SPC: 13-Nov-2014

Legal Category:POM

Black Triangle (CHM): NO

Updated on 05-Feb-2015 and displayed until 27-Apr-2015

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.8 - Undesirable effects - how to report a side effect

Date of revision of text on the SPC: 13-Nov-2014

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

In section 4.2 - clarity provided on the re-evaluation of reapplying the plaster
In section 4.8 - inclusion of the local Adverse Event reporting information

Updated on 11-Sep-2013 and displayed until 05-Feb-2015

Reasons for adding or 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 4.6 - Fertility, pregnancy and lactation
  • 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: 28-Aug-2013

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Section 2 updated – excipients with known effect.

Section 4.1 – in adults added at the end of the indication.

Section 4.3 – listed in section 6.1 added to first sentence.

Section 4.6 amended to include fertility section.

Section 9 and 10 updated to include the date of approval – 28 August 2013

Updated on 23-Jan-2012 and displayed until 11-Sep-2013

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties

Date of revision of text on the SPC: 13-Dec-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

5.1 - update to mechanism of action

Updated on 13-Jan-2012 and displayed until 23-Jan-2012

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.6 - Pregnancy and Lactation
  • 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

Date of revision of text on the SPC: 13-Dec-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



4.2 - advice usage long-term, in renal impairment patients,  in hepatic impairment,  paediatric patients

4.6 -added: "Animal studies do not indicate a teratogenic potential for lidocaine (see section 5.3)." 

5.1 - Update and revised wording on clinical study text/information.

5.2 - typo corrected

5.3 - Revised wording on preclinical information

6.1 - typo corrected

Updated on 22-Dec-2011 and displayed until 13-Jan-2012

Reasons for adding or updating:

  • Change to section 5.1 - Pharmacodynamic Properties
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 13-Dec-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

5.1 - amending the text to describe the pain relief on a 6 point scale.

10 - date of revision to 13.12.2011

Updated on 05-Dec-2011 and displayed until 22-Dec-2011

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 25-Nov-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Added to section 4.2 : "The plaster can be applied during the day or during the night"

Section 10: Date changed to 25 November 2011

Updated on 26-May-2011 and displayed until 05-Dec-2011

Reasons for adding or updating:

  • 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: 18-May-2011

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



Summary of changes: Section 4.8 of the SmPC was updated in order to enhance the readability and to avoid misunderstandings regarding administration site reactions and skin reactions in general. Details below.

 

SmPC OLD

SmPC REVISED

Summary of Product Characteristics

 

4.8 Undesirable effects

…

The most commonly reported adverse reactions were administration site reactions including erythema, rash, application site pruritus, application site burning, application site dermatitis, application site erythema, application site vesicles, dermatitis, skin irritation, and pruritus.

…

 

 

 

10        Date of revision of the text

04 September 2009

Summary of Product Characteristics

 

4.8 Undesirable effects

…

The most commonly reported adverse reactions were administration site reactions including (such as burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles). erythema, rash, application site pruritus, application site burning, application site dermatitis, application site erythema, application site vesicles, dermatitis, skin irritation, and pruritus.

 

…

10        Date of revision of the text

18 May 2011

Updated on 09-Sep-2009 and displayed until 26-May-2011

Reasons for adding or updating:

  • Change to section 4.2 - Posology and method of administration
  • Change to section 4.4 - Special warnings and precautions for Use

Date of revision of text on the SPC: 04-Sep-2009

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:

Sections 4.2 and 4.4 updated to reflect warnings concerning long-term use.

Section 4.2 updated statement:

Treatment outcome should be re-evaluated after 2-4 weeks. If there has been no response to Versatis after this period or if any relieving effect can solely be related to the skin protective properties of the plaster, treatment must be discontinued as potential risks may outweigh benefits in this context (see sections 4.4 and 5.1).

Section 4.4 updated statement:
One of the lidocaine metabolites, 2,6 xylidine, has been shown to be genotoxic and carcinogenic in rats (see section 5.3). Secondary metabolites have been shown to be mutagenic. The clinical significance of this finding is unknown. Consequently long term treatment with Versatis is only justified if there is a therapeutic benefit for the patient (see section 4.2).

 

Updated on 21-Oct-2008 and displayed until 09-Sep-2009

Reasons for adding or 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 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. 3 - Shelf Life
  • Change to section 6. 4 - Special Precautions for Storage
  • Change to section 6. 5 - Nature and Contents of Container
  • Change to section 6. 6 - Instructions for use, handling and disposal
  • Change to section 10 date of revision of the text
  • Change to section 2 - Qualitative and quantitative composition
  • Change to section 3 - Pharmaceutical form

Date of revision of text on the SPC: 20-Feb-2008

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:


SPC changes as follows:
 
Section 2
Update to format, addition of excipients.
 
Section 3
Update to format.
 
Section 4.1
Change
From:  'Versatis is indicated for the treatment of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).'
To:  'Versatis is indicated for the symptomatic relief of neuropathic pain associated with previous herpes zoster infection (post-herpetic neuralgia, PHN).'
 
Section 4.2
Clarification and further advice on applying the plaster and how long to use the plaster.
 
Section 4.3
Addition of: 'The plaster must not be applied to inflamed or injured skin, such as active herpes zoster lesions, atopic dermatitis or wounds.'
 
Section 4.4
Changes in warnings including addition of information on lidocaine metabolites and information on long term use.
 
Section 4.5
Format
 
Section 4.6
Statement on status of animal studies.
 
Section 4.8
Format
 
Section 5.1
Additional statements from post hoc clinical analyses.
 
Section 5.2
Reworded section on details on absorption details nad levels. Reduction in wording on biotransformation, elimination and linearity.
 
Section 5.3
Update in statements on tumorigenic and animal studies.   
 
Section 6.1
Removal of E numbers and update to statement for liquid sorbitol
 
Section 6.3
Clarification of wording.

Section 6.4
Clarification of wording.
 
Section 6.5
Clarification of wording.
 
Section 6.6
Clarification of wording.
 
Section 10
Update to date.

Updated on 18-Sep-2008 and displayed until 21-Oct-2008

Reasons for adding or updating:

  • Change to section 3 - Pharmaceutical form
  • Change to section 10 date of revision of the text

Date of revision of text on the SPC: 09-Jan-2007

Legal Category:POM

Black Triangle (CHM): NO

Free-text change information supplied by the pharmaceutical company:



3       PHARMACEUTICAL FORM

embossing  statement from "Lidocaine 5% plaster"  to  "Lidocaine 5%" 

10     DATE OF REVISION OF THE TEXT

new date of 09 January 2007

Updated on 05-Jan-2007 and displayed until 18-Sep-2008

Reasons for adding or updating:

  • New SPC for new product

Company contact details

Company image
Address

Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK

Medical Information e-mail
Medical Information Direct Line

+44 (0)870 351 8960

Medical Information Fax

+44 (0)1494 486298

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

lidocaine

Legal categories

POM - Prescription Only Medicine

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