Fentanyl Aurovitas Spain 25 micrograms/h transdermal patches EFG: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Fentanil Aurovitas Spain 25 micrograms/h transdermal patches EFG

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

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
This medicine has been prescribed for you (or your child) only. Do not pass it on to others, even if they have the same symptoms as you, because it may harm them.
If you experience any side effects, talk to your doctor, pharmacist or nurse, even if they are side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Fentanil Aurovitas Spain is and what it is used for
What you need to know before you use Fentanil Aurovitas Spain
How to use Fentanil Aurovitas Spain
Possible side effects
How to store Fentanil Aurovitas Spain
Contents of the pack and other information

1. What Fentanilo Aurovitas Spain is and what it is used for

This medicine is called Fentanilo Aurovitas Spain.

The patches help relieve severe and long-lasting pain:

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

Fentanilo Aurovitas Spain contains a medicine called fentanil. It belongs to a group of strong painkillers known as opioids.

2. What you need to know before using Fentanil Aurovitas Spain

Do not use Fentanil Aurovitas Spain:

If you are allergic to fentanyl or to any of the other ingredients of this medicine (listed in section 6).
If you have pain that only lasts a short time, such as sudden pain or pain after surgery.
If you have difficulty breathing, with slow or weak breathing.

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

Warnings and precautions

Fentanyl can have life-threatening adverse effects in people who are not regularly using prescribed opioids.

Fentanil Aurovitas Spain is a medicine that could be life-threatening to children, even if the patches have already been used. Please note that a patch (used or unused) may attract a child's attention, and if it adheres to the child’s skin or if the child puts it in their mouth, the result may be fatal.

Keep this medicine in a secure and safe place, out of reach of others; see section 5 for more information.

If the patch adheres to another person

The patch must only be used on the skin of the person for whom the doctor has prescribed it. There have been cases where a patch has accidentally adhered to another family member through close physical contact or sharing the same bed with the person wearing the patch. If the patch accidentally adheres to another person (particularly a child), the medicine from the patch can pass through the other person’s skin and may cause serious adverse effects, such as difficulty breathing, with slow or weak breathing, which could be fatal. If the patch adheres to another person’s skin, remove it immediately and seek medical help.

Take special care with Fentanil Aurovitas Spain

Consult your doctor or pharmacist before using this medicine if you are in any of the following situations. Your doctor will need to monitor you more closely:

If you have ever had lung or breathing problems.
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 injury.
If you are elderly, as you may be more sensitive to the effects of this medicine.
If you have a disorder called "myasthenia gravis," in which muscles become weak and tire easily.

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

While using the patch, inform your doctor if you experience breathing problems during sleep.

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

Pauses in breathing during sleep
Waking up at night due to shortness of breath
Difficulty staying asleep
Excessive daytime sleepiness.

Your doctor may decide to adjust your dose.

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

The patch no longer relieves your pain
An increase in pain
A change in the way you feel pain (for example, pain in another part of your body)
Pain from touch on your body that should not cause pain.

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

Adverse effects and Fentanil Aurovitas Spain

Fentanyl may make you unusually drowsy and may slow or weaken your breathing. In very rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as fentanyl or morphine). If you, your partner, or caregiver notice that the person wearing the patch is unusually drowsy, with slow or weak breathing:
Remove the patch.
Call a doctor or go immediately to the nearest hospital.
Keep the person moving and talking as much as possible.
If you develop a fever while using fentanyl, speak to your doctor. This may increase the amount of medicine passing through your skin.
Fentanyl may cause constipation; speak to your doctor or pharmacist for advice on how to prevent or relieve constipation.

In section 4 you can find the complete list of possible adverse effects.

While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Do not sunbathe or take prolonged hot baths, and avoid saunas or hot hydrotherapy baths. Doing so may increase the amount of medicine released from the patch.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid painkillers may cause the medicine to become less effective (the body becomes accustomed to it, known as pharmacological tolerance). You may also become more sensitive to pain while using the fentanyl transdermal patch. This is known as hyperalgesia. Increasing the patch dose may continue to reduce pain for a time, but it may also be harmful. If you notice the medicine is losing effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce the use of the fentanyl transdermal patch.

Dependence and addiction

This medicine contains fentanyl, which is an opioid. It may cause dependence and/or addiction.

