Prospect: information for the user

Fendivia 12 micrograms/hour transdermal patch

Fendivia 25 micrograms/hour transdermal patch

Fendivia 50 micrograms/hour transdermal patch

Fendivia 75 micrograms/hour transdermal patch

Fendivia 100 micrograms/hour transdermal patch

fentanyl

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

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you (or your child), and you must not give it to other people 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 do not appear in this prospect. See section 4.

6. Contents of the package and additional information

The name of your medication is Fendivia

The patches help to relieve very strong and persistent pain:

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

Fendivia contains a medication called fentanil. It belongs to a group of strong pain-relieving medications called opioids.

Do not use Fendivia:

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

Warnings and precautions

If the patch sticks to another person

The patch must be used only on the skin of the person for whom the doctor prescribed it. There have been some cases where the patch has accidentally stuck to another family member by physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally sticks to another person (particularly a child), the medication from the patch may pass through the other person's skin and may cause severe adverse effects, such as difficulty breathing, slow or weak breathing that can be fatal. In the event that the patch sticks to someone else's skin, it must be removed immediately and the person must see a doctor.

Be especially careful with Fendivia

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

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

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

While using the patch, inform your doctor if you have difficulty breathing while sleeping.

Opioids like Fendivia can cause sleep-related respiratory disturbances, such as sleep apnea (breathing interruptions during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Inform your doctor if you, your partner, or caregiver notice that you have any of the following symptoms:

• pauses in breathing during sleep

• waking up at night due to difficulty breathing

• difficulty staying asleep

• excessive daytime sleepiness.

Your doctor may decide to change your dose.

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

• the pain is no longer relieved by the patch

• an increase in pain

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

• pain when something touches your body that you would not expect to hurt.

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

Adverse effects and Fendivia

• Fendivia may make you feel unusually sleepy and make your breathing slower or weaker. In rare cases, these respiratory problemscan be life-threatening or even fatal, especially in people who have not used strong prescribed opioids before. If you, or your partner, or caregiver, observe that the person wearing the patch is unusually sleepy, with slow or weak breathing:

• Remove the patch
• Call a doctor or go to the nearest hospital immediately
• Have the person move and talk as much as possible

• If you have a feverwhile using Fendivia, talk to your doctor. This may increase the amount of medication that passes through your skin.
• Fendivia may cause constipation; talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

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

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

Long-term use and tolerance

This medication contains fentanyl, an opioid. Repeated use of opioid analgesics can 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 Fendivia. This is known as hyperalgesia. Increasing the dose of the patches may continue to reduce pain for a while, but it may also be harmful. If you notice that the

medication is losing its effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or to gradually reduce the use of Fendivia.

Dependence and addiction

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

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

• You or someone in your family has ever abused or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").

• You are a smoker.

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

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

• You need to use the medication for a longer time than indicated by your doctor.

• You need to use a higher dose than recommended.

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

• You have made repeated and unsuccessful attempts to stop using the medication or control 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 the medication, and how to do it safely.

Withdrawal symptoms when stopping Fendivia

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

Using Fendivia with other medications

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

Your doctor will know which medications can be used safely with Fendivia. You may need to be closely monitored if you are using any of the types of medications listed below or if you stop using any of the types of medications listed, as this may affect the dose of Fendivia you need.

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

• Other pain medications, such as other strong opioid analgesics (for example, buprenorphine, nalbuphine, or pentazocine) and some analgesics for neuropathic pain (gabapentin and pregabalin).
• Medications to 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 disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medications to relax muscles (such as cyclobenzaprine or diazepam).
• Some medications used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine). – see below for more information
• Some medications used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not use Fendivia in the 14 days following the interruption of these medications. – see below for more information
• Some antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, ciproheptadine, diphenhydramine, or hydroxyzine).
• Some antibiotics used to treat infections (such as erythromycin or clarithromycin).
• Medications used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medications used to treat HIV infection (such as ritonavir).
• Medications used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
• Medications to treat tuberculosis (such as rifampicin).
• Some medications used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Some medications used to treat nausea or dizziness (such as phenothiazines).
• Some medications used to treat heartburn or ulcers (such as cimetidine).
• Some medications used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Some medications used to treat blood cancer (such as idelalisib).

Using Fendivia with antidepressants

The risk of adverse effects increases if you are using medications such as certain antidepressants. Fendivia may interact with these medications, and you may experience changes in your mental state such as agitation, seeing, feeling, hearing, or smelling things that are not there (hallucinations), and other effects such as changes in blood pressure, rapid heartbeat, high body temperature, hyperactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (these may be signs of the serotonin syndrome). If used together, your doctor may want to monitor you closely to detect such adverse effects, especially when starting treatment or when changing the dose of your medication.

Using Fendivia with central nervous system depressants, including alcohol and some narcotics

The concurrent use of Fendivia and sedatives, such as benzodiazepines or related medications, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concurrent use should be considered only when there are no other possible treatment options.

