Fentanyl Matrix Kern Pharma 100 micrograms/h transdermal patches EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fentanilo Matrix Kern Pharma 100 micrograms/h transdermal patches EFG

Fentanyl

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, consult your doctor, pharmacist, or nurse.
This medicine has been prescribed for you (or your child) only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

What Fentanilo Matrix Kern Pharma is and what it is used for
What you need to know before using Fentanilo Matrix Kern Pharma
How to use Fentanilo Matrix Kern Pharma
Possible side effects
How to store Fentanilo Matrix Kern Pharma
Contents of the pack and other information

1. What Fentanilo Matrix Kern Pharma is and what it is used for

This medicine is called Fentanilo Matrix Kern Pharma.

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 Kern Pharma 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 Kern Pharma

Do not use Fentanilo Matrix Kern Pharma:

If you are allergic to fentanyl or to any of the other ingredients 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 Kern Pharma.

Warnings and precautions

Fentanyl Matrix Kern Pharma can have life-threatening adverse effects in people who are not regularly using prescribed opioids.
Fentanyl Matrix Kern Pharma is a medicine that could be life-threatening to children, even if the patches have already been used. Please note that a transdermal patch (used or unused) may be attractive to a child, and if it adheres to the child's skin or if the child puts it in their mouth, the result could be fatal.
Store this medicine in a safe and secure place, inaccessible to others (see section 5 for more information).

If the patch sticks 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 some reported cases where the patch has accidentally adhered 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 (particularly a child), the medication 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 attention.

Take special care with FentaniloMatrix Kern Pharma

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 FentaniloMatrix Kern Pharma.

While using the patch, inform your doctor if you experience breathing problems during sleep. Opioids such as fentanyl can cause sleep-related breathing disorders, such as sleep apnea (breathing pauses during sleep) and sleep-related hypoxemia (low blood oxygen levels). Talk to your doctor if you, your partner, or caregiver notice any of the following symptoms:

Breathing pauses during sleep
Waking up at night due to shortness of breath
Difficulty staying asleep
Excessive daytime sleepiness

Your doctor may decide to adjust your 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 how you feel pain (for example, pain in another part of your body)
Pain from body contact that should not cause pain

Do not change the dose on your own. Your doctor may decide to adjust the dose or change your treatment.

Adverse effects and FentaniloMatrix Kern Pharma

FentaniloMatrix Kern Pharma may cause unusual drowsiness and may make your breathing slower or weaker. In rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as FentaniloMatrix Kern Pharma or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually drowsy, with slow or weak breathing:
- Remove the patch.
- Call a doctor or go immediately to the nearest hospital.
- Encourage the person to move and speak as much as possible.
If you develop a fever while using FentaniloMatrix Kern Pharma, speak with your doctor. Fever may increase the amount of medication passing through your skin.
FentaniloMatrix Kern Pharma may cause constipation; speak with your doctor or pharmacist for advice on how to prevent or relieve constipation.

In section 4, you can find the complete list of possible adverse effects.

While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Avoid prolonged sun exposure, hot baths, saunas, or hot tubs. Doing so may increase the amount of medication 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 FentaniloMatrix Kern Pharma. 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 becoming less effective, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of FentaniloMatrix Kern Pharma.

Dependence and addiction

This medication contains fentanyl, which is an opioid. It may cause dependence and/or addiction.

Repeated use of Fentanilo Matrix Kern Pharma may also lead to dependence, abuse, and addiction, which could result in 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 medication you need to take or how frequently you need to take it. You may feel the need to continue using the medication even though it no longer helps relieve pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to Fentanilo Matrix Kern Pharma may be greater if:

You or any member of your family have abused alcohol or have experienced dependence on alcohol, prescription medications, 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 signs while using Fentanilo Matrix Kern Pharma, this could be a sign of dependence or addiction:

You need to use the medication for longer than prescribed by your doctor.
You need to use a higher dose than recommended.
You are using the medication 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 medication or to control its use.
You feel unwell when you stop using the medication, and you feel better once you resume taking it ("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 discontinue the medication, and how to do so safely.

Withdrawal syndrome upon discontinuation of Fentanilo Matrix Kern Pharma

Do not stop using this medication abruptly. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, nausea or vomiting, diarrhea, loss of appetite, tremors, chills, or sweating may occur. If you wish to stop using this medication, speak with your doctor first. Your doctor will advise you on how to do so, usually by gradually reducing the dose to minimize unpleasant withdrawal effects.

Use of Fentanilo Matrix Kern Pharma with other medicines

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 Kern Pharma if you purchase any medication at the pharmacy.

