Fentanyl Matrix Sandoz 50 micrograms/hour transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fentanil Matrix Sandoz 12 micrograms/hour transdermal patches EFG

Fentanil Matrix Sandoz 25 micrograms/hour transdermal patches EFG

Fentanil Matrix Sandoz 50 micrograms/hour transdermal patches EFG

Fentanil Matrix Sandoz 75 micrograms/hour transdermal patches EFG

Fentanil Matrix Sandoz 100 micrograms/hour 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, 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 must not be given to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Fentanil Matrix Sandoz is and what it is used for.

2. What you need to know before using Fentanil Matrix Sandoz.

3. How to use Fentanil Matrix Sandoz.

4. Possible side effects.

5. Storage of Fentanil Matrix Sandoz.

6. Contents of the pack and other information.

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

The name of this medicine is Fentanilo Matrix Sandoz.

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 receiving opioid medication and require ongoing pain treatment.

Fentanilo Matrix Sandoz contains a medicine called fentanil. It belongs to a group of strong painkillers known as opioids.

2. What you need to know before you start using Fentanil Matrix Sandoz

Do not use Fentanil Matrix Sandoz if:

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

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

Warnings and precautions

Fentanyl may have life-threatening adverse effects in people who are not regularly taking prescribed opioids. Fentanyl is a medicine that can be life-threatening to children, even if the patches have already been used. Be aware that a transdermal 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 can be fatal. Store this medicine in a secure and safe place where others cannot access it; see section 5 for more information.

If the patch sticks to another person

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

Take special care with Fentanilo Matrix Sandoz

Consult your doctor or pharmacist before using this medicine if any of the following apply to you. Your doctor will need to monitor you more closely if:

• you have ever had lung or breathing problems,
• you have ever had heart, liver, kidney problems or low blood pressure,
• you have ever had a brain tumor,
• you have ever had persistent headaches or head injuries,
• you are an elderly patient – you may be more sensitive to the effects of this medicine,
• you have a disorder called "myasthenia gravis," in which muscles become weak and tire easily.

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

While using the patch, inform your doctor if you have breathing problems 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). Speak to your doctor if you, your partner, or caregiver notice any of the following symptoms:

• pauses in breathing during sleep,
• waking up at night due to shortness of breath,
• difficulty staying asleep,
• excessive daytime sleepiness. Your doctor may decide to adjust the dose.

While using the patch, inform your doctor if you notice any change in your pain. If you experience:

• the patch no longer relieves your pain,
• an increase in pain,
• a change in the way you feel pain (for example, pain in a different part of your body),
• pain triggered by 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 Sandoz

• Fentanyl may cause unusual drowsiness and may make your breathing slower or weaker.

In very rare cases, these breathing problems may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as 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 immediately,
• call a doctor or go immediately to the nearest hospital,
• keep the person moving and talking as much as possible.
  • If you develop a fever while using fentanyl, inform your doctor. This 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.

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

Fentanilo Matrix, like other opioids, may affect the body’s normal hormone production, such as cortisol, prolactin, or sex hormones, especially if Fentanilo Matrix has been used 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 waterbeds, heat lamps, or tanning lamps. Avoid prolonged sun exposure, hot baths, saunas, or hot tubs. Doing so could 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 cause the drug to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). You may also become more sensitive to pain while using fentanyl transdermal patches. 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 is losing effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of fentanyl transdermal patches.

Dependence and addiction

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

Repeated use of Fentanilo Matrix Sandoz 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 lack of control over the amount of medication you need to take or how frequently you need to take it. You may feel the need to continue using the medication even though it does not help relieve your pain.

