FENTANYL AUROVITAS SPAIN 75 micrograms/hour TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Fentanilo Aurovitas Spain 75 micrograms/hour 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 further questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What is Fentanilo Aurovitas Spain and what is it used for
2. What you need to know before you use Fentanilo Aurovitas Spain
3. How to use Fentanilo Aurovitas Spain
4. Possible side effects
5. Storing Fentanilo Aurovitas Spain
6. Contents of the pack and other information

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

This medicine is called Fentanilo Aurovitas Spain.

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 who need continuous pain treatment.

Fentanilo Aurovitas Spain contains a medicine called fentanyl. It belongs to a group of strong pain-relieving medicines called opioids.

2. What you need to know before you use Fentanilo Aurovitas Spain

Do not use Fentanilo Aurovitas Spain:

• If you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• If you have pain that lasts only for a short time, such as sudden pain or pain after an operation.
• If you have breathing difficulties, 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 not sure, consult your doctor or pharmacist before using fentanyl.

Warnings and precautions

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

Fentanilo Aurovitas Spain is a medicine that could put the life of children at risk, even if the patches have already been used. Note that an adhesive patch (used or unused) could attract the attention of a child, and if it sticks to the child's skin or if the child puts it in their mouth, the result can be fatal.

Keep this medicine in a safe place, where other people cannot get to it, see section 5 for more information.

If the patch sticks 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 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 (especially a child), the medicine in the patch can pass through the skin of the other person and can cause serious side effects, such as breathing difficulties, with slow or weak breathing that can be life-threatening. If the patch sticks to the skin of another person, it must be removed immediately and medical help should be sought.

Be careful with Fentanilo Aurovitas Spain

Consult your doctor or pharmacist beforeusing this medicineif you are in any of the following situations. Your doctor will need to keep a closer eye on you:

• 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 condition called "myasthenia gravis", in which the muscles become weak and tire easily.

If you have any of the above conditions (or if you are not sure), consult your doctor or pharmacist before using fentanyl.

Tell your doctor if you have breathing problems while you are sleeping.

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

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

Your doctor may decide to change the dose.

Tell 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 there should be no pain.

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

Side effects and Fentanilo Aurovitas Spain

• Fentanyl can make you feel extremely sleepy and can slow down your breathing. In rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not used strong opioid painkillers before (such as fentanyl or morphine). If you, or your partner or caregiver, notice that the person wearing the patch is unusually sleepy, with slow or weak breathing:
• Remove the patch.
• Call a doctor or go to the nearest hospital immediately.
• Get the person to 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 medicine that passes through your skin.
• Fentanyl can cause constipation; talk 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 side effects.

When wearing the patch, do not expose it to direct heat, such as heat pads, electric blankets, hot water bottles, water beds, heat lamps or sunlamps. Do not take sunbaths or have long hot baths and do not use saunas or hot tubs. If you do, you 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 can make the medicine less effective (the body gets used to it, which is known as pharmacological tolerance). You may also become more sensitive to pain when using the fentanyl transdermal patch. This is known as hyperalgesia. Increasing the dose of the patches may continue to reduce the pain for a while, but it can also be harmful. If you notice that the medicine is becoming less effective, 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

Repeated use of fentanyl can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can lead to a feeling of lack of control over the amount of medicine you need to use or how often you need to use it. You may feel the need to continue using the medicine even if it no longer helps to relieve the 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 have been dependent on it, or have taken prescription medicines or illegal drugs (‘addiction’).
• You smoke.
• You have ever had mood problems (depression, anxiety or personality disorder) or have received treatment from a psychiatrist for other mental health problems.

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

• You need to use the medicine for longer than prescribed by your doctor.
• You need to use a higher dose than recommended.
• You are using the medicine for reasons other than those prescribed, for example, ‘to feel calm’ or ‘to help you sleep’.
• You have made repeated unsuccessful attempts to stop using the medicine or control your use of it.
• You feel unwell when you stop using the medicine, and you feel better once you start taking it again (‘withdrawal symptoms’).

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

Withdrawal symptoms when stopping Fentanilo Aurovitas Spain

Do not stop using this medicine suddenly. 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 medicine, talk to your doctor first. Your doctor will tell you how to do it, usually by gradually reducing the dose so that the unpleasant withdrawal effects are minimized.

Other medicines and Fentanilo Aurovitas Spain

Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. This includes medicines that you buy without a prescription and herbal medicines. You should also tell your pharmacist that you are using fentanyl if you buy any medicines from the pharmacy.

Your doctor will know which medicines can be safely taken 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 the types of medicines listed below, as this may affect the dose of fentanyl that you need.

