How does it work?

Qutenza patches contain the active ingredient capsaicin, which is the substance found naturally in red chilli peppers that gives them their heat. The patches are applied to the skin to relieve nerve pain that has resulted from damage to nerves in the skin. This damage may have been caused by diseases such as shingles or HIV infection, or by certain medicines or other conditions.

The capsaicin is absorbed from the patch through the skin and into the nerves in the area the patch is applied to.

Capsaicin works by desensitising sensory receptors called nociceptors. These receptors are found at the end of nerves. When activated by painful stimuli, they send nerve signals to the spinal cord and brain that result in the perception of pain. When capsaicin binds to these pain receptors it initially causes a painful burning sensation. However, with continued application of the capsaicin, the pain receptors become overloaded and desensitised and this makes them less responsive to painful stimulation. This relieves the nerve pain.

Qutenza patches will be applied to the painful area by a doctor or a nurse wearing special gloves. You should not touch the patches, as this can cause burning or stinging to your hands. The patches can initially cause reddening of the skin and a burning or stinging sensation. However, after a while the capsaicin starts to desensitise the pain receptors so that pain in the area is reduced. To reduce any initial pain, your doctor or nurse will apply a local anaesthetic to the skin before applying the patch. They may also use other painkillers or cooling compresses.

Your doctor or nurse will remove the patches after 30 minutes if you’re being treated for nerve pain on your feet or after 60 minutes if you’re being treated for nerve pain on other parts of your body. It can then take from 1 to 14 days for the full pain relief to take effect.

The treatment may be repeated every 90 days if necessary.

What is it used for?

• Nerve pain (peripheral neuropathic pain) in non-diabetic adults, for example after a shingles infection (post-herpetic neuralgia) or due to HIV infection.

Warning!

• Qutenza patches should be applied to cover the painful area of skin. The skin should be clean, dry, non-hairy and non-irritated. Any hair on the surface of the affected skin should be removed with a pair of scissors and not shaved off.
• Any contact of the patches with the eyes, mouth or other sensitive areas should be avoided.
• These patches must not be used on any part of the face or head.
• These patches must not be used on broken skin or open wounds.
• Because the patch application can be painful this may cause your blood pressure to go up temporarily during and after the treatment. Your doctor will monitor your blood pressure during the treatment for this reason. If you experience increasing pain or discomfort you should let your doctor know so this can be treated with painkillers.
• This medicine does not change the long-term function of your nerves. However, you should be aware that the area treated may be temporarily less sensitive to painful stimuli such as heat or sharpness after the treatment.

Use with caution in

• People with a recent history of heart problems.
• People with unstable or uncontrolled high blood pressure.

Not to be used in

• Diabetes.
• Children and adolescents under 18 years of age.

This medicine should not be used if you are allergic to any of its ingredients. Please inform your doctor or pharmacist if you havepreviously experienced such an allergy.

If you feel you have experienced an allergic reaction, stopusing this medicine and inform your doctor or pharmacist immediately.

Pregnancy and breastfeeding

Certain medicines should not be used during pregnancy orbreastfeeding. However, other medicines may be safely used in pregnancy orbreastfeeding providing the benefits to the mother outweigh the risks to theunborn baby. Always inform your doctor if you are pregnant or planning apregnancy, before using any medicine.

• The safety of this medicine during pregnancy has not been established. It should be used with caution during pregnancy. Seek further medical advice from your doctor.
• It is not known if this medicine passes into breast milk. The manufacturer states that as a precautionary measure, mothers should not breastfeed on the day of treatment with this medicine. Seek further medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individualpeople in different ways. The following are some of the side effects that areknown to be associated with this medicine. Just because a side effect is statedhere does not mean that all people using this medicine will experience that orany side effect.

Very common (affect more than 1 in 10 people)

• Pain and redness at site of application.

Common (affect between 1 in 10 and 1 in 100 people)

• Itching, swelling, blisters or dryness at patch application site.

Uncommon (affect between 1 in 100 and 1 in 1000 people)

• Nettle-type rash, numbness, burning sensation, tingling, dermatitis, inflammation, bruising and irritation at patch application site.
• Increased blood pressure (hypertension).
• Irritation in the eyes.
• Nausea.
• Throat irritation.
• Cough.
• Slowed conduction of electrical messages between the chambers of the heart (first degree atrioventricular block).
• Increased heart rate (tachycardia).
• Awareness of your heartbeat (palpitations).
• Changes in taste.
• Muscle spasms.

The side effects listed above may not include all of the sideeffects reported by the medicine's manufacturer.

For more information about any other possible risks associatedwith this medicine, please read the information provided with the medicine orconsult your doctor or pharmacist.

How can this medicine affect other medicines?

No significant interactions have so far been reported with this medicine. However, you should tell your doctor what other medicines you are taking before starting treatment with this medicine, and likewise, check with your doctor or pharmacist before taking any new medicines once you have started treatment. This includes medicines bought without a prescription and herbal medicines.

Other medicines containing the same active ingredient