Leaflet: information for the user

Durfenta 12 micrograms/hour transdermal patch EFG

Durfenta 25 micrograms/hour transdermal patch EFG

Durfenta 50 micrograms/hour transdermal patch EFG

Durfenta 75 micrograms/hour transdermal patch EFG

Durfenta 100 micrograms/hour transdermal patch EFG

fentanil

Read this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• This medicine has been prescribed for you (or your child) only, and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

This medication is called Durfenta

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.

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

Do not use Durfenta:

• If you are allergic to fentanyl or any of the other components of 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 is in any of the above circumstances. If you are unsure, consult your doctor or pharmacist before using Durfenta.

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 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 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 should be removed immediately and the person should seek medical attention.

Be especially careful with Durfenta

Consult your doctor or pharmacist beforeusing this medication if you are in any of the following circumstances. Your doctor will need 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 become weak and easily fatigued.

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

While using the patch, report to your doctor if you experience breathing problems while sleeping.Opioids like Durfenta 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 experience:

• the patch no longer alleviates the 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 dosage on your own. Your doctor may decide to modify the dosage or change the treatment.

Adverse effects and Durfenta

• Durfenta may make you feel exceptionally sleepy and cause your breathing to be slower or weaker. In rare cases, these respiratory problems can be life-threatening or even fatal, especially in people who have not used strong prescription opioids (such as Durfenta 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 Durfenta, talk to your doctor. This can increase the amount of medication that passes through your skin.
• Durfenta 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 will become more sensitive to pain when using Durfenta. 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 Durfenta.

Dependence and addiction

The repeated use of Durfenta 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 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 alleviate pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Durfenta 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 Durfenta, it could be a sign of dependence or addiction:

• You need to use the medication for a longer period than recommended 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 discontinue the medication, and how to do it safely.

Withdrawal symptoms when stopping Durfenta

Do not stop using this medication abruptly. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heart rate (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.

Other medications and Durfenta

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication. This includes over-the-counter medications and herbal remedies. You should also inform your pharmacist that you are using Durfenta if you purchase any medication at the pharmacy.

Your doctor will know which medications can be taken safely with Durfenta. They may need to monitor you closely if you are taking any of the types of medications listed below or if you stop taking any of the types of medications listed, as this may affect the dosage of Durfenta you need.

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

• Other pain medications, such as other strong opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine)and some neuropathic pain medications (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 health conditions (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 Durfenta in the 14 days following the discontinuation 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 stomach acid 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 Durfenta with antidepressants

The risk of adverse effects increases if you are taking certain antidepressants. Durfenta may interact with these medications, and you may experience changes in mental state such as agitation, seeing, feeling, hearing, or smelling things that are not present (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(which could be signs of a serotonin syndrome). If you are taking them together, your doctor may want to monitor you closely to detect these side effects, especially when starting treatment or when changing the dosage of the medication.

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

The concomitant use of Durfenta and medications with sedative effects, such as benzodiazepines or related medications, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Durfenta along with sedative medications, the dosage and duration of concomitant treatment should be limited by your doctor.

Please inform your doctor about any sedative medications you are taking, and followstrictlythe recommended dosage by your doctor. It may be helpful to inform friends or family members about the symptoms described above. Contact your doctor if you experience any of these symptoms.

Do not drink alcohol while using Durfenta, unless you have spoken with your doctor first.

Use in athletes

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

Surgery

If you think you will be receiving anesthesia, inform your doctor or dentist that you are using Durfenta.

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.

Durfenta should not be used during pregnancy, unless you have spoken with your doctor.

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

The prolonged use of Durfenta 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 breastfeed while using Durfenta. Do not breastfeed for 3 days after removing the Durfenta patch. This is because the medication may pass into breast milk.

Driving and operating machinery

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

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

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

Your doctor will decide what concentration of Durfenta 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 Durfenta, 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 Durfenta”).

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 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 (72 hours).
• 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 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), 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 hot 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 perforated line, indicated by an arrow.
• Gently tear or cut along the sealed edge of the package (if using scissors, cut along the sealed edge to avoid damaging the patch).

• Hold the two parts of the open package 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.
• Remove the plastic protective covering that covers the printed side of the patch.
• Carefully peel off one corner of the patch from the plastic protective covering that covers the adhesive side of the patch. Be careful not to touch the adhesive side of the patch.
• Press this adhesive side of the 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, 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, the 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 on using Durfenta

Activities during the use of 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 baths, or lamps.Do not take the sun or prolonged 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 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 patches of Durfenta 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, check the patch. If it no longer adheres well or has fallen off, replace the patch (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 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, phone 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 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, 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 to minimize unpleasant withdrawal symptoms. See also section 2. “Withdrawal symptoms when stopping the use of Durfenta”.
• If you stop using the patches, do not use them again without asking your doctor first. You may need a different dose to resume treatment.

