Fentanyl Matrix Stada 12 micrograms/h transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fentanil Matrix Stada 12 micrograms/h transdermal patches EFG

Fentanil Matrix Stada 25 micrograms/h transdermal patches EFG

Fentanil Matrix Stada 50 micrograms/h transdermal patches EFG

Fentanil Matrix Stada 75 micrograms/h transdermal patches EFG

Fentanil Matrix Stada 100 micrograms/h transdermal patches EFG

Read the entire 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 must not give it to others, 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 effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Fentanil Matrix Stada is and what it is used for
2. What you need to know before using Fentanil Matrix Stada
3. How to use Fentanil Matrix Stada
4. Possible adverse effects
5. How to store Fentanil Matrix Stada
6. Contents of the pack and other information

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

This medicine is called Fentanilo Matrix Stada.

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 Stada 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 Fentanilo Matrix Stada

Do not use Fentanilo Matrix Stada:

• If you are allergic to fentanyl or to any of the other ingredients of this medicine (listed in section 6).
• If you have short-term pain, such as sudden pain or pain after surgery.
• If you have difficulty breathing, with slow or weak breathing.

Do not use this medicine if you or your child are in any of the situations listed above. If you are unsure, consult your doctor or pharmacist before using Fentanilo Matrix Stada.

Warnings and precautions

Fentanil Matrix Stada may have dangerous, life-threatening effects in people who are not regularly using prescribed opioids. Fentanil Matrix Stada 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 a child's skin or if the child puts it in their mouth, the result could be fatal. Store this medicine in a secure and safe place, out of reach of others – see section 5 for more information.

If the patch sticks to another person

The patch must only be used on the skin of the person for whom the doctor has prescribed it. There have been some cases reported where the patch has accidentally stuck to another family member through close physical contact or by sharing the same bed with the person wearing the patch. If the patch accidentally sticks to another person (particularly a child), the medicine in the patch may pass through the other person’s skin and may cause serious adverse effects, such as difficulty breathing, slow or weak breathing, which could be fatal. If the patch sticks to another person’s skin, remove it immediately and seek medical help.

Take special care with Fentanilo Matrix Stada

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

While using the patch, inform your doctor if you experience breathing difficulties during sleep.

Opioids such as fentanyl can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing while sleeping) 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 while sleeping.
• Waking up at night due to shortness of breath.
• Difficulty staying asleep.
• Excessive daytime sleepiness.

Your doctor may decide to adjust your dose.

While using the patch, inform your doctor if you notice a change in your pain.

If you experience:

• The patch no longer relieves your pain.
• An increase in pain.
• A change in the way you feel pain (e.g., pain in another part of your body).
• Pain from touch 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 Fentanilo Matrix Stada

• Fentanyl may cause unusual drowsiness and may slow or weaken your breathing. In 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 fentanyl or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually drowsy, with slow or weak breathing:
  • Remove the patch.
  • Call a doctor or go immediately to the nearest hospital.
  • Encourage the person to move and speak as much as possible.
• If you develop a fever while using fentanyl, speak to your doctor. Fever may increase the amount of medicine passing through your skin.
• Fentanyl may cause constipation; speak to your doctor or pharmacist for advice on how to prevent or relieve constipation.

The complete list of possible adverse effects can be found in section 4.

Fentanyl, like other opioids, may affect the normal production of hormones in the body such as cortisol, prolactin, or sex hormones, especially if you have used fentanyl for long periods. The effects of these hormonal changes may include feeling unwell (including nausea and vomiting), loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility, or reduced sexual desire.

In addition, female patients may experience changes in their menstrual cycle, while male patients may experience impotence or breast enlargement. If you notice any of these signs, consult your doctor.

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 medicine released from the patch.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers may make the drug less effective (the body becomes accustomed to it, known as pharmacological tolerance). You may also become more sensitive to pain while using fentanyl. 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 losing 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

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

Repeated use of fentanyl may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of losing control over the amount of medicine you need to use or how often you need to use it. You may feel the need to continue using the medicine even if it does not help relieve pain.

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

• You or any family member have abused alcohol or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

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 prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, "to stay calm" or "to help you sleep."
• You have made repeated unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine, and feel better once you resume it ("withdrawal effects").

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

Withdrawal symptoms when stopping fentanyl

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

Other medicines and Fentanilo Matrix Stada

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines. This includes medicines bought without a prescription and herbal remedies. You should also inform your pharmacist that you are using fentanyl if you buy any medicine at the pharmacy.

