PROSPECTO : INFORMATION FOR THE USER

Abfentiq 200 micrograms lozenges EFG

Abfentiq 400 micrograms lozenges EFG

Abfentiq 600 micrograms lozenges EFG

Abfentiq 800 micrograms lozenges EFG

Abfentiq 1200 micrograms lozenges EFG

Abfentiq 1600 micrograms lozenges EFG

Fentanyl

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, 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 do not appear in this prospectus. See section 4.

1.What is Abfentiq and for what it is used

2.What you need to know before starting to use Abfentiq

3.How to use Abfentiq

4.Possible adverse effects

5Storage of Abfentiq

6.Contents of the package and additional information.

Abfentiq contains fentanil as its active ingredient, a potent analgesic that belongs to the group of opioids. Abfentiq is presented in lozenges with integrated oral applicator.

• Abfentiq is indicated for the treatment of breakthrough pain in adult cancer patients who are already taking other opioid medications for persistent pain (pain present all the time) caused by cancer. Breakthrough pain is sudden additional pain that appears on top of a baseline pain, and occurs despite taking usual opioid analgesic medications.
• Do not use Abfentiq if you have not been taking regularly every day, a prescribed opioid medication for persistent pain (pain present all the time), for at least one week, as not taking those medications may increase the likelihood 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.

Do not use Abfentiq

• If you are not regularly using an opioid medication prescribed by your doctor (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine), every day at the same time, for at least one week, to control persistent 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 to any of the other components 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 a severe obstructive lung disease.
• If you have short-term pain other than breakthrough pain.

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

Warnings and precautions:

During treatment with Abfentiq, continue to use the opioid analgesic medication you take for your persistent pain (present all the time) 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 take for your persistent pain (present all the time) associated with cancer has not yet stabilized.

• If you have any respiratory disease (such as asthma, wheezing, or shortness of breath).
• If you have any head injury or have experienced loss of 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 circulating volume.
• If you are diabetic.
• If you are over 65 years old, as it may be necessary to reduce the dose. Any increase in dose should be carefully monitored by your doctor.
• If you are taking antidepressants or antipsychotics; see the section “Use of other medications”.
• If you are taking analgesics for neuropathic pain (gabapentin and pregabalin).

Your doctor may need to monitor you more closely:

• If you or a family member have ever had abuse or dependence on alcohol, prescription medications, or drugs (“addiction”).
• If you are a smoker.
• If you have ever had mood-related problems (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, loss of appetite, fatigue, weakness, dizziness, and low blood pressure. Together, these symptoms may 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 hormone deficiency (androgen deficiency) with the use of opioids.
• You experience sleep-related respiratory problems: Abfentiq may cause sleep-related respiratory problems such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observes these symptoms, contact your doctor. Your doctor may consider reducing the dose.
• The repeated use of Abfentiq may lead to dependence and abuse that can cause a potentially fatal overdose. If you are concerned about the possibility of acquiring dependence on Abfentiq, it is essential to consult your doctor.

Children and adolescents

Abfentiq is not recommended for children under 16 years old.

Use in athletes

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

Use of Abfentiq with other medications

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

• Other fentanyl-based treatments that your doctor may have prescribed for breakthrough pain in the past. If you still have these fentanyl products at home, contact your pharmacist, who will advise you on how to dispose of them.

Inform your doctor or pharmacist if you are using or have recently used other medications, even those obtained without a prescription and herbal remedies. In particular, inform your doctor or pharmacist if you are using any of the following medications:

• Any medication that may cause drowsiness, such as sleep aids, anxiety medications, some allergy medications (antihistamines), or tranquilizers.
• Certain muscle relaxants (such as baclofen or diazepam).
• Any medication that may affect how the body eliminates Abfentiq, such as ritonavir or other medications that help 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 (used for bacterial infections) and the so-called “CYP3A4 inducers” such as rifampicin or rifabutin (used for bacterial infections), carbamazepine, phenobarbital, or phenytoin (used for seizures/convulsions).
• Any medication that may reduce or reverse the effect of Abfentiq (such as naloxone, pentazocine, or buprenorphine). They may cause withdrawal syndrome.
• If you are scheduled to undergo surgery that requires general anesthesia.
• The risk of adverse effects increases if you are taking medications such as certain antidepressants or antipsychotics. Abfentiq may interact with these medications, and you may experience changes in mental state (e.g., agitation, hallucinations, coma) and other effects such as high body temperature, increased heart rate, unstable blood pressure, and exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will tell you if Abfentiq is suitable for you.

