FENTANIL MATRIX STADA 50 micrograms/hour TRANSDERMAL PATCH

Introduction

Package Leaflet: Information for the User

Fentanilo Matrix Stada 12 micrograms/h transdermal patches EFG

Fentanilo Matrix Stada 25 micrograms/h transdermal patches EFG

Fentanilo Matrix Stada 50 micrograms/h transdermal patches EFG

Fentanilo Matrix Stada 75 micrograms/h transdermal patches EFG

Fentanilo Matrix Stada 100 micrograms/h transdermal patches EFG

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Fentanilo Matrix Stada and what is it used for
2. What you need to know before you use Fentanilo Matrix Stada
3. How to use Fentanilo Matrix Stada
4. Possible side effects

1. Storage of Fentanilo Matrix Stada

Contents of the pack and further information

1. What is Fentanilo Matrix STADA and what is it used for

This medicine is called Fentanilo Matrix Stada.

The patches help to relieve very strong and long-lasting pain:

• in adults who need continuous pain treatment
• in children over 2 years of age who are already using opioid medication and who need continuous pain treatment.

Fentanilo Matrix Stada contains a medicine called fentanyl. It belongs to a group of strong pain-relieving medicines called opioids.

2. What you need to know before you use Fentanilo Matrix STADA

Do not use Fentanilo Matrix Stada:

• If you are allergic to fentanyl or 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 an operation.
• If you have breathing difficulties, 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 not sure, talk to your doctor or pharmacist before using Fentanilo Matrix Stada.

Warnings and precautions

If the patch sticks to another person

The patch must only be used on the skin of the person it has been prescribed for. There have been cases where the patch has stuck accidentally to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch sticks accidentally to another person (especially a child), the medicine in the patch can pass through the skin of the other person and can cause serious side effects, such as breathing difficulties, with slow or weak breathing that can be fatal. If the patch sticks to someone else's skin, it must be removed immediately and a doctor must be seen.

Be careful with Fentanilo Matrix Stada

Talk to your doctor or pharmacist beforeusing this medicine if you are in any of the following situations. Your doctor will need to keep a closer eye on you:

• 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 an elderly person, as you may be more sensitive to the effects of this medicine.
• If you have a condition called "myasthenia gravis", where your muscles become weak and tire easily.

If you have any of the above conditions (or if you are not sure), talk to your doctor or pharmacist before using Fentanilo Matrix Stada.

Tell your doctor if you have breathing problems while you are asleep.

Opioids like fentanyl can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing while asleep) and sleep-related low blood oxygen levels. Talk to your doctor if you, your partner, or carer notice any of the following symptoms:

• pauses in breathing while asleep
• waking up at night due to lack of breath
• difficulty staying asleep
• excessive sleepiness during the day

Your doctor may decide to change your dose.

Tell your doctor if you notice a change in your pain.

If you feel:

• that the patch is no longer relieving your pain
• an increase in your pain
• a change in the way you feel pain (for example, you feel pain in a different part of your body)
• pain when you touch your body in a way that should not hurt.

Do not change your dose yourself. Your doctor may decide to change your dose or change your treatment.

Side effects and Fentanilo Matrix Stada

• Fentanyl can make you feel extremely sleepy and can slow down your breathing. In rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers before (such as fentanyl or morphine). If you, or your partner or carer, notice that the person wearing the patch is unusually sleepy, with slow or weak breathing:
• Remove the patch
• Call a doctor or go to the nearest hospital immediately
• Get the person to move and talk as much as possible

You can find a complete list of possible side effects in section 4.

While wearing the patch, do not expose it to direct heat, such as heat pads, electric blankets, hot water bottles, water beds, heat lamps, or tanning lamps. Do not take sunbaths or long hot baths, and do not use saunas or hot tubs. If you do, you may increase the amount of medicine released from the patch.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers can make the medicine less effective (your body gets used to it, which is known as tolerance). You may also become more sensitive to pain when using fentanyl. This is known as hyperalgesia. Increasing the dose of the patches may continue to reduce pain for a while, but it can also be harmful. If you notice that the medicine is becoming less effective, talk to your doctor. Your doctor will decide whether it is better to increase the dose or to gradually reduce the use of fentanyl.

