Label: information for the patient

Fentanilo Matrix Viatris 50 micrograms/hour transdermal patches EFG

Read this label carefully before starting to use this medication, as it contains important information for you.

-Keep this label, as you may need to refer to it again.

-If you have any questions, consult your doctor, pharmacist, or nurse.

-This medication has been prescribed only for you (or your child) and should not be given to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this label. See section 4.

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

2. What you need to know before starting to use Fentanilo Matrix Viatris

3. How to use Fentanilo Matrix Viatris

4. Possible adverse effects

5. Storage of Fentanilo Matrix Viatris

6. Contents of the package and additional information

Thename of your medication is Fentanilo Matrix Viatris.

Thepatcheshelp to relieve very strong and long-lasting pain.

• In adults who need continuous treatment for pain.
• In children over 2 years old who already use opioid medications and need continuous treatment for pain.

Fentanilo Matrix Viatris contains a medication called fentanilo. It belongs to a group of strong calming medicines, called opioids.

Do not use Fentanilo Matrix Viatris if:

• You are allergic to fentanyl or any of the other components of this medication (listed in section 6).
• You have pain that lasts only a short period of time, such as sudden pain or pain after surgery.
• You have difficulty breathing, slow breathing, or shallow breathing.

Do not use this medication if you or your child have any of the above situations. If in doubt, consult your doctor or pharmacist before starting to use Fentanilo Matrix Viatris.

Warnings and precautions

Applying the patch to another person

The patch should only be used on the skin of the person to whom it was prescribed. There have been reports of patches accidentally adhering to a family member if there is physical contact or if they share the same bed as the person wearing the patch. A patch that accidentally adheres to another person (especially a child) may cause the medication to pass through the skin of the other person and cause severe side effects, such as difficulty breathing, slow breathing, or shallow breathing, which can be fatal. If the patch adheres to the skin of another person, remove it immediately and seek medical attention.

Be extra careful with Fentanilo Matrix Viatris

Consult your doctor or pharmacist before starting to use this medication if any of the following circumstances apply to you; your doctor may need to monitor you more closely if:

• You have ever had problems with your lungs or breathing.
• You have ever had problems with your heart, liver, kidneys, or low blood pressure.
• You have ever had a brain tumor.
• You have ever had persistent headaches or head injuries.
• You are an elderly person, you may be more sensitive to the effects of this medication.
• You have a condition called "myasthenia gravis," in which your muscles weaken and tire easily.

If any of the above circumstances apply to you (or if you are unsure), consult your doctor or pharmacist before starting to use fentanyl.

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

• pauses in breathing while sleeping
• waking up at night due to lack of air
• difficulty staying asleep
• excessive daytime sleepiness.

Your doctor may decide to modify the dose.

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

• the patch no longer relieves pain
• an increase in pain
• a change in the way you feel pain (for example, you feel pain in another part of your body)
• pain when you come into contact with your body that should not cause pain.

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

Side effects and Fentanilo Matrix Viatris

• Fentanyl may leave you unusually drowsy and cause you to breathe more slowly or superficially. In rare cases, these breathing problemscan be potentially fatal, especially in people who have not previously used strong prescription opioid medications (such as Fentanilo Matrix Viatris) or morphine. If you, your partner, or caregiver observe that the person wearing the patch is unusually drowsy, breathing slowly, or breathing superficially:

• Remove the patch.
• Call a doctor or go to the nearest hospital immediately.
• Keep the person moving and talking as much as possible.

• If you have a fever while using fentanyl, tell your doctor: this may increase the amount of medication that passes through the skin.
• Fentanyl may cause constipation, consult your doctor or pharmacist for advice on how to prevent or alleviate constipation.

See section 4 for a complete list of possible side effects.

Long-term use and tolerance

This medication contains fentanyl, an opioid. Repeated use of opioid analgesics may make the medication less effective (your body becomes accustomed to it, known as pharmacological tolerance). It is also possible that you may become more sensitive to pain when using fentanyl. This is known as hyperalgesia. Increasing the dose of the patches may continue to reduce pain for a while, but it may also be harmful. If you notice that the medication is losing its effectiveness, consult your doctor. Your doctor will decide whether to increase the dose or gradually reduce the use of fentanyl.

