Package Insert: Information for the User

Abattra 12microgram/hour transdermal patch EFG

Fentanilo

Read this package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you (or your child), and you should not give it to others even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package insert. See section 4.

1.What is Abattra and how it is used

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

3.How to use Abattra

4.Adverse effects

5.Storage of Abattra

6. Contents of the package and additional information

This medication is calledAbattra.

The patches help to relieve very strong and persistent pain:

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

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

Do not use Abattra:

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

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

Warnings and precautions

If the patch sticks to another person

The patch should only be used on the skin of the person to whom the doctor has prescribed it. There have been some reported cases where the patch stuck accidentally to a person through close physical contact or sharing the same bed as the person wearing the patches. If the patch sticks accidentally to another person (especially a child), the medication from the patch can pass through the skin of the other person and may cause serious adverse effects, such as difficulty breathing with slow or weak breathing that can be fatal. In the event that the patch sticks to the skin of another person, it should be removed immediately and medical attention should be sought.

Be especially careful withAbattra

Consult your doctor or pharmacist beforeusing this medication if you are in any of the following circumstances. Your doctor will have to monitor you more closely:

• if you have ever had respiratory or breathing problems;
• if you have ever had heart, liver, or kidney problems, or low blood pressure;
• if you have ever had a brain tumor;
• if you have ever had persistent headaches or a head trauma;
• if you are an elderly person, as you may be more sensitive to the effects of this medication;
• if you have a condition called "myasthenia gravis," in which your muscles become weak and easily fatigued.

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

While using the patch, report to your doctor if you have breathing problems while sleeping.Opioids likeAbattracan cause sleep-related breathing disorders such as sleep apnea (pauses in breathing while sleeping) and sleep-related hypoxemia (low oxygen levels in the blood). Talk to your doctor if you, your partner, or caregiver observe any of the following symptoms:

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

Your doctor may decide to modify the dosage.

While using the patch, report to your doctor if you notice a change in the pain you feel.If you 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 you come into contact with your body that should not cause pain.

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

Adverse effects andAbattra

• This medicationmay make you feel exceptionally sleepy and make your breathing slower or weaker. In rare cases, these breathing problems can be life-threatening or even fatal, especially in people who have not used strong prescribed opioids before (such asAbattraor morphine). If you, or your partner or caregiver, observe that the person wearing the patch is unusually sleepy, breathing slowly or weakly:

- Remove the patch.

- Call a doctor or go to the nearest hospital immediately.

- Have the person move and talk as much as possible.

• If you have a fever while usingAbattra, talk to your doctor. This can increase the amount of medication that passes through your skin.
• This medicationmay cause constipation; talk to your doctor or pharmacist for advice on how to prevent or relieve constipation.

See section 4 for the complete list of possible adverse effects.

When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, hot tubs, or heat lamps or tanning beds. Do not take the sun or long hot baths and do not use saunas or hot tubs. If you do, it may increase the amount of medication released from the patch.

Use in athletes

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

Symptoms of withdrawal from Abattra

Do not stop using this medication abruptly. 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 medication, talk to your doctor first. Your doctor will advise you on how to do it, usually the dosage will be gradually reduced to minimize unpleasant withdrawal effects.

Long-term use and tolerance

This medication contains fentanyl, an opioid medication. Repeated use of opioid analgesics can make the medication less effective (you become accustomed to it, known as medication tolerance). It can also make you more sensitive to pain while using this medication, known as hyperalgesia. Increasing the dosage of the patches may help reduce pain for a while, but it can also be harmful. If you notice that your medication becomes less effective, talk to your doctor. Your doctor will decide whether it is better for you to increase the dosage or gradually reduce the use of this medication.

Dependence and addiction

The repeated use of this medication can also cause dependence, abuse, and addiction, which can lead to a potentially fatal overdose. The risk of these side effects may increase with a higher dosage and longer duration of use. Dependence or addiction can make you feel like you no longer have control over the amount of medication you need to use or how often you need to use it. You may feel like you need to continue using your medication, even if it no longer helps to relieve your pain.

The risk of becoming dependent or addicted to Abattra varies from person to person. You may be at 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, prescribed medications, or illegal drugs ("addiction");
• You are a smoker;
• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for another mental illness.

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

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

Other medications and Abattra

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

This includes over-the-counter medications and herbal remedies. You should also inform your pharmacist that you are usingAbattraif you buy any medication at the pharmacy.