However, if your doctor has prescribed Fendivia and sedatives simultaneously, the dose and duration of treatment should be limited by your doctor.

Inform your doctor of all sedatives you are using, and follow the recommended dose by your doctor.

It may be helpful to inform your family and friends of the signs and symptoms mentioned above. Talk to your doctor if you experience any of these symptoms.

Use in athletes

Inform athletes that this medication contains a component that may result in a positive analytical result in doping control.

Operations

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

Using Fendivia with alcohol

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

Fendivia may make you feel sleepy or breathe more slowly. Drinking alcohol may worsen these effects.

Pregnancy and breastfeeding

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

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

Fendivia should not be used during delivery, as the medication may affect the newborn's breathing.

Prolonged use of Fendivia during pregnancy may cause withdrawal symptoms (such as loud crying, nervousness, convulsions, poor feeding, and diarrhea) in your newborn baby that may be life-threatening if not recognized and treated. Talk to a doctor immediately if you think your baby may have withdrawal symptoms.

Do not use Fendivia if you are breastfeeding. Do not breastfeed for 3 days after removing the Fendivia patch. This is because the medication may pass into breast milk.

Driving and operating machinery

Fendivia may affect your ability to drive and operate machinery, as it may cause drowsiness or dizziness. If so, do not drive or operate tools or machinery. Do not drive while using this medication until you know how it affects you.

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

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

Your doctor will decide what concentration of Fendivia 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 it, your doctor will also explain what you can expect from the use of Fendivia, 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, withdrawal symptoms when stopping Fendivia).

How to apply and change the patches

• Each patch contains a sufficient amount of medication for3 days (72hours).
• You should change the patch every three days, unless your doctor has told you otherwise.
• Always remove the used patchbeforeapplying a new one.
• Change the patch alwaysat the same timeof the day every 3 days (72hours).
• If you are using more than one patch, change them all at the same time.
• Record the day of the week, date, and time each time you apply a patch to remember when to change it.
• The following table shows when to change the patch:

Where to apply the patch

Adults

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

Children

• Apply the patch always to the upper back so that your child has difficulty reaching it or removing it.
• Check occasionally that the patch is still adhered to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this could put their life in danger or be fatal.
• Keep your child under close observation for 48hours after:

• Applying the first patch
• Applying a patch with a higher dose

• The patch may take some time to reach its maximum effect. Therefore, your child may need other painkillers until the patch is effective. Your doctor will explain this.

Adults and children:

Do not apply the patch to

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

How to apply the patch

Step 1: Prepare the skin

• Before applying the patch, check that the skin is completely dry, clean, and fresh.
• If you need to wash the skin, use only cold water.
• Do not use soap or other cleaners, creams, moisturizers, oils, or talc before applying the patch.
• Do not apply the patch immediately after a bath or shower.

Step 2: Open the package

• Each patch is sealed in its own package.
• Open the package by cutting it along the dotted line with scissors.
• Cut the package edge completely to avoid damaging the patch inside.

• Hold the two package parts open and pull them apart.
• Remove the patch and use it immediately.
• Save the empty package to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from its package until you are ready to use it.
• Check that the patch is not damaged.
• Do not use the patch if it is divided or cut or has any damage.
• Never divide or cut the patch.

Step 3: Peel and press

• Make sure the patch will be covered by a loose garment and do not adhere it under elastic or tight clothing.
• Peel off carefully one half of the shiny plastic protective layer starting from the center of the patch. Be careful not to touch the adhesive part of the patch.
• Press this adhesive part of the patch onto the skin.
• Remove the other half of the protective layer and press the entire patch onto the skin with the palm of your hand.
• Hold it pressed for at least 30 seconds. Make sure the patch is well adhered, especially around the edges.

Step 4: Dispose of the patch

• As soon as you remove the patch, fold it in half, with the adhesive side sticking to itself.
• Put it back in the original package and dispose of it according to your pharmacist's instructions.
• Keep used patches out of sight and reach of children; although used, patches contain medication that can harm children and even be fatal.

Step 5: Wash your hands

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

More information about using Fendivia

Activities during patch use

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

• Do not use hot tubs.
• Do not cover the patch with elastic or tight clothing.

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

How long do the patches take to act?

• The first patch may take some time to reach its maximum effect.
• Your doctor may also give you additional painkillers during the first few days.
• After that, the patch should help relieve pain continuously, allowing you to stop taking other painkillers. However, your doctor may prescribe additional painkillers occasionally.

How long will you have to use the patches?

• The Fendivia patches are indicated for 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, you should check your patch. If it no longer adheres well or falls off, replace the patch (see also the sectionif the patch falls off).
• If your pain worsens over time while using the patches, your doctor may try patches with a higher dose or prescribe additional painkillers (or both).
• If increasing the patch dose does not help, your doctor may decide to stop using the patches.