Dependence and addiction

The repeated use of fentanyl may also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these side effects may be higher with a higher dose and longer use. Dependence or addiction may cause you to feel a lack of control over the amount of medication you should use or how often you should use it. You may feel the need to continue using the medication even if it no longer helps to relieve pain.

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

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

• You smoke.

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

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

• You need to use the medication for a longer period than prescribed by your doctor.

• You need to use a higher dose than recommended.

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

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

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

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

If you are wearing the patch, do not expose it to direct heat sources, such as heating pads, electric blankets, hot water bottles, hot tubs, or sunlamps. Do not take the sun or prolonged hot baths. Do not visit saunas or hot tubs or spas. If you do, you may increase the amount of medication you receive from the patch.

Other medications and Fentanilo Matrix Viatris

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication. This includes medications you buy without a prescription or herbal remedies. If you buy medications at the pharmacy, you should also inform the pharmacist that you are using fentanyl.

Your doctor will know which medications you can take safely with fentanyl. You may need to be monitored more closely if you are taking or stopping some of the types of medications listed below, as this may affect the potency of fentanyl you need.

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

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

• Medicationsto help you sleep (such as temazepam, zaleplon, or zolpidem).

• Medications to help you calm down (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medications for mental health conditions (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).

• Medicationsto relax muscles (such as cyclobenzaprine or diazepam).
• Some medicationsused to treat depressioncalled SSRIs or SNRIs (such ascitalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). See the information below.
• Some medications used to treatdepression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine).Do not take fentanyl in the 14 days after stopping these medications: see the information below.

• Some antihistamines, especially those that make you drowsy (such as chlorpheniramine, clemastine, ciproheptadine, diphenhydramine, or hydroxyzine).
• Some antibiotics used to treat infections (such as erythromycin or clarithromycin).
• Medications used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medications used to treat HIV infection (such as ritonavir).
• Medications used to treat arrhythmias (such as amiodarone, diltiazem, or verapamil).
• Medications used to treat tuberculosis (such as rifampicin).
• Some medications used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Some medications used to treat nausea or dizziness (such as phenothiazines).
• Some medications used to treat sunburn or ulcers (such as cimetidine).
• Some medications used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Some medications used to treat blood cancer (such as idelalisib).

Fentanilo Matrix Viatris with antidepressants

The risk of side effects increases if you are taking medications such as certain antidepressants. Fentanyl may interact with these medications and may cause changes in mental state, such as excitement, seeing, feeling, hearing, or smelling things that are not there (hallucinations), and other effects such as changes in blood pressure, rapid heart rate, high body temperature, hyperactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea.

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

Inform your doctor if you are taking any other medication that slows down your central nervous system (CNS depressants). For example, CNS depressants are products that make you drowsy, reduce anxiety, or decrease consciousness (see also "Other medications and Fentanilo Matrix Viatris"); alcohol and certain narcotics are also CNS depressants. Taking this type of medication with Fentanilo Matrix Viatris may cause severe drowsiness, reduced consciousness, breathing difficulties with slow or shallow breathing, coma, or death.

Do not drink alcohol while using Fentanilo Matrix Viatris, unless you first talk to your doctor.

Surgery

If you think you will receive anesthesia, inform your doctor or dentist that you are using fentanyl.

Pregnancy and breastfeeding

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

Do not use fentanyl during pregnancy, unless you have discussed it with your doctor.

Do not use fentanylduring labor, as the medication may affect the newborn's breathing.

Do not breastfeed while using fentanyl. Do not breastfeed for 3 days after removing the fentanyl patch. This is because the medication may pass into breast milk.

Driving and operating machinery

Fentanyl may affect your ability to drive and operate machinery,as it may cause drowsiness or dizziness. If this happens, do not drive or use tools or machinery. Do not drive while usingthismedication until you know how it affects you.

Talk to your doctor or pharmacist if you are unsure whether it is safe to drive while taking this medication.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, you must consult your doctor or pharmacist again.

