ABFENTIQ 400 micrograms LOZENGE TABLETS

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Abfentiq 200 micrograms buccal tablets EFG

Abfentiq 400 micrograms buccal tablets EFG

Abfentiq 600 micrograms buccal tablets EFG

Abfentiq 800 micrograms buccal tablets EFG

Abfentiq 1200 micrograms buccal tablets EFG

Abfentiq 1600 micrograms buccal tablets EFG

Fentanyl

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 signs of illness 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 and other information:

1. What is Abfentiq and what is it used for
2. What you need to know before you use Abfentiq
3. How to use Abfentiq
4. Possible side effects

5 Storage of Abfentiq

1. Contents of the pack and further information.

1. What is Abfentiq and what is it used for

Abfentiq contains the active substance fentanyl, a potent analgesic belonging to the group of opioids. Abfentiq is presented as buccal tablets with an integrated applicator.

• Abfentiq is indicated for the treatment of breakthrough pain in adult patients with cancer, who are already taking other opioid analgesics for their persistent background pain. Breakthrough pain is a sudden increase in pain that occurs in addition to a persistent background pain, and which is not relieved by the opioid analgesics used to treat the background pain.
• Do not use Abfentiq if you have not been taking a prescribed opioid medication every day for at least one week to control your persistent background pain, as the use of Abfentiq may increase the risk of your breathing becoming slower and/or shallower, and even stopping.
• Do not use Abfentiq to treat pain caused by wounds, surgery, headache, or migraines.

2. What you need to know before you use Abfentiq

Do not use Abfentiq

• if you are not regularly using a prescribed opioid medication (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine) every day at the same time, for at least one week, to control your persistent background pain. If you have not been using these medications, do not use Abfentiq, as its use may increase the risk of your breathing becoming slower and/or shallower, and even stopping
• if you are allergic (hypersensitive) to fentanyl or any of the other ingredients of Abfentiq (listed in Section 6).

• if you are currently taking monoamine oxidase inhibitors (MAOIs) for the treatment of severe depression (or have taken them in the last 2 weeks).
• if you have severe respiratory problems or severe obstructive pulmonary disease.
• if you have short-term pain that is not breakthrough pain

Do not use Abfentiq if you are in any of the above situations. If you are not sure, consult your doctor or pharmacist before using Abfentiq.

Warnings and precautions:

During treatment with Abfentiq, continue to use the opioid analgesic medication you are taking for your persistent background pain associated with cancer.

If you have any of the following conditions, consult your doctor or pharmacist before using Abfentiq:

• if the other opioid medication you are taking for your persistent background pain associated with cancer has not yet been stabilized.

• if you have any disease that affects your breathing (such as asthma, wheezing, or shortness of breath).
• if you have had a head injury or have lost consciousness.
• if you have heart problems, especially low heart rate.
• if you have liver or kidney problems, as these affect how the body eliminates the medication.
• if you have low blood pressure due to low fluid volume in the circulatory system.
• if you are diabetic.
• if you are over 65 years old, as the dose may need to be reduced. Any increase in dose should be carefully monitored by your doctor.
• if you are taking antidepressants or antipsychotics; see the section "Use with other medicines".
• if you are taking analgesics for neuropathic pain (gabapentin and pregabalin).

It is possible that your doctor will need to monitor you more closely:

• if you or a family member have ever had a history of substance abuse or dependence on alcohol, prescription medications, or street drugs ("addiction").
• if you are a smoker.
• if you have ever had problems related to your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

Consult your doctor if, DURING the use of Abfentiq:

• 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.
• you experience a combination of the following symptoms: nausea, vomiting, anorexia, 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.
• you have ever had adrenal insufficiency or a lack of sex hormones (androgen deficiency) with the use of opioids.
• if you experience sleep-related breathing disorders: Abfentiq may cause sleep-related breathing disorders 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, nighttime awakenings due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.
• the repeated use of Abfentiq can lead to dependence and abuse, which can cause a potentially life-threatening overdose. If you are concerned about the possibility of becoming dependent on Abfentiq, it is essential that you consult your doctor.

Children and adolescents

Abfentiq is not recommended for children under 16 years of age.

Use in athletes

This medication contains fentanyl, which can produce a positive result in doping tests.

Use of Abfentiq with other medicines

Tell your doctor or pharmacist if you are using or have recently used any of the following medicines:

• other fentanyl-based treatments that your doctor has previously prescribed for breakthrough pain. If you still have these fentanyl products at home, contact your pharmacist, who will tell you how to dispose of them.

