Fentanyl Matrix Normon 75 micrograms/h transdermal patches EFG
Spain
Table of Contents
- Package leaflet: Information for the user
- Introduction
- 1. What Fentanilo Matrix Normon is and what it is used for
- 2. What you need to know before using Fentanilo Matrix Normon
- 3. How to use Fentanilo Matrix Normon
- 4. Possible adverse effects
- 5. Storage of Fentanilo Matrix Normon
- 6. Contents of the pack and other information
- **OTHER PRESENTATIONS**
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Fentanil Matrix Normon 75 micrograms/h transdermal patch EFG
Fentanil
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, ask your doctor, pharmacist or nurse.
- This medicine has been prescribed for you (or your child) only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Fentanil Matrix Normon is and what it is used for
- What you need to know before using Fentanil Matrix Normon
- How to use Fentanil Matrix Normon
- Possible side effects
- How to store Fentanil Matrix Normon
- Contents of the pack and other information
1. What Fentanilo Matrix Normon is and what it is used for
This medicine is called Fentanilo Matrix Normon.
The patches help relieve severe and long-lasting pain:
- in adults who require continuous pain treatment
- in children over 2 years of age who are already using opioid medication and who require continuous pain treatment.
Fentanilo Matrix Normon contains a medicine called fentanil. It belongs to a group of strong painkillers known as opioids.
2. What you need to know before using Fentanilo Matrix Normon
Do not use Fentanilo Matrix Normon:
- If you are allergic to fentanyl or to any of the other components of this medicine (listed in section 6).
- If you have short-term pain, such as sudden pain or pain after surgery.
- If you have difficulty breathing, with slow or weak breathing.
Do not use this medicine if you or your child are in any of the above situations. If you are unsure, consult your doctor or pharmacist before using Fentanilo Matrix Normon.
Warnings and precautions
- Fentanilo Matrix Normon may cause life-threatening adverse effects in people who are not regularly using prescribed opioids.
- Fentanilo Matrix Normon is a medicine that could be life-threatening to children, even if the patches have already been used. Note that a transdermal patch (used or unused) may be attractive to a child, and if it adheres to the child's skin or the child puts it in their mouth, the result could be fatal.
- Keep this medicine in a secure and protected place, out of reach of others. See section 5 for more information.
If the patch adheres to another person
The patch must 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 adhered to another family member through close physical contact or by sharing the same bed with the person wearing the patch. If the patch accidentally adheres to another person (especially a child), the medicine from the patch can pass through the other person's skin and may cause serious adverse effects, such as difficulty breathing, slow or weak breathing, which could be fatal. If the patch adheres to another person's skin, remove it immediately and seek medical help.
Take special care with Fentanilo Matrix Normon
Consult your doctor or pharmacist before using this medicine if you are in any of the following situations. Your doctor will need to monitor you more closely:
- If you have ever had lung or breathing problems.
- If you have ever had heart, liver, or kidney problems, or low blood pressure.
- If you have ever had a brain tumor.
- If you have ever had persistent headaches or a head injury.
- If you are elderly, as you may be more sensitive to the effects of this medicine.
- If you have a disorder called "myasthenia gravis," in which muscles become weak and tire easily.
If you have any of the above conditions (or if you are unsure), consult your doctor or pharmacist before using Fentanilo Matrix Normon.
While using the patch, inform your doctor if you have breathing problems during sleep. Opioids such as 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:
- Pauses in breathing while sleeping.
- Waking up at night due to shortness of breath.
- Difficulty staying asleep.
- Excessive daytime sleepiness.
Your doctor may decide to adjust the dose.
While using the patch, inform your doctor if you notice a change in your pain. If you experience:
- The patch no longer relieves your pain.
- An increase in pain.
- A change in the way you feel pain (for example, pain in another part of your body).
- Pain caused by touch on your body that should not cause pain.
Do not change the dose on your own. Your doctor may decide to adjust the dose or change the treatment.
Adverse effects and Fentanilo Matrix Normon
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Fentanilo Matrix Normon may cause unusual drowsiness and may slow or weaken your breathing. In very rare cases, these breathing problems may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Fentanilo Matrix Normon or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually drowsy, with slow or weak breathing:
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Remove the patch.