Dependence and addiction

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

Repeated use of fentanyl can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can lead to a feeling of loss of control over the amount of medicine you need to use or how often you need to use it. You may feel a need to keep using the medicine even if it is no longer relieving your pain.

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

• You or a member of your family have abused alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood problems (depression, anxiety, or personality disorders) or have received treatment for other mental health diseases.

If you notice any of the following symptoms while using fentanyl, it could be a sign of dependence or addiction.

• You need to use the medicine for longer than your doctor has prescribed.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to feel calm" or "to help you sleep".
• You have tried to stop using the medicine several times but have been unable to.
• You feel unwell when you stop using the medicine, and you feel better once you start using it again ("withdrawal symptoms").

If you notice any of these signs, talk to your doctor to determine the best course of treatment for you, when it is appropriate to stop the medicine, and how to do it safely.

Withdrawal symptoms when stopping fentanyl

Do not stop using this medicine suddenly. You may experience withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling sick, diarrhea, loss of appetite, tremors, chills, or sweating. If you want to stop using this medicine, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimized.

Other medicines and Fentanilo Matrix Stada

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines that you buy without a prescription and herbal medicines. You should also tell your pharmacist that you are using fentanyl if you buy any medicines from the pharmacy.

Your doctor will know which medicines can be taken safely with fentanyl. You may need to be closely monitored if you are taking any of the following types of medicines or if you stop taking any of the following types of medicines, as this can affect the dose of fentanyl that you need.

In particular, tell your doctor or pharmacist if you are taking:

• Other pain medicines, such as other strong opioid painkillers (e.g., buprenorphine, nalbuphine, or pentazocine) and some painkillers for nerve pain (gabapentin and pregabalin).
• Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you calm down (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental health disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines to relax your muscles (such as cyclobenzaprine or diazepam).
• Certain 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
• Certain medicines used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use fentanilo in the 14 days after stopping these medicines. – see below for more information
• Certain antihistamines, especially those that cause drowsiness (such as chlorphenamine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Certain 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 infections (such as ritonavir).
• Medicines used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
• Medicines used to treat tuberculosis (such as rifampicin).
• Certain medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Certain medicines used to treat nausea or vomiting (such as phenothiazines).
• Certain medicines used to treat heartburn or stomach ulcers (such as cimetidine).
• Certain medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Certain medicines used to treat blood cancer (such as idelalisib).

Fentanilo Matrix Stada with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants.

Fentanyl can interact with these medicines, and you may experience changes in your mental state, such as agitation, seeing, feeling, hearing, or smelling things that are not there (hallucinations), and other effects, such as changes in blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (these could be signs of a Serotonin Syndrome). If they are used together, your doctor may want to keep a close eye on you to watch for these side effects, especially when starting treatment or when changing the dose of the medicine.

Use with central nervous system depressants, including alcohol and some narcotic medicines

Using fentanyl with sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be potentially fatal. Because of this, using them together should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking, and follow your doctor's dosing recommendations closely. It may be useful to inform friends or relatives so they are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

Do not drink alcohol while using fentanyl, unless you have talked to your doctor first.

Operations

If you think you are going to have an anesthetic, tell your doctor or dentist that you are using fentanyl.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Fentanyl should not be used during pregnancy, unless you have discussed it with your doctor.

Fentanyl should not be used during labor, as the medicine can affect the breathing of the newborn baby.

Long-term use of fentanyl during pregnancy can cause withdrawal symptoms in your newborn baby, such as high-pitched crying, irritability, convulsions, poor feeding, and diarrhea, which can be life-threatening if not recognized and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.

