FENTANIL MATRIX SANDOZ 100 micrograms/hour TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Fentanilo Matrix Sandoz 12 micrograms/hour transdermal patches EFG

Fentanilo Matrix Sandoz 25 micrograms/hour transdermal patches EFG

Fentanilo Matrix Sandoz 50 micrograms/hour transdermal patches EFG

Fentanilo Matrix Sandoz 75 micrograms/hour transdermal patches EFG

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

Contents of the pack and other information

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

5 Conservation of Fentanilo Matrix Sandoz.

1. Contents of the pack and additional information.

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

The name of this medicine is Fentanilo Matrix Sandoz.

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

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

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

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

Do not use Fentanilo Matrix Sandoz if:

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

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

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 has prescribed it. There have been cases where the patch has accidentally stuck to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally sticks to another person (especially a child), the medicine in the patch can pass through the skin of the other person and can cause serious side effects, such as breathing difficulties, slow or weak breathing, which can be fatal. If the patch sticks to another person's skin, it should be removed immediately and medical help should be sought.

Be careful with Fentanilo Matrix Sandoz

Consult your doctor or pharmacist beforeusing 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,
• you have ever had heart, liver, kidney, or low blood pressure problems,
• 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 condition called "myasthenia gravis", in which the muscles become weak and tired easily.

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

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

• breathing pauses while sleeping,
• waking up at night due to lack of air,
• difficulty staying asleep,
• excessive daytime sleepiness. Your doctor may decide to change the dose.

While using the patch, tell your doctor if you notice a change in the pain you feel.If you feel:

• that 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 there is contact with your body that should not cause pain.

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

Side effects and Fentanilo Matrix Sandoz

• Fentanyl can make you feel unusually sleepy and can slow down your breathing.

On rare occasions, these breathing problems can 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 sleepy, with slow or weak breathing:

• remove the patch,
• call a doctor or go immediately to the nearest hospital,
• keep the person moving and talking as much as possible.
  • If you have a fever while using fentanyl, tell your doctor. This can increase the amount of medicine that passes through your skin,
  • Fentanyl can cause constipation, talk 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 side effects.

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

Long-term use and tolerance

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

Dependence and addiction

Repeated use of Fentanilo Matrix Sandoz can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can cause a feeling of lack of 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 no longer helps to relieve the pain.

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

• You or any member of your family have abused alcohol or have been dependent on it, or have taken prescription drugs or illegal drugs ("addiction").
• You smoke.
• You have ever had mood problems (depression, anxiety, or 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 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 calm down" 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 you feel better once you take it again ("withdrawal symptoms").

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

Withdrawal symptoms when stopping Fentanilo Matrix Sandoz

Do not stop using this medicine suddenly. 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 medicine, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimal.

Other medicines and Fentanilo Matrix Sandoz

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines. This includes medicines obtained without a prescription and herbal remedies. You should also tell your pharmacist that you are using fentanyl if you buy 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 medicines listed below or if you stop taking any of the medicines listed below, as this may affect the dose of fentanyl you need.

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

• Other painkillers, such as other opioid painkillers (like buprenorphine, nalbuphine, or pentazocine) and some painkillers for nerve pain (gabapentin and pregabalin).
• Medicines to help you sleep (like temazepam, zaleplon, or zolpidem).
• Medicines to help you calm down (tranquilizers, like alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental disorders (antipsychotics, like aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines to relax muscles (like cyclobenzaprine or diazepam).
• Some medicines used to treat depression called SSRIs or SNRIs (like 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 (like isocarboxazid, phenelzine, selegiline, or tranylcypromine). You should not use fentanyl in the 14 days after stopping these medicines. - See below for more information.
• Some antihistamines, especially those that cause drowsiness (like chlorphenamine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Some antibiotics used to treat infections (like erythromycin or clarithromycin).
• Medicines used to treat fungal infections (like itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medicines used to treat HIV infection (like ritonavir).
• Medicines used to treat irregular heartbeats (like amiodarone, diltiazem, or verapamil).
• Medicines used to treat tuberculosis (like rifampicin).
• Some medicines used to treat epilepsy (like carbamazepine, phenobarbital, or phenytoin).
• Some medicines used to treat nausea or vomiting (like phenothiazines).
• Some medicines used to treat heartburn or stomach ulcers (like cimetidine).

• Some medicines used to treat angina (chest pain) or high blood pressure (like nicardipine).
• Some medicines used to treat blood cancer (like idelalisib).

