


Ask a doctor about a prescription for FENTANIL MATRIX NORMON 25 micrograms/hour TRANSDERMAL PATCHES
Package Leaflet: Information for the User
Fentanilo Matrix Normon 25 micrograms/h transdermal patch EFG
Fentanyl
Read all of this leaflet carefully before you start using this medicine because it contains important information for you.
Contents of the pack
This medicine is called Fentanilo Matrix Normon
The patches help to relieve very strong and long-lasting pain:
Fentanilo Matrix Normon contains a medicine called fentanyl. It belongs to a group of strong pain-relieving medicines called opioids.
Do not use Fentanilo Matrix Normon
Do not use this medicine if you or your child are in any of the above situations. If you are not sure, talk to your doctor or pharmacist before using Fentanilo Matrix Normon.
Warnings and precautions
If the patch sticks to another person
The patch should only be used on the skin of the person for whom the doctor has prescribed it. There have been cases where the patch has accidentally stuck to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally sticks to another person (especially a child), the medicine in the patch can pass through the skin of the other person and can cause serious side effects, such as breathing difficulties, with slow or weak breathing that can be life-threatening. If the patch sticks to someone else's skin, it should be removed immediately and medical help should be sought.
Be careful with Fentanilo Matrix Normon
Talk to your doctor or pharmacist beforeusing this medicine if you are in any of the following situations. Your doctor will need to monitor you more closely:
If you have any of the above conditions (or if you are not sure), talk to your doctor or pharmacist before using Fentanilo Matrix Normon.
While using the patch, tell your doctor if you have breathing problems while sleeping.Opioids like Fentanilo Matrix Normon can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing while sleeping) and sleep-related hypoxemia (low oxygen levels in the blood). Talk to your doctor if you, your partner, or caregiver notice any of the following symptoms:
Your doctor may decide to change the dose.
While using the patch, tell your doctor if you notice a change in the pain you feel. If you feel:
Do not change the dose on your own. Your doctor may decide to change the dose or change the treatment.
Side effects and Fentanilo Matrix Normon
You can find the complete list of possible side effects in section 4.
When wearing the patch, do not expose it to direct heat, such as heat pads, electric blankets, hot water bottles, water beds, heat lamps, or tanning lamps. Do not take sunbaths or have prolonged hot baths, and do not use saunas or hot tubs. If you do, you may increase the amount of medicine released from the patch.
Long-term use and tolerance
This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). You may also become more sensitive to pain when using Fentanilo Matrix Normon. This is known as hyperalgesia. Increasing the dose of the patches may continue to reduce the pain for a while, but it can also be harmful. If you notice that the medicine is becoming less effective, talk to your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of Fentanilo Matrix Normon.
Dependence and addiction
Repeated use of Fentanilo Matrix Normon can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can lead to a feeling of loss of control over the amount of medicine you need to use or how often you need to use it. You may feel the need to continue using the medicine even if it no longer helps to relieve the pain.
The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Fentanilo Matrix Normon may be greater if:
If you notice any of the following symptoms while using Fentanilo Matrix Normon, it could be a sign of dependence or addiction.
If you notice any of these signs, talk to your doctor to determine the best treatment for you, when it is appropriate to stop the medicine, and how to do it safely.
This medicine contains fentanyl, which is an opioid. It can cause dependence and/or addiction. |
Repeated use of Fentanilo Matrix Normon can also lead to dependence, abuse, and addiction, which can result in a potentially life-threatening overdose.
Withdrawal symptoms when stopping Fentanilo Matrix Normon
Do not stop using this medicine suddenly. You may experience withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling sick, diarrhea, loss of appetite, tremors, chills, or sweating. If you want to stop using this medicine, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimized.
Other medicines and Fentanilo Matrix Normon
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. You should also tell your pharmacist that you are using Fentanilo Matrix Normon if you buy any medicines from the pharmacy.
