Leaflet: information for the user

Fentanilo Aristo 100 micrograms buccal tablets EFG

Fentanilo Aristo 200 micrograms buccal tablets EFG

Fentanilo Aristo 400 micrograms buccal tablets EFG

Fentanilo Aristo 600 micrograms buccal tablets EFG

Fentanilo Aristo 800 micrograms buccal tablets EFG

Read this leaflet carefully before you start taking this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

The active ingredient of Fentanilo Aristo is fentanil citrate. Fentanil is a pain relief medication, this medication is known as an opioid used to treat breakthrough pain in adult patients who already receive maintenance treatment with other opioids for their persistent pain (present all the time) associated with cancer.

Breakthrough pain is additional and sudden pain that appears despite already receiving routine analgesic treatment with opioids.

Do not use Fentanilo Aristo:

• if you are not regularly using a prescribed opioid medication (e.g., codeine, fentanilo, hidromorfona, morfina, oxicodona, petidina) every day at the same time, for at least one week, to control persistent pain. If you have not been using those medications,do not usefentanilo as its use may increase the risk of your breathing becoming slower and/or shallower, and even stopping.
• if you are allergic to fentanilo or any of the other components of this medication (listed in section 6).
• if you have severe respiratory problems or chronic obstructive pulmonary disease.
• if you have short-term pain other than breakthrough pain.
• if you are taking a medication that contains sodium oxibate.

Warnings and precautions

During treatment with fentanilo, continue to use the opioid analgesic medication you take for your persistent pain (present all the time) associated with cancer.

While under treatment with fentanilo, do not use other fentanilo-based treatments that you have been previously prescribed for breakthrough pain. If you still have these fentanilo products at home, contact your pharmacist who will instruct you on how to dispose of them.

Keep this medication in a safe and protected place, where others cannot access it (see section 5, Fentanilo Aristo Storage for more information).

Inform your doctor or pharmacistBEFOREstarting to use fentanilo:

• if the other opioid medication you take for your persistent pain (present all the time) associated with cancer has not yet stabilized.
• if you have a respiratory disorder (such as asthma, wheezing, or difficulty breathing).
• if you have head injuries.
• if you have an abnormally low heart rate or other heart problems.
• if you have liver or kidney problems, as these organs affect how your body metabolizes the medication.
• if you have low blood volume or hypotension.
• if you are over 65 years old; you may need a lower dose and your doctor will carefully review any dose increase.
• if you are taking benzodiazepines (see section 2, "Other medications and Fentanilo Aristo"). The use of benzodiazepines may increase the likelihood of severe adverse effects, including death.
• if you are taking antidepressants or antipsychotics (selective serotonin reuptake inhibitors [SSRIs], serotonin and norepinephrine reuptake inhibitors [SNRIs], monoamine oxidase inhibitors [MAOIs]); see section 2, "Other medications and Fentanilo Aristo"). The use of these medications with fentanilo may cause aserotonin syndrome, a potentially life-threatening situation(see section 2, "Other medications and Fentanilo Aristo").
• if you have ever had adrenal insufficiency, a disorder in which the adrenal glands do not produce enough hormones, or hormone deficiency (androgen deficiency) with opioid use (see section 4, "Severe adverse effects").
• if you have ever abused or been dependent on opioids or any other medication, alcohol, or drugs.
• if you drink alcohol, see the section "Fentanilo use with food, drinks, and alcohol".

Consult your doctorDURINGuse of fentanilo:

• if you feel pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medication as prescribed by your doctor.
• if you experience a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure. Together, these symptoms may indicate a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.
• if you experience respiratory problems related to sleep: fentanilo may cause sleep-related respiratory problems such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Long-term use and tolerance

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

Dependence and addiction

Repeated use of fentanilo may 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 dose and longer use. Dependence or addiction may cause you to feel a lack of control over the amount of medication you should use or the frequency with which you should use it. You may feel the need to continue using the medication even if it does not help alleviate pain.

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

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

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

• you need to use the medication for a longer period than prescribed by your doctor.
• you need to use a higher dose 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 its use.
• you feel unwell when you stop using the medication (e.g., nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), 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 the medication, and how to do it safely.

Seek medical attentionURGENTLY:

• if you experience symptoms such as difficulty breathing or dizziness, swelling of the tongue, lips, or throat while using fentanilo. These may be early signs of a severe allergic reaction (anaphylaxis, hypersensitivity; see section 4, "Severe adverse effects").