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

• Other pain medicines, such as other opioid painkillers (e.g. buprenorphine, nalbuphine or pentazocine) and some painkillers for nerve pain (gabapentin and pregabalin).
• Medicines to help you sleep (such as temazepam, zaleplon or zolpidem).
• Medicines to help you calm down (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine or lorazepam) and medicines for mental health problems (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone or phenothiazines).
• Medicines to relax your muscles (such as cyclobenzaprine or diazepam).
• Certain medicines used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline or venlafaxine) – see below for more information.
• Certain medicines used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline or tranylcypromine). You must not use fentanilo in the 14 days after stopping these medicines – see below for more information.
• Certain antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, ciproheptadine, diphenhydramine or hydroxyzine).
• Certain antibiotics used to treat infections (such as erythromycin or clarithromycin).
• Medicines used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole or voriconazole).
• Medicines used to treat HIV infections (such as ritonavir).
• Medicines used to treat irregular heartbeats (such as amiodarone, diltiazem or verapamil).
• Medicines used to treat tuberculosis (such as rifampicin).
• Certain medicines used to treat epilepsy (such as carbamazepine, phenobarbital or phenytoin).
• Certain medicines used to treat nausea or vomiting (such as phenothiazines).
• Certain medicines used to treat heartburn or stomach ulcers (such as cimetidine).
• Certain medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Certain medicines used to treat blood cancer (such as idelalisib).

Using fentanyl with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants. Fentanyl can interact with these medicines 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, overactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting and diarrhea (these could be signs of a serotonin syndrome). If they are used together, your doctor may want to keep a close eye on you to look out for these side effects, especially when starting treatment or when changing the dose of the medicine.

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

Using fentanyl and sedative medicines such as benzodiazepines or related medicines at the same time increases the risk of drowsiness, breathing difficulties (respiratory depression), coma and can be life-threatening. For this reason, using them together should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking, and follow your doctor's dosage recommendations carefully. It may be useful 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 talked to your doctor first.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Operations

If you are going to have an operation, tell your doctor or dentist that you are using fentanyl.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice 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 medicine can affect the breathing of the newborn baby.

Long-term use of fentanyl during pregnancy may cause withdrawal symptoms in your newborn baby, such as loud crying, irritability, convulsions, poor feeding and diarrhea, which can be life-threatening if not recognized and treated. Talk to your doctor immediately if you think your baby may have withdrawal symptoms.

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

Driving and using machines

Fentanyl can affect your ability to drive and use machines or tools, as it can make you sleepy or dizzy. If this happens, do not drive or use machines or tools. Do not drive while using this medicine until you know how it affects you.

Talk to your doctor or pharmacist if you are not sure whether it is safe for you to drive while using this medicine.

3. How to use Fentanilo Aurovitas Spain

Follow your doctor's administration instructions for this medication exactly. In case of doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain what you can 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 when stopping treatment with Fentanilo Aurovitas Spain").

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 until now.

How to apply and change patches

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

Where to apply the patch

Adults

• Apply the patch to a flat area of the torso 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 occasionally to ensure 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 be life-threatening or 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 to you.

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 skin with wounds.
• Areas of skin with a lot of hair. If there is hair, do not shave it (skin becomes irritated 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 talcum powder before applying the patch.
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Open the envelope

• Each patch is sealed in its own envelope.
• The fentanyl patch should be removed from the protective pouch by folding the notch first (located near the tip of the arrow on the pouch label) and then carefully tearing the pouch material. If scissors are used to open the pouch, cut near the sealed edge to avoid damaging the patch inside the pouch.
• Remove the patch and use it immediately.
• Save the empty envelope to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from its envelope 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 if it has any damage.
• 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 one half of the shiny plastic protective layer, starting from the center of the patch. Try not to touch the adhesive part of the patch.
• Press this adhesive part of the patch onto the skin.
• Remove the other part of the protective layer and press the entire patch onto the skin with the palm of your hand.
• Hold it pressed for at least 30 seconds. Make sure the patch is well adhered, especially around the edges.

Step 4: Dispose of the patch

• As soon as you remove the patch, fold it in half, so that the adhesive side sticks to itself.
• Put it back in the original envelope and throw it away following your pharmacist's instructions.
• Keep used patches out of sight and reach of children; although they are used, 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 patches.

More information on using Fentanilo Aurovitas Spain

Daily activities during patch use

• Patches are water-resistant.
• You can shower or bathe with the patch on, but do not rub it.
• If your doctor agrees, you can exercise or play sports with the patch on.
• You can also swim with the patch on, but:
• Do not use hot tubs or whirlpools.
• Do not cover the patch with tight or elastic clothing.
• When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, waterbeds, or heat lamps or tanning lamps. Do not sunbathe or take long hot baths and do not use saunas. If you do, you could increase the amount of medication released from the patch.