Use of Abfentiq with sedatives:

The concomitant use of Abfentiq and sedatives, such as benzodiazepines or related medications, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may 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 simultaneously, the dose and duration of treatment should be limited by your doctor.

Inform your doctor of all sedatives you are taking and follow your doctor's recommended dose strictly. It may be helpful to inform your family or friends of the mentioned symptoms. 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 may drink a little water before using Abfentiq to moisten your mouth. However, do not drink or eat anything while using Abfentiq.
• Do not drink orange juice while using Abfentiq as it may affect how the body eliminates Abfentiq.
• Do not drink alcoholic beverages while on Abfentiq treatment as it may increase the risk of severe adverse effects.

Pregnancy, breastfeeding, and fertility

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

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

Fentanyl may pass into breast milk and cause adverse effects in the infant. Do not use Abfentiq if you are breastfeeding your child. Do not initiate breastfeeding within 48 hours of the last Abfentiq dose.

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

Driving and operating machinery

This medication may affect your ability to drive or operate certain tools or machinery. Consult your doctor about the safety for you to drive or operate certain tools or machinery after using Abfentiq.

Do not drive or operate certain tools or machinery if: you feel drowsy or dizzy; you have blurred vision or double vision; you have difficulty concentrating. It is essential to 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 them before taking this medication. It may cause tooth decay.

This medication contains less than 23 mg of sodium (1 mmol) per lozenge; it is essentially “sodium-free”.

Follow exactly the administration instructions of this medication as indicated by your doctor or pharmacist. 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 instructed you.

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

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

How the medication enters the body

When you put Abfentiq in your mouth:

• The dissolvable tablet 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 that you use the medication 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 your breakthrough pain, you may not feel sufficient relief from pain 30 minutes after starting to use a unit of Abfentiq (15 minutes after using the Abfentiq tablet). If this occurs, your doctor may allow you to use a second Abfentiq tablet of the same dose to treat the same episode of breakthrough pain.

Do not use a second unit unless your doctor tells you to.

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 units of Abfentiq with different concentrations available at home. However, keep only the concentrations of Abfentiq that you need at home. This allows you to prevent possible confusion and overdoses. Consult with your pharmacist on how to dispose of Abfentiq units that 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 your breakthrough pain over several consecutive episodes of breakthrough pain. Your doctor will decide if it is necessary to adjust your dose.

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

Using the medication

Opening the packaging

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

Do not open the packaging prematurely.

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

completely from the packaging.

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

the Abfentiq tablet in your mouth.

Using the Abfentiq unit

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

especially around your cheeks. Turn the applicator often.

• To achieve more effective relief, 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 breakthrough pain.

• Do not bite, suck, or chew the Abfentiq unit. This would result in

lower levels in the blood and less relief from pain 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.

Administration frequency

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

How many units of Abfentiq should you use

Do not use more than two Abfentiq tablets 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, want to vomit, or are very sleepy before the dissolvable tablet has completely dissolved, remove it from your mouth and ask someone else in the house to help you.

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.

• Seek medical help immediately if this occurs.

• In case of overdose or accidental ingestion, consult your doctor or pharmacist or call the Toxicological 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 think someone has accidentally used Abfentiq, seek medical help immediately. Try to keep the person awake (calling their name or shaking them by the arm or shoulder) until medical help arrives.

If you forget to use Abfentiq

If the breakthrough pain persists, you should use Abfentiq as instructed by your doctor. If the breakthrough pain disappears, do not use more Abfentiq until another episode of breakthrough pain occurs.