Your doctor will decide what dose of Fentanilo Matrix Viatris is most suitable, taking into account the severity of the pain, your general condition, and the type of pain treatment you have received so far.

Before starting treatment and regularly during it, your doctor will also explain to you what you can expect from the use of fentanilo, when and for how long you should use it, when you should contact your doctor, and when you should discontinue use (see also section 2, "Interruption of fentanilo treatment syndrome").

Use and change of patches

• There is enough medication in each patch to last3 days (72 hours).
• You must change the patch every 3 days, unless your doctor has told you otherwise.
• Always remove the old patchbeforeapplying a new one.
• Always change the patch at thesame timeof the day every 3 days (72 hours).
• If you use more than one patch, change them all at the same time.
• Record the day, date, and time of patch application, so you remember when to change it.
• The following table shows when to change the patch:

Where to apply the patch

Adults

• Place the patchon a smooth surface of the upper body or arm(not on a joint).

Use in children

• Always apply the patch to the upper back, so the child cannot reach it and remove it.
• Check frequently that the patch is still adhering to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this could pose a risk to life or even be fatal.
• Monitor your childvery closely in the 48 hours following:
• • The placement of the first patch.
  • The placement of a patch with a higher dose.
• It may take some time for the patch to reach its maximum effect.
• Therefore, your child may need additional painkillers until the patches are fully effective. Your doctor will advise you as necessary.

Adultsand children:

Do not apply the patch to

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

Applying a patch

Step 1: Skin preparation

• Ensure the skin is completely dry, clean, and fresh before placing the patch.
• If you need to wash the skin, wash it with water.
• Do not use soap, oil, lotion, alcohol, or other cleaners that may irritate the skin.
• Do not place the patch immediately after a bath or shower with hot water.

Step 2: Open the package

• Each patch is stored in a sealed bag.
• To open the package, make a small cut near the sealed edge of the package with the tip of the scissors (figure 1).

Figure 1:

• Gently break the bag andpull it apart completely (figure 2).

Figure 2:

• Hold the two sides of the open package, pull them apart to open the package on three sides, and remove the patch (figure 3).

Figure 3:

• Remove the patch and use it immediately (figure 4).

Figure 4:

• Save the empty package to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from its package until you are ready to use it.
• Check if the patch is damaged.
• Do not use the patch if it is torn, cut, or appears damaged.
• Never divide or cut the patch.

Step 3: Peel and press

• Ensure the patch is covered by loose clothing and not trapped under a strap or elastic band.
• The patch should stick immediately after opening the package. Once the protective film is removed, carefully peel one half of the transparent protective film away from the center of the patch. Try not to touch the adhesive side of the patch (figure 5).

Figure 5:

• Press this adhesive part of the patch onto the skin (figure 6).

Figure 6:

• Remove the other half of the protective film (figure 7).

Figure 7:

• Press the entire patch onto the skin with the palm of your hand.
• Hold the pressurefor at least 30 seconds. Ensure the patch sticks well to the skin, especially around the edges (figure 8).

Figure 8:

Step 4: How to dispose of the patch

• As soon as you remove the patch, fold it firmly in half so that it sticks together with the adhesive side.
• Return it to its original bag and dispose of it according to the instructions given by the pharmacist.
• Keep used patches out of sight and reach of children; although used, patches contain medication that can harm children and may be fatal.

Step 5: Wash

• Wash your hands always after handling the patch, only with clear water.

More information about the use of Fentanilo Matrix Viatris

Everyday activities while using the patches

• The patches are impermeable.
• You can take a shower or bath with the patch on, but do not rub it.
• If your doctor agrees, you can exercise or engage in sports with the patch on.
• You can also swim with the patch, but:

• Do not use it in saunas or hot tubs.
• Do not place a strap or elastic band over the patch.

• If you wear the patch, do not expose it to direct heat sources, such as heating pads, electric blankets, hot water bottles, hot tubs, or heat lamps or tanning beds. Do not take the sun, hot baths, or visit saunas for an extended period. If you do, you may receive more medication from the patch.

When will the patches start working?

