Fentanyl Aristo 800 micrograms buccal tablets EFG

Package leaflet: Information for the user

Introduction

Package 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 the entire 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 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, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Fentanilo Aristo is and what it is used for

The active substance in Fentanilo Aristo is fentanyl citrate. Fentanyl is a medicine used for pain relief. This medicine is known as an opioid and is used to treat breakthrough pain in adult patients who are already receiving maintenance treatment with other opioids for their persistent (constant) pain associated with cancer.

Breakthrough pain is a sudden, additional pain that occurs despite ongoing analgesic opioid treatment.

2. What you need to know before using Fentanil Aristo

DO NOT use Fentanil Aristo:

• if you are not already regularly taking an opioid medicine prescribed by your doctor (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine), every day at the same time, for at least one week to manage persistent pain. If you have not been using these medicines, do not use fentanyl, as it may increase the risk of your breathing becoming slower and/or shallower, or even stopping completely.
• if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• if you have severe respiratory problems or severe obstructive lung disease.
• if you are experiencing short-term pain not related to breakthrough pain.
• if you are taking a medicine containing sodium oxybate.

Warnings and precautions

While being treated with fentanyl, continue using the opioid pain medicine you are already taking for your persistent (constant) cancer-related pain.

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

Keep this medicine in a secure and safe place, out of reach of others (see section 5, Storage of Fentanil Aristo, for more information).

Inform your doctor or pharmacist BEFORE starting fentanyl:

• if the other opioid medicine you are taking for your persistent (constant) cancer-related pain has not yet been stabilized.
• if you have any condition affecting your breathing (such as asthma, wheezing, or difficulty breathing).
• if you have a head injury.
• if you have an unusually low heart rate or other heart problems.
• if you have liver or kidney problems, as these organs affect how your body metabolizes the medicine.
• if you have low blood volume or hypotension.
• if you are over 65 years of age; you may require a lower dose, and your doctor will carefully monitor any dose increase.
• if you are taking benzodiazepines (see section 2, under “Other medicines and Fentanil Aristo”). The use of benzodiazepines may increase the risk of serious adverse effects, including death.
• if you are taking antidepressants or antipsychotics (selective serotonin reuptake inhibitors [SSRIs], serotonin-norepinephrine reuptake inhibitors [SNRIs], monoamine oxidase inhibitors [MAOIs]); see section 2, under “Other medicines and Fentanil Aristo”). Using these medicines with fentanyl may cause serotonin syndrome, a potentially life-threatening condition (see section 2, under “Other medicines and Fentanil Aristo”).
• if you have ever had adrenal insufficiency—a condition in which the adrenal glands do not produce enough hormones—or sex hormone deficiency (androgen deficiency) with opioid use (see section 4, under “Serious adverse effects”).
• if you have ever had opioid abuse or dependence, or dependence on any other drug, alcohol, or illicit drugs.
• if you drink alcohol, consult section “Use of fentanyl with food, drinks, and alcohol”.

Consult your doctor DURING use of fentanyl:

• if you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medicine as prescribed by your doctor.
• if you develop a combination of the following symptoms: nausea, vomiting, anorexia, 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 sleep-related breathing disorders: fentanyl may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to difficulty breathing, trouble staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.

Long-term use and tolerance

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

Dependence and addiction

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

Repeated use of fentanyl may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of lack of control over the amount of medicine you need to take or how often you need to take it. You may feel the need to continue using the medicine even if it does not help relieve pain.

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

• you or any member of your family has abused alcohol or experienced dependence on alcohol, prescription medicines, or illegal drugs (“addiction”).
• you smoke.
• you have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

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

• you need to use the medicine for longer than prescribed by your doctor.
• you need to use a higher dose than recommended.
• 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 using the medicine or control its use.
• you feel unwell when you stop taking the medicine (e.g., nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), and feel better once you take it again (“withdrawal effects”).

