Package Insert: Information for the User

fentanilo matrix cinfa 25 micrograms/hour transdermal patches EFG

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

• Keep this package insert, as you may need to refer to it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only for you, and you should not give it to others who may have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this package insert. See section 4.

This medicine is called fentanilo matrix cinfa.

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 need continuous pain treatment.

fentanilo matrix cinfa contains a medicine called fentanilo. It belongs to a group of strong pain-relieving medicines called opioids.

No use fentanilo matrix cinfa

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use fentanyl matrix cinfa.

If the patch sticks to another person

The patch should only be used 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 through 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 medication in the patch can pass through the other person's skin and may cause serious 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 should be removed immediately and the person should seek medical attention.

Be especially careful with fentanyl matrix cinfa

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 fentanyl.

While using the patch, report to your doctor if you have breathing problems while sleeping.Fentanyl and other opioids 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 dosage.

While using the patch, report to 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 you come into contact with your body that should not cause pain.

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

Adverse effects and fentanyl matrix cinfa

• Fentanyl may make you feel exceptionally sleepy and cause your breathing to be slower or weaker. In rare cases, these breathing problemscan be life-threatening or even fatal, especially in people who have not used strong prescription painkillers (such as fentanyl or morphine) before. If you, or your partner or caregiver, observe that the person wearing the patch is unusually sleepy, breathing slowly or weakly:

• 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 fever while using fentanyl, talk to your doctor. This can increase the amount of medication that passes through your skin.
• Fentanyl can 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 painkillers can make the medication less effective (your body becomes accustomed to it, known as pharmacological tolerance). It is also possible that you will become more sensitive to pain when using fentanyl matrix cinfa. This is known as hyperalgesia. Increasing the dosage 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 dosage or to gradually reduce the use of fentanyl matrix cinfa.

Dependence and addiction

The repeated use of fentanyl matrix cinfa 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 dosage and longer use. Dependence or addiction can cause a feeling of loss of control over the amount of medication you should use or the frequency with which 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 matrix cinfa may be higher if:

• You orany 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 matrix cinfa, it could be a sign of dependence or addiction.

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

Withdrawal symptoms when stopping fentanyl matrix cinfa

Do not stop using this medication abruptly. 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 medication, talk to your doctor first. Your doctor will advise you on how to do it, usually by gradually reducing the dosage to minimize unpleasant withdrawal symptoms.

Children

Fentanyl is used in children over 2 years of age who are tolerant to opioids, who are already using opioid medication, and who need ongoing pain treatment.

Other medications and fentanyl matrix cinfa

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

This includes over-the-counter medications and herbal remedies. You should also inform your pharmacist that you are using fentanyl if you purchase any medication at the pharmacy.

Your doctor will know which medications can be used safely with fentanyl. 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 dosage of fentanyl you need.

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

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

Using fentanyl matrix cinfa with antidepressants

The risk of adverse effects increases if you are taking certain antidepressants. Fentanyl 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 (which may be signs of a serotonin syndrome). If you are using them together, your doctor may want to closely monitor you to detect these side effects, especially when starting treatment or when changing the dosage of the medication.

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

The concomitant use of fentanyl and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. For this reason, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes fentanyl along with sedatives, your doctor should limit the dosage and duration of concomitant treatment.

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

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

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 be receiving 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 or plan to become pregnant, consult your doctor or pharmacist before using this medication.

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

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

Prolonged use of fentanyl during pregnancy may cause withdrawal symptoms (such as loud crying, feeling restless, convulsions, poor feeding, and diarrhea) in your newborn, which can be potentially fatal if not recognized and treated. Talk to your doctor immediately if you think your newborn may be experiencing withdrawal symptoms.

Do not use fentanyl if you are breastfeeding. 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

Ask your doctor if you can drive or operate machinery during treatment with fentanyl. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel sleepy, dizzy, have blurred vision, or see double, or have difficulty concentrating. Be especially careful at the start of treatment, after increasing the dosage, after changing the formulation, and/or when taking it with other medications.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of fentanil matrix cinfa, 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 the use of fentanil matrix cinfa").

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

Your doctor will decide what concentration of fentanil 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.

How to apply and change the patches

• Each patch contains a sufficient amount of medication for3 days (72 hours).
• You should change the patch every 3 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 (72 hours).
• If you are using more than one patch, change them all at the same time.
• Note the day of the week, date and time each time a patch is applied 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 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 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), in irritated or damaged skin.
• 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 tearing or cutting along the perforation, marked with an arrow.
• Gently tear or cut the package edge (if using scissors, make the cut along the sealed edge to avoid damaging the patch).

