FENTANYL ARISTO 400 micrograms BUCCAL TABLETS

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 all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

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

Breakthrough pain is an additional, sudden pain that occurs despite already receiving regular pain-relieving treatment with opioids.

2. What you need to know before you use Fentanilo Aristo

DO NOT use Fentanilo Aristo:

• if you are not regularly using a prescribed opioid medicine (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, pethidine), every day at the same time, for at least one week, to control your persistent pain. If you have not been using these medicines, do not usefentanyl as its use may increase the risk of your breathing becoming slower and/or shallower and/or even stopping.
• if you are allergic to fentanyl or any of the other ingredients of this medicine (listed in section 6).
• if you have severe breathing problems or severe obstructive pulmonary disease.
• if you have short-term pain which is not breakthrough pain.
• if you are taking a medicine that contains sodium oxybate.

Warnings and precautions

During treatment with fentanyl, continue to use the opioid pain-relieving medicine you are taking for your persistent (ongoing) cancer pain.

While being treated with fentanyl, do not use other fentanyl treatments that you may have been prescribed previously for breakthrough pain. If you still have these fentanyl products at home, contact your pharmacist who will advise you how to dispose of them.

Keep this medicine out of the sight and reach of children and in a safe and secure place where other people cannot get to it (see section 5, Storage of Fentanilo Aristo for more information).

Tell your doctor or pharmacist BEFOREyou start using fentanyl:

• if the other opioid pain-relieving medicine you are taking for your persistent (ongoing) cancer pain is not yet stable.
• if you have any condition that affects your breathing (such as asthma, wheezing or breathing difficulties).
• if you have head injuries.
• if you have an exceptionally low heart rate or other heart problems.
• if you have liver or kidney problems, as these organs affect how your body breaks down the medicine.
• if you have low blood volume or low blood pressure.
• if you are over 65 years old; you may need a lower dose and your doctor will closely monitor any dose increases.
• if you are using benzodiazepines (see section 2, “Other medicines and Fentanilo Aristo”). The use of benzodiazepines may increase the likelihood of you experiencing serious side effects, including death.
• if you are using 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”. The use of these medicines with fentanyl may cause a 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 a lack of sex hormones (androgen deficiency) with the use of opioids (see section 4, “Serious side effects”).
• if you have ever had abuse or dependence on opioids or any other drug, alcohol or medication.
• if you drink alcohol, see the section “Using fentanyl with food, drinks and alcohol”.

Tell your doctor DURINGtreatment with fentanyl:

• if you feel 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 experience a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure. Together, these symptoms can be an indication of 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 apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty staying asleep or excessive sleepiness during the day. If you or someone else observes 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 pain-relievers can make the medicine less effective (your body gets used to it, which is known as pharmacological tolerance). You may also become more sensitive to pain when using fentanyl. This is known as hyperalgesia. Increasing the dose of fentanyl may continue to reduce the pain for a while, but it can also be harmful. If you notice that the medicine is becoming less effective, talk to your doctor. Your doctor will decide whether it is best for you to increase the dose or to gradually reduce the use of fentanyl.

Dependence and addiction

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

Repeated use of fentanyl can also lead to dependence, abuse and addiction, which could result in a potentially life-threatening overdose. The risk of these side effects may be greater with a higher dose and longer use. Dependence or addiction may cause you to feel a lack of control over the amount of medicine you use or how often you use it. You may feel the need to keep using the medicine even if it is no longer relieving your pain.

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

• you or a family member have abused alcohol or have been dependent on it, or have abused prescription medicines or illegal drugs (“addiction”).
• you smoke.
• you have ever had mood problems (depression, anxiety or personality disorder) or have been treated by a psychiatrist for other mental health problems.

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 feel calm” or “to help you sleep”.
• you have made repeated unsuccessful attempts to stop using the medicine or to control your use of it.
• you feel unwell when you stop using the medicine (for example, nausea, vomiting, diarrhoea, anxiety, shivering, shaking and sweating), and you feel better once you start using it again (“withdrawal symptoms”).

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

Seek IMMEDIATEmedical help:

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

What to do if someone accidentally takes Fentanilo Aristo

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

If someone accidentally takes fentanyl, they may experience the same side effects as 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

Tell your doctor or pharmacist before starting treatment with fentanyl if you are taking, have recently taken or might take any other medicines, including:

• the concomitant use of fentanyl and sedative medicines, such as benzodiazepines or related drugs, increases the risk of drowsiness, breathing difficulties (respiratory depression) and coma and may be potentially life-threatening. Therefore, concomitant use should only be considered when other treatment options are not possible.

