Qutenza 179mg cutaneous patches

Maa: Yhdistynyt kuningaskunta

Kieli: englanti

Lähde: MHRA (Medicines & Healthcare Products Regulatory Agency)

Aktiivinen ainesosa:

Capsaicin

Saatavilla:

Grunenthal Ltd

INN (Kansainvälinen yleisnimi):

Capsaicin

Annos:

179mg

Lääkemuoto:

Cutaneous patch

Antoreitti:

Cutaneous

luokka:

No Controlled Drug Status

Prescription tyyppi:

Valid as a prescribable product

Tuoteyhteenveto:

BNF: 10030200; GTIN: 5013346098582

Pakkausseloste

1 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 medicinal products for 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, chilli 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
irritation and pain. Sniffing or inhaling close to the

Valmisteyhteenveto

OBJECT 1
QUTENZA 179MG CUTANEOUS PATCH
Summary of Product Characteristics Updated 12-May-2017 | Grunenthal
Ltd
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 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
Qutenza 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 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.
The treatment area may be pre-treated with a topical anaesthetic or
the patient may be administered an
oral analgesic prior to application of Qutenza to reduce potential
application related discomfort. The
topical anaesthetic should be applied to cover the entire Qutenza