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

Seek urgent medical help:

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

What to do if someone accidentally takes Fentanil Aristo

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

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

Children and adolescents

Do not give this medicine to children and adolescents under 18 years of age.

Other medicines and Fentanil Aristo

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

• concomitant use of fentanyl and sedative medicines, such as benzodiazepines or related drugs, increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are possible.

However, if your doctor prescribes fentanyl together with sedative medicines, the dose and duration of concomitant treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking (such as sleeping pills, medicines for anxiety, certain medicines for allergic reactions [antihistamines], or tranquilizers), and strictly follow the dose recommended by your doctor. It may be helpful to inform friends or family members to alert them to the signs and symptoms described above. Contact your doctor if you experience such symptoms.

• certain muscle relaxants, such as baclofen, diazepam.

• any medicine that may affect how your body metabolizes fentanyl, such as ritonavir, nelfinavir, amprenavir, and fosamprenavir (medicines used to control HIV infection), or other inhibitors of the so-called CYP3A4 enzyme, such as ketoconazole, itraconazole, or fluconazole (used to treat fungal infections), troleandomycin, clarithromycin, or erythromycin (medicines for bacterial infections), aprepitant (used for severe nausea), diltiazem, and verapamil (medicines for high blood pressure or heart conditions).

• medicines called monoamine oxidase inhibitors (MAOIs) (used for severe depression), including if you have taken them within the last two weeks.

• certain types of strong painkillers called partial agonist/antagonists, such as buprenorphine, nalbuphine, and pentazocine (medicines for pain). While using these medicines, you may experience symptoms of withdrawal syndrome (nausea, vomiting, diarrhea, anxiety, chills, tremor, and sweating).

• certain pain medicines for neuropathic pain (gabapentin and pregabalin).

• the risk of adverse effects increases if you are taking medicines such as certain antidepressants or antipsychotics. Fentanyl may interact with these medicines, and you may experience changes in mental status (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will advise you whether fentanyl is suitable for you.

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

Use of Fentanil Aristo with food, drinks, and alcohol

• Fentanyl may be taken before or after meals, but not during meals. You may drink a small amount of water before using fentanyl to moisten your mouth, but you must not drink or eat anything while taking the medicine.
• Do not drink grapefruit juice while using fentanyl, as it may affect how your body metabolizes this medicine.
• Do not drink alcohol during treatment with fentanyl. Alcohol may increase the risk of serious adverse effects, including death.

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.

Pregnancy

Fentanyl should not be used during pregnancy unless advised by your doctor.

If fentanyl is used for a prolonged period during pregnancy, there is also a risk that the newborn may experience withdrawal symptoms, which could be potentially fatal if not identified and treated by a doctor.

Do not use fentanyl during childbirth, as fentanyl may cause respiratory depression in the newborn.

Breastfeeding

Fentanyl may pass into breast milk and cause adverse effects in the infant. Do not use fentanyl if you are breastfeeding. You should not start breastfeeding until at least 5 days after the last dose of fentanyl.

Driving and using machines

Ask your doctor whether it is safe for you to drive or operate machinery after taking fentanyl. Do not drive or operate machinery if: you feel drowsy or dizzy, have blurred or double vision, or have difficulty concentrating. It is important to know how you react to fentanyl before driving or operating machinery.

Use in athletes

Athletes are advised that this medicine contains a component that may result in a positive analytical finding in doping control tests.

Fentanyl contains sorbitol

This medicine contains 67.1 mg of sorbitol per oral tablet.

3. How to use Fentanilo Aristo

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

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

Dosage and frequency

When you first start using fentanyl, your doctor will help you find the dose that relieves your breakthrough pain. It is very important that you use fentanyl exactly as directed by your doctor. The initial dose is 100 micrograms.

During the process of determining the correct dose for you, your doctor may instruct you to take more than one tablet per episode. If breakthrough pain is not relieved within 30 minutes, use only one additional fentanyl tablet during this dose-adjustment period.