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

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

• Other pain medications, such as other opioid analgesics (for example, buprenorphine, nalbuphine, or pentazocine) and some analgesics for neuropathic pain (gabapentin and pregabalin).
• Sleeping medications (such as temazepam, zaleplon, or zolpidem).
• Medications to help you relax (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medications for mental disorders (antipsychotics, such as aripiprazole, haloperidol, olanzapine, risperidone, or phenothiazines).
• Medications to relax muscles (such as cyclobenzaprine or diazepam).
• Some medications used to treat depression called SSRIs or SNRIs (such as citalopram, duloxetine, escitalopram, fluoxetine, fluvoxamine, paroxetine, sertraline, or venlafaxine) - more information is below.
• Some medications used to treat depression or Parkinson's disease called MAOIs (such as isocarboxazid, phenelzine, selegiline, or tranylcypromine). Do not useAbattrain the 14 days following the interruption of these medications - more information is below.
• Some antihistamines, especially those that cause drowsiness (such as chlorpheniramine, clemastine, ciproheptadine, diphenhydramine, or hydroxyzine).
• Some antibiotics used to treat infections (such as erythromycin or clarithromycin).
• Medications used to treat fungal infections (such as itraconazole, ketoconazole, fluconazole, or voriconazole).
• Medications used to treat HIV infection (such as ritonavir).
• Medications used to treat irregular heartbeats (such as amiodarone, diltiazem, or verapamil).
• Medications used to treat tuberculosis (such as rifampicin).
• Some medications used to treat epilepsy (such as carbamazepine, phenobarbital, or phenytoin).
• Some medications used to treat nausea or dizziness (such as phenothiazines).
• Some medications used to treat heartburn or ulcers (such as cimetidine).
• Some medications used to treat angina (chest pain) or high blood pressure (such as nicardipine).
• Some medications used to treat blood cancer (such as idelalisib).

Use of Abattra with antidepressants

The risk of adverse effects increases if you are taking certain antidepressants. Abattramay interact with these medications and you may experience changes in 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, hyperactive 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 to detect such side effects, especially when starting treatment or when changing the dosage of your medication.

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

The use of Abattra and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be potentially fatal. Due to this, concurrent use should only be considered when other treatment options are not possible.

However, if your doctor prescribes Abattra along with sedatives, your doctor should limit the dosage and duration of concurrent treatment.

Inform your doctor about all sedatives you are taking and follow your doctor's recommendations closely. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Communicate with your doctor when you experience these symptoms.

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

Surgery

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using this medication.

Abattrashould not be used during pregnancy, unless you have spoken to your doctor.

Abattrashould not be used during delivery, as the medication may affect the newborn's breathing.

Prolonged use ofAbattraduring pregnancy may cause withdrawal symptoms (such as crying, restlessness, convulsions, poor feeding, and diarrhea) in your newborn, which can be potentially fatal if not recognized and treated. Talk to your doctor immediately if you think your newborn may have withdrawal symptoms.

Do not useAbattraif you are breastfeeding. Do not breastfeed for 3 days after removing the Abattrapatch. This is because the medication may pass into breast milk.

Driving and operating machinery

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

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

Abattracontains soy oil

This medication contains soy oil. In rare cases, soy oil may cause allergic reactions.

Do not use it if you are allergic to peanuts or soy.

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

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

Your doctor will decide what 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 the patches

• Each patch contains a sufficient amount of medicationfor 3 days (72 hours).
• You should change the patch every 3 days, unless your doctor has told you otherwise.
• Always remove the used patchbeforeapplying a new one.
• Change the patch alwaysat the same timeof the day every 3 days (72 hours).
• If you are using more than one patch, change them all at the same time.
• Record the day of the week, date and time each time a patch is applied to remember when to change it.
• The following table shows when to change the patch:

Where to apply the patch

Adults

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

Children

• Apply the patch always to the upper back so that your child has difficulty reaching it or removing it.
• Check occasionally that the patch is still adhered to the skin.
• It is essential that the child does not remove the patch and put it in their mouth, as this could put their life in danger or be fatal.
• Keep your child under close observation for 48 hours after:

• Applying the first patch.
• Applying a patch with a higher dose.

• The patch may take some time to reach its maximum effect. Therefore, your child may need other painkillers until the patch is effective. Your doctor will explain this.