Fentanilo Matrix Sandoz with antidepressants

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

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

Using fentanyl and sedative medicines like benzodiazepines or related medicines at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Because of this, using them together should only be considered when other treatment options are not possible.

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

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

Do not drink alcohol while using Fentanilo Matrix Sandoz unless you have talked to your doctor first.

Operations

If you think you are going to receive anesthesia, tell 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 are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

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

Fentanyl should not be used during labor because the medicine can affect the breathing of the newborn.

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

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

Driving and using machines

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

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

Fentanilo Matrix Sandoz contains soybean oil

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

3. How to use Fentanilo Matrix Sandoz

Always follow the administration instructions for this medication as indicated by your doctor. In case of 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 the pain, your general condition, and the type of pain treatment you have received so far.

Before starting treatment and regularly during treatment, your doctor will also explain what you can expect from using Fentanilo Matrix Sandoz, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2, Symptoms of withdrawal from stopping Fentanilo Matrix Sandoz).

Use and change of patches

• Each patch contains enough medication to last 3 days (72 hours).
• You should change the patch every three days, unless your doctor has told you otherwise.
• Always remove the used patch beforeapplying a new one.
• Always change the patch at the same timeof day every 3 days (72 hours).
• If you are using more than one patch, change them all at the same time.
• Make a note of the day, date, and time each time you apply a patch, to remember when you need to change it.

• The following table shows when you should change the patch:

Where to apply the patch

Adults

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

Children

• Always apply the patch to the upper back so that your child has difficulty reaching it or pulling it off.
• Check from time to time that the patch is still stuck 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 pain relievers until the patches are effective. Your doctor will explain this to you.

Adults and children:

Do not apply the patch to

• The same place twice in a row.
• Areas that move a lot (joints), irritated skin, or skin with cuts.
• Areas of skin with a lot of hair. If there is hair, do not shave it (shaving irritates the skin). Instead, cut it as close to the skin as possible.

Applying a patch

Step 1: Prepare the skin

• Before applying the patch, make sure your skin is completely dry, clean, and fresh.
• If you need to wash the skin, use only cold water.
• Do not use soap or other cleaners, creams, moisturizers, oils, or talcum powder before applying the patch.
• Do not apply the patch 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 the edge of the pouch completely (if you use scissors, make the cut along the sealed edge to avoid damaging the patch).
• Hold both sides of the open pouch and pull to separate them.
• Remove the patch and use it immediately.
• Save the empty pouch to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from its pouch until you are ready to use it.
• Inspect the patch to ensure it is not damaged.
• Do not use the patch if it is divided, cut, or appears to be damaged.
• Never divide or cut the patch.

Step 3: Remove and press

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

Step 4: Removing the patch

• As soon as you remove the patch, fold it firmly in half so that the adhesive side sticks to itself.
• Put it back in 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 can harm children and even be fatal.

Step 5: Wash your hands

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

More about using Fentanilo Matrix Sandoz

Daily activities during patch use

• The patches are waterproof.
• You can shower or bathe while using a patch, but do not rub it.
• If your doctor agrees, you can exercise or play sports while using the patch.
• You can also swim with the patch on, but:

• Do not use hot tubs or whirlpools.
• Do not place tight or elastic fabric over the patch.
  • While using the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, waterbeds, heat lamps, or tanning beds. Do not sunbathe or take long hot baths, and do not use saunas. If you do, you 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 maximum effect.
• Your doctor may give you other pain relievers during the first few days.
• After that, the patch should help relieve pain continuously, so you can stop taking other pain relievers. However, your doctor may prescribe additional pain relievers from time to time.

How long will you need to use the patches?

• Fentanyl patches are indicated for the treatment of prolonged 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, check the patch. If it is no longer sticking well or has come off, you should replace the patch (see also the section If the patch comes off).
• If your pain worsens over time while using these patches, your doctor may try patches with a higher dose or prescribe additional pain relievers (or both).
• If increasing the patch dose does not help, your doctor may decide to stop using the patches.

If you use too many patches or a patch with the wrong dose

If you have applied too many patches or a patch with the wrong dose, remove the patches and contact your doctor immediately, go to the hospital, or call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount applied.

Signs of overdose include breathing problems or weak breathing, fatigue, extreme drowsiness, inability to think clearly, walk or talk normally, and dizziness, dizziness, or confusion. An overdose can also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change your patch

• If you forget to change the patch, change it as soon as you remember and make a note of the day and time.
• Go back to changing the patch after 3 days (72 hours)as usual.
• If you are significantly delayed, you should talk to your doctor, as you may need some additional pain relievers, but do notapply an extra patch.