Your doctor will know which medicines can be taken safely with Fentanilo Matrix Kern Pharma. You may need to be closely monitored if you are taking or stop taking any of the types of medicines listed below, as this may affect the dose of Fentanilo Matrix Kern Pharma 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 antidepressants called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – more information below.
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 Kern Pharma within 14 days of stopping these medicines – more information below.
Some antihistamines, especially those that cause 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 with central nervous system depressants, including alcohol and certain narcotic medicines

Concomitant use of fentanyl and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes fentanyl together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and follow your doctor's recommendations carefully regarding dosage. 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 such symptoms.

Do not drink alcohol while using Fentanilo Matrix Kern Pharma unless you have discussed it with your doctor first.

Use of Fentanilo Matrix Kern Pharma with antidepressants

The risk of adverse effects increases if you are taking medicines such as certain antidepressants. Fentanilo Matrix Kern Pharma may interact with these medicines, and you may experience changes in mental status 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 rigidity, nausea, vomiting, and diarrhea (which 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 the medication is changed.

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive analytical doping test result.

Surgery

If you are planning to receive anesthesia, inform your doctor or dentist that you are using Fentanilo Matrix Kern Pharma.

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 Kern Pharma must not be used during pregnancy unless you have discussed it with your doctor.

Fentanilo Matrix Kern Pharma must not be used during childbirth, as the medicine may affect the newborn's breathing.

Prolonged use of Fentanilo Matrix Kern Pharma during pregnancy may cause withdrawal symptoms (such as high-pitched crying, restlessness, seizures, poor feeding, and diarrhea) in your newborn baby, which could be potentially fatal if not recognized and treated. Contact your doctor immediately if you think your baby may have withdrawal symptoms.

Do not use Fentanilo Matrix Kern Pharma if you are breastfeeding. You must not breastfeed for 3 days after removing the Fentanilo Matrix Kern Pharma patch. This is because the medicine can pass into breast milk.

Driving and using machines

Fentanilo Matrix Kern Pharma 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 are unsure whether you can drive while taking this medicine.

3. How to use Fentanilo Matrix Kern Pharma

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide which concentration of Fentanilo Matrix Kern Pharma is most suitable for you, based on the intensity of your pain, your general condition, and the type of pain treatment you have previously received.

Before starting treatment and regularly during treatment, your doctor will also explain to you what you can expect from using Fentanilo Matrix Kern Pharma, 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 Kern Pharma treatment").

How to apply and change the patches

Each patch contains a sufficient amount of medication for 3 days (72 hours).
You must change the patch every three days, unless your doctor has instructed 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 upper arm (never over a joint).

Children

Always apply the patch to the upper back to make it difficult for your child to reach or remove it.
Check regularly to ensure the patch remains adhered to the skin.
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.
Closely monitor your child for 48 hours after:
Applying the first patch.
Applying a patch with a higher dose.
The patch may take some time to reach its full effect. Therefore, your child may require additional painkillers 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 succession.
Areas that move frequently (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

Step 1: Prepare the skin

Before applying the patch, ensure the skin is completely dry, clean, and cool.
If washing the skin, 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.

Step 2: Open the pouch

Each patch is sealed in its own pouch.
Tear or cut to open the pouch.
Gently tear or completely cut along the edge of the pouch (if using scissors, cut close to the sealed edge to avoid damaging the patch).
Hold the two parts of the opened pouch and pull them apart.
Remove the patch and use it immediately.
Keep the empty pouch for later disposal of the used patch.
Use each patch only once.
Do not remove the patch from its pouch until you are ready to use it.
Check that the patch is not damaged.
Do not use the patch if it is split, cut, or otherwise damaged.
Never divide or cut the patch.

Step 3: Peel and press

Ensure the patch will be covered by loose clothing and do not apply it under tight or elastic fabric.
Carefully peel off half of the shiny plastic protective liner, starting from the center of the patch. Avoid touching the adhesive surface of the patch.
Press this adhesive part of the patch onto the skin.
Remove the remaining part of the protective liner and press the entire patch onto the skin with the palm of your hand.
Hold it in place for at least 30 seconds. Ensure the patch is firmly adhered, especially around the edges.

Step 4: Disposal of the patch

Immediately after removing the patch, fold it in half with the adhesive side sticking to itself.
Place it back into the original pouch and dispose of it according to your pharmacist's instructions.
Keep used patches out of the reach and sight of children; even when used, patches contain medication that can harm children and may even be fatal.

Step 5: Washing hands

Always wash your hands with water only after handling the patches.

