Abstral 200 micrograms sublingual tablets

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the patient

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 the entire 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms, as 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 Abstral is and what it is used for

2. What you need to know before taking Abstral

3. How to take Abstral

4. Possible adverse effects

5. How to store Abstral

6. Contents of the pack and other information

1. What Abstral is and what it is used for

Abstral is a treatment for adults who are already regularly taking strong opioid painkillers for their persistent cancer pain, but who require treatment for breakthrough pain. If you are unsure, consult your doctor.

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

The active substance in Abstral sublingual tablets is fentanyl. Fentanyl belongs to a group of strong painkillers known as opioids.

2. What you need to know before taking Abstral

Do not take Abstral

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

? If you have severe breathing problems

• If you are not already using an opioid medicine prescribed by your doctor (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine) regularly, at the same time each day, for at least one week to manage persistent pain. If you have not been using such medicines, do not use Abstral, as it may increase the risk of your breathing becoming slower and/or shallower, or even stopping completely.
• If you have short-term pain other than breakthrough pain.
• If you are being treated with medicines containing sodium oxybate.

Warnings and precautions

Keep this medicine in a safe and secure place, out of reach of other people (see section 5, Conservation of Abstral, for more information).

Talk to your doctor or pharmacist before taking Abstral if you have or have had any of the following conditions, as your doctor will need to consider them when prescribing your dose:

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

? Breathing problems or severe myasthenia (a condition characterized by muscle weakness).

? Heart problems, especially low heart rate.

• Low blood pressure.

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

? Brain tumor and/or increased intracranial pressure (increased pressure in the brain causing severe headache, nausea, vomiting, and blurred vision).

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

• If you are taking antidepressants or antipsychotics; see section “Use of Abstral with other medicines”.
• If you have ever experienced adrenal insufficiency or sex hormone deficiency (androgen deficiency) while using opioids.

While taking Abstral, inform your doctor or dentist that you are taking this medicine if:

• you are undergoing any surgery
• you experience pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose 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.

Long-term use and tolerance

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

Dependence and addiction

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

Repeated use of Abstral may also lead to dependence, abuse, and addiction, which could result in a potentially fatal overdose. The risk of these adverse effects may be higher with higher doses and prolonged use. Dependence or addiction may cause a feeling of lack of control over the amount of medication you need to take or how frequently you need to take it. You may feel the need to continue using the medication even though it does not help relieve pain.

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

• you or any member of your family have abused alcohol or experienced dependence on alcohol, prescription medications, or illegal drugs ("addiction").
• you smoke.
• you have ever had mood disorders (depression, anxiety, or a personality disorder) or have received psychiatric treatment for other mental illnesses.

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 medication for longer than prescribed by your doctor.
• you need to take a higher dose than recommended.
• you are using the medication for reasons other than those prescribed, for example, "to stay calm" or "to help you sleep."
• you have made repeated unsuccessful attempts to stop using the medication or control its use.
• you feel unwell when you stop taking the medication (e.g., nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), and you feel better once you take it again ("withdrawal effects").

If you notice any of these signs, consult your doctor to determine the best treatment approach for you, when it is appropriate to discontinue the medication, and how to do so safely.

Sleep-related breathing disorders

Abstral may cause sleep-related breathing disorders, including sleep apnea (interruptions in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing interruptions during sleep, waking up in the middle of the night due to shortness of breath, difficulty maintaining sleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor, who may consider reducing your dose.

Use in athletes

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

Use of Abstral with other medicines

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

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

? 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 rifabutin (medicines used to treat bacterial infections).
• Carbamazepine, phenytoin, or phenobarbital (medicines used to treat seizures).
• Herbal medicines containing St. John’s wort (Hypericum perforatum).

? Medicines containing alcohol.

• Medicines called monoamine oxidase inhibitors (MAOIs), used to treat severe depression and Parkinson’s disease. Inform your doctor if you have taken this type of medicine within the last two weeks.
• Certain types of strong painkillers called partial agonist/antagonists, such as buprenorphine, nalbuphine, and pentazocine (medicines used to treat pain). You may experience withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while using these medicines.

Abstral may increase the effect of medicines that make you feel sleepy (sedative medicines), including:

• other strong painkillers (opioid-type medicines, e.g., for pain and cough)
• some painkillers for neuropathic pain (gabapentin and pregabalin)
• general anesthetics (used to put you to sleep during surgery)
• muscle relaxants
• sleeping pills
• medicines used to treat
  • depression
  • allergies
  • anxiety (such as benzodiazepines, e.g., diazepam) and psychosis
• medicines containing clonidine (used to treat high blood pressure)

Using Abstral together with medicines that make you feel sleepy (sedative medicines), such as benzodiazepines, increases the risk of drowsiness, difficulty breathing (respiratory depression), and coma, and can be fatal. Therefore, using Abstral together with sedative medicines should only be considered when no other treatment options are possible.

However, if your doctor prescribes Abstral together with sedative medicines, they will limit the dose and duration of treatment.

Inform your doctor about all sedative medicines you are taking and strictly follow your doctor’s recommendations regarding dosage. It may be helpful to inform friends or family members so they can recognize the signs and symptoms listed above. Contact your doctor if you experience these symptoms.

The risk of certain 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 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 Abstral is suitable for you.

Abstral with food, drinks, and alcohol

Abstral may 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 treatment with Abstral, as it may increase the adverse effects of Abstral.

Pregnancy and breastfeeding

You should not take Abstral during pregnancy unless specifically instructed by your doctor.

