Qutenza 179mg cutaneous patch
Last Updated on eMC 12-May-2017 View document | Grunenthal Ltd 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-May-2017 and displayed until Current
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: 04-May-2017
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 7: Marketing Authorisation Holder
Updated following marketing authorisation transfer to Grunenthal GmbH, Zieglerstraße 6, 52078 Aachen, Germany
Section 10: Date of Revision of the text
04 May 2017
Updated on 23-Sep-2015 and displayed until 12-May-2017
Reasons for adding or updating:
- Correction of spelling/typing errors
Date of revision of text on the SPC: 20-Aug-2015
Legal Category:POM
Black Triangle (CHM): NO
Updated on 04-Sep-2015 and displayed until 23-Sep-2015
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 4.4 - Special warnings and precautions for use
- 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 6.6 - Special precautions for disposal and other handling
- Change to section 10 - Date of revision of the text
- Improved presentation of SPC
Date of revision of text on the SPC: 20-Aug-2015
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
The SmPC has been updated to remove the restriction of ‘non-diabetic’ from the indication, with associated changes throughout the rest of the document. Minor editorial/formatting changes have also been made.
The key changes are:
Section 4.1 Therapeutic indications
Removal of ‘non-diabetic’ so this section now reads “Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain”.
Section 4.2 Posology and method of administration
Posology: Addition of ‘painful diabetic peripheral neuropathy’ to the wording regarding treatment of the foot.
Method of administration: Re-wording of section ‘Precautions to be taken before handling or administering the medicinal product’ to read ‘Use of a mask and protective glasses is recommended, particularly during application and removal of the patch.’ Section 6.6 is also updated to this effect.
Section 4.4 Special warnings and precautions for use
Substantial re-wording of this section, including new advice to administer in a well ventilated area, the requirement to conduct a foot examination prior to application in PDPN patients, expansion of the warning on possible reduction in sensory function, and addition of the following statement “Particular attention should be given to diabetic patients with comorbidities of coronary artery disease, hypertension and cardiovascular autonomic neuropathy.”
Section 4.8 Undesirable effects
Figures in the introductory paragraph have been amended to reflect the additional trial data.
The adverse events ‘burning sensation’ and ‘pain in extremity’ have both been moved from Uncommon to Common in the AE table.
Section 5.1 Pharmacodynamic properties
Update to the Clinical efficacy and safety section to add clinical data for painful diabetic peripheral neuropathy.
Section 10 Date of Revision has been updated to reflect the European Commission decision date of 20 August 2015.
Updated on 11-Jun-2014 and displayed until 04-Sep-2015
Reasons for adding or updating:
- Change to section 2 - Qualitative and quantitative composition
- Change to section 4.2 - Posology and method of administration
- Change to section 4.4 - Special warnings and precautions for use
- Change to section 4.6 - Fertility, pregnancy and lactation
- Change to section 4.8 - Undesirable effects
- Change to section 4.8 - Undesirable effects - how to report a side effect
- Change to section 5.1 - Pharmacodynamic properties
- Change to section 6.3 - Shelf life
- Change to section 6.6 - Special precautions for disposal and other handling
- 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: 23-Apr-2014
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Section 2 Qualitative and Quantitative composition
- removal of ‘(8% w/w)’ from first sentence.
Section 4.2 Posology and method of administration - The Posology sub-section has been simplified – some text has been deleted from paragraph 2 (some of which has been moved under Method of administration).
Section 4.6 Fertility, pregnancy and lactation - addition of the following sentence under Fertility: ‘A reproductive toxicology study in rats showed a reduction in the number and percent of motile sperm and the number of pregnancies (see section 5.3).’
Section 4.8 Undesirable effects - removal of the following paragraph: ‘No treatment-related reductions in neurological function, as evaluated by Quantitative Sensory Testing (QST) and neurological examinations, have been observed during clinical trials in patients with peripheral neuropathic pain’
- addition of mandatory AE wording referring to MHRA’s Yellow Card Scheme.
Section 6.3 Shelf life - removal of the words ‘Unopened sachet’.
Section 6.6 Special precautions for disposal and other handling - Addition of stipulation that used and unused patches should be disposed of ‘immediately after use’ (this wording was previously located under 4.2)
Section 9 Date of latest renewal and Section 10 Date of Revision have also been updated.
Updated on 27-Mar-2013 and displayed until 11-Jun-2014
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
- Change to section 4.8 - Undesirable effects
- Change to section 6.6 - Special precautions for disposal and other handling
- 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: 11-Mar-2013
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
· Section 4.2 (Posology) – modification to the requirement to be pre-treated with a topical anaesthetic
· Section 4.2 (Method of Administration) - updated to provide further instructions (no air bubbles and no moisture).
· Section 4.4 (Special Warnings and precautions for use) – updated with regards to application site reactions
· Section 4.8 (Undesirable effects) – addition of application site pain, application site erythema, second degree burns, accidental exposure
· Section 6.6 (Special precautions for disposal and other handling) – reference to the use of mask and protective glasses
· Section 7 (Marketing Authorisation Holder) – updated to reflect the move of Astellas Pharma Europe B.V. (Marketing Authorisation Holder for Qutenza).
Updated on 23-Aug-2012 and displayed until 27-Mar-2013
Reasons for adding or updating:
- Removal of Black Triangle
Date of revision of text on the SPC: 21-Feb-2011
Legal Category:POM
Black Triangle (CHM): NO
Free-text change information supplied by the pharmaceutical company:
Removal of Black TriangleUpdated on 18-Apr-2011 and displayed until 23-Aug-2012
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
- Correction of spelling/typing errors
Date of revision of text on the SPC: 21-Feb-2011
Legal Category:POM
Black Triangle (CHM): YES
Free-text change information supplied by the pharmaceutical company:
In section 4.2 a revision to the description of the pre-treatment processes has been made.
In addition the a few minor editorial amendments to the SPC have been included.
In section 10 the last revision date of the text has been revised to correspondence with the date of the most recent Commission Decision as related to these changes.
Updated on 22-Jun-2010 and displayed until 18-Apr-2011
Reasons for adding or updating:
- New SPC for new product
Legal Category:POM
Black Triangle (CHM): YES
Grunenthal Ltd
Units 1 and 2 Stokenchurch Business Park, Ibstone Road, Stokenchurch, Buckinghamshire, HP14 3FE, UK
+44 (0)870 351 8960
+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
Legal categories
This site uses cookies. By continuing to browse the site you are agreeing to our policy on the use of cookies. Continue