More information on the use of Fentanilo Matrix Kern Pharma

Daily activities while using patches

The patches are water-resistant.
You may shower or bathe while wearing the patch, but do not rub it.
If your doctor agrees, you may exercise or engage in physical activity while wearing the patch.
You may also swim while wearing the patch, but:
Do not use hot tubs or whirlpool baths.
Do not cover the patch with elastic or tight-fitting clothing.
While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. 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 provide additional painkillers during the first few days.
Afterwards, the patch should help relieve pain continuously, allowing you to stop taking other painkillers. However, your doctor may occasionally prescribe additional painkillers.

How long will you need to use the patches?

Fentanilo Matrix Kern Pharma 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, go to a hospital, or call the Toxicology Information Service at 91 562 04 20, stating the medication and the amount applied.

Signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk or speak normally, and feeling faint, dizzy, or confused. 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, do so as soon as you remember, and note the date and time. Then resume changing the patch every 3 days (72 hours) as usual.
If the delay is significant, 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 and leave the patch in place for another 3 days (72 hours) or for the duration specified by your doctor before changing the patch as usual.
If patches tend to come off frequently, consult your doctor, pharmacist, or nurse.

If you wish to stop using the patches

Do not stop using this medication abruptly. Consult your doctor before discontinuing the patches. Your doctor will advise you on how to proceed, usually by gradually reducing the dose to minimize unpleasant withdrawal effects. See also section 2, "Withdrawal syndrome upon discontinuation of Fentanilo Matrix Kern Pharma treatment."
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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you, or your partner or caregiver, notice 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 needed.

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 Kern Pharma 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. These may be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).
Seizures (convulsions). (Uncommon: may affect up to 1 in 100 people).
Decreased 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.
Abnormal skin sensations such as tingling or prickling (paraesthesia).
Sensation of spinning (vertigo).
Rapid or irregular heartbeat (palpitations, tachycardia).
Increased blood pressure.
Shortness of breath (dyspnoea).
Diarrhoea.
Dry mouth.
Stomach pain or indigestion.
Excessive sweating.
Itching, rash, or redness of the skin.
Inability to urinate or fully 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 patch application site.
Flu-like illness.
Sensation of body temperature changes.
Fever.
Muscle cramps.
Difficulty achieving or maintaining an erection (impotence) or problems with sexual performance.
Difficulty swallowing.

Rare side effects (may affect up to 1 in 1,000 people)

Constriction of the pupils (miosis).
Occasional interruption of breathing (apnoea).

Frequency not known (cannot be estimated from available clinical data)

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 Kern Pharma (see section 2).

You may experience skin rash, redness, or mild itching 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 accustomed to it or more sensitive to pain), or may lead to dependence.

If you switch from another painkiller to Fentanilo Matrix Kern Pharma or stop using Fentanilo Matrix Kern Pharma 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 of newborns experiencing withdrawal symptoms after their mothers used Fentanilo Matrix Kern Pharma 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 Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you help provide more information on the safety of this medicine.

5. Storage of Fentanilo Matrix Kern Pharma

Where to store the patches

Keep all patches (used and unused) out of the sight and reach of children.

Store this medicine in a safe and secure place inaccessible to others. This medicine may cause serious harm or even be fatal to individuals who use it accidentally or intentionally when it has not been prescribed for them.

How long can Fentanilo Matrix Kern Pharma 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 the pharmacy.

This medicine does not require any special storage conditions.

Keep in the original packaging.

How to dispose of used patches or patches no longer needed

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 kept out of sight and reach of others, especially children, until they can be safely disposed of.

Medicines must not be disposed of via wastewater drains or household waste. Return empty containers and unused medicines to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fentanilo Matrix Kern Pharma 100 micrograms/h transdermal patches

The active substance is fentanyl.

Each transdermal patch (60 cm² release surface area) contains 19.2 mg of fentanyl, equivalent to a release rate of 100 micrograms of fentanyl per hour.

The other components are: acrylic polymer, lauryl alcohol, polyester/ethyl vinyl acetate film, silicone-coated polyester film, and printing ink.

Appearance of the product and contents of the pack

Fentanilo Matrix Kern Pharma 100 micrograms/h is a thin, transparent transdermal patch with rounded edges and the following imprint: "fentanyl 100 μg/h".

Fentanilo Matrix Kern Pharma is available in packs of 5 transdermal patches.

The following presentations are available: Fentanilo Matrix Kern Pharma 25 micrograms/h, Fentanilo Matrix Kern Pharma 50 micrograms/h, Fentanilo Matrix Kern Pharma 75 micrograms/h.

Marketing Authorization Holder and Manufacturer

Kern Pharma, S.L.

Venus, 72 - Pol. Ind. Colón II

08228 Terrassa - Barcelona

Spain

Date of the most recent revision of this summary: March 2025

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/