Abattra 12 micrograms/hour transdermal patches EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Abattra 12 micrograms/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, as 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet:

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

1. What Abattra is and what it is used for

This medicine is called Abattra.

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.

Abattra contains a medicine called fentanyl. It belongs to a group of strong pain-relieving medicines known as opioids.

2. What you need to know before starting to use Abattra

Do not use Abattra:

• if you are allergic to fentanyl, soy, peanut, or any of the other components of this medicine (listed in section 6);
• if you have short-term pain, such as sudden pain or pain after surgery;
• if you have difficulty breathing with slow or weak breathing.

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

Warnings and precautions

Abattra may have life-threatening adverse effects in people who are not regularly using prescribed opioids. Abattra is a medicine that could be fatal to children, even if the patches have already been used. Please note that an adhesive patch (used or unused) may be attractive to a child, and if it adheres to the child's skin or if the child puts it in their mouth, the result could be fatal. Store this medicine in a secure and safe place, out of reach of others; 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 some reports of the patch accidentally sticking to another person through close physical contact or by 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 may pass through that person's skin and cause serious adverse effects, such as difficulty breathing, slow or weak breathing, which could be fatal. If the patch sticks to another person’s skin, remove it immediately and seek medical attention.

Take special care with Abattra

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 any of the above conditions apply to you (or if you are unsure), consult your doctor or pharmacist before using Abattra.

While using the patch, inform your doctor if you experience breathing problems during sleep. Opioids such as Abattra can cause sleep-related breathing disorders, such as sleep apnea (pauses in breathing during sleep) 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 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 (e.g., pain in another part of your body);
• Pain triggered by touch that normally wouldn’t 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 Abattra

• This medicine may make you unusually drowsy and may slow or weaken your breathing. In very rare cases, these breathing problems may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (such as Abattra 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 Abattra, speak with your doctor. This may increase the amount of medicine passing through your skin.
• This medicine may cause constipation; speak with your doctor or pharmacist for advice on how to prevent or relieve constipation.

A complete list of possible adverse effects can be found in section 4.

Abattra, like other opioids, may affect the body’s normal hormone production, such as cortisol, prolactin, or sex hormones, especially if Abattra has been used for long periods. The effects of these hormonal changes may include feeling unwell or malaise (including vomiting), loss of appetite, fatigue, weakness, dizziness, low blood pressure, infertility, or reduced sex drive. In addition, female patients may experience changes in their menstrual cycle, while male patients may experience impotence or breast enlargement. If you notice any of these signs, consult your doctor.

While wearing the patch, do not expose it to direct heat sources such as heating pads, electric blankets, hot water bottles, heated water beds, heat lamps, or tanning lamps. Avoid prolonged sun exposure, hot baths, saunas, or hot tubs. Doing so could increase the amount of medicine released from the patch.

Use in athletes

Athletes are advised 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 abruptly. Withdrawal symptoms may occur, such as restlessness, difficulty sleeping, irritability, agitation, anxiety, awareness of heartbeat (palpitations), increased blood pressure, nausea or vomiting, diarrhea, loss of appetite, tremors, chills, or sweating. If you wish to stop using this medicine, 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 effects.

Long-term use and tolerance

This medicine contains fentanyl, an opioid medicine. Repeated use of opioid painkillers may make the medicine less effective (you become accustomed to it, known as drug tolerance). You may also become more sensitive to pain while using this medicine, known as hyperalgesia. Increasing the patch dose may help reduce pain further for a time, but it may also be harmful. If you notice your medicine becoming less effective, speak with your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce and stop using this medicine.

Dependence and addiction

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

Repeated use of this medicine may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these side effects may increase with higher doses and longer duration of use. Dependence or addiction may make you feel that you no longer have control over how much medicine you need or how often you need to use it. You may feel that you need to continue using the medicine, even when it no longer helps 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 a family member has ever abused or been dependent on alcohol, prescription medicines, or illegal drugs (“addiction”).
• You are a smoker.
• You have ever had mood disorders (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for a mental illness.