Do not use fentanyl if you are breastfeeding. You should not breastfeed for 3 days after removing the fentanyl patch. This is because the medicine can pass into breast milk.

Driving and using machines

Fentanilo Matrix Stada can affect your ability to drive or use machines or tools, as it can make you sleepy or dizzy. If this happens, do not drive or use machines or tools. Do not drive while using this medicine until you know how it affects you.

Talk to your doctor or pharmacist if you are unsure whether it is safe for you to drive while using this medicine.

3. How to use Fentanilo Matrix STADA

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide which concentration of fentanyl is most suitable for you, taking into account the intensity of your pain, your general condition, and the type of pain treatment you have received so far.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using fentanyl, 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, "Symptoms of withdrawal from stopping fentanyl").

How to apply and change patches

• Each patch contains enough medication for 3 days (72 hours).
• You should change the patch every three days, unless your doctor has told 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 them all at the same time.
• Make a note of the day of the week, date, and time each time you apply a patch to remember when you need to change it.
• The following table shows when you should change the patch:

Where to apply the patch

Adults

• Apply the patch to a flat area of the torso 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 occasionally to ensure the patch is still attached to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this could be life-threatening or 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 maximum effect. Therefore, your child may need other pain relievers until the patch is 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 a lot of hair. If there is hair, do not shave it (the skin becomes irritated with shaving). Instead, cut it as close to the skin as possible.

How to apply the patch

Step 1: Prepare the skin

• Before applying the patch, check that the skin is completely dry, clean, and fresh.
• If you need to wash the skin, use only cold water.
• Do not use soap or other cleaners, creams, moisturizers, oils, or talcum powder before applying the patch.
• Do not apply the patch immediately after a hot bath or shower.

Applicable to precut notched pouches:

Step 2: Open the pouch

• Each patch is sealed in its own pouch.
• Locate the precut notches at the ends of the seal.
• Carefully tear the edge of the pouch from one notch to the other.
• Then hold the two parts of the open pouch and pull to separate them.
• Remove the patch and use it immediately.
• Save 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 divided, cut, or damaged in any way.
• Never divide or cut the patch.

Applicable to child-resistant pouches without precut notches:

Step 2: Open the pouch

• Each patch is sealed in its own pouch.
• Cut the pouch at the edges of the seal indicated by the arrows.
  • Carefully tear the edge of the pouch completely, starting from the cuts.
  • Then hold the two parts of the open pouch and pull to separate them.

• Remove the patch and use it immediately.
• Save 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 divided, cut, or damaged in any way.
• Never divide or cut the patch.

Step 3: Peel and press

• Make sure the patch will be covered by loose clothing and do not attach it under tight or elastic fabric.
• Carefully peel off half of the shiny plastic protective layer, starting from the center of the patch. Try not to touch the adhesive part of the patch.
• Press this adhesive part of the patch onto the skin.
• Remove the other part of the protective layer and press the entire patch onto the skin with the palm of your hand.
• Hold it pressed for at least 30 seconds. Make sure the patch is well adhered, especially around the edges.

Step 4: Dispose of the patch

• As soon as you remove the patch, fold it firmly in half, so that the adhesive side of the patch sticks to itself.
  • Put it back in the original pouch and throw it away following the instructions of your pharmacist.
  • Keep used patches out of sight and reach of children; although they are used, patches contain medication that can harm children and even be fatal.

Step 5: Wash your hands

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

More information on using Fentanilo Matrix Stada

Daily activities during patch use

• Patches are water-resistant.
• You can shower or bathe with the patch on, but do not rub it.
• If your doctor agrees, you can exercise or play sports with the patch on.
• Do not use hot tubs or whirlpools.
• Do not cover the patch with tight or elastic clothing.
• When wearing the patch, do not expose it to direct heat, such as heated pads, electric blankets, hot water bottles, waterbeds, or heat lamps or tanning lamps. Do not sunbathe or take prolonged hot baths, and do not use saunas. If you do, you may increase the amount of medication released from the patch.

