Versatis 700 mg medicated plaster
- Name:
Versatis 700 mg medicated plaster
- Company:
Grunenthal Pharma Ltd.
- Active Ingredients:
- Legal Category:
Product subject to medical prescription which may be renewed (B)
Patient Information Leaflet Patient Information Leaflet last updated on medicines.ie: 03/08/18

XPIL
PACKAGE LEAFLET: INFORMATION FOR THE USER
PACKAGE LEAFLET: INFORMATION FOR THE USER
1. WHAT VERSATIS IS AND WHAT IT IS USED FOR
1. WHAT VERSATIS IS AND WHAT IT IS USED FOR
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VERSATIS
2. WHAT YOU NEED TO KNOW BEFORE YOU USE VERSATIS
3. HOW TO USE VERSATIS
3. HOW TO USE VERSATIS
4. POSSIBLE SIDE EFFECTS
4. POSSIBLE SIDE EFFECTS
5. HOW TO STORE VERSATIS
5. HOW TO STORE VERSATIS
6. CONTENTS OF THE PACK AND OTHER INFORMATION
6. CONTENTS OF THE PACK AND OTHER INFORMATION
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Grunenthal Pharma Ltd.

Company Products
When a pharmaceutical company changes any document, a new version is published on medicines.ie. For each version, we show the dates it was published on medicines.ie and the reasons for change.
Updated on 3 August 2018
Updated on 27 July 2018 PIL
Reasons for updating
- Change to section 6 - marketing authorisation holder
- Change to section 6 - marketing authorisation number
Updated on 24 July 2018 SPC
Reasons for updating
- Change to section 7 - Marketing authorisation holder
- Change to section 8 - Marketing authorisation number(s)
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 6 July 2018 SPC
Reasons for updating
- Change to section 9 - Date of first authorisation/renewal of the authorisation
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Date of last renewal updated
Updated on 7 February 2018 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Updated on 7 February 2018 PIL
Reasons for updating
- New PIL for new product
Updated on 7 February 2018 SPC
Reasons for updating
- Change to section 1 - Name of medicinal product
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 5.2 - Pharmacokinetic properties
- 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 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 2: Qualitative and quantitative composition - '50mg lidocaine per gram adhesive' has been deleted. E numbers for methyl parahydroxybenzoate, propyl parahydroxybenzoate and propylene glycol added.
Section 4.4: Special warning and precautions for use - E numbers for methyl parahydroxybenzoate, propyl parahydroxybenzoate and propylene glycol added.
Section 5.1: Pharmacodynamic properties - reference to 5% replaced with 700mg
Section 5.2: Pharmacokinetic properties - reference to 5% replaced with 700mg
Section 6.1: List of excipients - liquid sorbitol,
Section 6.4: Special precautions for use (new text I italics) - After first opening: Keep the sachet tightly closed to protect from light.
Updated on 7 February 2018 PIL
Reasons for updating
- Change to section 4 - possible side effects
- Change to section 5 - how to store or dispose
- Change to section 6 - what the product contains
- Change to section 6 - date of revision
- Change to name of medicinal product
Updated on 8 April 2015 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to Section 4.8 – Undesirable effects - how to report a side effect
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
....
If these has been no response to Versatis after this period (during the wearing time and/or during the plaster-free interval)
Section 4.8:
details on reporting suspected adverse reactions to HPRA
Dare of revision of text:
November 2014
Updated on 8 April 2015 PIL
Reasons for updating
- Change to date of revision
- Addition of information on reporting a side effect.
Updated on 25 June 2013 SPC
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 4.6 - Pregnancy and lactation
- Change to section 4.9 - Overdose
- Change to section 9 - Date of renewal of authorisation
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.1 - addition of 'in adults' as part of the indication
Section 4.3 - cross reference to Section 6.1
Section 4.6 - section titles and addition of statement on fertility data
Section 4.9 - addition of comma
Section 9 - dates of authorisations updated
Section 10 - date updated
Updated on 21 June 2013 PIL
Reasons for updating
- Change to information about pregnancy or lactation
- Change to date of revision
- Change to improve clarity and readability
Updated on 3 February 2012 PIL
Reasons for updating
- Change to improve clarity and readability
Updated on 30 January 2012 PIL
Reasons for updating
- Change to how the medicine works
- Change to date of revision
Updated on 30 January 2012 SPC
Reasons for 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 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
SPC section 4.2 – statement on long-term use, use in renally impaired patients, use in hepatically impaired patients, data related to children
SPC section 4.6 –statement updated related to animal data
SPC section 5.1 – update to statement on mechanism of action, updates to clinical data information and clarity of data
SPC section 5-2 - typographic
SPC section 5.3 – update to statements on toxicity, embryo-foetal development, male fertility
SPC section 10 - date
Updated on 22 December 2011 SPC
Reasons for updating
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
5.1. - Amending the text to describe the pain relief on a six point scale
10 - updating date
Updated on 12 December 2011 SPC
Reasons for updating
- Change to section 4.2 - Posology and method of administration
- Change to section 10 - Date of revision of the text
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
10 - date changed to 25/11/2011
Updated on 8 December 2011 PIL
Reasons for updating
- Change to date of revision
- Change to dosage and administration
- Change to MA holder contact details
Updated on 27 June 2011 SPC
Reasons for updating
- 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 be renewed (B)
Free text change information supplied by the pharmaceutical company
Section 4.8
Rewording of adverse events to state:
The most commonly reported adverse reactions were administration site reactions (such as burning, dermatitis, erythema, pruritus, rash, skin irritation, and vesicles).
Section 10
Date updated:
21/06/2011
Updated on 22 December 2010 SPC
Reasons for updating
- New SPC for new product
Legal category: Product subject to medical prescription which may be renewed (B)
Free text change information supplied by the pharmaceutical company
Updated on 17 December 2010 PIL
Reasons for updating
- New PIL for new product