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

• You or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medications, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood problems (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using Fentanilo Matrix Sandoz, it could be a sign of dependence or addiction:

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

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

Withdrawal symptoms when stopping Fentanilo Matrix Sandoz

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

Other medicines and Fentanilo Matrix Sandoz

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

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

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

• Other pain medicines, such as other opioid analgesics (like buprenorphine, nalbuphine, or pentazocine) and some analgesics for neuropathic pain (gabapentin and pregabalin).
• Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you calm down (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 used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). - See below for more information.
• 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. - See below for more information.
• Some antihistamines, especially those that cause drowsiness (such as chlorphenamine, 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 indigestion 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 Sandoz with antidepressants

The risk of adverse effects increases if you are taking medicines such as certain antidepressants. Fentanyl may interact with these medicines, and you may experience changes in mental state, such as feeling agitated, seeing, feeling, hearing, or smelling things that are not present (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, hyperactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (these could be signs of serotonin syndrome). If used together, your doctor may want to monitor you closely for these side effects, especially when starting treatment or when the dose of the medicine is changed.

Fentanilo Matrix Sandoz with central nervous system depressants, including benzodiazepines, alcohol, and some narcotic medicines

Concomitant use of fentanyl and sedative medicines such as benzodiazepines or related medicines increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Because of this, concomitant use should only be considered when other treatment options are not possible.

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

Inform your doctor about all sedative medicines you are taking, and strictly follow your doctor's dosage recommendations. It may be helpful to inform friends or family members who are aware of the signs and symptoms mentioned above. Contact your doctor if you experience such symptoms.

Do not consume alcohol while using Fentanilo Matrix Sandoz unless you have discussed it with your doctor beforehand.

Surgery

If you think you are going to receive anesthesia, inform your doctor or dentist that you are using Fentanilo Matrix Sandoz.

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 childbirth, 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 could 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 should not breastfeed for 3 days after removing the Fentanilo Matrix Sandoz patch. This is because the medicine can pass into breast milk.

Driving and using machines

Fentanilo Matrix Sandoz may affect your ability to drive and use machines or tools, as it may cause drowsiness or dizziness. If this happens, 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.

Fentanilo Matrix Sandoz contains soybean oil

Do not use this medicine if you are allergic to peanuts or soybeans.

3. How to use Fentanilo Matrix Sandoz

Always follow exactly the instructions for administering this medicine as given by your doctor. 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 to you what to expect from using Fentanilo Matrix, 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 Fentanilo Matrix Sandoz).

Use and changing of patches

• Each patch contains enough medicine to last 3 days (72 hours).

• You must change the patch every three days, unless your doctor has instructed otherwise.

• Always remove the used patch before applying a new one.

• Always change the patch at the same time of day every 3 days (72 hours).

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

• Record the day, 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 your patch on Change your patch on

Monday Thursday

Tuesday Friday

Wednesday Saturday

Thursday Sunday

Friday Monday

Saturday Tuesday

Sunday Wednesday

Where to Apply the Patch

Adults

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

Children

• Always apply the patch to the upper back to make it difficult for your child to reach or remove it.

• Check regularly to ensure the patch remains adhered to the skin.

• It is important that the child does not remove the patch and put it in their mouth, as this could be life-threatening or fatal.

• Closely monitor your child for 48 hours after:

• Applying the first patch.

• Applying a patch with a higher dose.

• The patch may take some time to reach its full effect. Therefore, your child may need additional painkillers until the patches become effective. Your doctor will advise you accordingly.

Adults and Children:

Do not apply the patch to

• The same site twice in a row.
• Areas with high movement (joints), or to irritated or cut skin.
• Hairy areas of skin. If there is hair, do not shave it (shaving may irritate the skin). Instead, cut the hair as close to the skin as possible.

Applying a Patch

Step 1: Prepare the Skin

• Before applying the patch, ensure the skin is completely dry, clean, and cool.
• If washing the skin, use only cold water.
• • Do not use soap or other cleansers, creams, moisturizers, oils, or talcum powder before applying the patch.
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Open the Pouch

• Each patch is sealed in its own pouch.
• Tear the pouch at the notch.
• Gently tear along the entire edge of the pouch (if using scissors, cut close to the sealed edge to avoid damaging the patch).
• Hold both sides of the open pouch and pull 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.
• Patches may occasionally show crystallization (white structures at the edges and/or on the surface of the matrix). The presence of crystals will not affect the performance of the patch. Do not touch the adhesive side of the patch or the crystals.
• Inspect the patch to ensure it is not damaged.
• Do not use the patch if it is split, cut, or appears damaged.
• Never divide or cut the patch.