Repeated use of fentanyl may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of lack of control over the amount of medication you need to take or how often you need to take it. You may feel a need to continue using the medication even though it does not help relieve your pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent on or addicted to the fentanyl transdermal patch may be greater if:

You or any member of your family have abused alcohol or been dependent on alcohol, prescription medications, or illegal drugs ("addiction").
You smoke.
You have ever had mood disorders (depression, anxiety, or a personality disorder) or have received treatment from a psychiatrist for other mental illnesses.

If you notice any of the following symptoms while using the fentanyl transdermal patch, this could be a sign of dependence or addiction:

You need to use the medication for longer 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, for example, "to stay calm" or "to help you sleep."
You have made repeated but 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 effects").

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

Withdrawal symptoms when stopping Fentanilo Aurovitas Spain

Do not stop using this medication abruptly. Withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of your heartbeat (palpitations), increased blood pressure, feeling sick or being sick, diarrhea, loss of appetite, tremors, chills, or sweating may occur. If you wish to stop using this medication, speak to your doctor first. Your doctor will advise you on how to do this; usually, the dose will be gradually reduced so that unpleasant withdrawal effects are minimized.

Other medicines and Fentanilo Aurovitas Spain

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines. This includes medicines obtained without a prescription 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 medicines can be taken safely with fentanyl. You may need to be closely monitored if you are taking any of the types of medicines listed below or if you stop taking any of them, as this may affect the dose of fentanyl you require.

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

Other pain medications, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, 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 antidepressants known as SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) – more information below.
Some medications used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use fentanyl within 14 days after stopping these medications – more information below.
Some antihistamines, especially those causing drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, 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 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 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).

Use of fentanyl with antidepressants

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

Use with central nervous system depressants, including alcohol and certain narcotic medicines

Concomitant use of fentanyl and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and may be life-threatening. For this reason, concomitant use should only be considered when no other treatment options are possible.

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

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor's dosing recommendations. It may be helpful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

Do not drink alcohol while using fentanyl unless you have discussed it with your doctor first.

Use in athletes

Athletes are advised that this medicine contains a component that may lead to a positive analytical finding in doping controls.

Surgery

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Fentanyl should not be used during pregnancy unless you have discussed it with 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 high-pitched crying, restlessness, seizures, poor feeding, and diarrhea) in your newborn baby, which could be potentially fatal if not recognized and treated. Speak to your doctor immediately if you think your baby may be experiencing withdrawal symptoms.

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

Driving and use of machines

Fentanyl may affect your ability to drive and use machines or tools, 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 any doubts about whether it is safe for you to drive while using this medication.

3. How to use Fentanilo Aurovitas Spain

Follow exactly the administration instructions for this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from using the fentanyl transdermal patch, when and for how long you should use it, when you should contact your doctor, and when you should stop using it (see also section 2, "Withdrawal syndrome upon discontinuation of Fentanilo Aurovitas Spain treatment").

Your doctor will decide which dose of fentanyl is most suitable for you, taking into account the intensity of your pain, your general condition, and the type of pain treatment you have been receiving up to now.

How to apply and change the patches

Each patch contains enough medicine for 3 days (72 hours).
You must change the patch every three days, unless your doctor has instructed you otherwise.
Always remove the used patch before applying a new one.
Always change the patch at the same time of day every 3 days (72 hours).
If you are using more than one patch, change all of them at the same time.
Record the day of the week, date, and time each time you apply a patch, so you remember when to change it.
The table below shows when you should change the patch:

Apply the patch on Change the patch on

Monday Thursday

Tuesday Friday

Wednesday Saturday

Thursday Sunday

Friday Monday

Saturday Tuesday

Sunday Wednesday

Where to apply the patch

Adults

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

Children

Always apply the patch to the upper back so that your child has difficulty reaching or removing it.
Check from time to time that the patch remains stuck to the skin.
It is important that the child does not remove the patch and put it in their mouth, as this could endanger their life or be fatal.
Closely monitor your child for 48 hours after:
Applying the first patch.
Applying a patch with a higher dose.
The patch may take some time to reach its full effect. Therefore, your child may need additional painkillers until the patch becomes effective. Your doctor will explain this to you.

Adults and children:

Do not apply the patch to

The same site two times in a row.
Areas that move a lot (joints), or to irritated or wounded skin.
Areas of skin with excessive hair. If there is hair, do not shave it (shaving may irritate the skin). Instead, cut the hair as close to the skin as possible.

