QUTENZA is a cutaneous patch for use on your skin. QUTENZA contains capsaicin and belongs to a group of medicines called anaesthetics. QUTENZA is used to relieve pain in patients who have nerve pain due to damage in nerves in the skin, due to shingles and HIV infection.
1. What QUTENZA is and what it is used for
2. What you need to know before you use QUTENZA
Do not use QUTENZA: if you are allergic (hypersensitive) to capsaicin, chilli peppers or any other ingredients in QUTENZA cutaneous patch (see section 6).
Warnings and precautions
Take special care with QUTENZA. Do not use QUTENZA on any part of your head or face. Do not use QUTENZA on broken skin or open wounds. Do not touch QUTENZA or 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 QUTENZA patches may cause coughing or sneezing. It is usual for the skin to sting or become red and burn during and after QUTENZA treatment for a short while. If you experience a lot of pain, your doctor will apply local cooling or give you medicine for pain. 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 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 analgesics when 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. Changes in the ability to feel when something is hot or sharp have been seen after use of capsaicin.
Children and adolescents
QUTENZA is not recommended for treatment in patients under 18 years of age.
Other medicines and QUTENZA
Always tell your healthcare provider if you are taking, any other medicine. (This includes complementary or traditional medicines.)
Pregnancy and breastfeeding
You should not use QUTENZA if you are pregnant. QUTENZA must be kept away from contact with babies. Mothers must not breastfeed their babies on the day of application. If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist or other healthcare provider for advice before using this medicine.
Driving and using machines
When QUTENZA has been applied to your hands or feet, changes in sensation may impair your ability to drive or to use machines.
Important information about some of the ingredients of the cleansing gel for QUTENZA
The cleansing 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
Do not share medicines prescribed for you with any other person. QUTENZA should only be applied by your doctor or by a nurse under the supervision of your doctor. QUTENZA is for use on your skin. Your doctor will mark the most painful areas on your skin with a pen or marker. Before placing the QUTENZA patches 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 QUTENZA patches 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 QUTENZA patches for you. Do not sniff or inhale close to the QUTENZA patches as this may cause coughing or sneezing. QUTENZA may 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 minutes if you’re being treated for nerve pain on your feet or 60 minutes 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 - 14 days until the full pain relief of QUTENZA takes effect. If after that time you still have a lot of pain, please talk to your doctor. QUTENZA therapy may be repeated at 90-day intervals, if necessary. You may be given pain medicines to take for the pain you experience with QUTENZA therapy. It is common for the skin to sting or become red and burn during QUTENZA treatment. Disposable socks may be worn on top of the QUTENZA patches if your feet are being treated. Sometimes your doctor or nurse may put a bandage on top of the QUTENZA patch to keep the patch firmly on your skin. At the end of the QUTENZA treatment 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 QUTENZA patch 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 QUTENZA patches away from the clinic. Do not use QUTENZA patches at home. If you have any further questions on the use of this product, ask your doctor or pharmacist. If you use QUTENZA longer than you should. Since a doctor or a nurse under the supervision of your doctor will administer QUTENZA, he/she will control the dosage. However, in the event of overdosage your doctor will manage the overdosage.
4. Possible side effects
QUTENZA can have side effects. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following:
Frequent side effects
- redness, pain on the area where the patch is applied
- itching, bumps, blisters, swelling, dryness on the area where the patch is applied
Less frequent 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. Not all side effects reported for QUTENZA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while using QUTENZA, please consult your health care provider for advice.
Reporting of side effects
If you get side effects, talk to your doctor, pharmacist or nurse. You can also report side effects to SAHPRA via the “6.04 Adverse Drug Reaction Reporting Form”, found online under SAHPRA’s publications: https://www.sahpra.org.za/Publications/Index/8. By reporting side effects, you can help provide more information on the safety of QUTENZA.
5. How to store QUTENZA
QUTENZA cutaneous patch: Store flat in original sachet and carton. Store at or below 25 °C. Cleansing gel: Store at or below 25 °C. Do not use QUTENZA after the expiry date printed on the carton after EXP. The expiry date refers to the last day of that month. STORE ALL MEDICINES OUT OF REACH OF CHILDREN. Disposal of used and unused QUTENZA patches and socks and gloves. These items may sting your fingers if you touch them. Your doctor or nurse will put them in a polythene bag before safely discarding them. QUTENZA patches and treatment-related materials should be disposed of properly.