QUTENZA Cutaneous patch Ref.[6296]
Active ingredients: Capsaicin

Source: European Medicines Agency (EU) |  Revision Year: 2017 |  Publisher: Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany

Product name and form

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%’.

Qualitative and quantitative composition

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

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



Silicone adhesives
Diethylene glycol monoethyl ether
Silicone oil
Ethylcellulose N50 (E462)

Backing layer:

Polyester backing film
Printing ink containing Pigment White 6

Removable protective layer:

Polyester release liner

Cleansing gel:

Macrogol 300
Purified water
Sodium hydroxide (E524)
Disodium edetate
Butylhydroxyanisole (E320)

Pack sizes and marketing

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.

Marketing authorization holder

Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany

Marketing authorization dates and numbers


Date of first authorisation: 15 May 2009

Date of latest renewal: 15 May 2014


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