Source: European Medicines Agency (EU) | Revision Year: 2017 | Publisher: Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany
Qutenza 179 mg 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.
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.
Diethylene glycol monoethyl ether
Ethylcellulose N50 (E462)
Polyester backing film
Printing ink containing Pigment White 6
Removable protective layer:
Polyester release liner
Sodium hydroxide (E524)
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
Date of first authorisation: 15 May 2009
Date of latest renewal: 15 May 2014
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