Tell your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription and herbal remedies. In particular, tell your doctor or pharmacist if you are using any of the following medicines:

• any medicine that can make you sleepy, such as sleeping pills, medications for anxiety, or certain medications for allergies (antihistamines) or tranquilizers.
• certain muscle relaxants (such as baclofen or diazepam).
• any medicine that can affect how the body eliminates Abfentiq, such as ritonavir or other medications used to control HIV infection (AIDS) or other medications called "CYP3A4 inhibitors" such as ketoconazole, itraconazole, or fluconazole (used for fungal infections) and troleandomycin, clarithromycin, or erythromycin (medications for bacterial infections) and "CYP3A4 inducers" such as rifampicin or rifabutin (medications for bacterial infections), carbamazepine, phenobarbital, or phenytoin (medications used to treat seizures/attacks)
• any medicine that can reduce or reverse the effect of Abfentiq (such as naloxone, pentazocine, buprenorphine). They can cause withdrawal syndrome.
• if you need to undergo surgery that requires general anesthesia.
• the risk of side effects increases if you are taking medications such as certain antidepressants or antipsychotics. Abfentiq can interact with these medications, 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, diarrhea). Your doctor will tell you if Abfentiq is suitable for you.

Use of Abfentiq with sedatives:

The concomitant use of Abfentiq and sedative medications, such as benzodiazepines or related medications, increases the risk of drowsiness, breathing difficulties (respiratory depression), coma, and can be life-threatening. Therefore, concomitant use should only be considered when there are no other possible treatment alternatives.

However, if your doctor has prescribed Abfentiq and sedatives at the same time, the dose and duration of treatment should be limited by your doctor.

Tell your doctor about all sedative medications you are taking and strictly follow the recommended dose prescribed by your doctor. It may be helpful to inform your family or friends about the signs and symptoms mentioned above. Talk to your doctor if you experience any of these symptoms.

Use of Abfentiq with food, drinks, and alcohol

• Abfentiq can be used before or after meals. However, do not use it during a meal.
• You can drink a little water before using Abfentiq to moisten your mouth. However, do not drink or eat anything while using Abfentiq.
• Do not drink grapefruit juice while using Abfentiq, as it may affect how the body eliminates Abfentiq.
• Do not drink alcoholic beverages while being treated with Abfentiq, as it may increase the risk of serious side effects.

Pregnancy, breastfeeding, and fertility

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

Do not use Abfentiq during labor, as it may cause breathing difficulties in the newborn. There is also a risk that the newborn may experience withdrawal syndrome if Abfentiq has been used for long periods during pregnancy.

Fentanyl can pass into breast milk and cause side effects in the breastfed child. Do not use Abfentiq if you are breastfeeding. You should not start breastfeeding until at least 48 hours after the last dose of Abfentiq.

Consult your doctor or pharmacist before using any medication if you are pregnant or breastfeeding.

Driving and using machines

This medication can affect your ability to drive or operate certain tools or machinery. Consult your doctor about the safety of driving or operating certain tools or machinery in the hours following the use of Abfentiq.

Do not drive or operate certain tools or machinery if: you feel drowsy or dizzy; you have blurred or double vision; you have difficulty concentrating. It is essential that you know how Abfentiq affects you before driving or operating certain tools or machinery.

Abfentiq contains glucose and sodium.

• This medication contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with them before taking this medication. It may cause cavities.

This medication contains less than 23 mg of sodium (1mmol) per buccal tablet; this is essentially "sodium-free".

3. How to use Abfentiq

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

When you start using Abfentiq for the first time, your doctor will work with you to find the Abfentiq dose that relieves your breakthrough pain. It is very important that you use Abfentiq exactly as your doctor has indicated.

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

• If you have doubts about the correct dose or questions about the use of Abfentiq, consult your doctor.

How the medicine penetrates the body

When you put Abfentiq in your mouth:

• The lozenge dissolves, and the drug is released. This process takes place in about 15 minutes.
• The drug is absorbed through the oral mucosa into the bloodstream.

The fact of using the medicine in this way allows it to be absorbed quickly, which means rapid relief from breakthrough pain.

Determining the correct dose

You should start to feel relief quickly while using Abfentiq. However, until you and your doctor determine the dose that effectively controls the breakthrough pain, you may not feel sufficient pain relief 30 minutes after starting to use one Abfentiq unit (15 minutes after finishing using the Abfentiq lozenge). If this happens, your doctor may allow you to use a second Abfentiq lozenge of the same dose to treat the same episode of breakthrough pain.

Do not use a second unit unless your doctor indicates it.

Never use more than two units to treat a single episode of breakthrough pain.

During the determination of the correct dose, you may need to have Abfentiq units of different concentrations at home. However, keep at home only the Abfentiq concentrations you need. This helps prevent possible confusion and overdose. Consult your pharmacist on how to dispose of the Abfentiq units you do not need.

