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QUTENZA Cutaneous patch (2017)

Active ingredients: Capsaicin

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.

Chemical substance
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
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
Carbomer
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
Authorization dates

Grünenthal GmbH, Zieglerstraße 6, 52078, Aachen, Germany

Date of first authorisation: 15 May 2009

Date of latest renewal: 15 May 2014

Marketing authorization number:

EU/1/09/524/001-002