Your doctor will know which medicines can be taken safely with Fentanilo Matrix Normon. You may need to be closely monitored if you are taking any of the following types of medicines or if you stop taking any of the following types of medicines, as this can affect the dose of Fentanilo Matrix Normon that you need.
In particular, tell your doctor or pharmacist if you are taking:
Using Fentanilo Matrix Normon with antidepressants
The risk of side effects increases if you are taking medicines such as certain antidepressants. Fentanilo Matrix Normon can interact with these medicines, and you may experience changes in your mental state, such as agitation, seeing, feeling, hearing, or smelling things that are not there (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (these could be signs of serotonin syndrome). If they are used together, your doctor may want to monitor you closely to detect these side effects, especially when starting treatment or when changing the dose of the medicine.
Using Fentanilo Matrix Normon with central nervous system depressants, including alcohol and some narcotic medicines
Using Fentanilo Matrix Normon and sedative medicines such as benzodiazepines or related medicines at the same time increases the risk of sleepiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.
However, if your doctor prescribes Fentanilo Matrix Normon with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.
Tell your doctor about all sedative medicines you are taking, and follow your doctor's dosage recommendations strictly. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.
Do not drink alcohol while using Fentanilo Matrix Normon, unless you have talked to your doctor first.
Use in athletes
Athletes are informed that this medicine contains a component that can result in a positive doping test.
Operations
If you are going to have an operation, tell your doctor or dentist that you are using Fentanilo Matrix Normon.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.
Fentanilo Matrix Normon should not be used during pregnancy, unless you have discussed it with your doctor.
Fentanilo Matrix Normon should not be used during labor, as the medicine can affect the breathing of the newborn.
Long-term use of Fentanilo Matrix Normon during pregnancy can cause withdrawal symptoms in your newborn baby, such as crying, irritability, convulsions, poor feeding, and diarrhea, which can be life-threatening if not recognized and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.
Do not use Fentanilo Matrix Normon if you are breastfeeding. You should not breastfeed for 3 days after removing the Fentanilo Matrix Normon patch. This is because the medicine can pass into breast milk.
Driving and using machines
Fentanilo Matrix Normon can affect your ability to drive or use machines or tools, as it can make you sleepy or dizzy. If this happens, do not drive or use machines or tools. Do not drive while using this medicine until you know how it affects you.
Talk to your doctor or pharmacist if you are unsure whether it is safe for you to drive while using this medicine.
Follow the administration instructions for this medication exactly as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.
Your doctor will decide which concentration of Fentanilo Matrix Normon is most suitable for you, taking into account the intensity of your pain, your general condition, and the type of pain treatment you have received so far.
Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using Fentanilo Matrix Normon, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2, "Withdrawal syndrome when stopping treatment with Fentanilo Matrix Normon").
How to apply and change patches
Apply the patch on | Change the patch on | |
Monday | Thursday | |
Tuesday | Friday | |
Wednesday | Saturday | |
Thursday | Sunday | |
Friday | Monday | |
Saturday | Tuesday | |
Sunday | Wednesday |
Where to apply the patch
Adults
Children
Adults and children:
Do not apply the patch to
How to apply the patch
Prepare the skin

Dispose of the patch
Wash
More information on the use of Fentanilo Matrix Normon
Daily activities during patch use
How long do the patches take to work?
How long will you need to use the patches?
If the pain worsens
If you use too many patches or a patch with the wrong dose
If you have applied too many patches or a patch with the wrong dose, remove them and contact your doctor immediately or call the Toxicology Information Service, phone: (91) 562 04 20, indicating the medication and the amount applied, or go to the hospital.
The signs of overdose include breathing problems or weak breathing, fatigue, extreme drowsiness, inability to think clearly or walk or speak normally, and dizziness, dizziness, or confusion. An overdose can also cause a brain disorder known as toxic leukoencephalopathy.