How many units should be used

Once you have determined the correct dose with your doctor, use 1 unit for an episode of breakthrough pain. Consult your doctor if your correct dose of Abfentiq does not relieve the breakthrough pain over several consecutive episodes of breakthrough pain. Your doctor will decide if it is necessary to modify the dose.

You must inform your doctor immediately if you use Abfentiq more than four times a day. In that case, it may be convenient to change the medication for persistent pain (present all the time). Once this is done, when the persistent pain is controlled, the doctor may need to change the Abfentiq dose again. To get better results, inform your doctor about the pain you are suffering from and how Abfentiq is working. This way, the dose can be changed if necessary.

Using the medicine

Opening the packaging

• Each Abfentiq unit is sealed in its own blister packaging.

Do not open the packaging ahead of time.

• Hold the blister packaging with the printed side facing away from you.
• Hold the short end of the blister packaging.
• Place the scissors near the end of the Abfentiq unit and cut off the long end completely (see the illustration).
• Separate the printed back of the blister packaging and pull it completely out of the packaging.

completely out of the packaging.

• Remove the Abfentiq unit from the blister packaging and immediately place

the Abfentiq lozenge in your mouth.

Using the Abfentiq unit

• Place the lozenge between your cheeks and gums.
• With the applicator, continuously move Abfentiq around your mouth,

especially around your cheeks. Turn the applicator often.

• To make the relief more effective, you must finish the Abfentiq unit completely

in about 15 minutes. If you finish it too quickly, you will swallow more medication and get less relief from the breakthrough pain.

• Do not bite or chew the Abfentiq unit. This will result in lower blood levels and less relief from the pain than if used as indicated.

If for any reason you do not finish the entire Abfentiq unit each time you experience breakthrough pain, contact your doctor.

Frequency of administration

Once you have achieved a dose that effectively controls your pain, do not use more than four Abfentiq units per day. If you think you may need more than four Abfentiq units per day, you must notify your doctor immediately.

How many Abfentiq units should you use

Do not use more than two Abfentiq lozenges to treat a single episode of breakthrough pain.

If you use more Abfentiq than you should

The most common side effects if you use too much are drowsiness, dizziness, and nausea.

• If you start to feel dizzy, nauseous, or very sleepy before the lozenge has dissolved completely, remove it from your mouth and ask someone else in the household for help.

A serious side effect of Abfentiq is slow and/or shallow breathing. This can occur if the Abfentiq dose is too high or if you use too much Abfentiq.

• If this happens, seek medical help immediately.

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

What to do if a child or adult accidentally uses Abfentiq

If you believe someone has accidentally used Abfentiq, seek medical help immediately. Try to keep the person awake (by calling their name or shaking their arm or shoulder) until medical help arrives.

If you forget to use Abfentiq

If the breakthrough pain still persists, you should use Abfentiq as your doctor has indicated. If the breakthrough pain disappears, do not use more Abfentiq until another episode of breakthrough pain appears.

If you interrupt treatment with Abfentiq

Do not stop using Abfentiq without consulting your doctor. No noticeable effects usually appear if you stop using Abfentiq. Continue using your usual opioid medication to treat persistent pain (present all the time) as your doctor indicates.

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

4. Possible side effects

Like all medications, Abfentiq can cause side effects, although not all people experience them. If you notice any side effect, contact your doctor.

The most serious side effects are shallow breathing, low blood pressure, and shock.

You or your caregiver should remove the Abfentiq unit from your mouth. Contact your doctor immediately and request urgent help if you experience any of the following side effects – you may need urgent medical attention:

• If you are very drowsy or have slow or shallow breathing.
• Difficulty breathing or dizziness, swelling of the tongue, lips, or throat that can be the first signs of a severe allergic reaction.

Note for caregivers:

If you observe that the patient using Abfentiq has slow and/or shallow breathing or has difficulty waking up, take the following measures IMMEDIATELY:

• Take the Abfentiq unit by the applicator, remove it from the patient's mouth, and keep it out of the reach of children or pets until you dispose of it.
• REQUEST URGENT ASSISTANCE
• While waiting for urgent assistance to arrive, if the person appears to be breathing slowly, encourage them to breathe every 5-10 seconds.

If you feel excessively dizzy, drowsy, or experience any other discomfort while using Abfentiq, remove the Abfentiq unit from your mouth using the applicator and dispose of it according to the instructions explained in this prospectus (see section 5). Then, contact your doctor for new instructions on using Abfentiq.

Very common side effects(may affect more than 1 in 10 patients):

• Vomiting, nausea/discomfort, constipation, stomach pain (abdominal)
• Asthenia (weakness), drowsiness, sedation, dizziness. Headache.
• Shortness of breath.