Adults and children:

Do not apply the patch to

• The same site twice in a row.
• Areas that move a lot (joints), irritated skin or wounds.
• Areas of skin with a lot of hair. If there is hair, do not shave it (the skin irritates with shaving). Instead, cut it as close to the skin as possible.

How to apply the patch

Step 1: Prepare the skin

• Before applying the patch, check that the skin is completely dry, clean and fresh.
• If you need to wash the skin, use only cold water.
• Do not use soap or other cleaners, creams, moisturizers, oils or talc before applying the patch.
• Do not apply the patch immediately after a hot bath or shower.

Step 2: Open the package

• Each patch is sealed in its own package.
• Open the package by tearing or cutting along the perforations marked with arrows.
• Tear gently or cut completely along the sealed edge (if using scissors, make the cut next to the sealed edge to avoid damaging the patch).

• Hold the two parts of the open package and pull to separate them.
• Remove the patch and use it immediately.
• Save the empty package to dispose of the used patch later.
• Use each patch only once.
• Do not remove the patch from its package until you are ready to use it.
• Check that the patch is not damaged.
• Do not use the patch if it is divided or cut or has any damage.
• Never divide or cut the patch.

Step 3: Peel and press

• Make sure the patch will be covered by a loose garment and do not stick it under elastic or tight clothing.
• Peel carefully one half of the plastic protective film starting from the center of the patch. Be careful not to touch the adhesive part of the patch.
• Press this adhesive part of the patch onto the skin.
• Remove the other half of the protective film and press the entire patch onto the skin with the palm of your hand.
• Hold for at least 30 seconds. Make sure the patch is well adhered, especially around the edges.

Step 4: Dispose of the patch

• As soon as you remove the patch, fold it in half, so that the adhesive side sticks to itself.
• Put it back in the original package and dispose of it according to your pharmacist's instructions.
• Keep used patches out of sight and reach of children; although used, patches contain medication that can harm children and even be fatal.

Step 5: Wash your hands

• Wash your hands only with water after handling the patches.

More information about using Abattra

Activities during the use of patches

• The patches are water-resistant.
• You can take a shower or bath with the patch on, but do not rub it.
• If your doctor agrees, you can exercise or engage in sports with the patch on.
• You can also swim with the patch on, but:

• Do not use hot tubs.
• Do not cover the patch with elastic or tight clothing.

• When wearing the patch, do not expose it to direct heat, such as heating pads, electric blankets, hot water bottles, hot tubs or lamps, or sunbathing. Do not take long hot baths or use saunas. If you do, you may increase the amount of medication released from the patch.

How long do the patches take to act?

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

How long will you have 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 no longer adheres well or has fallen off, replace the patch (see also the section If the patch falls off).
• If your pain worsens over time while using the patches, your doctor may try patches with a higher dose or prescribe additional painkillers (or both).
• If increasing the patch dose does not help, your doctor may decide to stop using the patches.

If you use too many patches or a patch with the wrong dose

If you have applied too many patches or a patch with the wrong dose, remove them and contact your doctor immediately, go to the hospital or call the Toxicology Information Service, tel: 91 562 04 20 indicating the medication and the amount applied.

Symptoms of overdose include breathing problems or weak breathing, fatigue, extreme drowsiness, inability to think clearly or walk or talk normally, and dizziness or confusion. An overdose can also cause a brain disorder known as toxic leukoencephalopathy.

If you forget to change the patch

• If you forget to change the patch, change it as soon as you remember and note the day and time. Change the patch again after3 days(72 hours), as usual.
• If you are delayed, you should contact your doctor because you may need some additional painkillers, butdo notapply additional patches.

If the patch falls off

• If the patch falls off before it should be changed, apply a new one immediately and note the day and time. Choose a new area of skin:

• In the trunk or arm.
• On the upper back of your child.

• Inform your doctor about this and leave the patch on for another3 days (72 hours)or for the time your doctor tells you, before changing the patch in the usual way.
• If the patches tend to fall off, consult your doctor, pharmacist or nurse.

If you want to stop using the patches

• Do not stop using this medication abruptly. If you want to stop using this medication, talk to your doctor first. Your doctor will tell you how to do it, usually the dose will be gradually reduced so that the unpleasant effects of withdrawal are minimal. See also section 2, “Withdrawal symptoms when stopping the use of Abattra”.
• If you stop using the patches, do not use 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.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

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

• Unusual drowsiness, slower or weaker breathing than expected.