How long do patches take to work?

• The first patch may take some time to reach its maximum effect.
• Your doctor may give you additional pain relievers during the first few days.
• Afterwards, the patch should help relieve pain continuously, so you can stop taking other pain relievers. However, your doctor may prescribe additional pain relievers occasionally.

How long will you need to use patches?

• Fentanyl patches are indicated for prolonged pain. Your doctor will tell you how long you can expect to use the patches.

If your pain worsens

• If your pain worsens suddenly after applying the last patch, you should check your patch. If it is no longer sticking well or has fallen off, you should replace the patch (see also the 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 pain relievers (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 and contact your doctor immediately, go to the hospital, or you can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount applied.

Signs of overdose include breathing problems or weak breathing, tiredness, extreme drowsiness, inability to think clearly or walk or talk normally, and feeling weak, dizzy, or confused. An overdose can 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 make a note of the day and time. Then change the patch again after 3 days (72 hours), as usual.
• If you are significantly late, you should talk to your doctor, as you may need additional pain relievers, but do not apply additional patches.

If the patch comes off

• If the patch falls off before it is due to be changed, apply a new one immediately and make a note of the day and time. Choose a new skin area:
  • On the torso or arm.
  • On the upper back of your child.
• Tell your doctor about this and leave the patch on for another 3 days (72 hours) or for the time your doctor indicates, 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 patches

• Do not stop using this medication abruptly. If you want to stop using this medication, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose so that the unpleasant effects of withdrawal are minimal. See also section 2, "Symptoms of withdrawal from stopping Fentanilo Matrix Stada".
• If you stop using patches, do not start using them again without asking your doctor first. You may need a different dose when you restart treatment.

If you have any other questions about using this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets them.

If you, your partner, or caregiver notice any of the following signs in the person wearing the patch, remove the patch and call a doctor or go to the nearest hospital immediately. You may need urgent medical treatment.

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the above recommendations and make the person wearing the patch move and talk as much as possible. In very rare cases, these breathing difficulties can be life-threatening or even fatal, especially in people who have not used strong opioid pain relievers before (such as fentanyl 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 can be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).
• Seizures (convulsions). (Uncommon, may affect up to 1 in 100 patients).
• Decreased level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people).

The following side effects have also been reported

Very common (may affect more than 1 in 10 people)

• Nausea, vomiting, constipation.
• Feeling drowsy (drowsiness).
• 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 there (hallucinations).
• Tremors or muscle spasms.
• Strange sensation in the skin, such as tingling or prickling (paresthesia).
• Feeling that everything is spinning (vertigo).
• Fast or irregular heartbeats (palpitations, tachycardia).
• Increased blood pressure.
• Shortness of breath (dyspnea).
• Diarrhea.
• Dry mouth.
• Stomach pain or indigestion.
• Excessive sweating.
• Itching, rash, or redness of the skin.
• Difficulty urinating or emptying the bladder completely.
• Extreme fatigue, weakness, or general malaise.
• Feeling cold.
• Swelling of the hands, ankles, or feet (peripheral edema).

Uncommon (may affect up to 1 in 100 people)

• Feeling agitated 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 color of the skin due to decreased oxygen in the blood (cyanosis).
• Loss of intestinal contractions (ileus).
• Skin rash with itching (eczema), allergic reaction, or other skin disorders where the patch is applied.
• Flu-like illness.
• Feeling of changed body temperature.
• Fever.
• Muscle contraction.
• Difficulty getting or maintaining an erection (impotence) or problems with sexual relationships.
• Difficulty swallowing.

Rare side effects (may affect up to 1 in 1000 people)

• Pupil constriction (miosis).
• Occasional interruption of breathing (apnea).

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

• Lack of male sex hormones (androgen deficiency).
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbances, nightmares).
• You may become dependent on fentanyl (see section 2).