Common side effects(may affect up to 1 in 10 patients):

• Confusion, anxiety, seeing or hearing things that are not there (hallucinations), depression, mood changes.
• Feeling unwell
• Seizure, muscle spasm, feeling of vertigo or dizziness, loss of consciousness, sedation, feeling of tingling, numbness, difficulty coordinating movements, increased or altered sensitivity to touch, convulsions (epileptic seizures).
• Dry mouth, oral inflammation, tongue disorders (e.g., burning sensation or ulcers), taste alterations.
• Gas, abdominal bloating, indigestion, decreased appetite, weight loss.
• Blurred or double vision.
• Sweating, skin rash, itching.
• Difficulty urinating
• Accidental injuries (e.g., falls).
• General discomfort.

Uncommon side effects(may affect up to 1 in 100 patients):

• Dental caries, intestinal paralysis, mouth ulcers, gum bleeding.
• Coma, difficulty speaking.
• Abnormal dreams, feeling of indifference, abnormal thoughts, excessive feeling of well-being.
• Vasodilation
• Urticaria

Frequency not known:

• Decreased gums, gum inflammation, tooth loss, severe respiratory problems, flushing, feeling of excessive heat, diarrhea, inflammation of arms or legs, fatigue.
• Drug dependence (addiction)
• Drug abuse
• Delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not really exist, sleep disorders, nightmares)

While using Abfentiq, you may experience irritation, pain, and ulcers at the application site and gum bleeding.

Prolonged treatment with fentanyl during pregnancy may cause withdrawal symptoms in the newborn, which can be potentially fatal (see section 2).

Reporting side effects

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

5. Conservation of Abfentiq

Keep this medication out of sight and reach of children.

The analgesic medication of Abfentiq is very potent and could be potentially fatal for a child if used accidentally. Abfentiq must be kept out of sight and reach of children.

• Do not use this medication after the expiration date shown on the blister packaging and carton after "EXP:". The expiration date is the last day of the month indicated.
• Store below 25°C.
• Always keep Abfentiq in its blister packaging until you are ready to use it. Do not use this medication if you notice that the blister packaging is damaged or opened before you are ready to use it.

Medicines should not be thrown away through wastewater or household waste. Deposit the packaging and medicines you no longer need in the pharmacy's SIGRE point. If in doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

• How to dispose of Abfentiq once used

Partially used Abfentiq units may still contain enough medication to be harmful or potentially fatal to a child.

Even if there is no medication left in the applicator, the applicator must be disposed of properly, as follows:

• If there is no medication left, throw the applicator away in a trash can that is out of the reach of children and pets.
• If there is medication left in the applicator, put the lozenge under a stream of hot water to dissolve the remaining medication and then throw the applicator away in a trash can that is out of the reach of children and pets.
• If you do not finish the entire Abfentiq unit and cannot dissolve the remaining medication immediately, put the Abfentiq unit out of the reach of children and pets until you have time to dispose of the partially used Abfentiq unit as explained.

• Do not throw away partially used Abfentiq units, Abfentiq applicators, or blister packaging down the toilet.

6. Package contents and additional information

Composition of Abfentiq 200, 400, 600, 800, 1200, 1600 micrograms

The active ingredient is fentanyl. Each lozenge contains 200, 400, 600, 800, 1200, or 1600 micrograms of fentanyl (as citrate).

The other components are:

Lozenge:

Hydrated dextrates, anhydrous citric acid, anhydrous sodium hydrogen phosphate, artificial berry flavor, magnesium stearate.

Edible adhesive used to attach the lozenge to the applicator:

Modified cornstarch-based edible adhesive (E 1450), hydrated dextrates, water.

Applicator:

ABS resin

Food ink (E-133)

Product appearance and packaging contents

Abfentiq is a system for administering medication directly through the oral mucosa. Each Abfentiq unit consists of a white solid medication attached to an applicator.

The unit is normally white; however, during storage, it may acquire a slightly speckled appearance. This is due to slight changes in the product's flavoring and does not affect the medication's action in any way.

Abfentiq is available in 6 different doses: 200, 400, 600, 800, 1200, and 1600 micrograms. The dose is marked on the white lozenge, on the applicator, on the blister packaging, and on the carton to ensure that you use the correct medication and dose. Each dose is associated with a specific color.

Each blister packaging contains a single Abfentiq unit, supplied in boxes of 3, 6, 15, or 30 individual Abfentiq units.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Manufacturer:

PRASFARMA, S.L.

c/ Sant Joan 11-15.

08560 Manlleu (Barcelona)

Spain

Local representative:

FERRER FARMA, S.A.

Av. Diagonal, 549 5ª planta

08029 Barcelona (Spain)

Date of the last revision of this prospectus: February 2022

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