• 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 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, so that the adhesive side sticks 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, the 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 the patches.

More information about the use of fentanil matrix cinfa

Activities during the use of the patches

• 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 tubs, or lamps or tanning beds. Do not take long hot baths or 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 give you additional painkillers during the first few days.
• After that, the patch should help relieve pain continuously, so you can stop taking other painkillers. However, your doctor may prescribe additional painkillers occasionally.

For how long will you have to use the patches?

• The fentanil patches are indicated for prolonged pain. Your doctor will tell you for 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 no longer adheres well or has fallen off, replace it (see also the section If 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 more fentanil matrix cinfa than you should

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

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 use fentanil matrix cinfa

• If you forget to change the patch, change it as soon as you remember and note the day and time. Then change the patch again after3 days (72 hours), 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 (72 hours)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 or pharmacist.

If you interrupt treatment with fentanil matrix cinfa

• 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 the dose will be gradually reduced so that the unpleasant effects of withdrawal are minimal. See also section 2, “Withdrawal symptoms when stopping the use of fentanil matrix cinfa”.
• If you stop using the patches, do not use them again without consulting your doctor first. You may need a different dose when you resume treatment.

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, 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 fentanyl or morphine) before. (Rare, may affect up to 1 in 100 patients).

• Brusque swelling of the face or throat, severe irritation, redness, or blisters on the skin. All of them can be signs of a severe allergic reaction. (Unknown frequency: cannot be estimated from available data).

• Seizures (convulsions). (Rare, may affect up to 1 in 100 patients).

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

The following side effects have also been reported

Very common (may affect more than 1 in 10 patients).

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

Common (may affect up to 1 in 10 patients).

• Allergic reaction.
• Loss of appetite.
• Difficulty sleeping.
• Depression.
• Feeling anxious or confused.
• Seeing, feeling, hearing, or smelling things that are not present (hallucinations).
• Trembling or muscle spasms.
• Strange sensation in the skin, such as tingling or prickling (paresthesia).
• Sensation of everything spinning (dizziness).
• Fast or irregular heartbeats (palpitations, tachycardia).
• Increased 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 malaise.
• Sensation of cold.
• Swelling of the hands, ankles, or feet (peripheral edema).

Rare (may affect up to 1 in 100 patients).

• 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 discoloration of the skin caused by a decrease in 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.

Rare (may affect up to 1 in 1,000 patients).

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

Unknown 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 are not present, sleep disturbances, nightmares).
• You may become dependent on fentanyl matrix cinfa (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 "tolerant" to it) or may cause dependence.

If you switch from another painkiller to fentanyl or stop using fentanyl 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.

Cases of newborn babies experiencing withdrawal symptoms after their mothers used fentanylo for an extended period during pregnancy have also been reported.

Reporting of side effects

If you experience any type of side effect, consult your doctor or pharmacist, 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 the 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.

Keep this medication out of the sight and reach of children.

This medication does not require special storage conditions.

Do not use this medication after the expiration date that appears on the box and on the pouch after CAD. The expiration date is the last day of the month indicated.

Do not use this medication if you observe that the patches are damaged.

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

Used patches must be folded firmly in half, so that the adhesive side of the patch adheres to itself. Then, they must be disposed of safely by introducing them into the original pouch and storing them, until they are disposed of safely.

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

Fentanilo matrix cinfa composition

• The active ingredient is fentanilo. Each patch contains 4.8 mg of fentanilo (released amount: 25 micrograms/hour).
• The other components are acrylic polymer, lauril alcohol, laminated polyester/ethyl vinyl acetate film, siliconized polyester film, ink.

Product appearance and packaging contents

It is presented in paper/film of polyethylene terephthalate/polyethylene/aluminum/coextruded polyamide that contains 1 transdermal patch. Each package contains 5 rectangular transdermal patches.

Fentanilo matrix cinfa are patches formed by: a transparent rectangular layer, a transparent, colorless, and opaque adhesive matrix that contains the active ingredient, and a transparent easily removable film.

Marketing authorization holder and manufacturer responsible

Cinfa Laboratories, S.A.

Olaz-Chipi Road, 10. Areta Industrial Estate

31620 Huarte (Navarra) - Spain

Last review date of this leaflet:March 2025

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

You can access detailed and updated information about this medicine by scanning with your mobile phone (smartphone) the QR code included in the leaflet and packaging. You can also access this information at the following internet address:https://cima.aemps.es/cima/dochtml/p/71853/P_71853.html

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