Patient Information Leaflet

Abstral 100 micrograms sublingual tablets

Abstral 200 micrograms sublingual tablets

Abstral 300 micrograms sublingual tablets

Abstral 400 micrograms sublingual tablets

Abstral 600 micrograms sublingual tablets

Abstral 800 micrograms sublingual tablets

fentanyl

Read this leaflet carefully before you start taking 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 only. Do not give it to others, even if they have the same symptoms, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4.

1.What is Abstral and what it is used for

2.What you need to know before starting to take Abstral

3.How to take Abstral

4.Possible side effects

1. Storage of Abstral

6.Contents of the pack and additional information

Abstralis a treatment for adultswho are already taking regular powerful pain medications (opioids)for their persistent cancer pain, but require treatment for breakthrough pain.If you are unsure, consult your doctor.

Breakthrough pain is a type of pain that appears suddenly, even though you have taken or used your usual opioid pain medication.

The active ingredient in Abstral sublingual tablets is fentanil. Fentanil belongs to a group of powerful pain medications called opioids.

Do not takeAbstral

?If you are allergic to fentanyl or any of the other ingredientsofthis medicine (listed in section 6)

?If you have severe breathing problems

• If you are not regularly taking a prescribed opioid medicine (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 those medicines, do not useAbstralas it may increase the risk of your breathing becoming slower and/or shallower, and even stopping.
• If you have short-term pain that is not breakthrough pain.
• If you are receiving treatment with medicines that contain sodium oxibate.

Warnings and precautions

Keep this medicine in a safe and protected place, out of reach of others (see section 5 Abstral Storage for more information).

Consult your doctor or pharmacist before starting to take Abstral if you have or have had any of the following symptoms, as your doctor will need to take them into account when prescribing your dose:

?A head injury, as Abstral may mask the extent of the damage.

?Respiratory problems or myasthenia gravis (a condition characterised by muscle weakness).

?If you have heart problems, especially low heart rate.

• Low blood pressure.

?Liver or kidney disease, as your doctor may need to adjust your dose with more caution.

?Brain tumour and/or elevated intracranial pressure(increased pressure in the brainthat causessevere headache,nausea, vomiting, and blurred vision).

?Mouth sores or mucositis (inflammation and redness of the inside of the mouth).

• If you are taking antidepressants or antipsychotics; see the section “Using Abstral with other medicines”.
• If you have ever had adrenal insufficiency or hormone deficiency (androgen deficiency) with the use of opioids.

When takingAbstral,inform your doctor or dentist that you are taking this medicine, if:

• You are going to have an operation
• 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.
• 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.

Long-term use and tolerance

This medicine contains fentanyl, an opioid. Repeated use of opioid analgesics may make the drug less effective (the body becomes accustomed to it, known as pharmacological tolerance). It is also possible that you may become more sensitive to pain when using Abstral. This is known as hyperalgesia. Increasing the dose of Abstral may continue to reduce pain for a time, but it may also be harmful. If you notice that the medicine is losing its effectiveness, consult your doctor. Your doctor will decide whether it is better to increase the dose or to gradually reduce the use of Abstral.

Dependence and addiction

The repeated use of Abstral may also cause dependence, abuse, and addiction, which could lead to a potentially fatal overdose. The risk of these adverse effects may be higher 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 should use or the frequency with which you should use it. You may feel the need to continue using the medicine even if it does not help to relieve pain.

The risk of dependence or addiction varies from person to person. The risk of becoming dependent or addicted to Abstral may be higher if:

• You or any member of your family have abused alcohol or experienced dependence on it, prescription medicines, or illegal drugs (“addiction”).
• You smoke.
• You have had any problems with your mood (depression, anxiety, or a personality disorder) or have been treated by a psychiatrist for other mental health conditions.

If you notice any of the following symptoms while using Abstral, it could be a sign of dependence or addiction.

• You need to use the medicine for longer than indicated 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 stay calm” or “to help you sleep”.
• You have made repeated and unsuccessful attempts to stop using the medicine or control its use.
• You feel unwell when you stop using the medicine (e.g., nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), and you feel better once you take it again (“withdrawal symptoms”).