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

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

• Other pain medicines, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine) and some medicines for nerve pain (gabapentin and pregabalin).
• Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you relax (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines to relax muscles (such as cyclobenzaprine or diazepam).
• Some antidepressants called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). – more information below
• Some medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use fentanyl within 14 days of stopping these medicines. – more information below
• Some antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Some antibiotics used to treat infections (such as erythromycin or clarithromycin).
• Medicines used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medicines used to treat HIV infection (such as ritonavir).
• Medicines used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
• Medicines used to treat tuberculosis (such as rifampicin).
• Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Some medicines used to treat nausea or dizziness (such as phenothiazines).
• Some medicines used to treat stomach acid or ulcers (such as cimetidine).
• Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Some medicines used to treat blood cancer (such as idelalisib).

Fentanilo Matrix Stada with antidepressants

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

Fentanyl may interact with these medicines, and you may experience changes in mental state such as agitation, seeing, feeling, hearing, or smelling things that are not present (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, overactive reflexes, lack of coordination, muscle rigidity, nausea, vomiting, and diarrhea (which could be signs of Serotonin Syndrome). If used together, your doctor may want to monitor you closely for these side effects, especially when starting treatment or when the dose is changed.

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

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

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

Inform your doctor about all sedative medicines you are taking and follow your doctor’s dosing recommendations closely. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Do not drink alcohol while using fentanyl, unless you have discussed it with your doctor first.

Surgery

If you are scheduled to receive anesthesia, inform your doctor or dentist that you are using fentanyl.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

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 may affect the newborn’s breathing.

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

Do not use fentanyl if you are breastfeeding. You must not breastfeed for 3 days after removing the fentanyl patch, as the medicine may pass into breast milk.

Driving and using machines

Fentanilo Matrix Stada may affect your ability to drive and use machines or tools, as it may cause drowsiness or dizziness. If so, do not drive or operate tools or machinery. Do not drive while using this medicine until you know how it affects you.

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

3. How to use Fentanil Matrix Stada

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 fentanyl concentration is most suitable for you, based on 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 to 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, "Withdrawal symptoms when stopping fentanyl").

How to apply and change the patches

• Each patch contains enough medicine 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.
• 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 periodically to ensure the patch remains adhered to the skin.
• It is important that the child does not remove the patch and put it in their mouth, as this could be life-threatening or fatal.
• 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.

Applies to pouches with pre-cut notches:

Step 2: Open the pouch

• Each patch is sealed in its own pouch.
• Locate the pre-cut 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 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 damaged in any way.
• Never divide or cut the patch.

Applies to child-resistant pouches without pre-cut notches:

Step 2: Open the pouch

• Each patch is sealed in its own pouch.

• Cut the pouch along the sealed edges indicated by the arrows.

  • Carefully tear the edge of the pouch completely, starting from the cuts.
  • Then 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 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 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 part of the protective layer and press the entire patch onto the skin with the palm of your hand.
• Hold pressure for at least 30 seconds. Ensure the patch is well adhered, especially around the edges.

Step 4: Disposing of the patch

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

Step 5: Washing hands

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

More information about using Fentanilo Matrix Stada

Daily activities while using the patches

• The patches are water-resistant.
• You may shower or bathe while wearing the patch, but do not rub it.
• If your doctor agrees, you may exercise or engage in sports while wearing the patch.
• Do not use hot hydrotherapy baths.
• Do not cover the patch with elastic or tight fabrics.
• While wearing the patch, avoid direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, heat lamps, or sunlamps. Do not sunbathe, take prolonged hot baths, or use saunas. Doing so could increase the amount of medication released from the patch.

How long do the patches take to work?

• The first patch may take some time to reach its full effect.
• Your doctor may provide additional painkillers during the first few days.
• Afterwards, the patch should provide continuous pain relief, allowing you to stop taking other painkillers. However, your doctor may occasionally prescribe additional painkillers.

How long will you need to use the patches?

• Fentanyl patches are indicated for long-lasting 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 your patch. If it is no longer adhering properly or has fallen off, replace it (also see the section “If the patch comes loose”).
• 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 medication and the amount applied.

Signs of overdose include difficulty breathing or weak breathing, fatigue, extreme drowsiness, inability to think clearly or to walk or speak normally, and feeling weak, dizzy, or confused. An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

• If you forget to change the patch, do so as soon as you remember, and note the date and time. Resume changing the patch every 3 days (72 hours) as usual.
• If you are significantly delayed, you should speak with your doctor, as you may need additional painkillers, but do not apply extra patches.

