Fentanyl Matrix Kern Pharma 75 micrograms/h transdermal patches EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fentanil Matrix Kern Pharma 75 micrograms/h transdermal patches EFG

Fentanyl

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 could 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 this leaflet

What Fentanil Matrix Kern Pharma is and what it is used for
What you need to know before using Fentanil Matrix Kern Pharma
How to use Fentanil Matrix Kern Pharma
Possible side effects
How to store Fentanil 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 fentanyl. It belongs to a group of strong painkillers known as opioids.

2. What you need to know before starting to use Fentanyl Matrix Kern Pharma

Do not use Fentanyl Matrix Kern Pharma:

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 Fentanyl Matrix Kern Pharma.

Warnings and precautions

Fentanilo Matrix Kern Pharma can have life-threatening adverse effects in people who are not regularly using prescribed opioids.
Fentanilo Matrix Kern Pharma is a medicine that could be life-threatening to children, even if the patches have already been used. Please note that an adhesive 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, out of reach of other people (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 cases in which the patch has accidentally adhered to another family member due to 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 from the patch may pass through that 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 (pauses in breathing 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:

Pauses in breathing 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 any 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 (e.g., pain in a different part of your body)
Pain when your body is touched in a way 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 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 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.
- Keep the person moving and talking 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). It is also possible to 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 may also be harmful. If you notice the medicine 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 medicine 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 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 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 problems (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, it 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 feel better once you start taking 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 discontinue the medication, and how to do so safely.

Withdrawal syndrome upon discontinuation of Fentanilo Matrix Kern Pharma treatment

Do not stop using this medication abruptly. Withdrawal symptoms may occur, such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, feeling sick or being sick, diarrhea, loss of appetite, tremors, chills, or sweating. 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 medication. 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 medications can be taken safely with Fentanilo Matrix Kern Pharma. You may need to be closely monitored if you are taking any of the types of medications listed below or if you stop taking any of them, 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 medications, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine) and some analgesics for neuropathic pain (gabapentin and pregabalin).
Medications to help you sleep (such as temazepam, zaleplon, or zolpidem).
Medications to help you calm down (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medications for mental disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
Medications to relax muscles (such as cyclobenzaprine or diazepam).
Some antidepressants known as SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – more information below.
Some medications 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 medications – more information below.
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).
Medications used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
Medications used to treat HIV infection (such as ritonavir).
Medications used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
Medications used to treat tuberculosis (such as rifampicin).
Some medications used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
Some medications used to treat nausea or dizziness (such as phenothiazines).
Some medications used to treat heartburn or ulcers (such as cimetidine).
Some medications used to treat angina (chest pain) or high blood pressure (such as nicardipine).
Some medications used to treat blood cancer (such as idelalisib).

Use with central nervous system depressants, including alcohol and certain narcotic medications

Concomitant use of fentanyl and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can 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 medications, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedative medications you are taking and carefully follow your doctor's recommendations regarding dosage. It may be helpful to inform friends or family members so they are aware of the aforementioned signs and symptoms. 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 medications such as certain antidepressants. Fentanilo Matrix Kern Pharma may interact with these medications, 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 stiffness, 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 medication is changed.

Use in athletes

Athletes are advised that this medication contains a component that may lead to a positive analytical result in doping control tests.

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 medication.

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

Fentanilo Matrix Kern Pharma should not be used during childbirth, as the medication 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. Speak with your doctor immediately if you think your baby may have withdrawal symptoms.

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

Driving and use of machines

Fentanilo Matrix Kern Pharma may affect your ability to drive and operate machinery 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 medication until you know how it affects you.

Talk to your doctor or pharmacist if you are unsure whether you can drive while taking this medication.

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, 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 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 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

Always apply the patch to the upper back so that your child has difficulty reaching or removing it.
Check from time to time that the patch remains stuck to the skin.
It is important that the child does not remove the patch and put it in their mouth, as this could endanger their life or be fatal.
Keep your child under close observation 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 need additional painkillers until the patch becomes effective. Your doctor will explain this to you.

Adults and children:

Do not apply the patch to

The same site twice in a row.
Areas that move a lot (joints), irritated skin, or skin with wounds.
Areas of skin with excessive hair. If there is hair, 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 you need to wash 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 to dispose of the used patch later.
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

Make sure 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 layer, starting from the center of the patch. Avoid touching the adhesive side of the patch.
Press this adhesive part of the patch onto the skin.
Remove the other half of the protective layer and press the entire patch onto the skin with the palm of your hand.
Press firmly for at least 30 seconds. Ensure the patch adheres well, especially around the edges.

Step 4: Dispose 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 the reach and sight of children; even when used, patches contain medicine that could harm children and may even be fatal.

Step 5: Wash hands

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

More information on using Fentanilo Matrix Kern Pharma

Daily activities while using the patches

The patches are water-resistant.
You may shower or bathe with the patch in place, but do not rub it.
If your doctor agrees, you may exercise or engage in sports while wearing the patch.
You may also swim with the patch in place, but:
Do not use hot tubs or whirlpool baths.
Do not cover the patch with elastic or tight fabrics.
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 medicine 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 prolonged pain. Your doctor will tell you 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 no longer adheres properly or has come off, 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 stop using the 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, indicating the medicine 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 feelings of faintness, dizziness, or confusion. 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 you are significantly delayed, you should 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 should be changed, apply a new one immediately and note the date and time. Choose a new area of skin:
On the trunk or arm.
On the upper back of your child.
Inform your doctor about this and keep the patch in place for another 3 days (72 hours) or for the time your doctor specifies, before changing the patch in the usual way.
If patches tend to fall off, consult your doctor, pharmacist, or nurse.

If you want to stop using the patches

Do not stop using this medicine abruptly. Consult your doctor before stopping the patches. Your doctor will advise you on how to do this, 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 need a different dose when restarting treatment.

If you have any further questions about using this medicine, 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, 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 all 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.
Tingling or prickling sensation on the skin (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 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).
Reduced 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.
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)

Lack 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 it does not resolve, 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 Kern Pharma, or if you 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 Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fentanil Matrix Kern Pharma

Where to store the patches

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

Store this medicine in a safe and secure place, inaccessible to other people. 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 Fentanil Matrix Kern Pharma be stored

Do not use this medicine after the expiry date stated on the carton and on the 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 you no longer need

Accidental exposure of another person to used or unused patches, especially in children, 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 in the original sachet and kept out of sight and reach of others, particularly children, until they are safely disposed of.

Medicines must not be disposed of via wastewater or household waste. Take any unused medicines and their packaging to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

6. Contents of the pack and other information

Composition of Fentanilo Matrix Kern Pharma 75 micrograms/h transdermal patches

The active substance is fentanyl.
Each transdermal patch (45 cm² release surface area) contains 14.4 mg of fentanyl, equivalent to a release rate of 75 micrograms of fentanyl per hour.
The other components are: acrylic polymer, lauryl alcohol, polyester/ethylene-vinyl acetate film, silicone-coated polyester film, and printing ink.

Appearance of the product and contents of the pack

Fentanilo Matrix Kern Pharma 75 micrograms/h is a thin, transparent transdermal patch with rounded edges and the following printed text: "fentanyl 75 μg/h".

Fentanilo Matrix Kern Pharma is available in packs containing 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 100 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 review of this leaflet: March 2025

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