Prospect: 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 this prospect carefully before starting to use this medication, as it contains important information for you.

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

1. Storage of Fentanilo Matrix Stada

Contents of the package and additional information

This medication is calledFentanilo Matrix Stada.

The patches help to relieve very strong and lasting pain:

•in adults who need continuous pain treatment

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

Fentanilo Matrix Stadacontains a medication called fentanilo. It belongs to a group of strong pain-relieving medications called opioids.

Do not use Fentanilo Matrix Stada:

•If you are allergic to fentanyl or any of the other components of this medication (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 medication if you or your child is in any of the above circumstances. If you are unsure, consult your doctor or pharmacist before using Fentanilo Matrix Stada.

Warnings and precautions

If the patch sticks to another person

The patch should only be used on the skin of the person for whom the doctor prescribed it. There have been some cases where the patch has accidentally stuck to another family member by 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 the other person's skin and cause severe adverse effects, such as difficulty breathing, slow or weak breathing that can be fatal. In the event that the patch sticks to someone else's skin, it should be removed immediately and the person should seek medical attention.

Be especially careful with Fentanilo Matrix Stada

Consult your doctor or pharmacist beforeusing this medication if you are in any of the following circumstances. Your doctor will have to monitor you more closely:

•If you have ever had respiratory 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 trauma.

•If you are an elderly person, as you may be more sensitive to the effects of this medication.

•If you have a condition called "myasthenia gravis," in which your muscles become weak and easily fatigued.

If you meet any of the above conditions (or if you are unsure), consult your doctor or pharmacist before using Fentanilo Matrix Stada.

While using the patch, report to your doctor if you have breathing problems while sleeping.

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

• Pauses in breathing while sleeping

• Waking up at night due to lack of air

• Difficulty staying asleep

• Excessive daytime sleepiness

Your doctor may decide to modify the dose.

While using the patch, report to your doctor if you notice a change in the pain you feel.

If you feel:

• The patch no longer relieves the pain

• An increase in pain

• A change in the way you feel the pain (for example, you feel pain in another part of your body)

• Pain when you come into contact with your body that should not cause pain.

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

Adverse effects and Fentanilo Matrix Stada

•Fentanilo may make you feel exceptionally sleepy and make yourbreathing slower or weaker. In rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers (such as fentanyl or morphine) before. If you, or your partner or caregiver, observe 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

- Make the person move and talk as much as possible

•If you have a fever while using fentanilo, talk to your doctor. This may increase the amount of medication that passes through your skin.

•Fentanilo may cause constipation; talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

See section 4 for the complete list of possible adverse effects.

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

Long-term use and tolerance

This medication contains fentanyl, an opioid. Repeated use of opioid painkillers can make the medication less effective (your body becomes accustomed to it, known as pharmacological tolerance). It is also possible that you will 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 may also be harmful. If you notice that the medication is losing its effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of fentanyl.

Dependence and addiction

The repeated use of fentanyl can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dose and longer use. Dependence or addiction may cause you to feel a lack of control over the amount of medication you should use or how often you should use it. You may feel the need to continue using the medication even if it does not help to relieve the pain.

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

• You or any family member have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs ("addiction").

• You smoke.

• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

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 medication for a longer period than indicated by your doctor.

• You need to use a higher dose than recommended.

• You are using the medication for reasons other than those prescribed, such as "to stay calm" or "to help you sleep."

• You have made repeated and unsuccessful attempts to stop using the medication or control your use.

• You feel unwell when you stop using the medication, and you feel better once you take it again ("withdrawal symptoms").

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

Withdrawal symptoms when stopping fentanyl

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

Other medications and Fentanilo Matrix Stada

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications and herbal remedies. You should also inform your pharmacist that you are using fentanyl if you buy any medication from the pharmacy.

Your doctor will know which medications can be taken safely withfentanyl. They may need to monitor you closely if you are taking any of the types of medications listed below or if you stop taking any of the types of medications listed, as this may affect the dose offentanylyou need.

