What Qutenzacontains
The active substance is capsaicin. Each 280cm 2patch contains a total of 179mg of capsaicin or 640micrograms of capsaicin per cm 2of patch (8%w/w).
The other ingredients of the Qutenza cutaneous patch are:
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
The Qutenzapatch is supplied with a tube of cleansing gel,which contains no active substance.
Cleansing gel contains:
macrogol 300
carbomer
purified water
sodium hydroxide (E524)
disodium edetate
butylhydroxyanisole (E320)
What Qutenzalooks like and contents of the pack
Qutenza is a cutaneous patch for use on your skin.
Each patch is 14cm x 20cm (280cm 2) 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 Qutenza carton contains 1 or 2sachetsand1tube of cleansing gel (50g). Not all pack sizes may be marketed.
Marketing Authorisation Holder:
Astellas Pharma Europe B.V.
Elisabethhof 19
2353 EW Leiderdorp
Netherlands
Manufacturer:
GP Grenzach Produktions GmbH (GP)
Emil-Barell-Strasse 7
D-79639 Grenzach-Wyhlen Germany
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
BelgiëBelgiqueBelgienAstellas Pharma B.V. BranchTélTel 32 02 5580710LuxembourgLuxemburgAstellas Pharma B.V.BranchBelgiqueBelgienTélTel 32 02 558071
Te. 359 2 862 53 72 MagyarországAstellas Pharma Kft.Tel. 36 061 361467
eská republikaAstellas Pharma s.r.o.Tel 420 236 080300 MaltaE.J. Busuttil Ltd.Tel 356 2144718
DanmarkAstellas Pharma asTlf 45 43 430355 NederlandAstellas Pharma B.V.Tel 31 071 545574
DeutschlandAstellas Pharma GmbHTel 49 089 454401 NorgeAstellas Pharma Tlf 47 66 76 46 0
ÖsterreichAstellas Pharma Ges.m.b.H.Tel 43 01 8772668EestiAstellas Pharma Europe B.V.HollandTel 31 071 545574
Astellas Pharmaceuticals AEBE 30 210 8189900 PolskaAstellas Pharma Sp.z.o.o.Tel. 48 225451 11
EspañaAstellas Pharma S.A.Tel 34 91 4952700 PortugalAstellas Farma, Lda.Tel 351 21 440132
FranceAstellas Pharma S.A.S.Tél 33 01 55917500 RomâniaS.C.Astellas Pharma SRLTel 40 021 361 04 9
IrelandAstellas Pharma Co. Ltd.Tel 353 01 4671555SlovenijaAstellas Pharma Europe B.V.NizozemskaTel 31 071 545574
ÍslandVistor hfSími 354 535 7000 Slovenská republikaAstellas Pharma s.r.o., Tel 421 2 4444 215
ItaliaAstellas Pharma S.p.A.Tel 39 02 921381 SuomiFinlandAstellas Pharma PuhTel 358 09 8560600
Astellas Pharmaceuticals AEBE 30 210 8189900 SverigeAstellas Pharma ABTel 46 040-650 15 0
United KingdomAstellas Pharma Ltd.Tel 44 0 1784 419615LatvijaAstellas Pharma Europe B.V.NderlandeTel 31 071 545574
Lietuva
Astellas Pharma Europe B.V.
Nyderlandai
Tel. +31 (0)71 5455745
This leaflet was last approved in MM/YYYY
The following information is intended for medical or healthcare professionals only.A complete Summary of Product Characteristics (SPC)is providedwith this leaflet.