PATIENT INFORMATION LEAFLET

Doloxital 12microgram/hour transdermal patch EFG

Fentanyl

Read 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. Do not give it to others, even if they have the same symptoms as you, as it may harm them.

-If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1.What isDoloxitaland what it is used for

2.What you need to know before you start usingDoloxital

3.How to useDoloxital

4.Possible side effects

5.Storage ofDoloxital

6.Contents of the pack and additional information

This medication is calledDoloxital.

The patches help to relieve intense 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.

Doloxitalcontains a medication called fentanilo. It belongsto a group ofstrong pain-relieving medications called opioids.

Do not use Doloxital

• If you are allergic to fentanyl, peanuts, soy, 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 an operation.
• 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 Doloxital.

Warnings and precautions

If the patch sticks to another person

The patch should only be used on the skin of people to whom the doctor has prescribed it. There have been some cases where the patch accidentally stuck to someone through close physical contact or by sharing the same bed as the patch wearer. If the patch accidentally sticks to another person (especially a child), the medication from the patch may pass through the other person's skin and 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 someone else's skin, remove it immediately and seek medical attention.

Be especially careful with Doloxital

Consult your doctor or pharmacist before using this medication if you are in any of the following circumstances. Your doctor will need 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 injury.
• If you are elderly, 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 using Doloxital.

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

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

Your doctor may decide to adjust your 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 pain
• an increase in pain
• a change in the way you feel pain (for example, feeling pain in another part of your body)
• pain when you come into contact with your body that should not cause pain.

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

Adverse effects and Doloxital

• Doloxital may make you feel exceptionally sleepy and cause your breathing to be slower or weaker. In rare cases, these breathing problems can be life-threatening or fatal, especially in people who have not used strong prescription painkillers (such as Doloxital or morphine) before. If you, or your partner, or caregiver notice 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 using Doloxital, talk to your doctor. This can increase the amount of medication that passes through your skin.
• Doloxital may 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.

Long-term use and tolerance

This medication contains fentanyl, an opioid. Repeated use of opioid painkillers can make the medication less effective (your body becomes accustomed to it, known as pharmacological tolerance). It is also possible that you may become more sensitive to pain when using Doloxital. This is known as hyperalgesia. Increasing the dosage of the patches may continue to reduce pain for a while, but it can also be harmful. If you notice that the medication is losing its effectiveness, consult your doctor. Your doctor will decide whether to increase your dosage or gradually reduce your use of Doloxital.

Dependence and addiction

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

The repeated use of Doloxital can also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher with a higher dosage and longer use. Dependence or addiction can cause you to feel a lack of control over the amount of medication you should use or how often you should use it. You may feel the need to continue using the medication even if it no longer helps to relieve pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Doloxital may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medications, or illegal drugs ("addiction").
• You smoke.
• You have ever had mood problems (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

If you notice any of the following symptoms while using Doloxital, it could be a sign of dependence or addiction:

• You need to use the medication for longer than recommended by your doctor.
• You need to use a higher dosage than recommended.
• You are using the medication for reasons other than those prescribed, such as "to stay calm" or "to help you sleep."
• You have made repeated and unsuccessful attempts to stop using the medication or control your use.
• You feel unwell when you stop using the medication, and you feel better once you take it again ("withdrawal symptoms").

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

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

Withdrawal symptoms from stopping Doloxital

Do not stop using this medication abruptly. You may experience 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. If you want to stop using this medication, talk to your doctor first. Your doctor will advise you on how to do it, usually by gradually reducing the dosage to minimize unpleasant withdrawal symptoms.

Other medications and Doloxital

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 using Doloxital if you buy any medication at the pharmacy.

Your doctor will know which medications can be taken safely with Doloxital. 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 can affect the dosage of Doloxital you need.

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

• Other pain medications, such as other strong opioid painkillers (e.g., buprenorphine, nalbuphine, or pentazocine) and some pain medications for neuropathic pain (gabapentin and pregabalin).
• Medications to help you sleep (such as temazepam, zaleplon, or zolpidem).
• Medications to help you calm down (tranquilizers, such as alprazolam, clonazepam, diazepam, hydroxyzine, or lorazepam) and medications for mental health conditions (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 use Doloxital in 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 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 stomach acid 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).

Using Doloxital with antidepressants

The risk of adverse effects increases if you are taking certain antidepressants. Doloxital may interact with these medications, 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, hyperactive reflexes, lack of coordination, muscle stiffness, nausea, vomiting, and diarrhea (which could be signs of a serotonin syndrome). If you are taking these medications together, your doctor may want to monitor you closely to detect these adverse effects, especially when starting treatment or changing the dosage of the medication.

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

The concurrent use of Doloxital and sedatives such as benzodiazepines or related medications increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. Due to this, concurrent use should only be considered when other treatment is not possible.

However, if your doctor prescribes Doloxital along with sedatives, the concurrent dosage and duration should be limited by your doctor.

Inform your doctor about all sedatives you are taking, and follow your doctor's dosage recommendation. It may be helpful to inform friends or family members to be aware of the signs and symptoms mentioned above. Consult your doctor if you experience any symptoms.

Do not drink alcohol while using Doloxital, unless you have spoken with your doctor first.

