179 mg cutaneous patch
capsaicin
What Qutenza is and what it is used for
Qutenza contains capsaicin and belongs to the group of anesthetics.
Qutenza is used to treat peripheral neuropathic pain in adults, either alone or in combination with other painkillers.
Qutenza is used to relieve pain in people who have nerve pain due to damaged nerves in the skin. Nerve damage to the skin can be caused by a variety of diseases, such as shingles, HIV infection, diabetes, certain medications, and certain other conditions. You may experience pain relief between 1 and 3 weeks after treatment.
What you need to know before using Qutenza
Do not use Qutenza
- if you are allergic to capsaicin, chili fruits, or any of the other ingredients of this medicine (listed in section 6).
Warnings and cautions
Talk to your doctor before using Qutenza.
Do not use Qutenza anywhere on the head or face.
Do not use Qutenza on damaged skin or open wounds.
Do not touch Qutenza or other materials that have come in contact with the treated skin surfaces as it may cause a burning sensation and burning sensation. Do not touch eyes, mouth, or other sensitive areas as it may cause irritation and pain. If this happens, rinse or rinse with cold water. Sniffing or inhalation near Qutenza patches may cause coughing, throat irritation, and sneezing.
It is normal for the skin to sting or turn red and burn for a short time during and after a Qutenza treatment. Your blood pressure may rise due to the pain and therefore your doctor will measure your blood pressure several times during treatment. If you experience severe pain, get local cooling or medication for the pain from your doctor. If you experience very severe pain, ask your doctor to remove the patch.
In general, minor, short-term changes in the ability to feel when something is hot or sharp have been observed after the use of capsaicin.
If you have unstable or poorly controlled high blood pressure or have had heart problems, your doctor will consider the risk of side effects on your heart or blood pressure before you receive Qutenza due to the potential stress treatment.
Children and young people
Qutenza is not recommended for the treatment of patients under 18 years of age.
Other medicines and Qutenza
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. Qutenza acts locally on the skin and is not expected to affect other medicines.
Pregnancy and breastfeeding
Qutenza should be used with caution if you are pregnant. You should stop breastfeeding before starting treatment with Qutenza. If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before using this medicine.
Driving and using machines
There are no studies on the effect of Qutenza on the ability to drive and use machines. When you use Qutenza, only very small amounts of the active substance can be present in the blood for a very short time. Therefore, Qutenza is unlikely to have any direct effects on your ability to concentrate or your ability to drive or use machines.
The cleansing gel for Qutenza contains butyl hydroxyanisole
Qutenza Cleansing Gel contains butyl hydroxyanisole, which may cause local skin reactions (eg contact dermatitis) or be irritating to eyes or mucous membranes.
How to use Qutenza
Qutenza should only be applied by a doctor or nurse under the supervision of a doctor.
A maximum of 4 patches should be used at a time
Qutenza is intended for use on the skin.
Your doctor or nurse will mark the most painful areas on your skin with a pencil or marker.
Before placing the Qutenza patches on your skin, wash the treatment surface or surfaces with soap and water and dry. The hair on the treated surfaces is cut.
Your doctor or nurse may apply an anesthetic gel or cream to the skin where the Qutenza patches are to be placed or give you a tablet or capsule of painkillers. This is done to reduce burning. Gel one or cream one should be removed, and the skin should be washed and dried thoroughly before applying Qutenza.
Your doctor or nurse may wear gloves, and sometimes mouth guards and goggles, when handling Qutenza patches. Do not inhale air through your nose or mouth near the Qutenza patches as you may start coughing or sneezing.
The Qutenza patches can be cut into smaller pieces to fit the treatment surface. Your doctor or nurse will remove the patches after 30 minutes if you are being treated for nerve pain in your feet or after 60 minutes if you are being treated for nerve pain in the skin elsewhere on your body.
It may take between 1 and 3 weeks before you experience Qutenza pain relief. If you still have a lot of pain after this time, talk to a doctor.
Qutenza treatment can be repeated if necessary at 90-day intervals. Contact a doctor if you experience insufficient pain relief or if the pain returns earlier.
You may be given painkillers to relieve the pain you are experiencing with Qutenza treatment.
It is common for the skin to sting or blush and burn during Qutenza treatment.
You can wear disposable socks on top of the Qutenza patches if the skin on your feet is treated.