What to do if someone accidentally takes Fentanilo Aristo

If you believe someone has accidentally taken fentanilo, seek immediate medical attention. Try to keep the person awake until emergency services arrive.

If someone accidentally takes fentanilo, they may experience the same side effects described in the section "If you use more fentanilo than you should."

Children and adolescents

Do not administer this medication to children and adolescents under 18 years of age.

Other medications and Fentanilo Aristo

Inform your doctor or pharmacist before starting treatment with fentanilo if you are taking, have taken recently, or may need to take any other medication, including the following:

• The concomitant use of fentanilo and sedative medications, such as benzodiazepines or related drugs, increases the risk of somnolence, difficulty breathing (respiratory depression), and 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 fentanilo with sedative medications, the dose and duration of concomitant treatment should be limited by your doctor.

Inform your doctor about all sedative medications you are taking (such as sleep aids, anxiety medications, some allergy medications [antihistamines], or tranquilizers) and follow your doctor's recommended dose strictly. It may be helpful to inform friends or family members to alert them to the symptoms and signs described above. Contact your doctor if you experience these symptoms.

• some muscle relaxants, such as baclofen, diazepam.

• any medication that may affect how your body metabolizes fentanilo, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir (medications that help control HIV infection) or other CYP3A4 inhibitors, such as ketoconazole, itraconazole, or fluconazole (used to treat fungal infections), troleandomycin, clarithromycin, or erythromycin (medications for bacterial infections), aprepitant (used for intense nausea) diltiazem, and verapamil (medications for hypertension or heart disease).
• medications called monoamine oxidase inhibitors (MAOIs) (used for severe depression), also if you have used them in the past two weeks.
• a type of potent pain relievers, called agonists/antagonists, such as buprenorphine, nalbuphine, and pentazocine (medications for pain). While using these medications, you may experience symptoms of withdrawal (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating).
• some pain relievers for neuropathic pain (gabapentin and pregabalin).
• The risk of adverse effects increases if you are taking medications such as certain antidepressants or antipsychotics. Fentanilo may interact with these medications, and you may experience changes in mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, unstable blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will tell you if fentanilo is suitable for you.

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

Fentanilo Aristo use with food, drinks, and alcohol

• Fentanilo can be taken before or after meals, but not during them. You can drink a little water before taking fentanilo to help moisten your mouth, but do not eat or drink anything while taking the medication.
• Do not drink grapefruit juice while using fentanilo, as it may affect how your body metabolizes this medication.
• Do not drink alcohol during treatment with fentanilo. It may increase the risk of severe adverse effects, including death.

Pregnancy and breastfeeding

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

Pregnancy

Fentanilo should not be used during pregnancy, except after consulting your doctor.

If you use fentanilo for a prolonged period during pregnancy, there is also a risk that the newborn may experience withdrawal symptoms that can be potentially fatal if not identified and treated by a doctor.

Do not use fentanilo during labor, as fentanilo may cause respiratory depression in the newborn.

Breastfeeding

Fentanilo may pass into the mother's bloodstream and cause adverse effects in the infant. Do not use fentanilo if you are breastfeeding your child. Do not initiate breastfeeding until at least 5 days have passed since the last dose of fentanilo.

Driving and operating machinery

Ask your doctor if you can drive or operate machinery safely after taking fentanilo. Do not drive or operate machinery if: you feel drowsy or dizzy, have blurred vision, see double, or have difficulty concentrating. It is essential to know how you react to fentanilo before driving or operating machinery.

Use in athletes

It is reported to athletes that this medication contains a component that may result in a positive analytical result in doping control as positive.

Fentanilo contains sorbitol

This medication contains 67.1 mg of sorbitol in each buccal tablet.

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

Your doctor will also explain to you what you can expect from the use of fentanilo, 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).

Dosage and frequency

When you start using fentanilo for the first time, your doctor will help you find the dose that will relieve your breakthrough pain. It is very important that you use fentanilo exactly as your doctor tells you. The initial dose is 100 micrograms.

During the determination of the correct dose for you, your doctor may have you take more than one tablet per episode. If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of fentanilo during the dose adjustment period.

Once you have determined the correct dose with your doctor, use 1 tablet for a breakthrough pain episode as a general rule. The analgesic dose you need may vary throughout treatment. You may need higher doses. If your breakthrough pain is not relieved after 30 minutes, use only 1 more tablet of fentanilo during this dose adjustment period. Consult your doctor if your correct dose of fentanilo does not relieve your breakthrough pain. Your doctor will decide if it is necessary to modify your dose.

