Fentanyl Aristo 100 micrograms buccal tablets EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Fentanilo Aristo 100 micrograms oromucosal tablets EFG

Fentanilo Aristo 200 micrograms oromucosal tablets EFG

Fentanilo Aristo 400 micrograms oromucosal tablets EFG

Fentanilo Aristo 600 micrograms oromucosal tablets EFG

Fentanilo Aristo 800 micrograms oromucosal tablets EFG

Read the entire leaflet carefully before you start using 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, as it may 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 (ongoing) pain associated with cancer.

Breakthrough pain is an additional, sudden episode of pain that occurs despite ongoing analgesic opioid treatment.

2. What you need to know before using Fentanilo Aristo

DO NOT use Fentanilo Aristo:

• if you are not already regularly taking an opioid medicine prescribed by your doctor (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day at the same time, for at least one week, to manage persistent pain. If you have not been taking 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 to 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 suffer from short-term pain other than breakthrough pain.
• if you are taking a medicine containing sodium oxybate.

Warnings and precautions

While being treated with fentanyl, continue using the opioid painkiller prescribed for your persistent (constant) cancer-related pain.

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

Keep this medicine in a safe and secure place, out of reach of others (see section 5, Storage of Fentanilo 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 head injuries.
• 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, “Other medicines and Fentanilo 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, “Other medicines and Fentanilo Aristo”). Taking these medicines with fentanyl may cause serotonin syndrome, a potentially life-threatening condition (see section 2, “Other medicines and Fentanilo 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, “Serious adverse effects”).
• if you have ever had opioid abuse or dependence, or dependence on any other drug, alcohol, or illicit substances.
• if you drink alcohol, refer to the section “Use of fentanyl with food, drinks, and alcohol.”

Consult your doctor DURING fentanyl treatment:

• 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, 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 sleep-related breathing disorders: fentanyl may cause sleep-related respiratory 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 painkillers may make the medicine less effective (your 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 losing effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or gradually reduce fentanyl use.

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 losing control over the amount of medicine you need to take or how often you take it. You may feel the need to keep 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 a family member has abused or been dependent 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, they could be signs of dependence or addiction:

• you need to use the medicine for longer than prescribed by your doctor.
• you need to take 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 assistance:

• 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, “Serious adverse effects”).

What to do if someone accidentally takes Fentanilo Aristo

If you suspect someone has accidentally taken fentanyl, seek immediate medical help. 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 Fentanilo Aristo

Inform your doctor or pharmacist before starting fentanyl treatment 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, breathing difficulties (respiratory depression), coma, and may be potentially fatal. Therefore, concomitant use should only be considered when no other treatment options are available.

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 used to treat bacterial infections), aprepitant (used for severe nausea), diltiazem, and verapamil (medicines used to treat high blood pressure or heart conditions).

• medicines called monoamine oxidase inhibitors (MAOIs) (used for severe depression), even if taken 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, tremors, and sweating).

• some 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 state (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 Fentanilo 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 help 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, 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 discussed with 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.

You should not use fentanyl during labor, as it 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 should be aware that this medicine contains a substance that may lead to a positive result in doping control tests.

Fentanilo Aristo 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 given by your doctor. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during treatment, your doctor will also explain to you 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 determination of the correct dose for you, your doctor may instruct you to take more than one tablet per episode. If breakthrough pain is not relieved after 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 dose of analgesic you require may vary throughout treatment. You may require higher doses. If breakthrough pain is not relieved after 30 minutes, use only one additional fentanyl tablet during this dose re-adjustment period. Consult your doctor if your correct fentanyl dose does not relieve your breakthrough pain. Your doctor will decide whether a dose modification 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 change the treatment you are receiving to control 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 relief, inform your doctor about your pain and how fentanyl is working for you, so they can modify the dose if necessary.

Do not change the doses of fentanyl or other analgesics on your own. Any change in dosing 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

The method of administration of fentanyl oral tablets is via the buccal route. When placing a tablet in the mouth, it dissolves and the medicine is absorbed through the buccal mucosa into the bloodstream. This method of taking the medicine allows for rapid absorption 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 strip 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 cheek (as shown in the photograph). Your doctor may also 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 than if you follow these instructions.
• The tablet should remain between the cheek and gum until it dissolves. This usually takes about 30 minutes.
• If irritation occurs, you may change the placement of the tablet on the gum.
• After 30 minutes, if 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 start feeling 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 can 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: 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 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 evaluate whether you need medications to reduce or eliminate withdrawal symptoms.

If you have any further questions about using 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 immediately.

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.

When occurring together, these symptoms may indicate 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 fatigue, weakness, migraine, numbness, swelling of arms or legs, withdrawal syndrome (which may manifest as the onset of 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 platelets (cells that help blood to clot);
• euphoria, nervousness, odd sensations, 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 of intense warmth (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, convulsion (epileptic seizure)
• 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 it is a possible adverse effect not listed in this leaflet. You may also report them directly via 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. Storage of Fentanilo Aristo

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 use 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 the sight and reach of children.

• Do not use this medicine after the expiry date stated on the blister pack and 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 should not be disposed of via wastewater or household waste. Dispose of unused containers and medicines at the SIGRE collection point at your pharmacy. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Fentanil 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 on one side with “1” for fentanyl 100 micrograms, “2” for fentanyl 200 micrograms, “4” for fentanyl 400 micrograms, “6” for fentanyl 600 micrograms, and “8” for fentanyl 800 micrograms.

They have an approximate diameter of 10 mm.

Each blister contains 4 buccal tablets, available in packs of 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 review of this leaflet: July 2025

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

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