QUTENZA 179 mg Transdermal Patch

Зміст інструкції

1. Qutenza 179 mg cutaneous patch
   1. What is Qutenza and what is it used for
   2. What you need to know before using Qutenza
   3. How to use Qutenza
   4. Possible side effects
   5. How to store Qutenza
   6. Contents of the pack and other information

Qutenza 179 mg cutaneous patch

capsaicin

Read this leaflet carefully before you start using this medicine as it contains important
information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor. See section 4.

Contents of this leaflet:

• 1. What Qutenza is and what it is used for
• 2. What you need to know before you use Qutenza
• 3. How to use Qutenza
• 4. Possible side effects
• 5. How to store Qutenza
• 6. Contents of the pack and other information

1. What is Qutenza and what is it used for

Qutenza contains capsaicin and belongs to the group of medicines defined as anesthetics.
Qutenza is indicated for the treatment of peripheral neuropathic pain in adults both alone and in
combination with other medicines for the treatment of pain.
Qutenza is used to relieve pain in people who have neuropathic pain due to damage to the nerves
of the skin. Damage to the nerves of the skin can be a consequence of a multitude of diseases
such as, for example, shingles, HIV infection, diabetes, certain medicines and other
pathologies. You may experience pain relief within a period of one to three weeks after treatment.

2. What you need to know before using Qutenza

Do not use Qutenza

• if you are allergic to capsaicin (also present in chili peppers) or to any of the other ingredients of this medicine (listed in section 6)

Warnings and precautions
Talk to your doctor before using Qutenza
Do not use Qutenza on parts of the head or face.
Do not use Qutenza on broken skin or open wounds.
Do not touch Qutenza or other materials that have come into contact with the treated areas because they may
cause burning and a stinging sensation. Do not touch your eyes, mouth or other sensitive areas as this
may cause irritation and pain. If this happens, rinse or wash with cold water.
Smelling or inhaling near Qutenza patches may cause coughing, sore throat or sneezing.
Usually the skin stings or becomes red and burns for a short time during and after treatment with
Qutenza. Due to the pain, blood pressure may rise and therefore the doctor will measure your
blood pressure several times during treatment. If you experience severe pain, the doctor will
locally cool the area or give you pain medication. If you experience very intense pain, ask your doctor to
remove the patch.
In general, after use of capsaicin, small short-term changes in the ability to feel heat or pungency have been observed.
If you suffer from unstable or poorly controlled hypertension or have had heart problems, before undergoing
treatment with Qutenza, your doctor will consider the risk of adverse effects on the heart or
blood pressure, due to the potential stress of the procedure.

Children and adolescents
Treatment with Qutenza is not recommended in patients under the age of 18 years.

Other medicines and Qutenza
Tell your doctor if you are taking, have recently taken or might take any other
medicines. Qutenza acts locally on the skin and is not expected to affect the effect of
other medicines.

Pregnancy and breastfeeding
Qutenza should be used with caution if you are pregnant.
You must stop breastfeeding during treatment with Qutenza. If you are
pregnant, suspect you are pregnant, are planning to become pregnant, or are breastfeeding,
ask your doctor for advice before using this medicine.

Driving and using machines
No studies have been conducted on the effects of Qutenza on the ability to drive and operate
machinery. When using Qutenza, only very small amounts of the active ingredient may be
present in the bloodstream for a very short time. Therefore, it is unlikely that Qutenza will have direct effects
on concentration or the ability to drive or operate machinery.

The cleaning gel for Qutenza contains butylhydroxyanisole
The cleaning gel for Qutenza contains butylhydroxyanisole, which may cause local skin reactions
(e.g. contact dermatitis) or irritation of the eyes and mucous membranes.

3. How to use Qutenza

Qutenza must be applied exclusively by the treating physician or by a nurse under the physician's supervision.
No more than 4 patches should be used at the same time.
Qutenza must be used on the skin.
The physician or nurse will outline the most painful areas on the skin with a pen or marker.
Before applying the Qutenza patches to the skin, the areas to be treated are washed with water and soap and
dried. The hair in the areas to be treated is cut.
Before placing the Qutenza patches on the skin, the physician or nurse may apply an anesthetic gel or
cream or administer a pain medication orally to reduce the
sensation of prickling. The gel or cream must be removed before the application of Qutenza and the
skin must be washed and dried thoroughly.
The physician or nurse must wear gloves, and sometimes a mask and protective eyewear,
while using the Qutenza patches. Do not smell or inhale near the Qutenza patches as it may
cause coughing or sneezing.
Qutenza can be cut into smaller pieces to adapt it to the area to be treated. The physician or
nurse will remove the patches after 30 minutes if treating nerve pain in the feet or 60
minutes if treating nerve pain in other parts of the body.
It may take 1 to 3 weeks before you can experience pain relief with
Qutenza. If, after this period of time, you still experience a lot of pain, talk to your doctor.
Therapy with Qutenza can be repeated at intervals of 90 days, if necessary. Consult your doctor
if pain relief is insufficient or if the pain returns sooner than expected.
You may be prescribed pain relievers to take for pain caused by therapy with
Qutenza.
It is quite common for the skin to sting or become red and burn during treatment with Qutenza.
Disposable socks can be worn over the Qutenza patches if the treatment is performed on the
feet.
Sometimes the physician or nurse may apply a bandage over the Qutenza patch to
keep the patch adhering to the skin.
Do not attempt to remove the patch yourself, but have it removed by the physician or nurse.
At the end of treatment with Qutenza, the physician or nurse will clean the treated skin with the gel
cleanser contained in the tube provided with the kit. The cleansing gel is left on the skin for a
minute and then removed to eliminate any medicinal residue remaining on the skin after treatment.
After removing the cleansing gel, the area is gently washed with water and soap.