Once the correct dose has been determined with your doctor, use one tablet per episode of breakthrough pain as a general rule. The analgesic dose you require may vary over time during treatment. You may need higher doses. If breakthrough pain is not relieved within 30 minutes, use only one additional fentanyl tablet during this dose-reassessment period. Consult your doctor if your correct dose of fentanyl does not relieve your breakthrough pain. Your doctor will decide whether a dose adjustment is necessary.

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

Inform your doctor immediately if you need to take fentanyl more than four times a day, as your treatment regimen may need to be changed. Your doctor may adjust the treatment you are receiving for controlling persistent pain; once persistent pain is controlled, your doctor may need to adjust your fentanyl dose. If your doctor suspects increased pain sensitivity (hyperalgesia) related to fentanyl, they may consider reducing the fentanyl dose (see section 2, “Warnings and precautions”). For more effective pain relief, inform your doctor about your pain and how fentanyl is working for you, so they can adjust the dose if necessary.

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

If you are unsure about the appropriate dose, or if you have any questions about using this medicine, contact your doctor.

Method of administration

Fentanyl oromucosal tablets are administered via the oral route. When a tablet is placed in the mouth, it dissolves and the medicine is absorbed through the oral mucosa into the bloodstream. This method of administration allows the medicine to be rapidly absorbed to relieve your breakthrough pain.

How to use the medicine

• Open the blister pack only when you are ready to use the tablet. The tablet should be used immediately after removal from the blister.
• Separate one unit from the blister pack by tearing along the perforations.
• Fold the blister unit along the indicated line.
• Peel back the backing of the blister to expose the tablet. DO NOT try to push the tablet out of the blister, as this may damage it.

• Remove the tablet from the blister and place it immediately without breaking it next to a molar, between the gum and the cheek (as shown in the photograph). Your doctor may alternatively instruct you to place the tablet under the tongue.
• Do not attempt to crush or split the tablet.

• Do not bite, suck, chew, or swallow the tablet, as this will result in less analgesic effect compared to following these instructions.
• The tablet should remain between the cheek and the gum until it dissolves, which usually takes about 30 minutes.
• If irritation occurs, you may change the placement of the tablet along the gumline.
• After 30 minutes, if any remnants of the fentanyl tablet remain, you may 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 begin to feel very dizzy or drowsy before the tablet has completely dissolved, rinse your mouth with water and immediately spit out any remaining tablet remnants into the sink or toilet.
• A serious adverse effect of fentanyl is slow and/or shallow breathing. This may occur if the fentanyl dose is too high or if you have taken too much fentanyl. In severe cases, taking too much fentanyl may lead to coma. If you feel very dizzy, very drowsy, or have slow or shallow breathing, seek immediate medical attention.
• An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, stating the medicine and the amount ingested.

If you forget to use Fentanilo Aristo

If breakthrough pain persists, you may take fentanyl as directed by your doctor. If breakthrough pain has subsided, do not take fentanyl until the next episode of breakthrough pain.

If you stop treatment with Fentanilo Aristo

You should stop using fentanyl when you no longer have any breakthrough pain. However, you must continue taking your regular opioid analgesic medication for persistent cancer pain as directed by your doctor. When you stop treatment with fentanyl, you may experience withdrawal symptoms similar to the possible adverse effects of fentanyl. If you experience withdrawal symptoms or are concerned about pain relief, consult your doctor. Your doctor will assess whether you need medication to reduce or eliminate withdrawal symptoms.

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 experiences them. If you notice any of these effects, inform your doctor.

Serious adverse effects

• The most serious adverse effects are shallow breathing, hypotension, and shock. Fentanyl, like other fentanyl-containing products, may cause very serious breathing problems that can lead to death. If you feel very drowsy or have slow and/or shallow breathing, you or your caregiver must contact your doctor immediately and seek urgent medical help.

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

• Nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure.