If the patch comes loose

• If the patch falls off before it is time to change it, apply a new one immediately and note the date and time. Choose a new 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 as usual.
• 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 medication abruptly. 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 symptoms. See also section 2, “Withdrawal symptoms when stopping Fentanilo Matrix Stada.”
• 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, observe any of the following signs in the person wearing the patch, remove the patch immediately and contact a doctor or go straight to the nearest hospital. Urgent medical treatment may be required.

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the instructions above 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 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 may all be signs of a serious 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 adverse effects have also been reported

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

• Nausea, vomiting, constipation
• Feeling sleepy (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 present (hallucinations)
• Tremors or muscle spasms
• Strange skin sensations such as tingling or prickling (paraesthesia)
• Sensation of spinning (vertigo)
• Fast or irregular heartbeat (palpitations, tachycardia)
• Increased blood pressure
• Feeling short of breath (dyspnoea)
• Diarrhoea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, rash or redness of the skin
• Inability to urinate or empty the bladder completely
• Severe tiredness, weakness or general malaise
• Feeling cold
• Swelling of the hands, ankles or feet (peripheral oedema)

Uncommon (may affect up to 1 in 100 people)

• Feeling restless or disoriented
• Feeling extremely happy (euphoria)
• Decreased sensation or sensitivity, especially in the skin (hypoesthesia)
• Memory loss
• Blurred vision
• Slow heart rate (bradycardia) or low blood pressure
• Bluish discoloration of the skin due to reduced oxygen in the blood (cyanosis)
• Loss of intestinal contractions (ileus)
• Itchy skin rash (eczema), allergic reaction, or other skin disorders at the application site
• Flu-like illness
• Sensation of body temperature changes
• Fever
• Muscle cramps
• Difficulty achieving or maintaining an erection (impotence) or problems with sexual performance
• Difficulty swallowing

Rare adverse 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 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 fentanyl (see section 2)

You may notice skin rash, redness, or mild itching at the site where the patch is applied. This is usually mild and disappears after removing the patch. If this does not happen, or if the patch causes significant skin irritation, inform your doctor.

Repeated use of the patches may cause the medicine to lose effectiveness (you may become tolerant to it or may become more sensitive to pain), or may lead to dependence.

If you switch from another painkiller to fentanyl, or if you stop using fentanyl suddenly, 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 newborn infants experiencing withdrawal symptoms after their mothers used fentanyl for a prolonged period during pregnancy.

Reporting of adverse effects

If you experience any kind of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fentanilo Matrix Stada

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, where others cannot access it. It may be highly harmful and even fatal to individuals who may accidentally or intentionally use this medicine when it has not been prescribed for them.

How long can Fentanilo Matrix Stada be stored

Do not use this medicine after the expiry date stated on the carton and sachet. The expiry date refers to the last day of the month indicated. If the patches have expired, return them to the pharmacy.

This medicine does not require any special storage conditions.

How to dispose of used patches or patches no longer needed

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 back into the original sachet and kept out of sight and reach of others, particularly children, until they can be safely disposed of.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at the pharmacy. Ask your pharmacist how to properly dispose of any medicines and packaging you no longer need. This way, you will help protect the environment.

6. Contents of the pack and other information

The active substance is fentanyl.

Fentanil Matrix Stada 12 micrograms/h transdermal patches EFG:

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

Fentanil Matrix Stada 25 micrograms/h transdermal patches EFG:

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

Fentanil Matrix Stada 50 micrograms/h transdermal patches EFG:

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

Fentanil Matrix Stada 75 micrograms/h transdermal patches EFG:

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

Fentanil Matrix Stada 100 micrograms/h transdermal patches EFG:

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

The other components are:

Adhesive layer: polyacrylate adhesive layer.

Backing film: polypropylene film, blue printing ink.

Release liner: silicone-coated polyethylene terephthalate film.

Nature and contents of the pack

Fentanil Matrix Stada is a transparent transdermal patch with an adhesive backing allowing it to be applied to the skin. The transdermal patches are marked with blue printing indicating the concentration.

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

Only certain pack sizes may be commercially available.

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
The Netherlands

This medicinal product is authorized in the European Economic Area (EEA) member states under the following names:

AT Fentanyl Stada
BE Fentanyl Matrix EG
CZ Adolor
DE Fentanyl STADA 12, 25, 50, 75, 100 Microgramm/h Matrixpflaster
ES Fentanilo Matrix Stada 12, 25, 50, 75, 100 microgramos/h parches transdérmicos EFG
FI Fentanyl Stada
FR Fentanyl EG
IT Fenvel
LU Fentanyl Matrix EG
NL Fentanyl CF

Date of the most recent review of this leaflet: February 2026

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