Do not touch the patch with your hands.
Do not touch your eyes, mouth or other sensitive areas.If you accidentally touch the Qutenza patch or
the treated skin before the cleansing gel is applied, you may experience burning and/or a stinging sensation. Call your doctor immediately.
Do not take the Qutenza patches away from the clinic.
Do not use the Qutenza patches at home.
If Qutenza is used for a longer time than prescribed.
An overdose is not expected to occur. However, if Qutenza is applied for a
longer period of time than intended, serious reactions at the application site may occur
such as pain, redness and itching.
If you have any doubts about the use of this product, ask your doctor or pharmacist .

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Contact your doctor immediatelyif any of the following occur:
If you feel that your heart is beating too fast, too slowly, or if it is beating irregularly.
Not common, affects up to 1 in 100 people
Severe redness in the area where the patch is applied, blistering/secretion from the
skin, skin that becomes very painful to the touch, swelling, skin that is moist or shiny. In a limited
number of cases, these may be signs of a burn requiring urgent medical
attention.
Frequency not known: the frequency cannot be estimated based on the available data

Call your doctorif any of the following side effects occur or worsen:
Very common: may affect more than 1 in 10 people:

• Redness or pain that persists for more than one day, in the area where the patch was applied.

Common: may affect up to 1 in 10 people:

• itching, swelling, blisters, bumps, dryness in the area where the patch was applied
• burning sensation, high blood pressure, cough, nausea, itching, pain in the limbs, muscle spasms, swelling of the limbs

Not common: may affect up to 1 in 100 people

• Skin swelling, stinging sensation, inflammation, increased or decreased skin sensitivity, skin irritation reaction, bruising on the patch application area.
• Decreased taste, reduced sensation in the limbs, eye irritation, throat irritation, herpes zoster

Frequency not known: the frequency cannot be estimated based on the available data

• Accidental exposure (including eye pain, eye and throat irritation, cough).

Reporting of side effects
If you get any side effects, talk to your doctor.
You can also report side effects directly through the national reporting system
described in Annex V * . By reporting side effects you can help provide more
information on the safety of this medicine.

5. How to store Qutenza

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the pack after Exp. The expiry date
refers to the last day of that month.
Qutenza cutaneous patch: Store flat in the sachet and in the original pack. Store at
a temperature below 25°C.
Cleansing gel: Store at a temperature below 25°C.
After opening the sachet, Qutenza must be applied within 2 hours.
Disposal of used and unused Qutenza patches.
These items may cause a pricking sensation on the fingers in case of contact. The doctor or
nurse will place them in a polyethylene bag before disposing of them safely. Qutenza patches and
treatment materials must be disposed of correctly.

6. Contents of the pack and other information

What Qutenza contains
The active ingredient is capsaicin. Each 280 cm patch contains a total of 179 mg of capsaicin or
640 micrograms of capsaicin per cm of patch (8% weight/weight).
The excipients of Qutenza cutaneous patch are:

Matrix:
silicone adhesives
diethylene glycol monoethyl ether
silicone oil
Ethylcellulose N50 (E462)

Support layer
polyethylene terephthalate (PET) film, internally siliconized
printing ink containing White Pigment 6

Removable protective layer (protective film)
fluoropolymer-coated polyester film
Qutenza patch is supplied with a tube of cleansing gel that does not contain any active ingredients.
The cleansing gel contains:
macrogol 300
carbomer
purified water
sodium hydroxide (E524)
disodium edetate
butylhydroxyanisole (E320)

Description of the appearance of Qutenza and contents of the pack
Qutenza is a cutaneous patch that is used on the skin.
Each patch measures 14 cm x 20 cm (280 cm ) and consists of an adhesive side containing the active
ingredient and a support layer which constitutes the external surface. The adhesive side is covered by a
removable, transparent, unprinted protective film, cut diagonally. The inscription ‘capsaicin 8%’ is embossed
on the external surface of the support layer.
Each box of Qutenza contains 1 or 2 sachets and 1 tube of cleansing gel (50 g). Not all pack sizes may
be marketed.