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

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

• certain muscle relaxants, such as baclofen, diazepam.

• any medicine that may affect how your body breaks down fentanyl, such as ritonavir, nelfinavir, amprenavir and fosamprenavir (medicines that help control HIV infection) or other inhibitors of the so-called CYP3A4, such as ketoconazole, itraconazole or fluconazole (used to treat fungal infections), troleandomycin, clarithromycin, or erythromycin (medicines for the treatment of bacterial infections), aprepitant (used for severe nausea) diltiazem and verapamil (medicines for treating high blood pressure or heart disease).
• monoamine oxidase inhibitors (MAOIs) (used for severe depression), even if you have used them in the last two weeks.
• certain potent pain-relievers, called partial agonist/antagonists, such as buprenorphine, nalbuphine and pentazocine (medicines for pain relief). While using these medicines, you may experience withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety, shivering, shaking and sweating).
• certain pain-relievers for nerve pain (gabapentin and pregabalin).
• the risk of side 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 and exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Your doctor will tell you if fentanyl is suitable for you.

Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines.

Using Fentanilo Aristo with food, drinks and alcohol

• Fentanyl may be used before or after meals, but not during meals. You may drink a little water before using fentanyl to help moisten your mouth, but do not drink or eat anything while taking the medicine.
• Do not drink grapefruit juice while using fentanyl, as it may affect how your body breaks down this medicine.
• Do not drink alcohol while using fentanyl. It may increase the risk of serious side effects, including death.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Pregnancy

Fentanyl should not be used during pregnancy, unless you have discussed it with your doctor.

If fentanyl is used for a long time during pregnancy, there is also a risk that the newborn baby may experience withdrawal symptoms which can be life-threatening if not identified and treated by a doctor.

Do not use fentanyl during labour, as fentanyl may cause breathing difficulties in the newborn baby.

Breast-feeding

Fentanyl may pass into breast milk and cause side effects in the breast-fed baby. Do not use fentanyl if you are breast-feeding. You should not start breast-feeding until at least 5 days after the last dose of fentanyl.

Driving and using machines

Ask your doctor if you can drive or use machines safely after taking fentanyl. Do not drive or use machines if: you feel drowsy or dizzy, you have blurred vision or double vision or you have difficulty concentrating. It is important that you know how you react to fentanyl before you drive or use machines.

Use in athletes

Athletes are informed that this medicine contains a component that may result in a positive doping test.

Fentanilo Aristo contains sorbitol

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

3. How to use Fentanilo Aristo

Follow your doctor's administration instructions for this medication exactly. If in doubt, consult your doctor or pharmacist again.

Before starting treatment and regularly during it, 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 start using fentanyl 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 fentanyl exactly as your doctor indicates. 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 the breakthrough pain is not relieved after 30 minutes, use only 1 more fentanyl tablet 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 dose of analgesic you need may vary throughout treatment. You may need higher doses. If the breakthrough pain is not relieved after 30 minutes, use only 1 more fentanyl tablet during this dose readjustment period. Consult your doctor if your correct dose of fentanyl 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 episode of breakthrough pain with fentanyl.

You should inform your doctor immediately if you need to take fentanyl 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 the persistent pain is controlled, your doctor may need to change your dose of fentanyl. If your doctor suspects increased sensitivity to pain (hyperalgesia) related to fentanyl, a reduction in the dose of fentanyl may be considered (see section 2, under "Warnings and precautions"). For more effective relief, inform your doctor about the pain you are experiencing and how fentanyl is working in your case, so that they can modify the dose if necessary.

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

If you are unsure of the correct dose or want to ask a question about using this medication, contact your doctor.

Method of administration

The method of administration of fentanyl oral tablets is by mouth. When you place a tablet in your mouth, it dissolves and the medication is absorbed by the oral mucosa and passes into the bloodstream. This way of taking the medication allows it to be absorbed quickly to relieve your breakthrough pain.

How to use the medication

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

• Remove the tablet from the blister pack and place it immediatelywithout 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 your tongue.
• Do not attempt to crush or break the tablet.

• Do not bite, suck, chew, or swallow the tablet, as this will make it have a lesser analgesic effect than if you follow these instructions.
• The tablet should remain between the cheek and gum until it dissolves. It usually takes about 30 minutes.
• In case of irritation, you can change the placement of the tablet on the gum.
• After 30 minutes, if there are still remnants of the fentanyl 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 dissolved completely, rinse your mouth with water and spit out the remaining tablet immediately in the sink or toilet.
• A serious adverse effect of fentanyl is slow and/or shallow breathing. This can occur if the dose of fentanyl is too high or if you have taken too much fentanyl. In severe cases, taking too much fentanyl can lead to a coma. If you feel very dizzy, very drowsy, or have slow or shallow breathing, seek immediate medical attention.
• An 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 Toxicology Information Service, phone: 91 562 04 20, indicating the medication and the amount ingested.