Wait at least 4 hours before treating another breakthrough pain episode with fentanilo.

You must inform your doctor immediately if you need to take fentanilo more than four times a day, as it may be necessary to change your treatment regimen. Your doctor may change the treatment you are receiving to control persistent pain; when persistent pain is controlled, your doctor may need to change your fentanilo dose. If your doctor suspects opioid-related hypersensitivity, it may be necessary to reduce your fentanilo dose (see section 2, "Warnings and precautions"). To achieve more effective relief, inform your doctor of the pain you suffer and how fentanilo is acting in your case, so that they can modify your dose as needed.

Do not change the doses of fentanilo or other analgesics on your own. Any change in dosing must be prescribed and monitored by your doctor.

If you are unsure of the correct dose, or if you wish to ask any questions about the use of this medication, contact your doctor.

Administration form

The administration form of fentanilo oral tablets is oral. By placing a tablet in the mouth, it dissolves and the medication is absorbed by the buccal mucosa and passes into the blood. This form of taking the medication allows it to be absorbed quickly to relieve your breakthrough pain.

How to use the medication

• Open the blister only when you are going to use the tablet. The tablet must be used immediately after it has been removed from the blister.
• Separate one of the units from the blister by tearing along the perforations.
• Double the blister unit along the indicated line.
• Peel the back of the blister to expose the tablet. DO NOT try to press the tablet to remove it from the blister, as this may damage it.

• Remove the tablet from the blister and place it immediately without breaking it near a molar, between the gum and the cheek (as indicated in the photograph). Your doctor may also instruct you to place the tablet under the tongue.
• Do not try to crush or break the tablet.

• Do not bite, suck, chew, or swallow the tablet, as this will make the analgesic effect less than if you follow these instructions.
• The tablet must remain between the cheek and the gum until it dissolves. It usually takes about 30 minutes.
• If irritation occurs, you can change the placement of the tablet in the gum.
• After 30 minutes, if there are still remnants of the fentanilo tablet, you can swallow them with a glass of water.

If you use more Fentanilo Aristo than you should

• The most common adverse effects are drowsiness, dizziness, or discomfort. If you start to feel very dizzy or drowsy before the tablet has completely dissolved, rinse your mouth with water and spit out the remaining tablet immediately in the sink or toilet.
• A serious adverse effect of fentanilo is slow and/or shallow breathing. This can occur if the dose of fentanilo is too high or if you have taken too much fentanilo. In severe cases, taking too much fentanilo can lead to coma. If you feel very dizzy, very drowsy, or have slow and/or shallow breathing, seek immediate medical attention.
• A overdose can also cause a brain disorder known as toxic leukoencephalopathy.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forgot to use Fentanilo Aristo

If the breakthrough pain persists, you can take fentanilo according to your doctor's instructions. If the breakthrough pain has disappeared, do not take fentanilo until the next breakthrough pain episode.

If you interrupt treatment with Fentanilo Aristo

You must discontinue fentanilo when you no longer have any breakthrough pain. However, you must continue taking your usual opioid analgesic medication to treat persistent cancer pain, as instructed by your doctor. When you discontinue fentanilo treatment, you may experience withdrawal symptoms similar to possible adverse effects of fentanilo. If you experience withdrawal symptoms or are concerned about pain relief, consult your doctor. Your doctor will evaluate whether you need medications to reduce or eliminate withdrawal symptoms.

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

Like all medicines, this medicine can cause side effects, although not everyone will experience them. If you notice any of them, inform your doctor.

Severe side effects

• The most severe side effects are shallow breathing, hypotension, and shock. Fentanyl, like other fentanyl-based products, can cause very serious respiratory problems that can lead to death. If you feel extremely drowsy or have slow and/or shallow breathing, you or someone who cares for you should contact your doctor immediately and request urgent help.

• Contact your doctor immediately if you experience a combination of the following symptoms

• Nausea, vomiting, loss of appetite, fatigue, weakness, dizziness, and low blood pressure.

Together, these symptoms may be a sign of a potentially fatal condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.

