Abfentiq 800 micrograms tablets for sucking EFG

Package leaflet: Information for the user

Introduction

PACKAGE LEAFLET: INFORMATION FOR THE USER

Abfentiq 200 micrograms lozenges for sucking EFG

Abfentiq 400 micrograms lozenges for sucking EFG

Abfentiq 600 micrograms lozenges for sucking EFG

Abfentiq 800 micrograms lozenges for sucking EFG

Abfentiq 1200 micrograms lozenges for sucking EFG

Abfentiq 1600 micrograms lozenges for sucking EFG

Fentanyl

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you and you should not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. See section 4.

Leaflet contents:

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

1. What Abfentiq is and what it is used for

Abfentiq contains as its active substance fentanyl, a potent analgesic belonging to the opioid group. Abfentiq is available as orally dissolving tablets with an integrated oral dispenser.

• Abfentiq is indicated for the treatment of breakthrough pain in adult cancer patients who are already receiving regular opioid therapy for persistent (constant) cancer-related pain. Breakthrough pain is sudden additional pain that occurs on top of a background of continuous pain, despite the use of regular opioid analgesics.
• Do not use Abfentiq if you have not been taking an opioid medication regularly every day for at least one week to treat persistent (constant) pain, because if you have not been receiving such treatment, using Abfentiq may increase the risk of your breathing becoming slow and/or shallow, or even stopping completely.
• Do not use Abfentiq to treat pain caused by injuries, surgery, headache, or migraines.

2. What you need to know before using Abfentiq

Do not use Abfentiq

• if you are not regularly taking an opioid medicine prescribed by your doctor (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine), every day at the same time, for at least one week, to control persistent pain. If you have not been taking these medicines, do not use Abfentiq, as its use may increase the risk of your breathing becoming slower and/or shallower, or even stopping completely.
• 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 inhibitor (MAOI) medicines for the treatment of severe depression (or have done so within the last 2 weeks).
• If you have severe respiratory problems or severe obstructive lung disease.
• If you have short-term pain other than breakthrough pain.

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

Warnings and precautions

While being treated with Abfentiq, continue using the opioid analgesic medicine you take for your persistent (constant) cancer-related pain.

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

• If the other opioid medicine you are taking for your persistent (constant) cancer-related pain has not yet been stabilized.
• If you have a medical condition affecting your breathing (such as asthma, wheezing, or shortness of breath).
• If you have a head injury or have ever lost consciousness.
• If you have heart problems, especially a low heart rate.
• If you have liver or kidney problems, as these affect how your body eliminates the medicine.
• 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 of age, as a lower dose may be required. Any dose increase should be carefully monitored by your doctor.
• If you are taking antidepressants or antipsychotics; see the section “Use of other medicines”.
• 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 has ever had alcohol, prescription medicine, or drug abuse or dependence (“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 illnesses.

Consult your doctor if, DURING the use of Abfentiq:

• 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.
• You develop a combination of the following symptoms: nausea, vomiting, anorexia, fatigue, weakness, dizziness, and low blood pressure. Together, these symptoms may indicate a potentially life-threatening condition called adrenal insufficiency, in which the adrenal glands do not produce enough hormones.
• You have previously experienced adrenal insufficiency or sex hormone deficiency (androgen deficiency) with opioid use.
• You develop 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 breathing pauses during sleep, waking up at night due to difficulty breathing, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.
• Repeated use of Abfentiq may lead to dependence and abuse, which could result in a potentially fatal overdose. If you are concerned about becoming dependent on Abfentiq, it is important to consult your doctor.

Children and adolescents

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

Use in athletes

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

Use of Abfentiq with other medicines

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

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

Inform 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, inform your doctor or pharmacist if you are using any of the following medicines:

• Any medicine that may make you sleepy, such as sleeping pills, medicines for treating anxiety, some medicines for treating allergies (antihistamines), or tranquilizers.
• Certain muscle relaxants (such as baclofen or diazepam).
• Any medicine that may affect how your body eliminates Abfentiq, such as ritonavir or other medicines used to control HIV infection (AIDS), or other medicines known as “CYP3A4 inhibitors” such as ketoconazole, itraconazole, or fluconazole (used for fungal infections), and troleandomycin, clarithromycin, or erythromycin (medicines for bacterial infections), and so-called “CYP3A4 inducers” such as rifampicin or rifabutin (medicines for bacterial infections), carbamazepine, phenobarbital, or phenytoin (medicines used to treat seizures/episodes).
• Any medicine that may reduce or reverse the effect of Abfentiq (such as naloxone, pentazocine, buprenorphine). These may cause withdrawal symptoms.
• If you are scheduled for surgery requiring general anesthesia.
• The risk of adverse effects increases if you are taking medicines such as certain antidepressants or antipsychotics. Abfentiq may interact with these medicines, and you may experience changes in mental status (e.g., agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure, exaggerated reflexes, muscle rigidity, lack of coordination, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Your doctor will advise you whether Abfentiq is suitable for you.