If a patch comes off

• If a patch falls off before you need to change it, apply a new one immediately and make a note of the day and time. Use a new area of skin:

• On the torso or arm.
• On the upper back of your child.

• Tell your doctor what happened and leave the new patch on for 3 days (72 hours)or as directed by your doctor, before changing the new patch 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 want to stop using this medication, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose so that the unpleasant effects of withdrawal are minimal. See also section 2, "Symptoms of withdrawal from stopping Fentanilo Matrix Sandoz".
• If you stop using the patches, do not start using them again without asking your doctor first. You may need a different dose when you restart treatment.

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

4. Possible side effects

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

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

• Unusual feeling of 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 can be life-threatening or even fatal, especially in people who have not used strong opioid pain relievers before (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 can be signs of a severe allergic reaction. (Frequency cannot be estimated from the available data).

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

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

The following side effects have also been reported

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

• nausea, vomiting, constipation,
• feeling 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 there (hallucinations),
• tremors or muscle spasms,
• strange sensation on the skin, such as tingling or prickling (paresthesia),
• feeling that everything is spinning (vertigo),
• rapid or irregular heartbeats (palpitations, tachycardia),
• increased blood pressure,
• feeling short of breath (dyspnea),
• diarrhea,
• dry mouth,
• stomach pain or indigestion,
• excessive sweating,
• itching, rash, or redness of the skin,
• inability to urinate or empty the bladder completely,
• extreme fatigue, weakness, or general malaise,
• feeling cold,
• swelling of the hands, ankles, or feet (peripheral edema).

Uncommon (may affect up to 1 in 100 people):

• feeling agitated or disoriented,
• feeling extremely happy (euphoria),
• decreased sensation or sensitivity, especially in the skin (hypoesthesia),
• memory loss,
• blurred vision,
• slow heart rate (bradycardia) or low blood pressure,
• blue discoloration of the skin due to decreased oxygen in the blood (cyanosis),
• loss of intestinal contractions (ileus),
• skin rash with itching (eczema), allergic reaction, or other skin disorders where the patch is applied,
• flu-like illness,
• feeling of changed body temperature,
• fever,
• muscle contraction,
• difficulty getting or maintaining an erection (impotence) or problems having sex,
• difficulty swallowing.

Rare (may affect up to 1 in 1,000 people):

• pupil constriction (miosis),
• occasional interruption of breathing (apnea).

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

• lack of male sex hormones (androgen deficiency),
• delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbances, nightmares),
• you may become dependent on Fentanilo Matrix Sandoz patches (see section 2).

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

Repeated use of the patches can cause the medication to lose its effectiveness (you get used to it or become more sensitive to pain) or can cause dependence.

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

There have also been reports of newborn babies who experienced withdrawal symptoms after their mothers used Fentanilo Matrix Sandoz for a prolonged period during pregnancy.

Reporting side effects

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

5. Storage of Fentanilo Matrix Sandoz

Where to store the patches

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

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

How long can you store Fentanilo Matrix Sandoz

Do not use this medication after the expiration date shown on the box and on the pouch after "CAD/EXP". The expiration date is the last day of the month indicated.

Store in the original package.

How to dispose of used patches or patches that are no longer used

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

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

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

6. Package contents and additional information

Composition of Fentanilo Matrix Sandoz

The active ingredient is fentanyl.

Fentanilo Matrix Sandoz 12 micrograms/hour transdermal patches

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

Fentanilo Matrix Sandoz 25 micrograms/hour transdermal patches

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

Fentanilo Matrix Sandoz 50 micrograms/hour transdermal patches

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

Fentanilo Matrix Sandoz 75 micrograms/hour transdermal patches

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

Fentanilo Matrix Sandoz 100 micrograms/hour transdermal patches

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

The other components are:

Protective film (remove before applying the patch to the skin):

Siliconized poly(ethylene terephthalate) laminate

Adhesive matrix layer:

Hydrogenated colophony resin

Poly(2-ethylhexyl acrylate-co-vinyl acetate)

Refined soybean seed oil

Waterproof coating film:

Poly(ethylene terephthalate) laminate

Printing ink

Appearance of the product and packaging content

Fentanilo Matrix Sandoz is a transparent, rounded, and oblong transdermal patch with an adhesive membrane and covered with a protective film (which is removed before applying the patch) so it can be stuck to the skin.

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

Hospital packs with 5 transdermal patches.

Only some pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Hexal AG

Industriestrasse 25

83607 Holzkirchen

Germany

Date of the last revision of thisleaflet:May 2025

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