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Call a doctor or go immediately to the nearest hospital.
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Encourage the person to move and speak as much as possible.
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If you develop a fever while using Fentanilo Matrix Normon, speak to your doctor. This may increase the amount of medicine passing through your skin.
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Fentanilo Matrix Normon may cause constipation; speak to your doctor or pharmacist for advice on how to prevent or relieve constipation.
The complete list of possible adverse effects can be found in section 4.
While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated waterbeds, or heat or tanning lamps. Avoid prolonged sun exposure, hot baths, saunas, or hot tubs. Doing so could 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 may cause the drug to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). You may also become more sensitive to pain while using Fentanilo Matrix Normon. This is known as hyperalgesia. Increasing the patch dose may continue to reduce pain for a time, but it could also be harmful. If you notice the medicine is losing effectiveness, consult 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 may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of lack 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 does not help relieve your 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 higher if:
- You or any member of your family have abused alcohol or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
- You smoke.
- You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.
If you notice any of the following symptoms while using Fentanilo Matrix Normon, it could be a sign of dependence or addiction:
- You need to use the medicine for longer than prescribed by your doctor.
- You need to use a higher dose than recommended.
- You are using the medicine for reasons other than those prescribed, for example, to stay calm or to help you sleep.
- You have made repeated unsuccessful attempts to stop using the medicine or control its use.
- You feel unwell when you stop using the medicine, and feel better once you take it again ("withdrawal effects").
If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to stop the medicine, and how to do so safely.
This medicine contains fentanyl, which is an opioid. It may cause dependence and/or addiction. |
Repeated use of Fentanilo Matrix Normon may also lead to dependence, abuse, and addiction, which could result in potentially fatal overdose.
Withdrawal symptoms when stopping Fentanilo Matrix Normon
Do not stop using this medicine abruptly. Withdrawal symptoms may occur, such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, feeling or being sick, diarrhoea, loss of appetite, tremors, chills, or sweating. If you wish to stop using this medicine, speak to your doctor first. Your doctor will advise you on how to do this, usually by gradually reducing the dose so that unpleasant withdrawal effects are minimized.
Other medicines and Fentanilo Matrix Normon
Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines purchased without a prescription and herbal remedies. You should also inform your pharmacist that you are using Fentanilo Matrix Normon if you purchase any medicine from the pharmacy.
Your doctor will know which medicines can be safely taken with Fentanilo Matrix Normon. You may need to be closely monitored if you are taking any of the types of medicines listed below or if you stop taking any of these medicines, as this may affect the dose of Fentanilo Matrix Normon you require.
In particular, inform your doctor or pharmacist if you are taking:
- Other pain medicines, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine) and some analgesics for neuropathic pain (gabapentin and pregabalin).
- Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
- Medicines to help you relax (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
- Medicines to relax muscles (such as cyclobenzaprine or diazepam).
- Some medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). – see below for more information
- Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Fentanilo Matrix Normon within 14 days of stopping these medicines. – see below for more information
- Some antihistamines, especially those causing drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
- Some antibiotics used to treat infections (such as erythromycin or clarithromycin).
- Medicines used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
- Medicines used to treat HIV infection (such as ritonavir).
- Medicines used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
- Medicines used to treat tuberculosis (such as rifampicin).
- Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
- Some medicines used to treat nausea or dizziness (such as phenothiazines).
- Some medicines used to treat stomach burning or ulcers (such as cimetidine).
- Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
- Some medicines used to treat blood cancer (such as idelalisib).
Use of Fentanilo Matrix Normon with antidepressants
The risk of adverse effects increases if you are taking medicines such as certain antidepressants. Fentanilo Matrix Normon may interact with these medicines, and you may experience changes in mental state such as agitation, seeing, feeling, hearing, or smelling things that are not present (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, hyperactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhoea (these could be signs of serotonin syndrome). If used together, your doctor may want to monitor you closely for these side effects, especially when starting treatment or when the dose of medicine is changed.