You may notice rashes, redness, or mild itching of the skin at the patch application site. It is usually mild and disappears after removing the patch. If it does not, or if the patch irritates your skin a lot, tell your doctor.

Repeated use of patches can make the medication less effective (you get used to it or become more sensitive to pain) or can cause dependence.

If you switch from another pain reliever to fentanyl or if you stop using fentanyl abruptly, you may experience withdrawal symptoms, such as dizziness, feeling sick, diarrhea, anxiety, or tremors. Tell your doctor if you notice any of these effects.

There have also been reports of newborn babies experiencing withdrawal symptoms after their mothers used fentanyl for a prolonged period during pregnancy.

Reporting side effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fentanilo Matrix STADA

Where to store patches

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

Store this medication in a safe and protected place, where others cannot access it. It can be very harmful and cause death to people who may use this medication accidentally or intentionally when it has not been prescribed for them.

How long can you store Fentanilo Matrix Stada

Do not use this medication after the expiration date shown on the box and pouch. The expiration date is the last day of the month indicated. If patches are expired, take them to the pharmacy.

This medication does not require special storage conditions.

How to dispose of used or unused patches

Accidental exposure of another person to used and unused patches, especially children, can result in a fatal outcome.

Used patches should be folded firmly in half, so that the adhesive side of the patch sticks to itself. Then they should be thrown away safely by putting them back in the original pouch and keeping them out of sight and reach of others, especially children, until they are disposed of safely.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

The active ingredient is fentanyl.

Fentanilo Matrix Stada 12 micrograms/h transdermal patches EFG:

Each transdermal patch contains 2.063 mg of fentanyl in a 3.75 cm2 surface area. The release rate is 12.5 micrograms of fentanyl per hour.

Fentanilo Matrix Stada 25 micrograms/h transdermal patches EFG:

Each transdermal patch contains 4.125 mg of fentanyl in a 7.5 cm2 surface area. The release rate is 25 micrograms of fentanyl per hour.

Fentanilo Matrix Stada 50 micrograms/h transdermal patches EFG:

Each transdermal patch contains 8.25 mg of fentanyl in a 15 cm2 surface area. The release rate is 50 micrograms of fentanyl per hour.

Fentanilo Matrix Stada 75 micrograms/h transdermal patches EFG:

Each transdermal patch contains 12.375 mg of fentanyl in a 22.5 cm2 surface area. The release rate is 75 micrograms of fentanyl per hour.

Fentanilo Matrix Stada 100 micrograms/h transdermal patches EFG:

Each transdermal patch contains 16.5 mg of fentanyl in a 30 cm2 surface area. The release rate is 100 micrograms of fentanyl per hour.

The other components are:

Adhesive layer: acrylic adhesive layer.

Supporting film: polypropylene laminate, blue printing ink.

Removable coating: siliconized polyethylene terephthalate (PET) laminate.

Appearance of the Product and Package Contents

Fentanilo Matrix Stada is a transparent transdermal patch with an adhesive backing so that it can be stuck onto the skin. The transdermal patches are marked with blue printing indicating the concentration.

Fentanilo Matrix Stada is available in packs of 1, 3, 4, 5, 8, 10, 16, or 20 transdermal patches.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio Stada, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

Stada Arzneimittel AG

Stadastraße 2 – 18

D-61118 Bad Vilbel

Germany

or

Centrafarm Services B.V.

Van de Reijtstraat 31-E

4814 NE Breda

Netherlands

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

AT Fentanyl Stada

BE Fentanyl Matrix EG

CZ Adolor

DE Fentanyl STADA 12, 25, 50, 75, 100 Mikrogramm/h Matrixpflaster

ES Fentanilo Matrix Stada 12, 25, 50, 75, 100 micrograms/h transdermal patches EFG

FI Fentanyl Stada

FR Fentanyl EG

IT Fenvel

LU Fentanyl Matrix EG

NL Fentanyl CF

Date of the Last Revision of this Leaflet:May 2025

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