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

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

The signs of overdose include breathing problems or weak breathing, fatigue, extreme drowsiness, inability to think clearly or walk or speak normally, and 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 to change the patch, change it as soon as you remember and note the day and time. Then, change the patch after3 days (72hours), as usual.
• If you are late, you should talk to your doctor, as you may need additional painkillers, butdo notapply additional patches.

If the patch falls off

• If the patch falls off before it should be changed, apply a new one immediately and note the day and time. Choose a new skin area:
• On the trunk or arm
• On the upper back of your child
• Inform your doctor about this and leave the patch on for another3 days (72hours)or for the time your doctor tells you, before changing the patch in the usual way.
• If the patches tend to fall off, consult your doctor, pharmacist, or nurse.

If you want to stop using the patches

• Do not stop using this medication suddenly. 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 to minimize withdrawal symptoms. See also section 2 “Withdrawal symptoms when stopping Fendivia”.
• If you stop using the patches, do not use them again without asking your doctor first. You may need a different dose when restarting treatment.

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

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

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

• Unusual drowsiness, slower or weaker breathing than expected.

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

• Sharp swelling of the face or throat, severe irritation, redness, or blisters on the skin.

They may all 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).

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

The following side effects have also been reported

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

• Nausea, vomiting, constipation
• Feeling sleepy (Drowsiness)
• Feeling dizzy
• Headache

Common (may affect up to 1 in 10 people)

• Allergic reaction
• Loss of appetite
• Difficulty sleeping
• Depression
• Feeling anxious or confused
• Seeing, feeling, or hearing things that are not there (hallucinations)
• Trembling or muscle spasms
• Strange sensation in the skin, such as tingling or prickling (paresthesia)
• Sensation of everything spinning (dizziness)
• Irregular or rapid heartbeats (palpitations, tachycardia)
• High blood pressure
• Sensation of lack of air (dyspnea)
• Diarrhea
• Dry mouth
• Stomach pain or indigestion
• Excessive sweating
• Itching, rash, or redness of the skin
• Difficulty urinating or emptying the bladder completely
• Intense fatigue, weakness, or general discomfort
• Sensation of cold
• Swelling of the hands, ankles, or feet (peripheral edema)

Rare (may affect up to 1 in 100 people)

• Feeling agitated or disoriented
• Sensation of being extremely happy (euphoria)
• Decreased sensation or sensitivity, especially in the skin (hypoesthesia)
• Memory loss
• Blurred vision
• Slow heart rate (bradycardia) or low blood pressure
• Blue skin color caused by 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
• Sensation of change in body temperature
• Fever
• Muscle contraction
• Difficulty obtaining or maintaining an erection (impotence) or problems with sexual relations
• Difficulty swallowing

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

• Pupil constriction (miosis)
• Occasional interruption of breathing (apnea)

Frequency not known (cannot be estimated from available data)

• Low levels of male sex hormones (androgen deficiency)
• Delirium (symptoms may include agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares)
• You may become dependent on Fendivia (see section 2).

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

Repeated use of the patches may make the medicine less effective (you become accustomed or may become more sensitive to pain), or you may become dependent.

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

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

Reporting of side effects

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

Where to Store the Patches

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

Store this medication in a safe and secure location where other people cannot access it. It may cause serious harm and be fatal to people who use this medication by accident or intentionally when not prescribed.

How Long Can You Store Fendivia

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

How to Dispose of Used Patches or Unused Patches

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

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

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

Composition of Fendivia

The active principle is: Fentanyl.

The patches are available in 5 different doses (see table below).

The other components are: Dipropylene glycol, hydroxypropyl cellulose, dimethicone, silicone adhesive (amine-resistant), ethylene-vinyl acetate (EVA, release membrane), polyethylene terephthalate (PTE, outer plastic sheet), polyester coated with fluoropolymer (protective sheet) and printing ink.

Appearance of the product and contents of the package

Fendivia is a transparent and rectangular transdermal patch. Each patch is packaged in a heat-sealed, child-resistant, paper, aluminum, and polyethylene terephthalate (PET) envelope.

Each transdermal patch has printed in a specific color the commercial name, active principle, and dose:

Fendivia 12 micrograms/hour: brown print

Fendivia 25 micrograms/hour: red print

Fendivia 50 micrograms/hour: green print

Fendivia 75 micrograms/hour: light blue print

Fendivia 100 micrograms/hour: gray print

The patches are supplied in carton containers containing 1, 3, 5, 10, and 20 patches. Only some package sizes may be marketed.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

ISTITUTO GENTILI S.r.l.

Via San Giuseppe Cottolengo 15

20143 Milan, Italy

Responsible for manufacturing:

LTS Lohmann Therapie-Systeme AG
Lohmannstrasse 2
D – 56626 Andernach
Germany

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

Local representative:

FERRER FARMA, S.A.

Av. Diagonal, 549, 5th Floor,

08029 Barcelona (Spain)

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

Matrifen: Cyprus

Quatrofen: Sweden

Fendivia: Spain

Last review date of this prospectus: 12-06-2024

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