Surgery

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

Pregnancy and breastfeeding

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

Doloxital should not be used during pregnancy, unless you have spoken with your doctor.

Doloxital should not be used during delivery, as the medication can affect the newborn's breathing.

Prolonged use of Doloxital during pregnancy may cause withdrawal symptoms (such as loud crying, feeling restless, 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 use Doloxital if you are breastfeeding. Do not breastfeed for 3 days after removing the Doloxital patch. This is because the medication may pass into breast milk.

Driving and operating machinery

Doloxital may affect your ability to drive and operate machinery, as it can 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.

Doloxital contains soy oil

This medication contains soy oil. Do not use it if you are allergic to peanuts or soy.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from using Doloxital, when and for how long you should use it, when you should contact your doctor, and when you should discontinue use (see also section 2, “Withdrawal symptoms when stopping Doloxital”).

Follow exactly the administration instructions for this medication indicated by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will decide what concentration of Doloxital 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 medication for 3 days (72 hours).
• You should change the patch every 3 days, unless your doctor has told you otherwise.
• Always remove the used patch before applying a new one.
• Change the patch always at the same time of 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 you apply a patch 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 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 bath or shower.

Step 2: Open the package

• Each patch is sealed in its own package.
• To open the package, first make two cuts, as indicated by the arrows.
• Then, carefully tear both edges of the package completely (if you use scissors, make the cut along the sealed edge to avoid damaging the patch).

• Hold the two parts of the open package and pull them apart.
• 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, cut, or damaged in any way.
• 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 adhere it under elastic or tight clothing.
• Peel off carefully one half of the shiny plastic protective layer 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 layer and press the entire patch onto the skin with the palm of your hand.
• Hold it pressed for at least 30 seconds. Make sure the patch is well adhered, especially around the edges.

Step 4: Dispose of the patch

• As soon as you remove the patch, fold it in half, so that the adhesive side sticks to itself.
• Put it back in the original 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

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

More information on using Doloxital

Activities during patch use

• 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 or whirlpools.
  • 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 tanning beds. 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, allowing you to stop taking other painkillers. However, your doctor may prescribe additional painkillers occasionally.

How long will you need to use the patches?

• The Doloxital patches are 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 while using the patches, your doctor may try patches with a higher dose or prescribe additional painkillers (or both).
• If increasing the patch dose does not help, your doctor may decide to stop using the patches.

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

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

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

In case of overdose or incorrect dose, remove the patches and contactyourdoctoror pharmacist immediately orcall the Toxicology Information Service,tel:91 562 04 20 indicating the medication and the amountadministered.

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. Then, change the patchafterthree days(72 hours), asusual.
• Ifyou are lateby a lot,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:

• On 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 to minimize the unpleasant effects of withdrawal. See also section 2, “Withdrawal symptoms when stopping Doloxital”.
• If you stop using the patches, do not use them again without asking 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.

Ifyou, or your partner or caregiver, observeany of thefollowing signs inthe person wearing thepatch, remove the patch and call a doctor or go immediately to the nearest hospital. 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 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 analgesics (such asDoloxitalor morphine) before. (Rare, may affect up to 1 in 100 patients).

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

They can 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).

Also, the following side effects have 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 present (hallucinations)
• Trembling or muscle spasms
• Strange sensation on the skin, such as tingling or prickling (paresthesia)
• Sensation of everything spinning (dizziness)
• Fast or irregular 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 skin color caused by decreased oxygen in the blood (cyanosis)
• Loss of intestinal contractions (ileus)
• Rash on the skin 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)

• 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 present, sleep disorders, nightmares)
• You may become dependent on Doloxital (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 produce dependence.

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

There have also been cases of newborn babies experiencing withdrawal symptoms after their mothers used Doloxital for a prolonged period during pregnancy.

Reporting side effects

If you experience any type of side effect, consult your doctor or pharmacist, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://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.

Store in the original packaging to protect it from light. This medication does not require any special storage temperature.

Store this medication in a safe and protected place, inaccessible to other people. This medication can cause severe and even fatal harm to people who use it accidentally or intentionally when not prescribed.

How Long to Store Doloxital

Do not use this medication after the expiration date that appears on the box and on the packaging 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 packaging and storing 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 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 Doloxital

-The active ingredient is fentanil.

Each transdermal patch contains 2.55 mg of fentanil on a surface of 4.25 cm2and releases 12.5 micrograms of fentanil per hour

The other components are:

Matrix components:

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

Removable coating:

Polyethylene terephthalate, polyester, siliconized.

Supporting film printed:

Polyethylene terephthalate film, printing ink.

Appearance of the product and contents of the package

Transdermal patch.

Opaque, colorless, rectangular patch with rounded corners and printed on the supporting film “Fentanyl 12 µg/h” in individually sealed sachets.

Doloxital 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

Madrid, Spain

Manufacturer responsible:

Luye Pharma AG

Am Windfeld 35

83714 Miesbach

Germany

Or

Laboratorios Medicamentos Internacionales, S.A. (Medinsa)

C/Solana, 26

28850, Torrejón de Ardoz

Madrid, Spain

Thisleaflethas been approved in April 2025

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