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

Sleep disorders

Abstral may cause sleep disorders, including sleep apnea (interrupted breathing while sleeping) and sleep hypoxemia (low oxygen levels in the blood). Symptoms may include interrupted breathing while sleeping, waking up in the middle of the night due to lack of air, difficulty staying asleep, or excessive daytime sleepiness. If you or someone else observes these symptoms, contact your doctor to evaluate the possibility of reducing the dose.

Use in athletes

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

Using Abstral with other medicines

Inform your doctor or pharmacist that you are taking, have taken recently, or may need to take any other medicine (other than the opioid pain medicines you take regularly for pain).

Some medicines may increase or decrease the effects of Abstral. Therefore, if you start, change the dose, or stop treatment with the following medicines, inform your doctor, as it may be necessary to adjust your Abstral dose:

?Certain types of antifungal medicines containing substances such as ketoconazole or itraconazole (used to treat fungal infections).

?Certain types of antibiotics used to treat infections (called macrolides, containing substances such as erythromycin).

?Certain types of antiviral medicines called protease inhibitors, which contain, for example, ritonavir (used to treat viral infections).

• Rifampicin or rifabutina (medicines used to treat bacterial infections).
• Carbamazepine, phenytoin, or phenobarbital (medicines used to treat seizures).
• Medicines based on plants that contain St. John's Wort (Hypericum perforatum).

?Medicines that contain alcohol.

• Medicines called monoamine oxidase inhibitors (MAO),used to treat severe depressionand Parkinson's disease. Inform your doctor if you have taken this type of medicine in the last two weeks.
• Determined types of potent analgesics, called agonists/antagonists, such as buprenorphine, nalbuphine, and pentazocine (medicines for pain relief). You may experience withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while using these medicines.

Abstralmay increase the effect of medicines that make you feel sleepy (sedatives), including:

• Otherpotent pain medicines(opioid medicines, e.g.,for pain and cough)
• Some medicines for neuropathic pain (gabapentin and pregabalin)
• General anaesthetics (used to put you to sleep during operations)
• Muscle relaxants
• Sleeping pills
• Medicines used to treat
• • depression
  • allergies
  • anxiety (such as benzodiazepines, e.g., diazepam) and psychosis
• Medicines that contain clonidine (used to treat high blood pressure)

The use of Abstral at the same time as medicines that make you feel sleepy (sedatives),such as benzodiazepines, increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma, and may be fatal. Therefore, the use of Abstral with sedatives should only be considered when other treatment options are not possible.

However, if your doctor prescribes Abstral with sedatives, you should limit the dose and duration of treatment.

Inform your doctor of all sedatives you are taking and follow your doctor's instructions strictly about the dose. It may be helpful to inform friends or family members to recognize the signs and symptoms indicated above. Contact your doctor if you have these symptoms.

The risk of some other adverse effects increases if you are taking medicines such as certain antidepressants or antipsychotics. Abstral may interact with these medicines and you may experience changes in mental state (e.g., agitation, hallucinations, coma) and other effects such as increased body temperature, 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 Abstral is suitable for you.

Abstral with food, drinks, and alcohol

Abstralmay cause drowsiness in some people. Do not consume alcohol without consulting your doctor as it may make you feel more drowsy than usual.

Do not drink grapefruit juice during your treatment withAbstralas it may increase the adverse effects ofAbstral.

Pregnancy and breastfeeding

You should not takeAbstralduring pregnancy unless your doctor has specifically told you to.

Fentanyl may pass into the mother's bloodstream and cause adverse effects in the infant. Do not use Abstral if you are breastfeeding. Do not start breastfeeding until at least 5 days have passed since your last dose of Abstral.

Consult your doctor or pharmacist before using any medicine during pregnancy or breastfeeding.

Driving and operating machinery

Abstralmay reduce your mental and/or physical ability to perform potentially hazardous tasks such as driving or operating machinery.

If you feel dizzy, sleepy, or have blurred vision while taking Abstral, do not drive or operate machinery.

Abstral contains sodium

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

Before takingthis medicationfor the first time, your doctor will explain how to take it to effectively treat your pain episodes.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from using this medication, when and for how long you should use it, when to contact your doctor, and when to discontinue use (see also section 2).