Especially, inform your doctor or pharmacist if you are taking:

•Other pain medications, such as other opioid painkillers (e.g., buprenorphine, nalbuphine, or pentazocine) and some nerve pain medications (gabapentin and pregabalin).

•Sleeping medications (such as temazepam, zaleplon, or zolpidem).

•Anxiety medications (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medications for mental health conditions (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).

•Muscle relaxants (such as cyclobenzaprine or diazepam).

•Some medications used to treat depression called SSRIs or SNRIs, such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). – More information is below

•Some medications used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not usefentanylin the 14 days following the interruption of these medications. – More information is below

•Some antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, ciproheptadine, 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).

Fentanilo Matrix Stada with antidepressants

The risk of adverse effects increases if you are taking certain antidepressants.

Fentanilo may interact with these medications and you may experience changes in 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, hyperactive reflexes, lack of coordination, muscle rigidity, nausea, vomiting, and diarrhea (which may be signs of a Serotonin Syndrome). If used together, your doctor may want to monitor you closely to detect these side effects, especially when starting treatment or when changing the dose of the medication.

Use with central nervous system depressants, including alcohol and some narcotics

The use of fentanilo with sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Due to this, concurrent use should only be considered when other treatment options are not possible.

However, if your doctor prescribes fentanilo along with sedatives, the dose and duration of concurrent treatment should be limited by your doctor.

Inform your doctor about all sedatives you are taking and follow your doctor's recommended dosing closely. It may be helpful to inform friends or family members about the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

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

Surgery

If you think you will be receiving anesthesia, inform your doctor or dentist that you are using fentanilo.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Fentanilo should not be used during pregnancy, unless you have talked to your doctor.

Fentaniloshould not be used during delivery, as the medication may affect the newborn'sbreathing.

Prolonged use of fentanilo during pregnancy may cause withdrawal symptoms (such as crying, restlessness, convulsions, poor feeding, and diarrhea) in your newborn, which may be potentially fatal if not recognized and treated. Talk to your doctor immediately if you think your newborn may have withdrawal symptoms.

Do not usefentaniloif you are breastfeeding. Do not breastfeed for 3 days after removing the fentanilopatch. This is because the medication may pass into breast milk.

Driving and operating machinery

Fentanilo Matrix Stadamay affect your ability to drive and operate machinery, as it may cause drowsiness or dizziness. If this is the case, do not drive or operate machinery. Do not drive while using this medication until you know how it affects you.

Talk to your doctor or pharmacist if you have any doubts about whether it is safe for you to drive while using this medication.

Follow the administration instructions of this medication exactly as indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

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

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of 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 fentanyl use").

How to apply and change the patches

•Each patch contains a sufficient amount of medication for3 days (72 hours).

•You should change the patch every three days, unless your doctor has told you otherwise.

•Always remove the used patchbeforeapplying a new one.

•Change the patch alwaysat the same timeof the day every 3 days (72 hours).

•If you are using more than one patch, change them all at the same time.

•Note the day of the week, date, and time each time you apply a patch to remember when to change it.

•The following table shows when to change the patch:

Where to apply the patch

Adults

•Apply the patch to a flat area of the trunk or arm (never over a joint).

Children

•Apply the patch always to the upper back of your child so that they have difficulty reaching or removing it.

•Check occasionally that the patch is still adhered to the skin.

•It is essential that the child does not remove the patch and put it in their mouth, as this could put their life in danger 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 maximum effect. Therefore, your child may need other painkillers 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 wounds.

•Areas of skin with a lot of hair. If there is hair, do not shave it (the skin irritates 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 talc before applying thepatch.

•Do not apply the patch immediately after a bath or shower.

Applicable to the packages with a precut notch:

Step 2: Open the package

•Each patch is sealed in its own package.

•Locate the precut notches on the sealed edges.

•Carefully tear the package edge from one notch to the other.

•Then hold the two open package parts and pull them apart.

•Remove the patch and use it immediately.

•Save the empty package to dispose of the used patch later.

