Qutenza
Land: Den Europæiske Union
Sprog: engelsk
Kilde: EMA (European Medicines Agency)
Indlægsseddel
(PIL)
04-12-2023
Produktets egenskaber
(SPC)
04-12-2023
Offentlige vurderingsrapport
(PAR)
08-10-2015
Aktiv bestanddel:
capsaicin
Tilgængelig fra:
Grunenthal GmbH
ATC-kode:
N01BX04
INN (International Name):
capsaicin
Terapeutisk gruppe:
Anesthetics
Terapeutisk område:
Neuralgia
Terapeutiske indikationer:
Qutenza is indicated for the treatment of peripheral neuropathic pain in adults either alone or in combination with other medicinal products for pain.
Produkt oversigt:
Revision: 19
Autorisation status:
Authorised
Autorisation dato:
2009-05-15
Indlægsseddel
23
B. PACKAGE LEAFLET
24
PACKAGE LEAFLET: INFORMATION FOR THE USER
QUTENZA 179 MG CUTANEOUS PATCH
capsaicin
READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE BECAUSE IT CONTAINS
IMPORTANT INFORMATION FOR YOU.
Keep this leaflet. You may need to read it again.
If you have any further questions, ask your doctor.
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them,
even if their signs of illness are the same as yours.
If you get any side effects talk to your doctor. This includes any
possible side effects not listed
in this leaflet. See section 4.
WHAT IS IN THIS LEAFLET
1.
What Qutenza is and what it is used for
2.
What you need to know before Qutenza is used
3.
How to use Qutenza
4.
Possible side effects
5.
How to store Qutenza
6.
Contents of the pack and other information
1.
WHAT QUTENZA IS AND WHAT IT IS USED FOR
Qutenza contains capsaicin and belongs to a group of medicines called
anaesthetics.
Qutenza is indicated for the treatment of peripheral neuropathic pain
in adults either alone or in
combination with other medicines for the treatment of pain.
Qutenza is used to relieve pain in people who have nerve pain due to
damaged nerves in the skin.
Damaged nerves in your skin may occur as a result of a variety of
diseases such as shingles, HIV
infection, diabetes, certain medicines and other conditions. You may
experience pain relief between 1
and 3 weeks after treatment.
2.
WHAT YOU NEED TO KNOW BEFORE QUTENZA IS USED
DO NOT USE QUTENZA
if you are allergic to capsaicin (also present in chili peppers) or
any other ingredients of this
medicine (listed in section 6).
WARNINGS AND PRECAUTIONS
Talk to your doctor before using Qutenza
Do not use Qutenza on any part of your head or face.
Do not use Qutenza on broken skin or open wounds.
Do not touch Qutenza or other materials that have come in contact with
the treated areas as it may
cause burning and stinging. Do not touch your eyes, mouth or other
sensitive areas as it may cause
irritat
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Produktets egenskaber
1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
Qutenza 179 mg cutaneous patch
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each 280 cm
2
cutaneous patch contains a total of 179 mg of capsaicin or 640
micrograms of capsaicin
per cm
2
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.
3.
PHARMACEUTICAL FORM
Cutaneous patch.
Each patch is 14 cm x 20 cm (280 cm
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%’.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Qutenza is indicated for the treatment of peripheral neuropathic pain
in adults either alone or in
combination with other medicinal products for the treatment of pain.
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
The Qutenza cutaneous patch should be applied by a physician or by a
health care professional under
the supervision of a physician.
Posology
The cutaneous patch should be applied to the most painful skin areas
(using up to a maximum of
4 patches). The painful area should be determined by the physician or
by a health care professional
and marked on the skin. Qutenza must be applied to intact,
non-irritated, dry skin, and allowed to
remain in place for 30 minutes for the feet (e.g. HIV-associated
neuropathy, painful diabetic peripheral
neuropathy) and 60 minutes for other locations (e.g. postherpetic
neuralgia).
Qutenza treatments may be repeated every 90 days, as warranted by the
persistence or return of pain.
Re-treatment after less than 90 days can be considered for individual
patients only after a careful
assessment by the physician (see also section 5.1). A minimum interval
of 60 days between treatments
is to be observed.
It is recommended to treat sufficiently long and t
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