How to apply the patch

Step 1: Prepare the skin

Before applying the patch, ensure the skin is completely dry, clean, and cool.
If you need to wash the skin, use only cold water.
Do not use soap or other cleansers, creams, moisturizers, oils, or talcum powder before applying the patch.
Do not apply the patch immediately after a hot bath or shower.

Step 2: Open the pouch

Each patch is sealed in its own pouch.
To remove the fentanyl patch from the protective pouch, first bend the notch (located near the tip of the arrow on the label of the pouch) and then carefully tear the pouch material. If scissors are used to open the pouch, cut close to the sealed edge to avoid damaging the patch inside.
Remove the patch and use it immediately.
Keep the empty pouch to dispose of the used patch later.
Use each patch only once.
Do not remove the patch from its pouch until you are ready to use it.
Check that the patch is not damaged.
Do not use the patch if it is split, cut, or otherwise damaged.
Never divide or cut the patch.

Step 3: Peel and press

Make sure the patch will be covered by loose clothing and do not adhere it under tight or elastic fabric.
Carefully peel off half of the shiny plastic protective liner starting from the center of the patch. Avoid touching the adhesive side of the patch.
Press this adhesive part of the patch onto the skin.
Remove the other part of the protective liner and press the entire patch onto the skin with the palm of your hand.
Hold it in place for at least 30 seconds. Ensure the patch adheres well, especially around the edges.

Step 4: Dispose of the patch

Immediately after removing the patch, fold it in half with the adhesive side sticking to itself.
Place it back into the original pouch and dispose of it according to your pharmacist's instructions.
Keep used patches out of sight and reach of children; even when used, patches contain medication that can harm children and may even be fatal.

Step 5: Washing hands

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

More information on the use of Fentanilo Aurovitas Spain

Daily activities while using patches

The patches are water-resistant.
You may shower or bathe while wearing the patch, but do not rub it.
If your doctor agrees, you may exercise or engage in sports while wearing the patch.
You may also swim while wearing the patch, but:
Do not use hot tubs or hydrotherapy baths.
Do not cover the patch with elastic or tight fabrics.
While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, or heat or tanning lamps. Do not sunbathe for prolonged periods, take hot baths, or use saunas. Doing so could increase the amount of medication released from the patch.

How long do the patches take to work?

The first patch may take some time to reach its full effect.
Your doctor may provide you with additional painkillers during the first few days.
Afterwards, the patch should help relieve pain continuously, allowing you to stop taking other painkillers. However, your doctor may occasionally prescribe additional painkillers.

How long will you need to use the patches?

Fentanyl patches are indicated for long-term pain. Your doctor will tell you how long you can expect to use the patches.

If pain worsens

If your pain suddenly worsens after applying the last patch, check the patch. If it is no longer adhering properly or has come off, replace the patch (see also the section "If the patch comes 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 immediately and contact your doctor right away or go to a hospital.

You may also call the Toxicology Information Service at telephone number 91 562 04 20, stating the medication and the amount ingested or applied.

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

If you forget to change the patch

If you forget to change the patch, do so as soon as you remember, and note the date and time. Then resume changing the patch every 3 days (72 hours) as usual.
If you are significantly delayed, you should speak with your doctor, as you may need additional painkillers, but do not apply extra patches.

If the patch comes off

If the patch falls off before it is time to change it, apply a new one immediately and note the date and time. Choose a new skin site:
On the trunk or arm.
On the upper back of your child.
Inform your doctor about this and keep the new patch in place for another 3 days (72 hours) or for the time your doctor specifies, before changing the patch as usual.
If patches tend to come off frequently, consult your doctor, pharmacist, or nurse.

If you want to stop using the patches

Do not stop using this medication abruptly. If you wish to stop using this medication, speak with your doctor first. Your doctor will advise you on how to do so, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms. See also section 2, "Withdrawal symptoms when stopping Fentanilo Aurovitas Spain".
If you stop using the patches, do not reuse them without first consulting your doctor. You may need a different dose when restarting treatment.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse 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 immediately and contact a doctor or go to the nearest hospital straight away. Urgent medical treatment may be required.

Unusual drowsiness, slower or weaker breathing than expected.

Follow the instructions above and encourage the person wearing the patch to move and speak as much as possible. In very rare cases, these breathing difficulties can be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as fentanyl or morphine). (Uncommon, may affect up to 1 in 100 patients).

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

All of these may be signs of a serious allergic reaction. (Frequency cannot be estimated from available data).

Seizures (convulsions). (Uncommon, may affect up to 1 in 100 patients).
Decreased level of consciousness or loss of consciousness. (Uncommon, may affect up to 1 in 100 patients).

