ABATTRA 12 MICROGRAMS/HOUR TRANSDERMAL PATCHES

Introduction

Package Leaflet: Information for the User

Abattra 12micrograms/hour transdermal patch EFG

Fentanyl

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 and other information:

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

1. What is Abattra and what is it used for

This medicine is called Abattra.

The patches help to relieve very strong and long-lasting pain:

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

Abattra 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 Abattra

Do not use Abattra:

• if you are allergic to fentanyl, soya, peanut, or any of the other ingredients of this medicine (listed in section 6);
• if you have short-term pain, 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 this medicine.

Warnings and precautions

If the patch sticksto another person

The patch should only be used on the skin of the person it has been prescribed for. There have been reports of cases where the patch has stuck accidentally to another person through close physical contact or sharing the same bed as the patch wearer. If the patch sticks accidentally to another person (especially a child), the medicine in the patch can pass through the other person's skin and can cause serious side effects, such as breathing difficulties, with slow or weak breathing that can be fatal. If the patch sticks to another person's skin, it should be removed immediately and medical attention should be sought.

Be especially careful withAbattra

Consult your doctor or pharmacist beforeusing this medicine if 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 an elderly person, as you may be more sensitive to the effects of this medicine.
• If you have a condition called "myasthenia gravis", where your 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 Abattra.

While using the patch, tell your doctor if you have breathing problems while you are asleep.Opioids like Abattra can cause sleep-related breathing disorders such as sleep apnea (pauses in breathing while asleep) 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 asleep;
• waking up at night due to lack of breath;
• difficulty staying asleep;
• excessive sleepiness during the day.

Your doctor may decide to change the dose.

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

• that the patch no longer relieves your pain;
• an increase in pain;
• a change in the way you feel pain (for example, you feel pain in a different part of your body);
• pain when you touch your body that should not hurt.

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

Side effects andAbattra

• This medicine 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 Abattra 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 Abattra, talk to your doctor. This can increase the amount of medicine that passes through your skin.
  • This medicine can cause constipation; talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

You can find the complete list of possible side effects in section 4.

While 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 prolonged hot baths, and do not use saunas or hot tubs. If you do, you may increase the amount of medicine released from the patch.

Use in athletes

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

Withdrawal symptoms when stopping Abattra

Do not stop using this medicine suddenly. You may experience withdrawal symptoms such as restlessness, difficulty sleeping, irritability, agitation, anxiety, feeling your heartbeat (palpitations), increased blood pressure, feeling sick, diarrhea, loss of appetite, tremors, chills, or sweating. 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 minimal.

Long-term use and tolerance

This medicine contains fentanyl, an opioid medicine. Repeated use of opioid painkillers can make the medicine less effective (you get used to it, which is known as tolerance to the medicine). You may also become more sensitive to pain while using this medicine, which is known as hyperalgesia. Increasing the dose of the patches may help to reduce the pain further for a while, but it can also be harmful. If you notice that your medicine is becoming less effective, talk to your doctor. Your doctor will decide whether it is better for you to increase the dose or gradually reduce the use of this medicine.

Dependence and addiction

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

Repeated use of this medicine can also lead to dependence, abuse, and addiction, which can result in a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer use. Dependence or addiction can make you feel that you no longer have control over the amount of medicine you need to use or how often you need to use it. You may feel that you need to continue using your medicine, even when it no longer helps to relieve your pain.

The risk of becoming dependent or addicted varies from person to person. You may have a higher risk of becoming dependent or addicted to Abattra if:

• You or someone in your family has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs ("addiction").
• You are a smoker.
• You have ever had problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for another mental illness.

If you notice any of the following signs while using Abattra, it could be a sign that you have become dependent or addicted:

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

If you notice any of these signs, talk to your doctor to discuss the best course of treatment for you, including when it is appropriate to stop and how to stop safely.

Other medicines and Abattra

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

This includes medicines obtained without a prescription and herbal medicines. You should also tell your pharmacist that you are using Abattra if you buy any medicines from the pharmacy.

Your doctor will know which medicines can be taken safely with Abattra. 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 Abattra 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 disorders (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 should not use Abattra in the 14 days after stopping these medicines - see below for more information.
• Certain antihistamines, especially those that cause drowsiness (such as chlorphenamine, 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 infection (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 Abattra with antidepressants

The risk of side effects increases if you are taking medicines such as certain antidepressants. Abattra 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 can be signs of serotonin syndrome). If used together, your doctor may want to monitor you closely to detect such side effects, especially when starting treatment or when changing the dose of your medicine.

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

Using Abattra 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 potentially fatal. Because of this, using them together should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking and follow your doctor's instructions closely. It may be useful to inform friends or family members so they are aware of the signs and symptoms mentioned above. Contact your doctor when you experience these symptoms.

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

Operations

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

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.

Abattra should not be used during pregnancy, unless you have discussed it with your doctor.

Abattra should not be used during labor, as the medicine can affect the baby's breathing.

Long-term use of Abattra during pregnancy can cause withdrawal symptoms in your newborn baby, such as high-pitched 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 Abattra if you are breastfeeding. You should not breastfeed for 3 days after removing the Abattra patch. This is because the medicine can pass into breast milk.

Driving and using machines

Abattra can affect your ability to drive or 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 unsure whether it is safe for you to drive while using this medicine.

Abattracontains soya oil

This medicine contains soya oil. In rare cases, soya oil can cause allergic reactions.

Do not use this medicine if you are allergic to peanut or soya.