Step 3: Peel and Press

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

Step 4: Removing the Patch

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

Step 5: Washing Hands

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

More on the Use of Fentanilo Matrix Sandoz

Daily Activities While Using the Patches

• The patches are waterproof.

• You may shower or bathe while wearing a patch, but do not rub it.

• If your doctor agrees, you may exercise or engage in sports while wearing the patch.

• You may also swim while wearing the patch, but:

• Do not use hot tubs or whirlpool baths.

• Do not place tight or elastic fabric over the patch.

  • While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, heat lamps, sunbeds, or saunas. Avoid prolonged sun exposure, hot baths, and saunas. Doing so may increase the amount of medication released from the patch.

How Quickly Do the Patches Work?

• The first patch may take some time to reach its full effect.
• Your doctor may prescribe 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 the treatment of long-term pain. Your doctor will inform you how long you can expect to use the patches.

If Pain Worsens

• If your pain suddenly worsens after applying the last patch, check the patch. If it is no longer adhering properly or has detached, replace the patch (see also section "If the Patch Detaches").
• If your pain worsens over time while using these 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 the patches immediately and contact your doctor, go to a hospital, or call the Toxicology Information Service at 91 562 04 20, indicating the medication and amount applied.

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

If You Forget to Change Your 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, speak to your doctor, as you may need additional painkillers, but do not apply an extra patch.

If a Patch Detaches

• If a patch falls off before it needs to be changed, apply a new one immediately and note the date and time. Use a new skin site:

• On the trunk or arm.

• On the upper back of your child.

• Inform your doctor about the incident and leave the new patch in place for another 3 days (72 hours) or as directed by your doctor before changing it as usual.

• If your patches continue 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 discontinue the patches, speak to your doctor first. Your doctor will guide 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 Sandoz.”
• If you stop using the patches, do not restart them without first consulting your doctor. You may require a different dose when resuming treatment.

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

4. Possible adverse effects

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

If you, or your partner, or caregiver notice any of the following signs in the person wearing the patch, remove the patch immediately and contact a doctor or go straight to the nearest hospital. Urgent medical treatment may be needed.

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the above recommendations and keep the person wearing the patch moving and talking as much as possible. In very rare cases, these breathing difficulties may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Fentanilo Matrix Sandoz or morphine). (Uncommon, may affect up to 1 in 100 people).

• Sudden swelling of the face or throat, severe irritation, redness or blisters on the skin. These may be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).

• Seizures (convulsions). (Uncommon, may affect up to 1 in 100 people).

• Reduced level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 people).

The following adverse effects have also been reported

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

• nausea, vomiting, constipation,
• feeling sleepy (somnolence),
• feeling dizzy,
• headache,

Common (may affect up to 1 in 10 people):

• allergic reaction,
• loss of appetite,
• difficulty sleeping,
• depression,
• feeling anxious or confused,
• seeing, feeling, hearing or smelling things that are not present (hallucinations),
• tremors or muscle spasms,
• unusual skin sensations such as tingling or prickling (paraesthesia),
• sensation of spinning (vertigo),
• rapid or irregular heartbeat (palpitations, tachycardia),
• increased blood pressure,
• shortness of breath (dyspnoea),
• diarrhoea,
• dry mouth,
• stomach pain or indigestion,
• excessive sweating,
• itching, rash or redness of the skin,
• inability to urinate or empty the bladder completely,
• extreme 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 heartbeat (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 (may affect up to 1 in 1,000 people):

• constricted 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 Fentanilo Matrix Sandoz transdermal patches (see section 2).