Use of Abfentiq with sedatives

Concomitant use of Abfentiq and sedative medicines, such as benzodiazepines or related medicines, increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may be life-threatening. Therefore, concomitant use should only be considered when no other treatment alternatives are available.

However, if your doctor has prescribed Abfentiq and sedative medicines simultaneously, the dose and duration of treatment must be limited by your doctor.

Inform your doctor about all sedative medicines you are taking and strictly follow the dose recommended by your doctor. It may be helpful to inform family members or friends about the signs and symptoms mentioned above. Speak with your doctor if you experience any of these symptoms.

Use of Abfentiq with food, drinks, and alcohol

• Abfentiq may be used before or after meals. However, do not use it during a meal.
• You may drink a small amount of water before using Abfentiq to moisten your mouth. However, you should not drink or eat anything while using Abfentiq.
• Do not drink grapefruit juice while using Abfentiq, as it may affect how your body eliminates the medicine.
• Do not consume alcoholic beverages while being treated with Abfentiq, as this may increase the likelihood of serious adverse effects.

Pregnancy, breastfeeding, and fertility

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

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

Fentanyl may pass into breast milk and cause adverse effects in the infant. 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 medicine if you are pregnant or breastfeeding.

Driving and operating machinery

This medicine may affect your ability to drive or operate certain tools or machinery. Consult your doctor about whether it is safe for you to drive or operate 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; or you have difficulty concentrating. It is important that you understand how Abfentiq affects you before driving or operating certain tools or machinery.

Abfentiq contains glucose and sodium.

• This medicine contains glucose. If your doctor has told you that you have an intolerance to certain sugars, consult with him before taking this medicine. It may cause dental caries.

This medicine contains less than 23 mg of sodium (1 mmol) per orally disintegrating tablet; this is essentially “sodium-free”.

3. How to use Abfentiq

Follow exactly the administration instructions for this medicine given 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 directed by your doctor.

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

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

How the medicine enters the body

When you place Abfentiq in your mouth:

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

Using the medicine in this way allows for rapid absorption, meaning fast relief of breakthrough pain.

Determining the correct dose

You should start to feel relief quickly when using Abfentiq. However, until you and your doctor determine the dose that effectively controls breakthrough pain, you may not experience sufficient pain relief within 30 minutes after starting to use one unit of Abfentiq (15 minutes after finishing 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 breakthrough pain episode.

Do not use a second unit unless instructed by your doctor.

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

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

How many units to use

Once you and your doctor have determined the correct dose, use 1 unit for a breakthrough pain episode. Consult your doctor if your correct dose of Abfentiq does not relieve your breakthrough pain over several consecutive episodes. Your doctor will decide whether a dose adjustment is needed.

You must inform your doctor immediately if you use Abfentiq more than four times a day. In this case, your doctor may consider changing your medication for persistent pain (pain present all the time). Once this is done, and your persistent pain is under control, your doctor may need to adjust your Abfentiq dose again. For best results, inform your doctor about your pain 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 pack.

Do not open the packaging too early.

• Hold the blister pack with the printed side facing away from you.

• Hold the short end of the blister pack.

• Place the scissors near the end of the Abfentiq unit and cut completely across the long end (see illustration).

• Peel back the printed back panel of the blister pack and remove it completely from the packaging.

• Remove the Abfentiq unit from the blister pack and immediately place the Abfentiq lozenge in your mouth.

Using the Abfentiq unit

• Place the lozenge between your cheek and gums.

• Using the applicator, continuously move Abfentiq around your mouth, especially along the inside of your cheeks. Rotate the applicator frequently.

• For optimal relief, the entire Abfentiq unit should be dissolved within about 15 minutes. If you finish it too quickly, you will swallow more medication and obtain less relief from breakthrough pain.

• Do not bite or chew the Abfentiq unit. This would result in lower blood levels and less pain relief than when used as directed.

• 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 established 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 daily, inform your doctor immediately.

How many Abfentiq units you should 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 of overdose are drowsiness, dizziness, and nausea.

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

A serious side effect of Abfentiq is slow and/or shallow breathing. This may 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, contact your doctor or pharmacist or call the Toxicology Information Service. Telephone: 91 562 04 20, stating the name of the medicine and the amount ingested.