If you interrupt treatment with Abfentiq

Do not stop using Abfentiq without consulting your doctor. There are usually no noticeable effects if you stop using Abfentiq. Continue using your usual opioid medication to treat persistent pain (present all the time) as instructed by your doctor.

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

Like all medicines, Abfentiq may cause side effects, although not everyone will experience them.If you notice any side effects, contact your doctor.

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

You or your caregiver must remove the Abfentiq unit from the 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 dizzy, swelling of the tongue, lips, or throat, which may be the first signs of a severe allergic reaction.

Important note for caregivers:

If you observe that the patient using Abfentiq has slow and/or shallow breathing or if it is difficult to wake them, take the following immediate measures:

• Take the Abfentiq unit by the applicator, remove it from the patient's mouth, and keep it out of reach of children or pets until you dispose of it.
• REQUEST URGENT ASSISTANCE
• Whilewaiting for urgent assistance to arrive, if it seems that the person is 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 leaflet (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/malaise, constipation, abdominal pain (stomach)
• Weakness (asthenia), drowsiness, sedation, dizziness. Headache.
• Lack 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.
• Uncomfortable feeling
• Attack, muscle spasm, sensation of vertigo or dizziness, loss of consciousness, sedation, sensation of numbness, tingling, difficulty coordinating movements, increased or altered sensitivity to touch, convulsions (epileptic seizures).
• Dry mouth, oral inflammation, tongue disorders (e.g., burning sensation or ulcers), alterations in taste.
• Gas, abdominal swelling, indigestion, decreased appetite, weight loss.
• Blurred vision or double vision.
• Sweating, skin rashes, pruritus.
• 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, bleeding gums.
• Coma, difficulty speaking.
• Abnormal dreams, feeling indifferent, abnormal thoughts, excessive feeling of well-being.
• vasodilation
• Urticaria

Frequency not known:

• Decreased gums, gum inflammation, tooth loss, severe respiratory problems, flushing, feeling very hot, 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 are not there, sleep disorders, nightmares)

You may experience irritation, pain, and ulcers at the application site and bleeding gums while using Abfentiq.

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

Reporting of Side Effects

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

Maintain this medication out of the sight and reach of children.

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

• Do not use this medication after the expiration date that appears on the blister pack and carton after “CAD:”. The expiration date is the last day of the month indicated.
• Store below 25°C.
• Maintain Abfentiq always in its blister pack until you are ready to use it. Do not use this medication if you observe that the blister pack is damaged or open before you are ready to use it.

Medications should not be disposed of through drains or trash. Deposit the containers and medications that you do not need in the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of the containers and medications that you do not need. In this way, you will help to protect the environment.

• How to eliminate Abfentiq once used

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

Even if there is still some medication or none in the applicator, the applicator must be disposed of properly, as follows:

• If there is no medication left, throw the applicator in a trash container that is out of the reach of children and pets.
• If there is medication left in the applicator, place the tablet under a hot water faucet to dissolve the remains and then throw the applicator in a trash container that is out of the reach of children and pets.
• If you do not finish the entire unit of Abfentiq and cannot dissolve the remaining medication immediately, place 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 the partially used Abfentiq units, Abfentiq applicators, or blister packs in the toilet.

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

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

The other components are:

Lozenge:

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

Edible adhesive used to attach the lozenge to the applicator:

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

Applicator:

ABS resin

Food coloring (E-133)

Appearance of the product and contents of the package

Abfentiq is a system for the administration of medication directly through the oral mucosa. Each unit of Abfentiq 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 flavoring of the product and does not in any way affect the action of the medication.

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, and on the packaging, to ensure that you use the correct medication and dose. Each dose is associated with a specific color.

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

Only some package sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

Marketing authorization holder:

FERRER INTERNACIONAL, S.A.

Gran Vía Carlos III, 94

08028 Barcelona (Spain)

Responsible manufacturer:

PRASFARMA, S.L.

c/ Sant Joan 11-15.

08560 Manlleu (Barcelona)

Spain

Local representative:

FERRER FARMA, S.A.

Av. Diagonal, 549 5th floor

08029 Barcelona (Spain)

Last review date of this leaflet: February 2022

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