•Use each patch only once.

•Do not remove the patch from its package until you are ready to use it.

•Check that the patch is not damaged.

•Do not use the patch if it is divided or cut or has any damage.

•Never divide or cut the patch.

Applicable to the tamper-evident packages without a precut notch:

Step 2: Open the package

•Each patch is sealed in its own package.

•Incise the package on the sealed edges indicated by the arrows.

• Carefully tear the package edge completely, starting from the incisions.
• Then hold the two open package parts and pull them apart.

•Remove the patch and use it immediately.

•Save the empty package to dispose of the used patch later.

•Use each patch only once.

•Do not remove the patch from its package until you are ready to use it.

•Check that the patch is not damaged.

•Do not use the patch if it is divided or cut or has any damage.

•Never divide or cut the patch.

Step 3: Peel and press

•Make sure the patch will be covered by a loose garment and do not adhere it under an elastic or tight fabric

•Peel off carefully one half of the shiny plastic protective layer starting from the center of the patch. Be careful not to touch the adhesive part 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

•Hold 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 in half, so that the adhesive side sticks to itself.

• Put it back in the original package and dispose of it according to the instructions of your pharmacist.
• Keep used patches out of sight and reach of children; although used, the patches contain medication that can harm children and even be fatal.

Step 5: Wash your hands

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

More information about the use of Fentanilo Matrix Stada

Activities during the use of the patches

•The patches are water-resistant

•You can take a shower or bath with the patch on, but do not rub it

•If your doctor agrees, you can exercise or engage in sports with the patch on

•Do not use hot tubs or saunas

•Do not cover the patch with elastic or tight fabrics

•When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, hot tubs, or heat lamps or tanning beds. Do not take the sun or prolonged hot baths and do not use saunas. If you do, you may increase the amount of medication released from the patch.

How long does it take for the patches to act?

•The first patch may take some time to reach its maximum effect.

•Your doctor may give you additional painkillers during the first few days.

•After that, the patch should help relieve pain continuously, allowing you to stop taking other painkillers. However, your doctor may prescribe additional painkillers occasionally.

How long will you have to use the patches?

•The fentanyl patches are indicated for chronic pain. Your doctor will tell you how long you can expect to use the patches.

If the pain worsens

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

The signs of overdose include breathing problems or weak breathing, fatigue, extreme drowsiness, inability to think clearly or walk or speak normally, and feeling weak, dizzy, or confused. An overdose can also cause a toxic encephalopathy.

If you forget to change the patch

•If you forget to change the patch, change it as soon as you remember and note the day and time. Then change the patch after3 days (72 hours), as usual.

•If you are late, you should talk to your doctor, as you may need additional painkillers, butdo notapply additional patches.

If the patch falls off

•If the patch falls off before it should be changed, apply a new one immediately and note the day and time. Choose a new skin area:

-On the trunk or arm

- On the upper back of your child

•Inform your doctor about this and leave the patch on for another3 days (72 hours)or for the time your doctor tells you, before changing the patch in the usual way.

•If the patches tend to fall off, consult your doctor, pharmacist, or nurse.

If you want to stop using the 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 the dose will be gradually reduced so that the unpleasant effects of withdrawal are minimal. See also section 2, "Symptoms of withdrawal from Fentanilo Matrix Stada".

•If you stop using the patches, do not use them again without asking your doctor first. You may need a different dose to resume treatment

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

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

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

•Unusual drowsiness, slower or weaker breathing than expected.

Follow the previous recommendations and have the person wearing the patch move and talk as much as possible. In very rare cases, these breathing difficulties can compromise life or even be fatal, especially in people who have not used strong opioid analgesics (such as fentanyl or morphine) before. (Rare, may affect up to 1 in 100 people).

•Brusque swelling of the face or throat, severe irritation, redness, or blisters on theskin. All of them can be signs of a severe allergic reaction. (The frequency cannot beestimated from the available data).

•Seizures (convulsions). (Rare, may affect up to 1 in 100 patients).