Follow the previous recommendations and have the person wearing the patch move and speak as much as possible. In very rare cases, these breathing difficulties can compromise life or even be fatal, especially in people who have not used strong opioid analgesics (such as Abattra or morphine) before. (Rare, may affect up to 1 in 100 patients).

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

They may all be signs of a severe allergic reaction. (Frequency cannot be estimated from available data).

• Seizures (convulsions). (Rare, may affect up to 1 in 100 patients).

• Decreased level of consciousness or loss of consciousness. (Rare, 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 sleepy (drowsiness).
• 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, or hearing things that are not there (hallucinations).
• Trembling or muscle spasms.
• Strange sensation in the skin, such as tingling or prickling (paresthesia).
• Sensation of everything spinning (dizziness).
• Irregular or rapid heartbeats (palpitations, tachycardia).
• Increased blood pressure.
• Sensation of lack of air (dyspnea).
• Diarrhea.
• Dry mouth.
• Stomach pain or indigestion.
• Excessive sweating.
• Itching, rash, or redness of the skin.
• Difficulty urinating or emptying the bladder completely.
• Intense fatigue, weakness, or general discomfort.
• Sensation of cold.
• Swelling of the hands, ankles, or feet (peripheral edema).

Rare (may affect up to 1 in 100 people)

• Feeling agitated or disoriented.

• Sensation of being extremely happy (euphoria).
• Decreased sensation or sensitivity, especially in the skin (hypoesthesia).
• Memory loss.
• Blurred vision.
• Slow heart rate (bradycardia) or low blood pressure.
• Blue discoloration of the skin caused by decreased oxygen in the blood (cyanosis).
• Loss of intestinal contractions (ileus).
• Skin rash with itching (eczema), allergic reaction, or other skin disorders where the patch is applied.
• Flu-like illness.
• Sensation of change in body temperature.
• Fever.
• Muscle contraction.
• Difficulty obtaining or maintaining an erection (impotence) or problems with sexual relations.
• Difficulty swallowing.

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

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

Unknown (frequency cannot be estimated from available data)

• Male sex hormone deficiency (androgen deficiency).
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not there, sleep disturbances, nightmares).
• You may become dependent on Abattra (see section 2).

You may notice rashes, redness, or a mild itching sensation on the skin where the patch is applied. It is usually mild and disappears after removing the patch. If not, or if the patch irritates your skin a lot, inform your doctor.

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

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

Cases of newborn babies experiencing withdrawal symptoms after their mothers used Abattra for an extended period during pregnancy have also been reported.

Reporting side effects

If you experience any type of side effect, consult your doctor, pharmacist, even if it is a side effect that does not appear in this leaflet. You can also report them directly through theSistema Español de Farmacovigilancia de Medicamentos de Uso Humano:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Where to Store the Patches

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

This medication does not require special storage conditions.

Store this medication in a protected and secure location where other people cannot access it.This medication can be very harmful and cause death to people who may accidentally or intentionally use it when not prescribed.

How Long Can You Store Abattra

Do not use this medication after the expiration date that appears on the box and on the package after CAD. 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 in 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 safely disposed of by placing them in the original package and keeping them out of sight and reach of other people, especially children, until they are safely disposed of. Unused patches should be returned to the pharmacy.

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

Composition of Abattra

The active principle is fentanil.

Abattra 12 µg/h: Each transdermal patch contains 2.55 mg of fentanil on a surface of 4.25 cm 2 and releases 12.5 micrograms of fentanil per hour.

The other components are:

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

Removable coating : Polyethylene terephthalate, polyester, siliconized

Printed support film : Polyethylene terephthalate sheet, printing ink

Appearance of the product and contents of the packaging

Transdermal patch.

Opaque, colorless, rectangular patch with rounded corners and printed on aluminum backing: “Fentanyl 12 µg/h “in sealed individual packets.

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

Only some packaging sizes may be marketed.

Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850 - Torrejón de Ardoz

Spain

Responsible for manufacturing:

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 medicine is authorized in the member states of the European Economic Area and in the United Kingdom (Northern Ireland) with the following names:

Germany: Fentavera 12/25/50/75/100 Mikrogramm/Stunde transdermales Pflaster

Spain: Abattra 12/25/50/75/100 microgramos/hora parche transdérmico EFG

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

Last review date of this leaflet: April 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/