• It may take some time for the first patch to reach its maximum effect.
• Your doctor may provide you with additional painkillers, also for the first day.
• After that, the patch should help you relieve pain continuously, so you can stop taking other painkillers. However, your doctor may prescribe additional painkillers from time to time.

How long will you use the patches?

• The fentanilo patches are for long-term pain. Your doctor will be able to tell you how long you can use the patches.

If the pain worsens

• If your pain worsens suddenly after applying the last patch, check the patch. If it no longer adheres well or has come off, replace the patch (see also the section If the patch comes off).
• If the pain worsens over time while using the patches, your doctor may try a patch with a higher dose or give you an additional painkiller (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 if you wear the patch with the wrong dose

If you have applied too many patches or the patch has the wrong dose, remove them and contact your doctor or pharmacist immediately,call the Toxicology Information Service, phone 91 562 04 20 (indicating the medication and the amount applied), or go to the nearest hospital. Bring the packaging and remaining patches with you.

The signs of overdose include difficulty breathing or shallow breathing, fatigue, extreme drowsiness, inability to think clearly, walk, or speak normally, as well as fainting, dizziness, or confusion. An overdose can also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

• If you forget, change the patch as soon as you remember and note the day and time. Change the patch again after 3 days (72 hours), as usual.
• If you take a long time to change the patch, you should talk to your doctor because you may need additional painkillers, but do not apply another patch.

If a patch comes off

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

• The upper body or arm.
• The shoulder of your child.

• Tell your doctor what happened and leave the patch on for another 3 days (72 hours) or as instructed by your doctor, before changing the patch in the usual way.
• If the patches continue to fall off, talk to your doctor, pharmacist, or nurse.

If you want to stop using the patches

• Talk to your doctor if you want to stop using these patches.
• If you have been using them for a while, it is possible that your body has become accustomed to them. If you stop using them suddenly, you may not feel well.
• If you stop using patches, do not start using them again without first asking your doctor. You may need a patch with a different dose when you start again.

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

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

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

• If you feel unusually drowsy, if you breathe more slowly or more weakly than usual.Follow the advice given earlier and have the person wearing the patch move and talk as much as possible.In very rare cases, these breathing difficulties can be potentially fatal, especially in people who have not used strong opioid sedatives before (such as fentanyl or morphine). (Rare, may affect up to 1 in 100 people)..
• Sudden swelling of the face or throat,severe irritation, redness, or blisters on the skin. They may be signs of a severe allergic reaction (frequency cannot be estimated from available data).
• Seizures (convulsions).(Rare, may affect up to 1 in 100 people).
• Loss of consciousnessor decreased level of consciousness. (Rare, may affect up to 1 in 100 people).

The following side effects have also been reportedside effects

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

• Nausea, vomiting, constipation.
• Drowsiness.
• Dizziness.
• Headache.

Common (may affect up to 1 in 10 people)

• Allergic reaction.
• Loss of appetite.
• Difficulty sleeping.
• Depression.
• Anxiety or confusion.
• Seeing, feeling, or hearing things that do not exist (hallucinations).
• Muscle tremors or spasms.
• Strange sensation in the skin, such as tinglingor pins and needles (paresthesia).
• Sensation of movement (vertigo).
• Fast or irregular heartbeat(palpitationsor tachycardia).
• High blood pressure.
• Lack of breath(dyspnea).
• Diarrhea.
• Dry mouth.
• Stomach pain or indigestion.
• Excessive sweating.
• Itching, hives, or redness of the skin.
• Inability to urinate or empty the bladder completely.
• Sensation of fatigue, weakness, orgeneral malaise.
• Sensation of cold.
• Swollen hands, feet, or ankles (peripheral edema).

Rare (may affect up to 1 in 100 people)

• Disorientation or excitement.
• Sensationof overwhelming joy (euphoria).
• Decreased sensitivity, especially in the skin(hypoesthesia).
• Memory loss.
• Blurred vision.
• Slow heartbeat (bradycardia) orlow blood pressure.
• Blue spots on the skin caused by low oxygen levels in the blood (cyanosis).
• Lack ofintestinal contractions(ileus).
• Hives with itching on the skin (eczema), allergic reactionor other skin disorderswhere the patch has been applied.
• Flu-like illness.
• Sensation ofchange in body temperature.
• Fever.
• Muscle twitching.
• Difficulty achieving andmaintaining an erection(impotence) or sexual problems.
• Difficulty swallowing.