Your doctor or nurse may place a bandage on top of the Qutenza patch to hold the patch firmly in place.
Do not try to remove the patch yourself. The doctor or nurse will remove it for you.
After the Qutenza treatment, the doctor or nurse cleanses the treated skin with cleansing gel from a tube that comes with the Qutenza kit. The cleansing gel is allowed to remain on the skin for one minute and then wiped off so that drugs that may remain on the skin after the treatment disappear. Once the cleansing gel has dried off, wash the skin surface gently with soap and water.
Do not touch the patch with your hands.
Do not touch eyes, mouth, or other sensitive areas. If you accidentally touch the Qutenza patch or treated skin before applying the cleansing gel, it may burn and/or sting. Call the doctor immediately.
Do not bring Qutenza patches from the reception.
Do not use Qutenza patches at home.
If Qutenza is used for longer than it should
Overdose is unlikely, but if Qutenza is applied longer than it should, you may experience severe reactions on the treatment surface such as pain, redness, and itching.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Contact your doctor immediately if the following occurs:
- If you experience that your heart is beating too fast, too slow, or abnormal.
- Uncommon: may affect up to 1 in 100 people.
- Deep redness in the area where the patch is applied, blistering / hydration on the skin, skin that hurts a lot when you touch it, becomes swollen, gets wet, or becomes shiny. In a few cases, this may be a sign of a second-degree burn and needs immediate supervision.
- No known frequency: the frequency can not be calculated from the available data.
Tell your doctor if the following side effects occur or get worse:
Very common: may affect more than 1 user in 10
- Redness or pain in the area where the patch is applied that lasts more than a day.
Common: may affect up to 1 in 10 users
- Itching, bumps, blisters, swelling, dryness in the area where the patch is applied, burning sensation, and pain in arms and legs.
Uncommon: may affect up to 1 in 100 people
- Skin streaks, tingling sensation, inflammation, increased or decreased sensitivity, skin reaction, irritation, or bruising in the area where the patch is applied
- Decreased ability to feel the taste, decreased sensation in arms and legs, eye irritation, cough, irritation of the throat, nausea, itching, muscle cramps, shingles, swollen arms, and legs.
No known frequency: can not be calculated from the available data
- Accidental exposure (including eye pain, eye and throat irritation, and cough)
How to store Qutenza
Keep this medicine out of the sight and reach of children
Do not use this medicine after the expiry date which is stated on the carton after EXP. The expiration date is the last day of the specified month.
Qutenza cut patch: Store flat in original bag and original carton. Do not store above 25 ° C.
Cleaning gel: Do not store above 25 ° C.
Once the bag has been opened, Qutenza should be applied within 2 hours.
Handling of used and unused Qutenza patches
These objects can burn your fingers if you touch them. The doctor or nurse places them in a polyethylene bag which is then disposed of safely. Qutenza patches and treatment materials should be discarded according to current instructions.
Contents of the package and other information
Content declaration
The active substance is capsaicin. Each 280 cm 2 patch contains a total of 179 mg of capsaicin or 640 micrograms of capsaicin per cm 2 of the patch (8% by weight).
The other ingredients in Qutenza cutaneous patches are:
Adhesive matrix layer
silicone adhesive
diethylene glycol monoethyl ether
silicone oil
ethylcellulose N50 (E462)
Outer layer
polyethylene terephthalate (PET) film siliconized inside
ink with Pigment White 6
A removable protective layer (protective film)
polyester film, coated with a fluoropolymer
The Qutenza patch is supplied with a tube of cleansing gel that does not contain any active substance.
The cleansing gel contains:
macrogol 300
carbomer
purified water
sodium hydroxide (E524)
disodium edetate
butyl hydroxyanisole (E320)
What the medicine looks like and the contents of the pack
Qutenza is a patch that is intended for use on the skin.
Each patch is 14 cm x 20 cm (280 cm 2 ) and consists of an adhesive matrix layer containing the active substance and an outer layer. The adhesive layer is covered with a removable, clear, diagonally cut protective film without pressure. The outside of the outer layer is stamped with “capsaicin 8%”.
Each Qutenza carton contains 1 or 2 bags and 1 tube of cleaning gel (50 g). Not all pack sizes may be marketed.
Marketing Authorization Holder and Manufacturer
Grünenthal GmbH
Zieglerstraße 6
52078 Aachen
Germany