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

• You need to use the medicine for longer than prescribed by your doctor.
• You need to use more than the prescribed dose.
• You are using the medicine for reasons other than those prescribed, for example, “to stay calm” or “to help you sleep.”
• You have made repeated unsuccessful attempts to stop or control your medicine use.
• When you stop taking the medicine, you feel unwell and feel better once you take it again (“withdrawal effects”).

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

Other medicines and Abattra

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

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

Your doctor will know which medicines can be safely taken with Abattra. You may need to be monitored closely 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 Abattra you need.

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

• Other pain medicines, such as other opioid analgesics (e.g., buprenorphine, nalbuphine, or pentazocine) and some medicines for neuropathic pain (gabapentin and pregabalin).
• Medicines to help you sleep (such as temazepam, zaleplon, or zolpidem).
• Medicines to help you relax (sedatives, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medicines for mental disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medicines 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 medicines used to treat depression or Parkinson’s disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). You must not use Abattra within 14 days of stopping these medicines – more information below.
• Some antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, cyproheptadine, diphenhydramine, or hydroxyzine).
• Some 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).
• Some medicines used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Some medicines used to treat nausea or dizziness (such as phenothiazines).
• Some medicines used to treat heartburn or ulcers (such as cimetidine).
• Some medicines used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Some medicines used to treat blood cancer (such as idelalisib).

Use of Abattra with antidepressants

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

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

Concomitant use of Abattra and sedative medicines such as benzodiazepines or related drugs increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use 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.

Inform your doctor about all sedative medicines you are taking and follow your doctor’s advice closely. 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 Abattra unless you have first spoken with your doctor.

Surgery

If you are scheduled to receive anesthesia, inform your doctor or dentist that you are using Abattra.

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.

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

Abattra should not be used during childbirth, as the medicine may affect the newborn’s breathing.

Prolonged use of Abattra 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 with your doctor immediately if you think your baby may have withdrawal symptoms.

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

Driving and using machines

Abattra 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 medicine 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 medicine.

Abattra contains soybean oil

This medicine contains soybean oil. In very rare cases, soybean oil may cause allergic reactions.

It should not be used if you are allergic to peanuts or soy.

3. How to use Abattra

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

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

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

How to apply and change the patches

• Each patch contains 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.
• Note down 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 adhered 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.

• 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 full effect. Therefore, your child may need additional painkillers until the patch becomes effective. Your doctor will advise you accordingly.

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 wounded skin.
• hairy areas of skin. 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.
• Open the pouch by tearing or cutting along the notches indicated by the arrows.
• Gently tear or completely cut along the edge of the pouch (if using scissors, cut close to the sealed edge to avoid damaging the patch).

• Hold the two parts of the opened pouch and pull them apart.
• 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 apply it under elastic or tight fabric.
• Carefully peel back 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 half 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: Disposing 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 as instructed by your pharmacist.
• 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 patches.

More Information on the Use of Abattra

Daily Activities While Using Patches

• Patches are water-resistant.

• You may shower or bathe with the patch in place, but do not rub it.

• If your doctor agrees, you may exercise or engage in physical activity while wearing the patch.

• You may also swim with the patch on, 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 waterbeds, heat lamps, or tanning lamps. Avoid prolonged sun exposure, hot baths, and saunas. Doing so 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 full effect.
• Your doctor may provide 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?

• This medicine is indicated for long-term pain. Your doctor will advise you on how long you can expect to use the patches.

If Pain Worsens

• If your pain suddenly worsens after applying the latest patch, check the patch. If it is no longer adhering properly or has come off, replace the patch (see also 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, go to a hospital, or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medication and the amount 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, contact your doctor, as you may need additional pain relief, 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 on for another 3 days (72 hours) or for the time specified by your doctor before changing the patch in the usual way.

• 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 medicine abruptly. If you wish to stop using this medicine, speak with your doctor first. Your doctor will advise you on how to do this, usually by gradually reducing the dose to minimize unpleasant withdrawal symptoms. See also section 2, “Withdrawal Symptoms When Stopping Abattra”.
• If you stop using the patches, do not restart them without first consulting your doctor. You may need a different dose when resuming treatment.