Follow exactly the administration instructions forthis medicationgiven by your doctor. If in doubt, consult your doctor or pharmacist again.

YOU should only use this medication as instructed by your doctor. Do not use it for anyone else, as it could cause SERIOUS health risks, especially in children.

Abstral is a type of medication different from others you may have used to treat breakthrough pain.You must always take the Abstral dose as instructed by your doctor;thismay be a different dose from what you have used with other pain medications.

Starting treatment – Establishing the most suitable dose

To ensure the treatment with Abstral is successful, your doctor will need to identify the most suitable dose for treating your breakthrough pain.This medicationis available in a wide range of doses. You may need to try different doses ofthe medicationduring different pain episodes before finding the most suitable dose.Your doctor will helpyou with this task and find the most suitable dose for you.

If you do not get adequate pain relief witha dose, your doctormay instruct you to take an additional dose to treat a breakthrough pain episode.

Do not take a second doseunless your doctor instructs you to do so,as you may experience an overdose.

Your doctor may advise you to take a dose composed of more than one tablet at the same time.Do this only if instructed by your doctor.

After taking the last dose, wait at least two hours before treating another breakthrough pain episode with Abstral.

Continuing treatment –Once the most suitable dose has been established

Once you and your doctorhave established an Abstral dose that controls your pain episodes, you should not take this dose more than four times a day.A dose of the medication may consist of more than one tablet.

After taking the last dose, wait at least two hours before treating another breakthrough pain episode with Abstral.

If you believe the dose ofthe medicationyou are using does not adequately control your pain episodes, inform your doctor, as you may need to adjust the dose.

You should not change your dose ofthis medicationunless instructed to do so by your doctor.

Medication intake

This medicationmust be used sublingually. This means you should place the tablet under your tongue, where it will dissolve quickly to allow fentanyl to be absorbed through the mouth lining. Once absorbed, fentanyl begins to act to relieve pain.

When you have a breakthrough pain episode, take the dose indicated by your doctor as follows:

• If your mouth is dry, take a sip of water to moisten it. Spit out or swallow the water.
• Remove the (the) tablet(s) from the blister pack immediately before use as follows:
• • Separate one of the units from the blister pack by tearing along the perforation line (keep the remaining units together).
  • Peel the edge of the foil where the arrow indicates and carefully removethe tablet.Do not attempt to press the Abstral sublingual tablets through the top foil, as this will damage the tablets.
• Place the tablet under your tongue as far back as possible, and let it dissolve completely.
• Abstralwill dissolve quickly under the tongue and be absorbed to provide you with pain relief. Therefore, it is essential not to suck, chew, or swallow the tablet.
• You should not drink or eat anything until the tablet has dissolved completely under your tongue.

If you take more medicationthan you should:

?Remove any remaining tablets from your mouth

?Tell your caregiver or someone else what happened

?Contact your doctor, pharmacist, or local hospital immediately and ask for instructions

?While waiting for the doctor, keep the person awake by talking to them or shaking them occasionally

?A overdose can also cause a brain disorder known as toxic leukoencephalopathy.

The symptoms of an overdose include:

?Extreme drowsiness

?Slow, shallow breathing

• Coma

If this happens, seek medical help immediately.

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

If you interrupt treatment withAbstral

You should stop usingthis medicationwhen you no longer have breakthrough pain. However, you should continue taking your usual opioid pain medications for persistent cancer pain as recommended by your doctor. You may experience withdrawal symptoms similar to the possible side effects of Abstral when you interrupt treatment with Abstral. If you experience withdrawal symptoms or are concerned about pain relief, consult your doctor, who will evaluate whether you need medication to reduce or suppress withdrawal symptoms.

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

Like all medicines,this medicinecanproduce side effects, although not all people will experience them.

If you start to feel unusual or extreme drowsiness or your breathing becomes shallow and slow, you or your caregiver should contact your doctor or local hospital for emergency assistance (also see section 3 “If you take more Abstral than you should”).