The following adverse effects have also been reported

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

Nausea, vomiting, constipation.
Feeling sleepy (somnolence).
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).
Tremors or muscle spasms.
Abnormal skin sensations such as tingling or prickling (paresthesia).
Sensation of spinning (vertigo).
Rapid or irregular heartbeat (palpitations, tachycardia).
Increased blood pressure.
Shortness of breath (dyspnea).
Diarrhea.
Dry mouth.
Stomach pain or indigestion.
Excessive sweating.
Itching, rash, or redness of the skin.
Inability to urinate or empty the bladder completely.
Severe tiredness, weakness, or general malaise.
Feeling cold.
Swelling of the hands, ankles, or feet (peripheral edema).

Uncommon (may affect up to 1 in 100 patients)

Feeling restless or disoriented.
Feeling extremely happy (euphoria).
Decreased sensation or sensitivity, especially in the skin (hypoesthesia).
Memory loss.
Blurred vision.
Slow heart rate (bradycardia) or low blood pressure.
Bluish discoloration of the skin due to reduced oxygen in the blood (cyanosis).
Loss of intestinal contractions (ileus).
Skin rash with itching (eczema), allergic reaction, or other skin disorders at the application site.
Flu-like illness.
Sensation of body temperature changes.
Fever.
Muscle cramps.
Difficulty achieving or maintaining an erection (impotence) or problems with sexual performance.
Difficulty swallowing.

Rare (may affect up to 1 in 1000 patients)

Constriction of the pupils (miosis).
Occasional interruption of breathing (apnea).

Frequency not known (cannot be estimated from available data)

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

You may experience skin rash, redness, or mild itching at the application site. This is usually mild and disappears after removing the patch. If it does not resolve, or if the patch causes significant skin irritation, inform your doctor.

Repeated use of the patches may cause the medicine to lose effectiveness (you may become tolerant to it or may become more sensitive to pain), or may lead to dependence.

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

Cases have also been reported of newborn infants experiencing withdrawal symptoms after their mothers used fentanyl for a prolonged period during pregnancy.

Reporting of adverse effects

If you experience any adverse effects, talk to your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Fentanyl Aurovitas Spain

Where to store the patches

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

How long can Fentanyl Aurovitas Spain be stored

Do not use this medicine after the expiry date stated on the carton and on the sachet. The expiry date refers to the last day of the month indicated. If the patches have expired, return them to the pharmacy.

Storage conditions

Do not store above 30°C.

Store this medicine in a safe and secure place inaccessible to others. This medicine may cause serious harm or even be fatal to individuals who accidentally or intentionally use it when it has not been prescribed for them.

How to dispose of used patches or patches you no longer need

Accidental exposure of other people, especially children, to used or unused patches may result in a fatal outcome.

Used patches should be folded firmly in half so that the adhesive side sticks to itself. They should then be safely discarded by placing them into the original sachet and kept out of sight and reach of others, especially children, until they are safely disposed of.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of medicines and their packaging that you no longer need. This helps protect the environment.

6. Contents of the pack and other information

Composition of Fentanilo Aurovitas Spain

The active substance is fentanyl. Each patch releases 25 micrograms of fentanyl per hour. Each 7.5 cm² patch contains 4.125 mg of fentanyl.
The other components are:

Adhesive layer: polyacrylate adhesive layer.

Backing layer: polypropylene film, blue printing ink.

Release liner: silicone-coated polyethylene terephthalate film.

Appearance of the product and contents of the pack

Fentanilo Aurovitas Spain is a transparent transdermal patch with an adhesive backing allowing it to be applied to the skin. The transdermal patches have a blue print indicating the dose.

Fentanilo Aurovitas Spain is available in packs containing 3, 4, 5, 8, 10, 16 or 20 transdermal patches.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Aurovitas Spain, S.A.U.

Avda. de Burgos, 16-D

28036 Madrid

Spain

Manufacturer

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

This medicinal product is authorized in the European Economic Area member states under the following names:

Germany Fentanyl Actavis 25 Mikrogramm/h transdermales Pflaster

Spain Fentanilo Aurovitas Spain 25 microgramos/h parches transdérmicos EFG

Netherlands Fentanyl Aurobindo 25 μg/uur, pleister voor transdermaal gebruik

Portugal Fentanilo Aurovitas

Date of the most recent review of this leaflet: March 2025

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