Label: information for the user

Qutenza 179mg topical patch

capsaicin

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor.
• This medication has been prescribed only for you, and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.

1.What is Qutenza and how is it used

2.What you need to know before starting to use Qutenza

3.How to use Qutenza

4.Possible adverse effects

5.Storage of Qutenza

6.Contents of the package and additional information

Qutenza contains capsaicin and belongs to a group of medicines called anesthetics.

Qutenza is indicated for the treatment of peripheral neuropathic pain in adults alone or in combination with other pain medications for pain treatment.

Qutenza is used to relieve pain in people who suffer from peripheral neuropathic pain due to nerve damage to the skin. The skin nerves can be damaged as a result of various diseases, such as shingles, HIV infection, diabetes, certain medications, and other disorders. You may notice pain relief between week 1 and 3 after treatment.

Do not use Qutenza

Warnings and precautions

Consult your doctor before starting to use Qutenza.

Do not use Qutenza on any part of the head or face.

Do not use Qutenza on damaged skin or open wounds.

Do not touch Qutenza or other materials that have come into contact with 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. If this happens, rinse or flush with cold water. Inhaling or breathing near Qutenza patches may cause coughing, throat irritation, or sneezing.

It is common for the skin to itch, redden, and burn during Qutenza treatment and for a short period. Due to pain, it is possible that your blood pressure may rise, so your doctor will take your blood pressure several times during treatment. If it hurts a lot, your doctor will apply local cold or give you a pain medication. If you experience very intense pain, consult your doctor to have the patch removed.

Generally, there have been mild, temporary alterations in the ability to notice if an object is hot or sharp after using capsaicin.

If you have unstable or poorly controlled high blood pressure or have had heart problems, your doctor will weigh the risk of you experiencing cardiac side effects or blood pressure changes due to the possible stress caused by the procedure.

Children and adolescents

Qutenza is not recommended for patients under 18 years old.

Other medications and Qutenza

Inform your doctor if you are taking, have taken recently, or may need to take any other medication. Qutenza acts locally on the skin and is not expected to affect other medications.

Pregnancy and breastfeeding

Qutenza should be used with caution if you are pregnant. Before starting Qutenza treatment, breastfeeding should be suspended. If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before using this medication.

Driving and operating machinery

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 are detected in the blood and for a very short time. Consequently, it is unlikely that Qutenza will have direct effects on your concentration or ability to drive or operate machinery.

The Qutenza cleaning gel contains butyl hydroxyanisole

The Qutenza cleaning gel may cause local skin reactions (such as contact dermatitis) or eye and mucous membrane irritation because it contains butyl hydroxyanisole.

Only your doctor ornurse under their supervision can apply Qutenza.

No more than 4 patches can be used at the same time.

Qutenza is applied to the skin.

Your doctor ornurse will mark the most painful areas of your skin with a pen or marker.

Before applying the Qutenza patches to the skin, the treatment area or areas must be washed with water and soap and thoroughly dried. The hair in the areas to be treated will be shaved.

Before placing the Qutenza patch on the skin, your doctor ornurse may apply a topical anesthetic gel or cream or give you an oral pain medication to reduce any stinging sensation. The gel or cream must be removed before applying Qutenza and the skin must be washed and dried completely.

Your doctor ornurse may wear gloves, and sometimes a mask and protective glasses, during the handling of the Qutenza patches. Do not inhale or breathe near the Qutenza patches as they may cause coughing or sneezing.

Qutenza can be cut into smaller pieces to adapt it to the treatment area. Your doctor ornurse will remove the patches after 30minutes if you are receiving treatment for neurological pain in the feet or 60minutes if the treatment is applied to other parts of the body.

It may take between 1 and 3 weeks before you notice relief from pain with Qutenza. If after that time you continue to feel a lot of pain, talk to your doctor.

If necessary, Qutenza treatment can be repeated at intervals of 90days. If you experience insufficient pain relief or the pain returns, consult your doctor.

You may receive pain medication for pain related to Qutenza treatment.

It is common for the skin to itch, become red and burn during Qutenza treatment.

If the treatment is applied to the feet, you can wear disposable socks over the Qutenza patches.

It is possible that your doctor or nurse will place a bandage over the Qutenza patch to keep it well attached to the skin.

