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.
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:
Common side effects:
Uncommon side effects:
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.