If you have any doubts about using this product, 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 may compromise life or even be fatal, especially in people who have not used strong opioid analgesics (such as Durfenta or morphine) before. (Rare, may affect up to 1 in 100 people).

• Sharp 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. (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 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, 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)
• 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 discomfort
• 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 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.

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 there, sleep disturbances, nightmares)
• You may become dependent on Durfenta (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.

The repeated use of patches may make the medicine less effective (you become accustomed to it or become more sensitive to pain) or may cause dependence.

If you switch from another analgesic to Durfenta or if you stop using Durfenta 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 Durfenta for an extended period during pregnancy have also been reported.

Reporting of adverse effects:

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:https://www.notificaram.es. By reporting adverse 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 protected location, inaccessible to other people. This medication may cause severe harm or even be fatal to individuals who use it accidentally or intentionally, when not prescribed.

How Long to Store Durfenta

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

Do not store at a temperature above 25 °C.

Store in the original package to protect it from moisture.

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 disposed of through drains or 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 containers and medications you no longer need. This way, you will help protect the environment.

Composition of Durfenta

• The active ingredient is fentanil.

Each transdermal patch of Durfenta 12 micrograms/hour contains 1.375 mg of fentanil on a surface of 5 cm2, releasing 12.5 micrograms of fentanil per hour.

Each transdermal patch of Durfenta 25 micrograms/hour contains 2.75 mg of fentanil on a surface of 10 cm2, releasing 25 micrograms of fentanil per hour.

Each transdermal patch of Durfenta 50 micrograms/hour contains 5.5 mg of fentanil on a surface of 20 cm2, releasing 50 micrograms of fentanil per hour.

Each transdermal patch of Durfenta 75 micrograms/hour contains 8.25 mg of fentanil on a surface of 30 cm2, releasing 75 micrograms of fentanil per hour.

Each transdermal patch of Durfenta 100 micrograms/hour contains 11.0 mg of fentanil on a surface of 40 cm2, releasing 100 micrograms of fentanil per hour.

• The other components are:

Backing film:

Polyethylene terephthalate film with a fluorocarbon release coating.

Support film:

Pigmented copolymer film of polyethylene terephthalate/ethylvinylacetate.

Adhesive matrix:

Dimethicone adhesive (dimethicone, silicate resin).

Dimethicone.

Rate-controlling membrane:

Copolymer film of ethylvinylacetate.

Adhesive to skin:

Dimethicone adhesive (dimethicone, silicate resin).

Dimethicone.

Protective film:

Polyethylene terephthalate film with a fluorocarbon release coating.

Printing inks:

Beige and orange or red or green or blue or grey ink.

Appearance of the product and contents of the package

The transdermal patch Durfenta is rectangularwith rounded corners, printed on its backing with:

• Diagonal beige stripes with "Fentanyl" repetitive in orange font alternating with diagonal orange stripes with "12μg/h" repetitive in beige font.

• Diagonal beige stripes with "Fentanyl" repetitive in red font alternating with diagonal red stripes with "25μg/h" repetitive in beige font.

• Diagonal beige stripes with "Fentanyl" repetitive in green font alternating with diagonal green stripes with "50μg/h" repetitive in beige font.

• Diagonal beige stripes with "Fentanyl" repetitive in blue font alternating with diagonal blue stripes with "75μg/h" repetitive in beige font.

• Diagonal beige stripes with "Fentanyl" repetitive in grey font alternating with diagonal grey stripes with "100μg/h" repetitive in beige font.

Each patch has a posterior adhesive for attaching to the skin. The patch is covered by two large transparent protective films that are removed before application.

Durfenta is available in packages of 3, 4, 5, 8, 9, 10, 16, 19 or 20 transdermal patches.

Only some package sizes may be marketed.

Marketing authorization holder and responsible manufacturer:

Lavipharm S.A.

Agias Marinas Street

GR-19002 Peania, Attica,

Greece

For further information about this medicine, please contact the local representative of the marketing authorization holder:

Especialidades Farmacéuticas Centrum, S.A.,

Sagitario Street, 14, 03006 Alicante, Spain

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

AustriaLafene 12/25/50/75/100 Mikrogramm/h transdermal Pflaster

SpainDurfenta 12/25/50/75/100 microgramos/hora parche transdérmico EFG

IrelandFentadur 12/25/50/75/100 microgram/hour transdermal patch

DenmarkLafene

LuxembourgRecorfen 25/50/75/100 μg/h transdermal Pflaster // dispositif transdermique

PortugalFentaniloLavipharm12,25, 50, 75, 100 μg/h sistema transdermico

RomaniaFentanylLavipharm12, 25, 50, 75, 100 micrograme/h plasture transdermic

Last review date of this leaflet:March 2024

For detailed and updated information about this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/