Do not try to remove the patch yourself. Your doctor or nurse will remove it.

At the end of Qutenza treatment, your doctor or nurse will clean the treated area with the cleaning gel contained in a tube included in the package..The cleaning gel will be left to act for one minute on the skin and then removed to eliminate any remaining medication on the skin after treatment. Once the cleaning gel is removed, the area will be washed gently with water and soap.

Do not touch the patch with your hands.

Do not touch your eyes, mouth or sensitive areas.If you accidentally touch the Qutenza patch or the treated skin before applying the cleaning gel, you may feel burning or stinging sensation. Call your doctor immediately.

Do not take the Qutenza patches out of the clinic.

Do not use Qutenza patches at home.

If you use Qutenza for longer than you should

It is unlikely to occur an overdose. However, if Qutenza is applied for longer than it should, you may experience severe reactions in the application area such as pain, redness and itching.

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

Like all medications, this medication may produce adverse effects, although not everyone will experience them.

If any of the following effects occur,consult your doctor immediately:

• If you feel your heart is beating very fast, very slowly, or irregularly.
• • Rare: may affect up to 1 in 100 people

• Intense redness in the area where the patch is applied, blistering/exudation of the skin, skin that becomes very painful to the touch, swollen, moist, or shiny. In a small number of cases, these may be signs of a burn that requires urgent medical attention.
• • Unknown frequency: the frequency cannot be estimated from the available data

Consult your doctorif the following adverse effects occur or worsen:

Very common: may affect more than 1 in 10 people

• Redness or pain in the area where the patch is applied for more than one day.

Common: may affect up to 1 in 10 people

• Itching, bumps, blisters, swelling, dryness in the area where the patch is applied.
• Burning sensation, hypertension, cough, nausea, itching, pain in the extremities, muscle spasms, swelling of the extremities.

Rare: may affect up to 1 in 100 people

• Hives, tingling, inflammation, increased or decreased skin sensitivity, skin reaction, irritation, hematoma in the area where the patch is applied.

• Reduced sense of taste, decreased sensitivity in the extremities, eye irritation, throat irritation, herpes zoster.

Unknown frequency: the frequency cannot be estimated from the available data

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

If you experience any type of adverse effect, consult your doctor, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through thenational notification system included in theAppendixV. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Qutenza patch: Store flat in the original box and overwrap. Store below25°C.

Cleaning gel: Store below25°C.

After opening the overwrap, Qutenza must be applied within a two-hour period.

Disposal of used and unused Qutenza patches.

If you touch these components, you may feel a burning sensation on your fingers. Your doctor or nurse will put them in a polyethylene bag and dispose of them safely. Qutenza patches and related treatment materials should be disposed of properly.

Composition of Qutenza

The active ingredient is capsaicin. Each patch of 280cm2contains a total of 179mg of capsaicin or 640micrograms of capsaicin per each cm2of patch (8%p/p).

The other components of the Qutenza transdermal patch are:

Matrix:

silicone adhesives

diethylglycol monoethyl ether

silicone oil

ethylcellulose N50 (E462)

Backing layer:

polyethylene terephthalate (PET) film, with the inner surface siliconized

ink for printing containing the pigment White 6

Removable protective layer(protective layer)

polyester film with fluoropolymer coating

The Qutenza patch is supplied with a tube of cleaning gel that does not contain any active ingredient.

The cleaning gel contains:

macrogol 300

carbomer

purified water

sodium hydroxide (E524)

sodium edetate

butylated hydroxyanisole (E320)

Appearance of Qutenza and packaging contents

Qutenza is a transdermal patch that is applied to the skin.

Each patch measures14cmx20cm(280cm2) and consists of an adhesive face containing the active ingredient and an external reinforcement layer. The adhesive face is covered by a transparent, unprinted, and diagonally cut protective layer that is removed before applying the patch. The external surface of the reinforcement layer bears the imprint «capsaicin8%».

Each box of Qutenza contains 1 or 2blister packs and 1tube of cleaning gel (50g). Some packaging sizes may only be marketed.

Marketing authorization holder and manufacturer responsible

Grünenthal GmbH

Zieglerstraße 6

52078 Aachen

Germany

Last review date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/.

This information is intended solely for doctors or healthcare professionals.

The leaflet includes the technical data sheet or complete summary of product characteristics (RCP).