Use with central nervous system depressants, including alcohol and certain narcotic medicines
Concomitant use of Fentanilo Matrix Normon and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.
However, if your doctor prescribes Fentanilo Matrix Normon together with sedative medicines, your doctor should limit the dose and duration of concomitant treatment.
Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s dosing recommendations. 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 discussed it with your doctor first.
Use in athletes
Athletes are advised that this medicine contains a component that may result in a positive doping test.
Surgery
If you are planning to receive anesthesia, inform 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 plan to become pregnant, consult your doctor or pharmacist 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 childbirth, as the medicine may affect the newborn’s breathing.
Prolonged use of Fentanilo Matrix Normon during pregnancy may cause withdrawal symptoms (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhoea) in your newborn baby, which may be potentially fatal if not recognized and treated. Speak to your doctor immediately if you think your baby may have withdrawal symptoms.
Do not use Fentanilo Matrix Normon if you are breastfeeding. You must 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 may affect your ability to drive and use machines or tools, as it may cause drowsiness or dizziness. If so, do not drive or operate tools or machinery. Do not drive while using this medicine until you know how it affects you.
Talk to your doctor or pharmacist if you have any doubts about whether it is safe for you to drive while using this medicine.
3. How to use Fentanilo Matrix Normon
Follow exactly the instructions for use of this medicine given by your doctor. If in doubt, please 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 to you what you can expect from the use of 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 upon discontinuation of Fentanilo Matrix Normon treatment”).
How to apply and change the patches
- Each patch contains a sufficient amount of medication for 3 days (72 hours).
- You should change the patch every three days, unless your doctor has instructed you otherwise.
- Always remove the used patch before applying a new one.
- Always change the patch at the same time of day every 3 days (72 hours).
- If you are using more than one patch, change all of them at the same time.
- Record the day of the week, date, and time each time you apply a patch, so you remember when to change it.
- The table below shows when you should change the patch:
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
- Apply the patch to a flat area of the trunk or arm (never over a joint).
Children
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Always apply the patch to the upper back to make it difficult for your child to reach or remove it.
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Check periodically to ensure the patch remains adhered to the skin.
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It is important that the child does not remove the patch and put it in their mouth, as this could be life-threatening or fatal.
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Closely monitor your child for 48 hours after:
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Applying the first patch
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Applying a patch with a higher dose
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The patch may take some time to reach its full effect. Therefore, your child may need additional pain relief until the patch becomes effective. Your doctor will advise you accordingly.
Adults and children:
Do not apply the patch to
- The same site twice in a row.
- Areas with high movement (joints), irritated skin, or skin with wounds.
- Areas of skin with excessive hair. If hair is present, do not shave it (shaving may irritate the skin). Instead, cut the hair as close to the skin as possible.
How to apply the patch
Preparing the skin
- Before applying the patch, ensure the skin is completely dry, clean, and cool.
- If washing the skin is necessary, use only cold water.
- Do not use soap or other cleansers, creams, moisturizers, oils, or talcum powder before applying the patch.
- Do not apply the patch immediately after a hot bath or shower.
Disposing of the patch
- Immediately after removing the patch, fold it in half so that the adhesive side sticks to itself.
- Place it back into the original pouch and dispose of it according to your pharmacist's instructions.
- Keep used patches out of sight and reach of children; even when used, patches contain medication that could seriously harm or even kill children.
Handwashing
- Always wash your hands with water only after handling patches.
More information on the use of Fentanilo Matrix Normon
Daily activities while using patches
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The patches are water-resistant.
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You may shower or bathe with the patch in place, but do not rub it.
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If your doctor agrees, you may exercise or engage in sports while wearing the patch.
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You may also swim while wearing the patch, but:
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Do not use hot tubs or whirlpool baths.
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Do not cover the patch with elastic or tight bandages.
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While wearing the patch, avoid direct exposure to heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, heat lamps, or sunlamps. Avoid prolonged sun exposure, hot baths, and saunas. Doing so may increase the amount of medication released from the patch.
How long do the patches take to work?
- The first patch may take some time to reach its full effect.
- Your doctor may prescribe additional painkillers during the first few days.