If you forget to use Fentanilo Aristo

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

If you interrupt treatment with Fentanilo Aristo

You should stop fentanyl when you no longer have any breakthrough pain. However, you should continue taking your usual opioid analgesic medication to treat persistent cancer pain, as indicated 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, you should consult your doctor. Your doctor will assess whether you need medication to reduce or eliminate withdrawal symptoms.

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

4. Possible adverse effects

Like all medications, this medication can cause adverse effects, although not everyone will experience them. If you notice any of them, inform your doctor.

Serious adverse effects

• The most serious adverse effects are shallow breathing, low blood pressure, and shock. Fentanyl, like other fentanyl-based products, can cause very serious respiratory problems that can lead to death. If you feel very drowsy or have slow and/or shallow breathing, you or your caregiver should contact your doctor immediately and seek urgent 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 can be a sign of a potentially life-threatening disorder 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 site of application 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 of anxiety or confusion, depression, insomnia
• altered taste, weight loss
• drowsiness, sedation, excessive fatigue, weakness, migraine, numbness, inflammation of arms or legs, withdrawal syndrome (which can manifest with the following adverse 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 sores
• 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 cells that help blood clot;
• euphoria, nervousness, strangeness, restlessness or slowness; seeing or hearing things that are not real (hallucinations), altered state of consciousness, changes in mental state, drug dependence (addiction), disorientation, lack of concentration, loss of balance, vertigo, speech problems, ringing in the ears, ear discomfort;
• altered or blurred vision, red eyes;
• heart rate too low, feeling of excessive heat (hot flashes), high blood pressure;
• serious 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, cracked lips, dental disorders;
• esophageal inflammation, intestinal paralysis, gallbladder disorder;
• cold sweat, facial swelling, generalized itching, hair loss, muscle cramps, muscle weakness, general discomfort, chest discomfort, thirst, feeling of cold, feeling of heat, difficulty urinating;
• general discomfort;
• flushing.

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

• thought disorders, movement disorders
• blisters in the mouth, dry lips, presence of pus under the skin in the mouth
• testosterone deficiency, strange feeling in the eye, observation of flashes of light, fragile nails
• allergic reactions such as skin rash, redness, swelling of lips and face, hives

Unknown:frequency cannot be estimated from available data

• loss of consciousness, respiratory arrest, convulsion (seizure)
• sex hormone deficiency (androgen deficiency)
• drug dependence (addiction) (see section 2)
• drug abuse (see section 2)
• pharmacological tolerance (see section 2)
• delirium (symptoms may consist of a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not real, altered sleep, and nightmares)
• prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which can be potentially fatal (see section 2)

Reporting adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Fentanilo Aristo

Keep this medication in a safe and protected place, where others cannot access it. This medication can cause serious harm and even be fatal if used accidentally or intentionally by someone who has not been prescribed it.

The analgesic fentanyl is very strong and can be a risk to life if taken accidentally by a child. This medication should be kept out of sight and reach of children.

• Do not use this medication after the expiration date shown on the label of the blister packs 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. Keep in the original packaging to protect it from moisture.

Medications should not be thrown down the drain or into the trash. Deposit the packaging and medications you no longer need at the SIGRE collection point in the pharmacy. Ask your pharmacist how to dispose of the packaging and medications you no longer need. This will help protect the environment.

6. Package contents and additional information

Composition of Fentanilo Aristo

The active ingredient 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 ingredients are mannitol, sorbitol, citric acid, macrogol, L-arginine, and magnesium stearate.

Appearance of the product and package contents

The oral tablets are white, round, and engraved with "1" on one side for fentanyl 100 micrograms, with "2" on one side for fentanyl 200 micrograms, with "4" on one side for fentanyl 400 micrograms, with "6" on one side for fentanyl 600 micrograms, and with "8" on one side for fentanyl 800 micrograms

They have a diameter of approximately 10 mm.

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

Only some pack sizes may be marketed.

Marketing authorization holder

Aristo Pharma GmbH

Wallenroder Straße 8-10

13435 Berlin

Germany

Manufacturer

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

Date of the last revision of this leaflet:July 2025

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

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