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

Other adverse effects

Very common: may affect more than 1 in 10 patients

• dizziness, headache
• nausea, vomiting
• at the application site of the tablet: pain, ulcer, irritation, bleeding, numbness, loss of sensation, redness, swelling, or spots

Common: may affect up to 1 in 10 patients

• feeling anxious or confused, depression, insomnia
• altered taste, weight loss
• drowsiness, sedation, excessive tiredness, weakness, migraine, numbness, swelling of arms or legs, withdrawal syndrome (which may present with the following adverse effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating), tremors, falls, chills
• constipation, mouth inflammation, dry mouth, diarrhoea, heartburn, loss of appetite, stomach pain, stomach discomfort, indigestion, toothache, mouth ulcers
• itching, excessive sweating, rash
• shortness of breath, sore throat
• decrease in white blood cells, decrease in red blood cells, decrease or increase in blood pressure, heart rate too high
• muscle pain, back pain
• fatigue

Uncommon: may affect up to 1 in 100 patients

• throat discomfort;
• decrease in blood cells that help blood to clot;
• euphoria, nervousness, oddness, restlessness or sluggishness; seeing or hearing things that are not real (hallucinations), altered consciousness, changes in mental state, drug dependence (addiction), disorientation, difficulty concentrating, loss of balance, dizziness, speech problems, ringing in the ears, ear discomfort;
• blurred or altered vision, red eyes;
• heart rate too low, feeling very hot (hot flushes), hypertension;
• serious breathing problems, difficulty breathing during sleep;
• one or more of the following mouth problems: ulcer, loss of sensation, discomfort, abnormal colour, soft tissue changes, tongue disorders, pain, blisters or ulcers on the tongue, gum pain, cracked lips, dental disorders;
• oesophagitis, intestinal paralysis, gallbladder disorder;
• cold sweat, facial swelling, generalized itching, hair loss, muscle cramps, muscle weakness, general malaise, chest discomfort, thirst, feeling cold, feeling hot, difficulty urinating;
• general malaise;
• flushing.

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

• thought disorders, movement disturbances
• blisters in the mouth, dry lips, presence of pus under the skin in the mouth
• lack of testosterone, unusual sensation in the eye, perception of flashes of light, brittle nails
• allergic reactions such as skin rash, redness, swelling of lips and face, urticaria

Not known: frequency cannot be estimated from available data

• loss of consciousness, respiratory arrest, seizure (epileptic fit)
• 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 disturbances, and nightmares)
• prolonged fentanyl treatment during pregnancy may cause withdrawal symptoms in the newborn, which may be potentially life-threatening (see section 2)

Reporting of adverse effects

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

5. Fentanilo Aristo Storage Instructions

Store this medicine in a safe and secure place, out of reach of others. This medicine may cause serious harm or even be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.

The fentanyl painkiller is very strong and may be life-threatening if accidentally taken by a child. This medicine must be kept out of sight and reach of children.

• Do not use this medicine after the expiry date stated on the label of the blister packs and on the carton, following EXP. The expiry date refers to the last day of the month indicated.
• Do not store above 30°C. Keep in the original packaging to protect from moisture.

Medicines must not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point in your pharmacy. 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 Fentanilo Aristo

The active substance is fentanyl. Each tablet contains:

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

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

Appearance of the product and contents of the pack

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

They have an approximate diameter of 10 mm.

Each blister contains 4 buccal tablets. The tablets are packaged in boxes containing either 4 or 28 buccal tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Aristo Pharma GmbH
Wallenroder Straße 8-10
13435 Berlin
Germany

Manufacturer

Bluepharma – Indústria Farmacêutica S.A.
S. Martinho do Bispo, Coimbra
3045-016, Portugal

Or

ARDENA PAMPLONA, S.L. Polígono Mocholi, C/ Noain, n°1
Noain, 31110 (Navarra), Spain

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Aristo Pharma Iberia, S.L.
C/ Solana, 26
28850 Torrejón de Ardoz
Madrid, Spain

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

Detailed information about this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

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