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

• nausea

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

• dizziness, headache, excessive drowsiness
• shortness of breath/difficulty breathing
• inflammation inside the mouth, vomiting, constipation, dry mouth
• sweating, fatigue/weakness/lack of energy

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

• allergic reaction, tremors/shaking, altered or blurred vision, slow or rapid heart rate, low blood pressure, memory loss
• depression, suspicious/thoughts without reason, feeling of confusion, disorientation, anxiety/unhappiness/restlessness, feeling unusually happy/healthy, mood changes
• feeling of permanent fullness, stomach pain, indigestion
• mouth ulcers, tongue problems, pain in the mouth or throat, throat constriction, lip or gum ulcers
• loss of appetite, loss or alteration of sense of smell/taste
• drowsiness/somnolence, difficulty sleeping or sleep alterations, attention problems/easy distraction, lack of energy/weakness/loss of strength
• skin changes, skin rash, itching, nocturnal sweating, decreased sensitivity to touch, easy bruising
• joint pain or stiffness, muscle stiffness
• withdrawal syndrome(which may manifest as the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), accidental overdose, in men inability to achieve or maintain an erection, general discomfort

Side effects of unknown frequency (frequency cannot be estimated from available data):

• swelling of the tongue, severe respiratory problems, falls, flushing, feeling of excessive heat, diarrhea, convulsion (epileptic crisis), inflammation of arms or legs, seeing or hearing things that are not real (hallucinations), fever, reduction or loss of consciousness, and itching with delirium (symptoms may consist of a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that really do not exist, sleep disturbances, nightmares)
• pharmacological tolerance, drug dependence (addiction), drug abuse (see section 2).

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

Reporting of suspected adverse reactions

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 Pharmacovigilance of Medicines for Human Use:www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

The pain relief provided by Abstral medication is very strong and can be extremely hazardous if a child accidentally takes it. Keep out of children's sight and reach. .

Store this medication in a safe and protected location, inaccessible to other individuals. This medication can cause severe harm or even be fatal to individuals who use it accidentally or intentionally, when not prescribed.

It is recommended to store the medication in a closed or locked location.

Do not use this medication after the expiration date that appears on the blister pack after CAD. The expiration date is the last day of the month indicated.

Store below 25°C.

Store in the original packaging to protect it from moisture.

Medications should not be disposed of through drains or trash. Deposit empty containers and unused medications at the SIGRE point of the pharmacy. In case of doubt, ask your pharmacist how to dispose of empty containers and unused medications. By doing so, you will help protect the environment.

Composition of Abstral

The active ingredient is fentanil. A sublingual tablet contains:

100 micrograms of fentanil (as citrate)

200 micrograms of fentanil (as citrate)

300 micrograms of fentanil (as citrate)

400 micrograms of fentanil (as citrate)

600 micrograms of fentanil (as citrate)

800 micrograms of fentanil (as citrate)

The other components are mannitol (E421), microcrystalline cellulose, croscarmellose sodium, and magnesium stearate.

Appearance of Abstral and packaging content

Abstral is a small white sublingual tablet that must be placed under the tongue. It is available in a wide range of doses and forms. Your doctor will prescribe the appropriate dose (form) and number of tablets for you.

The 100 microgram tablet is a white, round tablet

The 200 microgram tablet is a white, oval tablet

The 300 microgram tablet is a white, triangular tablet

The 400 microgram tablet is a white, diamond-shaped tablet

The 600 microgram tablet is a white, D-shaped tablet

The 800 microgram tablet is a white, capsule-shaped tablet

Available in packs of 10 or 30 tablets.

Only some pack sizes may be marketed.

Marketing Authorization Holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36

28027 Madrid

Spain

Responsible for manufacturing

RECIPHARM LEGANES S.L.U.

Calle Severo Ochoa, 13

28914 Leganes (Madrid)

Spain

This medicine is authorized in the member states of the European Economic Area and the United Kingdom (Northern Ireland) with the following names:

Abstral:

Germany, Cyprus, Denmark, Slovenia, Spain, Finland, France, Greece, Ireland, Iceland, Italy, Netherlands, Norway, Portugal, United Kingdom (Northern Ireland), Sweden.

Lunaldin:

Estonia, Latvia, Lithuania, Czech Republic, Slovak Republic, Romania.

This leaflet has been revised in:December 2024

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