Marketing authorisation holder and manufacturer
Grünenthal GmbH
Zieglerstraβe 6
52078 Aachen
Germany
For further information on this medicinal product, contact the local representative of the marketing
authorisation holder:

België/Belgique/Belgien
S.A. Grünenthal N.V.
Lenneke Marelaan 8
1932 Sint-Stevens-Woluwe
België/Belgique/Belgien
Tél/Tel: + 32 (0)2 290 52 00
[email protected]

Lietuva
UAB “STADA – Nizhpharm – Baltija“
Tel: +370 5 2603926

България
STADA Pharma Bulgaria EOOD
25A, Cherni vrah Blvd, fl.4
1421 Sofia, Bulgaria
Teл.: +359 29624626

Luxembourg/Luxemburg
S.A. Grünenthal N.V.
Lenneke Marelaan 8
1932 Sint-Stevens-Woluwe
België/Belgique/Belgien
Tél/Tel: + 32 (0)2 290 52 00
[email protected]

Česká republika
STADA PHARMA CZ s.r.o.
Tel: +420 257888111

Magyarország
Hemopharm GmbH
Germany
Tel.: +49 61729689

Danmark
Grünenthal Denmark ApS
Tlf: +45 8888 3200

Malta
Grünenthal GmbH
Germany
Tel.: +49-241-569-0

Deutschland
Grünenthal GmbH
Zieglerstr. 6
DE-52078 Aachen
Tel: + 49 241 569-1111
[email protected]

Nederland
Grünenthal B.V.
De Corridor 21K
NL-3621 ZA Breukelen
Tel:+31 (0)30 6046370
[email protected]

Eesti
UAB “STADA – Nizhpharm – Baltija“
Lithuania
Tel: +370 5 2603926

Norge
Grünenthal Norway AS
Tlf: +47 22 99 60 54

Ελλάδα
ΒΙΑΝΕΞ Α.Ε.
Οδός Τατοΐου
GR-146 71 Νέα Ερυθραία
Τηλ: + 30 210 8009111-120
[email protected]

Österreich
Grünenthal GmbH
Campus 21, Liebermannstraße A01/501
2345 Brunn am Gebirge
Tel: +43(0)2236 379 550-0

España
Grünenthal Pharma, S.A.
C/Dr. Zamenhof, 36
E-28027 Madrid
Tel: +34 (91) 301 93 00

Polska
STADA Poland Sp. Z.o o.
Tel.: +48 227377920

France
Laboratoires Grünenthal SAS
Immeuble Eurêka
19 rue Ernest Renan
CS 90001

• F- 92024 Nanterre Cedex Tél: + 33 (0)1 41 49 45 80 PortugalGrünenthal, S.A. Alameda Fernão Lopes, 12-8.º A P-1495 - 190 Algés Tel: +351 / 214 72 63 00

România
S.C. STADA M&D S.R.L.
Spatiul Independentei 1b, sectorul 4
Bucuresti
Tel: +40 213160640

Ireland
Grünenthal Pharma Ltd
4045 Kingswood Road,
Citywest Business Park
IRL – Citywest Co., Dublin
Tel: +44 (0)870 351 8960
[email protected]

Hrvatska
STADA d.o.o..
Hercegovačka 14
10 000 Zagreb
Tel: +385 1 37 64 111

Slovenija
STADA d.o.o
Dunajska cesta 156
1000 Ljubljana
Tel: +386 1589 6710

Ísland
Vistor hf.
Denmark
Sími: +354 535 7000

Slovenská republika
STADA PHARMA Slovakia, s.r.o.
Tel: +421 252621933

Italia
Grünenthal Italia S.r.l.
Tel: +39 02 4305 1

Suomi/Finland
Grünenthal Finland Oy
Puh/Tel: +358 44 240 9190

Κύπρος
ΒΙΑΝΕΞ Α.Ε.
Οδός Τατοΐου
GR-146 71 Νέα Ερυθραία-Ελλάδα
Τηλ: + 30 210 8009111-120
[email protected]

Sverige
Grunenthal Sweden AB
Tel: +46 (0)8 643 40 60

United Kingdom (Northern Ireland)
Grünenthal Pharma Ltd
4045 Kingswood Road,
Citywest Business Park
IRL – Citywest Co., Dublin
Tel: +44 (0)870 351 8960
[email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines
Agency: http://www.ema.europa.eu
The following information is intended exclusively for physicians or healthcare professionals.

Latvija
UAB “STADA – Nizhpharm – Baltija“
Lithuania
Tel: +370 5 2603926