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

• Pupil constriction(miosis).
• Stopping breathing from time to time (apnea).

Not known (frequency cannot be estimated from available data)

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

You may notice hives, redness, or mild itching of the skin in the patch area. Normally,it is mild anddisappears after you have removed the patch.If not, or if the patch irritates your skin a lot, tell your doctor.

Continued use of the patches may make the medicine less effective (become “tolerant” to it)or may cause dependence.

If you change from another sedative to fentanyl or suddenly stop using fentanyl, you may experience a certain withdrawal syndrome such asuncomfortable feelings, dizziness, nausea, diarrhea, anxiety, or tremors.Inform your doctor if you notice any of these effects.

There have also been reports of newborns experiencing withdrawal effects after their mothers used fentanyl for a long time during pregnancy.

Reporting of side effects:

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

Where should I store the patches

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

Conserve this medication in a safe and protected place, to which no other people can access. This medication can cause severe and even fatal damage to people who use it accidentally, or intentionally when not prescribed.

How long can Fentanilo Matrix Viatris be stored

Do not useFentanilo Matrix Viatrisafter the expiration date indicated onthe box and in the airtight bag. The expiration date is the last day of the month indicated.If the patches have expired, take them to the pharmacy.

This medication does not require special storage conditions.

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

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

Used patches must be foldedfirmly in half, so that they stick togetherby the adhesive side.Dispose of them safely, by placing them in the original airtight bag andstoring them out of sight and reach of other people, especially children, until they are disposed of safely.Ask your pharmacist how to dispose of the packaging and medications you no longer need.

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

Fentanyl Matrix Viatris Composition

The active ingredient is fentanyl. Each transdermal patch contains 8.4 mg of fentanyl on a surface of 21.0 cm2, which releases 50 micrograms of fentanyl per hour.

The other components are:

Acrylic adhesive, siliconized polyester film (protective coating), ethylene-vinyl acetate copolymer film (support layer) and white printing ink.

Appearance of the product and packaging contents

Fentanyl Matrix Viatris is a transparent rectangular patch, printed with white ink and covered with a removable protective film.

The patches contain the following imprint: Fentanyl 50 µg/h

The patch is covered by a transparent protective film that is removed before application to expose the adhesive side, allowing it to adhere to the skin.

The patches are individually packaged in sealed pouches and conditioned in a box.

Fentanyl Matrix Viatris is available in packaging sizes of 3, 4, 5, 8, 10, 16 and 20 transdermal patches. Some packaging sizes may not be commercially available.

Marketing Authorization Holder

Viatris Limited

Damastown Industrial Park

Mulhuddart, Dublin 15

Dublin

Ireland

Responsible Person

McDermott Laboratories Limited trading as Gerard Laboratories

35/36/75/76/77/80 Baldoyle Industrial Estate, Grange Road

Dublin 13

Ireland

Or

Mylan Hungary Ltd.

H-2900 Komarom

Mylan utca 1

Hungary

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Viatris Pharmaceuticals, S.L.U.

C/ General Aranaz, 86

28027 - Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

GermanyFentanyl Mylan 50 Mikrogamm/Stunde, transdermales Pflaster

DenmarkFentanyl Mylan

SpainFentanilo Matrix Viatris 50 microgramos/hora patches transdérmicos EFG

FranceFentanyl Viatris 50 µg/h, dispositif transdermique

NorwayFentanyl Mylan

NetherlandsFentanyl matrixpleister Mylan 50 microgram/uur, pleister voor transdermaal gebruik

PortugalFentanilo Mylan

Czech RepublicFentanyl Mylan 50mikrogramu/hodinu, transdermální náplast

Last review date of this leaflet:March 2024

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)https://www.aemps.gob.es/