- Afterwards, the patch should provide continuous pain relief, allowing you to stop taking other painkillers. However, your doctor may occasionally prescribe additional painkillers as needed.
How long will you need to use the patches?
- Fentanilo Matrix Normon patches are indicated for long-term pain. Your doctor will advise you on how long you can expect to use the patches.
If pain worsens
- If your pain suddenly worsens after applying the last patch, check the patch. If it is no longer adhering properly or has detached, replace the patch (see also section "If the patch comes off").
- If your pain worsens over time while using the patches, your doctor may try patches with a higher dose or prescribe additional painkillers (or both).
- If increasing the patch dose does not help, your doctor may decide to discontinue the use of patches.
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 immediately and contact your doctor right away or call the Toxicology Information Service at 8919 562 04 20, stating the medication and amount applied, or go to the hospital.
Signs of overdose include difficulty breathing or weak breathing, fatigue, extreme drowsiness, inability to think clearly or to walk or speak normally, dizziness, confusion, or lightheadedness. An overdose may also cause a brain disorder known as toxic leukoencephalopathy.
If you forget to change the patch
- If you forget to change the patch, change it as soon as you remember and note the date and time. Resume changing the patch every 3 days (72 hours) as usual.
- If there is a significant delay, speak to your doctor, as you may need additional painkillers, but do not apply extra patches.
If the patch comes off
- If the patch falls off before it is time to change it, apply a new one immediately and note the date and time. Choose a new skin site:
- On the trunk or arm
- On the upper back of your child
- Inform your doctor about this and continue wearing the patch for another 3 days (72 hours) or for the duration specified by your doctor before changing it again as usual.
- If patches tend to fall off frequently, consult your doctor, pharmacist, or nurse.
If you wish to stop using the patches
- Do not stop using this medication abruptly. If you wish to discontinue this medication, speak to your doctor first. Your doctor will guide you on how to do so, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms. See also section 2, "Withdrawal symptoms when stopping Fentanilo Matrix Normon."
- If you stop using the patches, do not reuse them without first consulting your doctor. You may require a different dose when restarting treatment.
If you have any further questions about the use of this medication, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
If you, or your partner or caregiver, observe any of the following signs in the person wearing the patch, remove the patch immediately and contact a doctor or go straight to the nearest hospital. Urgent medical treatment may be required.
- Unusual drowsiness, slower or weaker breathing than expected.
Follow the above recommendations and encourage the person wearing the patch to move and speak as much as possible. In very rare cases, these breathing difficulties may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Fentanilo Matrix Normon or morphine). (Uncommon, may affect up to 1 in 100 people).
- Sudden swelling of the face or throat, severe irritation, redness, or blisters on the skin.
All of these may be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).
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Seizures (convulsions). (Uncommon, may affect up to 1 in 100 people).
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Reduced level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people).
The following adverse effects have also been reported
Very common (may affect more than 1 in 10 people)
- Nausea, vomiting, constipation
- Feeling sleepy (somnolence)
- Feeling dizzy
- Headache
Common (may affect up to 1 in 10 people)
- Allergic reaction
- Loss of appetite
- Difficulty sleeping
- Depression
- Feeling anxious or confused
- Seeing, feeling, hearing, or smelling things that are not present (hallucinations)
- Tremors or muscle spasms
- Unusual skin sensations such as tingling or prickling (paraesthesia)
- Sensation of spinning (vertigo)
- Fast or irregular heartbeat (palpitations, tachycardia)
- Increased blood pressure
- Feeling short of breath (dyspnoea)
- Diarrhoea
- Dry mouth
- Stomach pain or indigestion
- Excessive sweating
- Itching, rash, or redness of the skin
- Inability to urinate or to completely empty the bladder
- Severe tiredness, weakness, or general malaise
- Feeling cold
- Swelling of the hands, ankles, or feet (peripheral oedema)
Uncommon (may affect up to 1 in 100 people)
- Feeling restless or disoriented
- Feeling extremely happy (euphoria)
- Decreased sensation or sensitivity, especially in the skin (hypoesthesia)
- Memory loss
- Blurred vision
- Slow heart rate (bradycardia) or low blood pressure
- Bluish discoloration of the skin due to reduced oxygen in the blood (cyanosis)
- Loss of intestinal contractions (ileus)
- Itchy skin rash (eczema), allergic reaction, or other skin disorders at the site of patch application
- Flu-like illness
- Sensation of body temperature changes
- Fever
- Muscle cramps
- Difficulty achieving or maintaining an erection (impotence) or problems with sexual performance
Rare adverse effects (may affect up to 1 in 1,000 people)
- Constriction of the pupils (miosis)
- Occasional interruption of breathing (apnoea)
The following adverse effects have also been reported, but their exact frequency is unknown:
- Deficiency of male sex hormones (androgen deficiency)
- Delirium (symptoms may include a combination of restlessness, agitation, disorientation, confusion, fear, seeing or hearing things that are not real, sleep disturbances, nightmares)
- You may become dependent on Fentanilo Matrix Normon (see section 2).