You may experience skin rashes, redness or mild itching at the site where the patch is applied. These are usually mild and disappear after removing the patch. If they do not resolve, or if the patch causes significant skin irritation, inform your doctor.

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

If you switch from another painkiller to Fentanilo Matrix Sandoz, or if you suddenly stop using Fentanilo Matrix Sandoz, you may experience withdrawal symptoms such as dizziness, feeling sick, diarrhoea, anxiety or tremors. Inform your doctor if you experience any of these effects.

Cases have also been reported of newborn infants experiencing withdrawal symptoms after their mothers used Fentanilo Matrix Sandoz for a prolonged period during pregnancy.

Reporting of adverse effects

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

5. Storage of Fentanilo Matrix Sandoz

Where to store the patches

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

Store this medicine in a protected and secure place, where others cannot access it. It can be very harmful and even fatal to individuals who may accidentally or intentionally use this medicine when it has not been prescribed to them.

How long can Fentanilo Matrix Sandoz be stored

Do not use this medicine after the expiry date stated on the carton and on the sachet after “CAD/EXP”. The expiry date refers to the last day of the month indicated.

Store in the original packaging.

How to dispose of used patches or patches you no longer need

A used or unused patch accidentally sticking to another person, especially a child, can be fatal.

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 stored out of sight and reach of others, especially children, until they are safely disposed of.

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

6. Contents of the container and additional information

Composition of Fentanilo Matrix Sandoz

The active substance is fentanyl.

Fentanilo Matrix Sandoz 12 micrograms/hour transdermal patches

Each transdermal patch (5.25 cm² absorption surface area) contains: 2.89 mg of fentanyl (corresponding to a release rate of 12.5* micrograms/hour of fentanyl).

*The lowest dose may be indicated as 12 µg/h (however, the actual dose is 12.5 µg/h) in order to distinguish it from a 125 µg/h dose that could be prescribed using multiple patches.

Fentanilo Matrix Sandoz 25 micrograms/hour transdermal patches

Each transdermal patch (10.5 cm² absorption surface area) contains: 5.78 mg of fentanyl (corresponding to a release rate of 25 micrograms/hour of fentanyl).

Fentanilo Matrix Sandoz 50 micrograms/hour transdermal patches

Each transdermal patch (21 cm² absorption surface area) contains: 11.56 mg of fentanyl (corresponding to a release rate of 50 micrograms/hour of fentanyl).

Fentanilo Matrix Sandoz 75 micrograms/hour transdermal patches

Each transdermal patch (31.5 cm² absorption surface area) contains: 17.34 mg of fentanyl (corresponding to a release rate of 75 micrograms/hour of fentanyl).

Fentanilo Matrix Sandoz 100 micrograms/hour transdermal patches

Each transdermal patch (42 cm² absorption surface area) contains: 23.12 mg of fentanyl (corresponding to a release rate of 100 micrograms/hour of fentanyl).

Other components are:

Protective liner (to be removed before applying the patch to the skin):

Siliconized poly(ethylene terephthalate) film

Adhesive matrix layer:

Hydrogenated rosin resin
Poly(2-ethylhexyl acrylate-co-vinyl acetate)
Refined soybean seed oil

Waterproof backing film:

Poly(ethylene terephthalate) film
Printing ink

Presentation of the product and contents of the container

Fentanilo Matrix Sandoz is a transparent, rounded, oblong transdermal patch with an adhesive membrane, covered by a protective liner (which is removed before application) allowing it to be affixed to the skin.

Fentanilo Matrix Sandoz is available in packages containing 3, 5, 7, 10, 14, 16, and 20 transdermal patches.

Hospital packs containing 5 transdermal patches.

Only certain package sizes may be commercially available.

Marketing Authorization Holder and Manufacturing Responsibility

Marketing Authorization Holder

Sandoz Farmacéutica S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Hexal AG

Industriestrasse 25

83607 Holzkirchen

Germany

Date of the most recent review of this leaflet: November 2025.

Detailed 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/).