What is it and how is it used?

Qutenza is used to relieve pain in people without diabetes who have nerve pain due to damage in nerves in the skin. Damaged nervesin your skin may occur as a result of a variety of diseases such as shinglesand HIV infection,certain medicinesand other conditions. Qutenzacan be used either alone or in combination with other medicines that you may take to treat your pain.

Table of Contents
What do you have to consider before using it?
How is it used?
What are possible side effects?
How should it be stored?
Further information

What do you have to consider before using it?

Do not use Qutenza

·if you are allergic (hypersensitive) to capsaicin, chilli peppers or any other ingredientsinthe Qutenza cutaneous patch(see section 6 at the end of the leaflet)

Take special care with Qutenza

Do not use Qutenzaon any part of your head or face.

Do not use Qutenzaon broken skin or open wounds.

Do not touch Qutenzaor 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. Sniffing or inhaling close to the Qutenzapatches may cause coughing or sneezing.

Itis usual for the skin to sting or become red and burn during and after Qutenzatreatment for a short while. Because of the pain, your blood pressure may go up and therefore, your doctor will measure your blood pressure several times during your treatment. If you experience a lot of pain, your doctor will apply local cooling or give you medicine for pain.

If you have unstable or poorly controlled high blood pressure or recently had heart problems, your doctor will consider the risk of adverse reactions to your heart or blood pressure due to the potential stress of the procedure before treating you with Qutenza.

If you are using high doses of opioids, you may not respond to oral opioid analgesicswhen used for acute pain during and following the treatment procedure. In this case, your doctor will use other measures to reduce your pain following Qutenza treatment.

Though no changes have been seen in the function of the nerves in patients treated with Qutenza, small, short-term changes in the ability to feel when something is hot or sharp have been seen after use of capsaicin.

Use in children and adolescents

Qutenzais not recommended for treatment in patients under 18years of age.

Using other medicines

Qutenzaacts locally on your skin and is not expected to influence other medicines. Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

Pregnancy and breast-feeding

Qutenzashould be used with caution if you are pregnant and/or breastfeeding. If you are pregnant, or think you may be pregnant, or breast-feeding tell your doctor before Qutenzatreatment.

Driving and using machines

There are no studies of the effects of Qutenzaon the ability to drive and use machines. When using Qutenza, only very small amounts of the active substance may be present in the blood stream for a very short time. Therefore, Qutenzais unlikely to have any direct effects on your thinking or your ability to drive or use machinery.

Important information about some of the ingredients of the cleansing gelfor Qutenza

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

How is it used?

Qutenzashould only be applied by your doctor or by a nurse under the supervision of your doctor.

Qutenzais for useon your skin.

Your doctor will mark the most painful areas onyour skin with a pen or marker.

Before placing the Qutenzapatches on the skin, the treatment area(s) will be washed with soap and water and dried. Hair in treatment areas will be clipped.

Before placing the Qutenzapatches on the skin, your doctor or nurse will apply a numbing gel or cream to reduce stinging.

Your doctor or nurse will wear gloves to prepare the Qutenzapatches for you. Do not sniff or inhale close to the Qutenzapatches as this may cause coughing or sneezing.
Qutenzamay be cut into smaller pieces to fit the treatment area. No more than 4 patches should be used at the same time. Your doctor or nurse will remove the patches after 30 minutesif you?re being treated for nerve pain on your feetor 60minutes if you?re being treated for nerve pain on other parts of your body. Do not touch the patch with your hands as it may cause burning and stinging.

Usually you will feel some pain relief on the first day the patch is applied. It may take up to 1-14days until the full pain relief of Qutenzatakes effect. If after that time you still have a lot of pain, please talk to your doctor.

Qutenzatherapy may be repeated at 90-day intervals, if necessary.

You may be given pain medicines to take for the pain you experience with Qutenzatherapy.

It is common for the skin to sting or become red and burn during Qutenzatreatment.

Disposable socks may be worn on top of the Qutenzapatches if your feet are being treated.

Sometimes your doctor or nurse may put a bandage on top of the Qutenzapatch to keep the patch firmly on your skin.

At the end of the Qutenzatreatment your doctor or nurse will clean the treated skin with cleansing gel from a tube supplied with the kit.Cleansing gel will be left on your skin for one minute and then wiped off to remove any remaining medicine that may be left on your skin after treatment. After the cleansing gel has been wiped off, the area will be gently washed with soap and water.

Do not touch your eyes, mouth or other sensitive areas.If you accidentally touch the Qutenzapatch or treated skin before cleansing gel is applied it may burn and/or sting. Call your doctor immediately.

Do not attempt to remove the patch yourself. Your doctor or nurse will remove it for you.

Do not take Qutenzapatches away from theclinic.

Do not use Qutenzapatches at home.

If you have any further questions on the use of this product, ask your doctor or pharmacist .

What are possible side effects?

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

The frequency of possible side effects listed below is defined using the following convention:Very common (affects more than 1 user in 10)
Common (affects 1 to 10 users in 100)
Uncommon (affects 1 to 10 users in 1,000)

Very common side effects:

redness, pain on the area where the patch is applie

Common side effects:

itching, bumps, blisters, swelling, dryness on the area where the patch is applie

Uncommon side effects:

wheals, prickling sensation, inflammation of the skin, increased sensitivity, inflammation, skin reaction, irritation, bruising on the area where the patch is applied

high blood pressure, slowing of the electrical signals in the heart, rapid beating of the heart, abnormal awareness of the beating of the heart, decreased taste, reduced sensations in limbs,

burning sensation, eye irritation, cough, throat irritation, nausea, itching, pain in limbs, muscle spasms, shingles, swelling of limbs.

If any of the side effects becomes serious, or if you notice any side effects not listed in this leaflet, please tell your doctor, nurse or pharmacist immediately.

How should it be stored?

Keep out of the reach and sight of children.

Do not use Qutenzaafter the expiry date printed on the carton after EXP. The expiry date refers to the last day of that month.

Qutenza cutaneous patch: Store flat in original sachet and carton. Store below 25°C.

Cleansing gel: Store below 25°C.

After opening sachet, Qutenza should be appliedwithin 2 hours.

Disposal of used and unused Qutenzapatches and socksand gloves.

These items may sting your fingers if you touch them. Your doctor or nurse will put them in a polyethylene bag before safely discarding them. Qutenzapatches and treatment-related materials should be disposed of properly.

Further information

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.

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