You may experience rashes, redness, or mild itching of the skin at the site where the patch is applied. This is usually mild and disappears after removing the patch. If this does not happen, or if the patch causes significant skin irritation, inform your doctor.
Repeated use of the patches may cause the medicine to lose effectiveness (you may become tolerant to it or more sensitive to pain), or may lead to dependence.
If you switch from another painkiller to Fentanilo Matrix Normon, or if you stop using Fentanilo Matrix Normon abruptly, you may experience withdrawal symptoms such as dizziness, feeling unwell, diarrhoea, anxiety, or tremors. Inform your doctor if you notice any of these effects.
Cases have also been reported in newborn infants who experienced withdrawal symptoms after their mothers used Fentanilo Matrix Normon for a prolonged period during pregnancy.
Reporting of adverse effects
If you experience any adverse effect, talk to your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Fentanilo Matrix Normon
Where to store the patches
Keep all patches (used and unused) out of sight and reach of children.
Store this medicine in a protected and secure place, inaccessible to others.
This medicine may be extremely harmful and even fatal to people who accidentally or intentionally use it, even when it has not been prescribed for them.
How long can Fentanilo Matrix Normon be stored
Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the last day of the month indicated. If the patches have expired, return them to a pharmacy.
Do not use this medicine if you notice that the patches are damaged.
Keep in the original packaging to protect from moisture.
How to dispose of used patches or patches no longer in use
Accidental exposure of other individuals, especially children, to used or unused patches may result in a fatal outcome.
Used patches should be folded firmly in half so that the adhesive side sticks to itself. They should then be safely discarded by placing them back into the original sachet and storing them out of sight and reach of others, especially children, until they can be safely disposed of. Ask your pharmacist how to properly dispose of containers and medicines you no longer need.
Medicines must not be disposed of via wastewater or household waste. Take unused containers and medicines to a SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to dispose of unused medicines and packaging. This helps protect the environment.
6. Contents of the pack and other information
Composition of Fentanilo Matrix Normon The active substance is fentanyl.
Each transdermal patch (45 cm² release surface area) contains 14.4 mg of fentanyl, delivering a dose of 75 micrograms/hour.
- Other components of the patch are:
Adhesive layer: Acrylic polymer, lauryl alcohol
Backing layer: Silicone-treated polyester film
Peelable liner: Polyester / ethylene vinyl acetate film
Printing ink
Appearance of the product and contents of the pack
Fentanilo Matrix Normon 75 micrograms/h is a thin, transparent transdermal patch with rounded edges and printed with: "fentanyl 75 µg/h".
Fentanilo Matrix Normon is available in packs of 5 transdermal patches.
Marketing Authorization Holder and Manufacturer
LABORATORIOS NORMON, S.A.
Ronda de Valdecarrizo, 6 – 28760 Tres Cantos – Madrid (SPAIN)
OTHER PRESENTATIONS
Fentanil Matrix Normon 25 micrograms/h transdermal patch EFG
Fentanil Matrix Normon 50 micrograms/h transdermal patch EFG
Fentanil Matrix Normon 100 micrograms/h transdermal patch EFG
Date of the most recent review of this leaflet: March 2025
Other sources of information
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/