If you have any further questions about the use of this medicine, 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, notice any of the following signs in the person wearing the patch, remove the patch immediately and contact a doctor or go immediately to the nearest hospital. Urgent medical treatment may be needed.

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the instructions above and try to keep the person wearing the patch active and talking as much as possible. In very rare cases, these breathing difficulties may be life-threatening or even fatal, especially in people who have not previously used strong opioid painkillers (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 may 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 adverse effects have also been reported

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

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

Common (may affect up to 1 in 10 people)

• 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 skin sensations such as tingling or prickling (paraesthesia).
• Sensation that everything is spinning (vertigo).
• Fast or irregular heartbeat (palpitations, tachycardia).
• Increased blood pressure.
• Feeling short of breath (dyspnoea).
• Diarrhoea.
• Dry mouth.
• Stomach pain or indigestion.
• Excessive sweating.
• Itching, rash or redness of the skin.
• Inability to urinate or fully empty the bladder.
• Severe tiredness, weakness or general malaise.
• Feeling cold.
• Swelling of the hands, ankles or feet (peripheral oedema).

Uncommon (may affect up to 1 in 100 people)

• Feeling restless or disoriented.

• Sensation of being extremely happy (euphoria).

• Decreased sensation or sensitivity, especially in the skin (hypoesthesia).

• Memory loss.

• Blurred vision.

• Slow heart rate (bradycardia) or low blood pressure.

• Bluish discoloration of the skin due to reduced oxygen in the blood (cyanosis).

• Loss of intestinal contractions (ileus).

• Itchy skin rash (eczema), allergic reaction or other skin disorders at the site of patch application.

• Flu-like illness.

• Sensation of body temperature change.

• Fever.

• Muscle cramps.

• Difficulty achieving or maintaining an erection (impotence) or problems with sexual performance.

• Difficulty swallowing.

Rare side effects (may affect up to 1 in 1,000 people)

• Constriction of the pupils (miosis).
• Occasional interruption of breathing (apnoea).

Not known (frequency 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 Abattra (see section 2).

You may experience skin rashes, redness, or mild itching at the site where the patch is applied. These are usually mild and disappear after removing the patch. If they do not, 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 Abattra or if you stop using Abattra suddenly, you may experience withdrawal symptoms such as dizziness, feeling unwell, diarrhoea, 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 Abattra for a prolonged period during pregnancy.

Reporting of adverse effects

If you experience any adverse effect, consult your doctor or pharmacist, even if it is not listed in this leaflet. You can 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 Abattra

Where to store the patches

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

This medicine does not require any special storage conditions.

Store this medicine in a safe and secure place, where others cannot access it. It may be highly harmful and cause death in people who may accidentally or intentionally use this medicine when it has not been prescribed for them.

How long can you store Abattra

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

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

Accidental exposure of other persons, 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 back into the original sachet and kept out of sight and reach of others, especially children, until they are safely disposed of. Unused patches should be returned to the pharmacy.

Medicines must not be disposed of via wastewater or household waste. Take empty containers and unused medicines to the SIGRE Point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of containers and medicines you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abattra

The active substance is fentanyl.

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

The other components are:

Components of the matrix: Extract of Aloe vera oil (based on soybean oil, tocopheryl acetate), rosin resin, poly(2-ethylhexyl acrylate, vinyl acetate) (50:50)

Peelable backing: Polyethylene terephthalate, polyester, siliconized

Printed backing film: Polyethylene terephthalate film, printing ink

Appearance of the product and contents of the pack

Transdermal patch.

Opaque, colourless, rectangular patch with rounded corners, printed on the aluminium backing: “Fentanyl 12 µg/h” in individually sealed pouches.

Abattra is available in packs containing 5, 10 and 20 transdermal patches.

Only certain pack sizes may be marketed.

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 - Torrejón de Ardoz

Spain

Manufacturer:

Luye Pharma AG
Am 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 (EEA) under the following names:

Germany: Fentavera 12/25/50/75/100 Microgram/Hour Transdermal Patch

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

Date of the most recent revision of this leaflet: July 2025

Detailed and up-to-date 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/