What to do if a child or adult accidentally uses Abfentiq

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

If you forget to use Abfentiq

If breakthrough pain is still present, you should use Abfentiq as directed by your doctor. If the breakthrough pain has gone away, do not use more Abfentiq until another episode of breakthrough pain occurs.

If you stop using Abfentiq

Do not stop using Abfentiq without consulting your doctor. Noticeable effects are not usually experienced when you stop using Abfentiq. Continue taking your usual opioid medication for persistent pain (pain present all the time) as directed by your doctor.

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

4. Possible adverse effects

Like all medicines, Abfentiq may cause adverse effects, although not everyone experiences them. If you notice any adverse effect, contact your doctor.

The most serious adverse 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 seek urgent help if you experience any of the following adverse effects – you may require 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, which may be early signs of a severe allergic reaction.

Note for caregivers:

If you observe that the patient using Abfentiq has slow and/or shallow breathing or is difficult to awaken, take the following measures IMMEDIATELY:

• Grasp the Abfentiq unit by the applicator, remove it from the patient’s mouth, and keep it out of reach of children or pets until it is disposed of.
• SEEK EMERGENCY ASSISTANCE
• While waiting for emergency help to arrive, if the person appears to be breathing slowly, prompt 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 provided in this leaflet (see section 5). Then contact your doctor for further instructions on the use of Abfentiq.

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

• Vomiting, nausea/discomfort, constipation, stomach (abdominal) pain
• Asthenia (weakness), somnolence, sedation, dizziness, headache
• Shortness of breath

Common adverse 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, vertigo or dizziness, loss of consciousness, sedation, tingling sensation, numbness, difficulty coordinating movements, increased or altered sensitivity to touch, seizures (epileptic fits)
• Dry mouth, mouth inflammation, tongue disorders (e.g., burning sensation or ulcers), taste disturbances
• Gas, abdominal bloating, indigestion, decreased appetite, weight loss
• Blurred or double vision
• Sweating, skin rashes, skin itching
• Difficulty urinating
• Accidental injuries (e.g., falls)
• General malaise

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

• Dental caries, intestinal paralysis, mouth ulcers, bleeding gums
• Coma, difficulty speaking
• Abnormal dreams, feeling of indifference, abnormal thoughts, excessive feeling of well-being
• Blood vessel dilation
• Urticaria (hives)

Frequency not known:

• Decreased gums, gum inflammation, tooth loss, serious breathing problems, flushing, sensation of intense warmth, diarrhea, swelling 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 real, sleep disturbances, nightmares)

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

Prolonged fentanyl treatment during pregnancy may cause withdrawal symptoms in the newborn, which may be potentially fatal (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 Abfentiq

Keep this medicine out of the sight and reach of children.

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

• Do not use this medicine after the expiry date stated on the blister pack and carton after “EXP:”. The expiry date refers to the last day of the month indicated.
• Store below 25°C.
• Always keep Abfentiq in its original blister packaging until ready to use. Do not use this medicine if you notice the blister pack is damaged or open before use.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and their packaging to the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to properly dispose of unused medicines and their packaging. This helps protect the environment.

• How to dispose of Abfentiq after use

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

Regardless of whether any medicine remains in the applicator, the applicator must be properly discarded as follows:

• If no medicine remains, dispose of the applicator in a waste container that is out of reach of children and pets.

• If medicine remains in the applicator, place the tablet under a stream of warm running water to dissolve any remaining residue, then dispose of the applicator in a waste container that is out of reach of children and pets.

• If you do not use an entire Abfentiq unit and cannot dissolve the remaining medicine immediately, store the partially used Abfentiq unit out of reach of children and pets until you have time to properly dispose of it as described above.

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

6. Contents of the pack and other information

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

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

The other components are:

Buccal tablet:

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

Edible adhesive used to attach the tablet to the applicator:

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

Applicator:

ABS resin

Food-grade ink (E-133)

Appearance of the product and contents of the pack

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

The unit is normally white; however, during storage it may develop a slightly mottled appearance. This is due to minor changes in the flavouring component and does not in any way affect the action of the medicine.

Abfentiq is available in 6 different strengths: 200, 400, 600, 800, 1200, and 1600 micrograms. The strength is marked on the white tablet, on the applicator, on the blister, and on the outer carton to ensure that you use the correct medicine and dose. Each strength is associated with a specific colour.

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

Only certain pack sizes may be commercially available.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation 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, 5th floor

08029 Barcelona (Spain)

Date of the most recent revision of this summary: February 2022

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