3. How to use Abattra

Follow your doctor's instructions for taking this medication exactly. If you are unsure, consult your doctor or pharmacist again.

Before starting treatment and frequently during treatment, your doctor will also explain what you can expect from using Abattra, when and for how long you should use it, when to contact your doctor, and when to stop it (see also section 2, Symptoms of withdrawal from stopping Abattra).

Your doctor will decide which concentration of this medication is most suitable for you, taking into account the intensity of your pain, your general condition, and the type of pain treatment you have received so far.

How to apply and change patches

• Each patch contains enough medication for 3 days (72 hours).
• You should change the patch every three days, unless your doctor has told you otherwise.
• Always remove the used patch beforeapplying a new one.
• Change the patch always 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.
• Write down 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 attached 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 pain relievers 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 (the 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.
• Open the envelope by tearing or cutting it along the notches, marked with arrows.
• Gently tear or completely cut the edge of the envelope (if using scissors, make the cut along the sealed edge to avoid damaging the patch).

• Hold the two parts of the open envelope and pull to separate them.
• 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 not stuck 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 well in half, so that the adhesive side sticks to itself.
• Put it back in the original envelope and throw it away following the instructions of your pharmacist.
• 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 Abattra

Daily activities during patch use

• The 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 fabrics.

• 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 beds. Do not sunbathe or take 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 work?

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

How long will you need to use the patches?

• This medication is 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 is no longer sticking 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 pain relievers (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 you can also call the Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount applied.

Signs of overdose include breathing problems or weak breathing, fatigue, 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 write down the day and time. Change the patch again after 3 days(72 hours), as usual.
• If you are significantly late, you should contact your doctor because you may need some additional pain relievers, 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 write down the day and time. Choose a new skin area:

• On the torso or arm.
• On the upper back of your child.

• Tell your doctor about this and leave the patch on for another 3 days (72 hours)or for the time your doctor indicates, 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 so that the unpleasant effects of withdrawal are minimal. See also section 2, “Withdrawal symptoms when stopping Abattra”.
• If you stop using the patches, do not start using them again without consulting your doctor first. You may need a different dose when you resume treatment.

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

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone gets 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 used strong opioid pain relievers before (such as Abattra 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 people)

• Nausea, vomiting, constipation.
• Feeling drowsy (drowsiness).
• Feeling dizzy.
• Headache.

Common (may affect up to 1 in 10 people)

• Allergic reaction.
• Lack of appetite.
• Difficulty sleeping.
• Depression.
• Feeling anxious or confused.
• Seeing, feeling, hearing, or smelling things that are not there (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 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.
• 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 people)

• 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).
• Lack 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 side effects (may affect up to 1 in 1,000 people)

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

Unknown frequency (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 really there, sleep disturbances, nightmares).
• You may become dependent on Abattra (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, tell your doctor.

Repeated use of patches can cause the medication to lose effectiveness (you get used to it or become more sensitive to pain) or can cause dependence.

If you switch from another pain reliever to Abattra or if you stop using Abattra abruptly, you may experience withdrawal symptoms, such as dizziness, feeling sick, diarrhea, anxiety, or tremors. Tell your doctor if you notice any of these effects.

There have also been reports of newborn babies who experienced withdrawal symptoms after their mothers used Abattra for a prolonged period during pregnancy.

Reporting side effects

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

5. Storage of Abattra

Where to store the patches

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

This medication does not require special storage conditions.

Keep this medication in a safe and secure place where others cannot access it. It can be very harmful and cause death to people who may use this medication accidentally or intentionally when it has not been prescribed for them.

How long can you store Abattra

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

How to dispose of used or unused patches

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 sticks to itself. Then, they should be thrown away safely by putting them in the original envelope and keeping them out of sight and reach of others, especially children, until they are disposed of safely. Unused patches should be returned to the pharmacy.

Medications should not be thrown down the drain or into the trash. Deposit the packaging 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 packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Abattra

The active ingredient is fentanyl.

Abattra 12 µg/h: Each transdermal patch contains 2.55 mg of fentanyl on a surface area of 4.25 cm2 and releases 12.5 micrograms of fentanyl per hour.

The other components are:

Matrix components: Aloe vera oil extract (based on soy tocopherol acetate), colophony resin, poly(2-ethylhexyl acrylate, vinyl acetate) (50:50)

Removable coating: Polyethylene terephthalate, polyester, siliconized

Printed support film: Polyethylene terephthalate laminate, printing ink

Appearance of the Product and Package Contents

Transdermal patch.

Opaque, colorless, rectangular patch with rounded corners and printed on the aluminum support: “Fentanyl 12 µg/h “in individually sealed pouches.

Abattra is available in packages of 5, 10, and 20 transdermal patches.

Only some package sizes may be marketed.

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 - Torrejón de Ardoz

Spain

Manufacturer:

Luye Pharma AGAm Windfeld, 35

Miesbach-83714

Germany

or

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/ Solana, 26

28850 – Torrejón de Ardoz, Madrid

Spain

or

Acino AG

Leopoldstraße, 115

80804 – Munich, Germany

This medicinal product is authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Germany: Fentavera 12/25/50/75/100 Mikrogramm/Stunde transdermal patch

Spain: Abattra 12/25/50/75/100 micrograms/hour transdermal patch EFG

United Kingdom (Northern Ireland): Fencino 12/25/50/75/100 micrograms/h transdermal patch

Date of the Last Revision of this Leaflet:May 2025

Detailed and updated 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/