If you forgot to change the patch
If the patch comes off
If you want to stop using the patches
If you have any other questions about the use of this medication, ask your doctor or pharmacist.
Like all medications, this medication can cause adverse effects, although not everyone will experience them.
If you, your partner, or caregiver notice any of the following signs in the person wearing the patch, remove the patch and call a doctor or go to the nearest hospital immediately. You may need urgent medical treatment.
Follow the above recommendations and make the person wearing the patch move and talk as much as possible. In very rare cases, these breathing difficulties can be life-threatening or fatal, especially in people who have not previously used strong opioid pain relievers (such as Fentanilo Matrix Normon or morphine). (Uncommon, may affect up to 1 in 100 people).
These can be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).
The following adverse effects have also been reported
Very common (may affect more than 1 in 10 people)
Common (may affect up to 1 in 10 people)
Uncommon (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1000 people)
The following side effects have also been reported, but their exact frequency is unknown:
You may notice rashes, redness, or mild itching of the skin at the patch application site. It is usually mild and disappears after removing the patch. If it does not, or if the patch irritates your skin a lot, inform your doctor.
Repeated use of the patches can cause the medication to lose effectiveness (you get used to it or become more sensitive to pain) or can cause dependence.
If you switch from another pain reliever to Fentanilo Matrix Normon or if you stop using Fentanilo Matrix Normon abruptly, you may experience withdrawal symptoms, such as dizziness, feeling sick, diarrhea, anxiety, or tremors. Inform your doctor if you notice any of these effects.
There have also been reports of newborns experiencing withdrawal symptoms after their mothers used Fentanilo Matrix Normon for a prolonged period during pregnancy.
Reporting side effects
If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System for Human Use: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.
Where to store the patches
Keep all patches (used and unused) out of sight and reach of children.
Store this medication in a protected and secure place, where others cannot access it. It can be very harmful and cause death to people who may use this medication accidentally or intentionally when it has not been prescribed for them.
How long can you store Fentanilo Matrix Normon
Do not use this medication after the expiration date shown on the box and on the envelope. The expiration date is the last day of the month indicated. If the patches are expired, take them to the pharmacy.
Do not use this medication if you notice that the patches are damaged.
Store in the original packaging to protect it from moisture.
How to dispose of used or unused patches
Accidental exposure of another person to used and unused patches, especially children, can result in a fatal outcome.
Used patches should be folded firmly in half, so that the adhesive side of the patch sticks to itself. Then, they should be thrown away safely by placing them in the original envelope and keeping them out of sight and reach of others, especially children, until they are disposed of safely. Ask your pharmacist how to dispose of the packaging and medications you no longer need.
Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need in the SIGRE collection point at the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.
Composition of Fentanilo Matrix Normon
Each transdermal patch (15 cm2 area of the release surface) contains 4.8 mg of fentanyl, which releases a dose of 25 micrograms/hour.
Adhesive layer:Acrylic polymer, lauric alcohol
Supporting film:Polyester film, silicone-treated.
Removable coating:Polyester/ethylene-vinyl acetate film
Printing ink
Appearance of the product and package contents
Fentanilo Matrix Normon 25 micrograms/h is a thin, transparent transdermal patch with rounded edges and the following printing: "fentanyl 25 µg/h".
Fentanilo Matrix Normon is available in packages of 5 transdermal patches.
Marketing authorization holder and manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
Fentanilo Matrix Normon 50 micrograms/h transdermal patch EFG
Fentanilo Matrix Normon 75 micrograms/h transdermal patch EFG
Fentanilo Matrix Normon 100 micrograms/h transdermal patch EFG
Date of the last revision of this leaflet: March 2025
Other sources of information
Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/
The average price of FENTANIL MATRIX NORMON 25 micrograms/hour TRANSDERMAL PATCHES in October, 2025 is around 14.63 EUR. Prices may vary depending on the region, pharmacy, and whether a prescription is required. Always check with a local pharmacy or online source for the most accurate information.
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