•Decreased level of consciousness or loss of consciousness. (Rare, 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

•Drowsiness (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, or hearing things that are not present (hallucinations)

•Tremors or muscle spasms

•Strange sensation on the skin, such as tingling or prickling (paresthesia)

•Sensation of everything spinning (dizziness)

•Irregular or rapid heartbeats (palpitations, tachycardia)

•Increased blood pressure

•Sensation of lack of air (dyspnea)

•Diarrhea

•Dry mouth

•Stomach pain or indigestion

•Excessive sweating

•Itching, redness, or rash on the skin

•Difficulty urinating or emptying the bladder completely

•Intense fatigue, weakness, or general discomfort

•Sensation of cold

•Swelling of the hands, ankles, or feet (peripheral edema)

Rare (may affect up to 1 in 100 people)

•Feeling agitated or disoriented

•Sensation of being extremely happy (euphoria)

•Decreased sensation or sensitivity, especially in the skin (hypoesthesia)

•Memory loss

•Blurry vision

•Slow heart rate (bradycardia) or low blood pressure

•Blue discoloration of the skin caused by a decrease in oxygen in the blood (cyanosis)

•Loss of intestinal contractions (ileus)

•Skin rash with itching (eczema), allergic reaction, or other skin disorderswhere the patch is applied

•Influenza-like illness

•Sensation of change in body temperature

•Fever

•Muscle contraction

•Difficulty obtaining or maintaining an erection (impotence) or problems withmaintaining sexual relations

•Difficulty swallowing

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

•Pupil constriction (miosis)

•Occasional interruption of breathing (apnea)

Unknown frequency (cannot be estimated from available data):

•Low levels 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 present, sleep disturbances, nightmares)

•You may become dependent on fentanyl (see section 2)

You may notice rashes, redness, or a mild itching sensation on the skin where the patch is applied. It is usually mild and disappears after removing the patch. If not, or if the patch irritates your skin a lot, inform your doctor.

The repeated use of patches may make the medication less effective (you become accustomed to it or you may become more sensitive to pain) or may cause dependence.

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

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

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Where to store the patches

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

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

How long can you store Fentanilo Matrix StadaFentanilo Matrix Stada

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

This medication does not require special storage conditions.

How to dispose of used patches or patches no longer in use

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

Used patches should be folded firmly in half, so that the adhesive side of the patch adheres to itself. Then, they should be safely disposed of by placing them in the original package and storing them out of sight and reach of other people, especially children, until they are safely disposed of.

Medications should not be thrown away through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE point of the pharmacy.Ask your pharmacist how to dispose of containers and medications you no longer need. This way, you will help protect the environment.

The active ingredient is fentanil.

Fentanilo Matrix Stada 12 micrograms/h transdermal patches EFG:

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

Fentanilo Matrix Stada 25 micrograms/h transdermal patches EFG:

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

Fentanilo Matrix Stada 50 micrograms/h transdermal patches EFG:

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

Fentanilo Matrix Stada 75 micrograms/h transdermal patches EFG:

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

Fentanilo Matrix Stada 100 micrograms/h transdermal patches EFG:

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

The other components are:

Adhesive layer: acrylic adhesive layer.

Support film: polypropylene sheet, blue printing ink.

Removable coating: polyethylene terephthalate sheet (siliconized).

Appearance of the product and contents of the package

Fentanilo Matrix Stada is a transparent transdermal patch with an adhesive backing that can be stuck to the skin. The transdermal patches are marked with a blue imprint with the concentration.

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

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Laboratorio Stada, S.L

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer responsible

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 with the following names:

ATFentanyl Stada

BEFentanyl Matrix EG

CZAdolor

DEFentanyl STADA 12, 25, 50, 75, 100 Mikrogramm/h Matrixpflaster

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

FIFentanyl Stada

FRFentanyl EG

ITFenvel

LUFentanyl Matrix EG

NLFentanyl CF

Last review date of this leaflet:April 2024

For detailed and updated information on this medicinal product, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/