How long do patches take to work?

• 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 may be able to stop taking other painkillers. However, your doctor may prescribe additional painkillers occasionally.

How long will you need to use the patches?

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

If your pain worsens

• If your pain worsens suddenly after applying the last patch, check the patch. If it is no longer adhering well or has come off, you should 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 and contact your doctor immediately or go to a hospital.

You can also call the Toxicology Information Service, phone 91 562 04 20, indicating the medication and the amount taken or applied.

Signs of overdose include breathing problems or weak breathing, tiredness, extreme drowsiness, inability to think clearly or walk or talk normally, and dizziness, 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 make a note of the day and time. Change the patch again after 3 days (72 hours), as usual.
• If you are significantly delayed, you should talk to your doctor, as you may need additional painkillers, but do notapply additional patches.

If the patch comes off

• If the patch falls off before it is due to be changed, apply a new one immediately and make a note of the day and time. Choose a new skin area:
• On the torso or arm.
• On the upper back of your child.
• Inform your doctor and leave the patch on for another 3 days (72 hours)or for the time indicated by your doctor, before changing the patch in the usual way.
• If 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 so that the unpleasant withdrawal effects are minimal. See also section 2, "Symptoms of withdrawal when stopping Fentanilo Aurovitas Spain".

• If you stop using the patches, do not start using them again without asking your doctor first. You may need a different dose when you restart treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

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

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the above recommendations and make the person wearing the patch move and talk 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 can be signs of a severe 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 side effects have also been reported

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

• Nausea, vomiting, constipation.
• Feeling drowsy (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).
• Tremors or muscle spasms.
• Strange sensation on the skin, such as tingling or prickling (paresthesia).
• Feeling that everything is spinning (vertigo).
• Fast or irregular heartbeats (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.
• Difficulty urinating or emptying the bladder completely.
• Extreme fatigue, 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 agitated 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 color of the skin due to 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.
• Feeling of changed body temperature.
• Fever.
• Muscle contraction.
• Difficulty getting or maintaining an erection (impotence) or problems having sex.
• Difficulty swallowing.

Rare (may affect up to 1 in 1000 patients)

• Pupil contraction (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 agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not really there, sleep disturbances, nightmares).
• You may become dependent on fentanyl (see section 2).

You may notice rashes, redness, or mild itching of the skin at the patch application site. It is usually mild and disappears after removing the patch. If it does not, or if the patch irritates your skin a lot, inform your doctor.

Repeated use of patches can make the medication less effective (you get used to it or become more sensitive to pain) or can cause 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 sick, diarrhea, anxiety, or tremors. Inform your doctor if you notice any of these effects.

There have also been reports of newborns experiencing withdrawal symptoms after their mothers used fentanyl for a prolonged period during pregnancy.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Monitoring System: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Fentanilo Aurovitas Spain

Where to store the patches

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

How long can you store Fentanilo Aurovitas Spain

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

Storage conditions

Do not store above 30°C.

Keep this medication in a safe and protected place, inaccessible to others. This medication can cause serious harm and even be fatal if used accidentally or intentionally by people who have not been prescribed it.

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

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

Used patches should be folded firmly in half, so that the adhesive side of the patch sticks to itself. Then, they should be thrown away safely by putting them back in the original envelope and keeping them out of sight and reach of others, especially children, until they are disposed of safely.

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

6. Package Contents and Additional Information

Composition ofFentanylAurovitas Spain

• The active ingredient is fentanyl. Each patch releases 75 micrograms of fentanyl per hour. Each 22.5 cm2 patch contains 12.375 mg of fentanyl.
• The other components are:

Adhesive layer: acrylic adhesive layer.

Supporting film: polypropylene film, blue printing ink.

Release layer: silicone-coated polyethylene terephthalate film.

Appearance of the Product and Package Contents

Fentanilo Aurovitas Spain is a transparent transdermal patch with an adhesive backing for attachment to the skin. The transdermal patches have a blue print indicating the dose.

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

Only some package 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 Member States of the European Economic Area under the Following Names:

Germany Fentanyl Actavis 75 Mikrogramm/h transdermal patch

Spain Fentanilo Aurovitas Spain 75 micrograms/h transdermal patches EFG

Netherlands Fentanyl Aurobindo 75 μg/ hour, transdermal patch

Portugal Fentanilo Aurovitas

Date of the Last Revision of this Leaflet:March 2025

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