Source: European Medicines Agency (EU) Revision Year: 2017 Publisher: Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany
Qutenza 179 mg cutaneous patch.
| Pharmaceutical Form |
|---|
|
Cutaneous patch. Each patch is 14 cm x 20 cm (280 cm²) and consists of an adhesive side containing the active substance and an outer surface backing layer. The adhesive side is covered with a removable, clear, unprinted, diagonally cut, release liner. The outer surface of the backing layer is imprinted with ‘capsaicin 8%’. |
Each 280 cm² cutaneous patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per cm² of patch.
Excipient with known effect: Each 50 g tube of cleansing gel for Qutenza contains 0.2 mg/g butylhydroxyanisole (E320).
For the full list of excipients, see section 6.1.
| Active Ingredient | Description | |
|---|---|---|
| Capsaicin |
Capsaicin, or 6-nonenamide, N-[(4-hydroxy-3-methoxyphenyl) methyl]-8-methyl, (6E), is a highly selective agonist for the transient receptor potential vanilloid 1 receptor (TRPV1). The initial effect of capsaicin is the activation of TRPV1-expressing cutaneous nociceptors, which results in pungency and erythema due to the release of vasoactive neuropeptides. |
| List of Excipients |
|---|
|
Patch: Matrix: Silicone adhesives Backing layer: Polyester backing film Removable protective layer: Polyester release liner Cleansing gel: Macrogol 300 |
The Qutenza patch is stored in a paper coated aluminium foil sachet with acrylnitrile-acrylic acid copolymer heat seal layer.
Qutenza is available in a kit containing one or two individually sealed Qutenza patches and a 50 g tube of cleansing gel.
Not all pack sizes may be marketed.
Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany
EU/1/09/524/001-002
Date of first authorisation: 15 May 2009
Date of latest renewal: 15 May 2014
| Drug | Countries | |
|---|---|---|
| QUTENZA | Austria, Cyprus, Ecuador, Estonia, Spain, Finland, France, Ireland, Lithuania, Netherlands, Poland, Romania, United Kingdom, South Africa |
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