Other side effects

Very common:may affect more than 1 in 10 patients

• Dizziness, headache
• Nausea, vomiting
• At the site of the tablet: pain, ulcer, irritation, bleeding, numbness, loss of sensation, redness, swelling, or patches

Common:may affect up to 1 in 10 patients

• Feeling of anxiety or confusion, depression, insomnia
• Alteration of taste, weight loss
• Drowsiness, sedation, excessive fatigue, weakness, migraine, numbness, inflammation of arms or legs, withdrawal syndrome (which may manifest as the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), tremors, falls, chills
• Constipation, inflammation of the mouth, dry mouth, diarrhea, heartburn, loss of appetite, stomach pain, stomach discomfort, indigestion, toothache, mouth ulcers
• Itching, excessive sweating, rash
• Shortness of breath, throat pain
• Decreased white blood cells, decreased red blood cells, decreased or increased blood pressure, high heart rate
• Muscle pain, back pain
• Fatigue

Uncommon:may affect up to 1 in 100 patients

• Throat pain;
• Decreased cells that help blood to clot;
• Euphoria, nervousness, strangeness, restlessness, or slowness; seeing or hearing things that are not real (hallucinations), alteration of consciousness, changes in mental state, dependence on the drug (addiction), disorientation, lack of concentration, loss of balance, dizziness, speech problems, ringing in the ears, ear discomfort;
• Altered or blurred vision, red eyes;
• Too low or too high heart rate, feeling too hot (heat stroke), high blood pressure;
• Severe respiratory problems, difficulty breathing during sleep;
• One or more of the following problems in the mouth: ulcer, loss of sensation, discomfort, abnormal color, alteration of soft tissues, alteration of the tongue, pain, blisters, or ulcers on the tongue, gum pain, chapped lips, dental problems;
• Inflammation of the esophagus, intestinal paralysis, bile duct disorder;
• Cold sweat, facial edema, generalized itching, hair loss, muscle cramps, muscle weakness, general discomfort, chest discomfort, thirst, feeling cold, feeling hot, difficulty urinating;
• General discomfort;
• Flush.

Rare:may affect up to 1 in 1,000 patients

• Mental disorders, movement disorder
• Mouth blisters, dry lips, presence of pus under the skin in the mouth
• Lack of testosterone, strange sensation in the eye, observation of flashes of light, brittle nails
• Allergic reactions such as skin rash, redness, swelling of lips and face, urticaria

Unknown:the frequency cannot be estimated from the available data

• Loss of consciousness, respiratory arrest, convulsion (epileptic crisis)
• Lack of sex hormones (androgen deficiency)
• Drug dependence (addiction) (see section 2)
• Drug abuse (see section 2)
• Pharmacological tolerance (see section 2)
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not real, sleep alteration, and nightmares)
• Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which can be potentially fatal (see section 2)

Reporting of 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 prospectus. You can also report them directly through the Spanish System for the 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.

Conserve this medication in a safe and protected place, where no other people can access it. This medication can cause severe damage and even be fatal to people who use it accidentally or intentionally, when not prescribed.

The analgesic fentanilo is very strong and can be a life-threatening risk if taken accidentally by a child. This medication must be kept out of the sight and reach of children.

• Do not use this medication after the expiration date that appears on the blister packaging and on the box after CAD. The expiration date is the last day of the month indicated.
• Do not store at a temperature above 30°C. Store in the original packaging to protect it from humidity.

Medications should not be disposed of through drains or in the trash. Deposit the containers and medications you no longer need at the SIGRE collection point at the pharmacy. 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 Fentanilo Aristo

The active ingredient is fentanil. Each tablet contains:

• 100 micrograms of fentanil (as citrate).
• 200 micrograms of fentanil (as citrate).
• 400 micrograms of fentanil (as citrate).
• 600 micrograms of fentanil (as citrate).
• 800 micrograms of fentanil (as citrate).

The other components are mannitol, sorbitol, citric acid, macrogol, L-arginine, and magnesium stearate.

Appearance of the product and content of the container

The buccal tablets are white, round, and engraved with “1” on one face for fentanil 100 micrograms, with “2” on one face for fentanil 200 micrograms, with “4” on one face for fentanil 400 micrograms, with “6” on one face for fentanil 600 micrograms, and with “8” on one face for fentanil 800 micrograms.

They have an approximate diameter of 10 mm.

Each blister contains 4 buccal tablets, which are presented in boxes of 4 or 28 buccal tablets.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Responsible for manufacturing

Bluepharma – Industria Farmaceutica S.A.

S.Martinho do Bispo, Coimbra,

3045-016, Portugal

Or

ARDENA PAMPLONA, S.L. Poligono Mocholi, C/Noain, n°1

Noain, 31110 (Navarra), Spain

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Aristo Pharma Iberia, S.L.

C/ Solana, 26

28850, Torrejón de Ardoz

Madrid. Spain

Last review date of this leaflet:October 2024

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

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