Fentanyl may pass into maternal blood and cause adverse effects in the infant. Do not use Abstral if you are breastfeeding. You should 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 using machines

Abstral may reduce your mental and/or physical ability to perform potentially dangerous tasks such as driving or operating machinery.

If you feel dizzy, drowsy, 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; this is essentially “sodium-free.”

3. How to take Abstral

Before taking this medicine for the first time, your doctor will explain to you how to take it properly in order to effectively treat your breakthrough pain episodes.

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

Always follow exactly the instructions given by your doctor for taking this medicine. If in doubt, consult your doctor or pharmacist again.

YOU MUST USE THIS MEDICINE ONLY AS INSTRUCTED BY YOUR DOCTOR. NO ONE ELSE SHOULD USE THIS MEDICINE, as it may cause SERIOUS health risks, especially in children.

Abstral is a different type of medicine compared to other medicines you may have used previously to treat breakthrough pain. You must always take Abstral exactly as prescribed by your doctor; your dose may differ from doses of other breakthrough pain medicines you have used before.

Starting treatment – Determining the most appropriate dose

For Abstral treatment to be successful, your doctor will need to identify the most appropriate dose for treating your breakthrough pain. This medicine is available in a wide range of doses. You may need to try different doses during different pain episodes before finding the most suitable one. Your doctor will assist you in this process and determine the most appropriate dose for you.

If you do not achieve adequate pain relief with a given dose, your doctor may instruct you to take an additional dose to treat a breakthrough pain episode.

Do not take a second dose unless specifically instructed by your doctor, as this could lead to overdose.

Your doctor may advise you to take a dose consisting of more than one tablet at the same time. Only do this if your doctor has specifically instructed you to do so.

After taking the last dose, wait at least two hours before using Abstral to treat the next breakthrough pain episode.

Continuing treatment – Once the most appropriate dose has been established

Once you and your doctor have established a dose of Abstral that effectively controls your pain episodes, you must not take this dose more than four times a day. A single dose of the medicine may consist of more than one tablet.

After taking the last dose, wait at least two hours before using Abstral to treat the next breakthrough pain episode.

If you feel that the dose you are currently taking does not adequately control your pain episodes, inform your doctor, as your dose may need to be adjusted.

Do not change your dose of this medicine unless instructed by your doctor.

How to take the medicine

This medicine is intended for sublingual use. This means that you should place the tablet under your tongue, where it will dissolve quickly, allowing fentanyl to be absorbed through the lining of your mouth. Once absorbed, fentanyl begins to work to relieve your pain.

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

• If your mouth is dry, take a sip of water to moisten it. Spit or swallow the water.
• Remove the tablet(s) from the blister pack immediately before use as follows:
  • Separate one unit from the blister strip by tearing along the dotted line/perforations (keep the remaining blister units together).
  • Peel back the foil starting at the arrow and carefully remove the tablet. Do not attempt to push the Abstral sublingual tablets through the upper foil, as this may damage the tablets.
• Place the tablet under your tongue as far back as possible and allow it to dissolve completely.
• Abstral will dissolve rapidly under the tongue and be absorbed to provide pain relief. It is therefore important that you do not suck, chew, or swallow the tablet.
• Do not eat or drink anything until the tablet has completely dissolved under your tongue.

If you take more medicine than you should:

? Remove any remaining tablets from your mouth

? Inform your caregiver or another person about what has happened

? Contact your doctor, pharmacist, or nearest hospital immediately and ask for instructions on what to do

? While waiting for medical help, keep the person awake by talking to them or gently shaking them from time to time.

Symptoms of overdose include:

? Extreme drowsiness

? Slow, shallow breathing

• Coma

An overdose may also cause a brain disorder known as toxic leukoencephalopathy.

If this occurs, seek immediate medical assistance.

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at 91 562 04 20, stating the name of the medicine and the amount ingested.

If you stop using Abstral

You should stop using this medicine when you no longer experience breakthrough pain. However, you must continue taking your regular opioid medicines for persistent cancer pain as directed by your doctor. You may experience withdrawal symptoms similar to the possible adverse effects of Abstral when stopping treatment with Abstral. If you experience withdrawal symptoms or are concerned about pain relief, consult your doctor, who will assess whether you need any medication to reduce or suppress withdrawal symptoms.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

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

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

• nausea

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

• dizziness, headache, excessive sleepiness
• shortness of breath/difficulty breathing
• mouth inflammation, vomiting, constipation, dry mouth
• sweating, tiredness/fatigue/lack of energy

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

• allergic reaction, tremors/shaking, blurred or altered vision, slow or fast heart rate, low blood pressure, memory loss
• depression, suspicious thoughts/unfounded fears, confusion, disorientation, anxiety/unhappiness/restlessness, feeling unusually happy/healthy, mood changes
• persistent feeling of fullness, stomach pain, indigestion
• mouth ulcers, tongue problems, mouth or throat pain, throat tightness, ulcers on lips or gums
• loss of appetite, loss or change in sense of smell/taste
• dizziness/drowsiness, difficulty sleeping or sleep disturbances, attention problems/easily distracted, lack of energy/weakness/loss of strength
• skin disorders, skin rash, itching, night sweats, decreased sensitivity to touch, tendency to bruise easily
• joint pain or stiffness, muscle stiffness
• withdrawal syndrome (which may manifest as the following adverse effects: nausea, vomiting, diarrhoea, anxiety, chills, tremors and sweating), accidental overdose, in men inability to achieve or maintain an erection, malaise

Adverse effects with unknown frequency (frequency cannot be estimated from available data):

• swelling of the tongue, severe breathing problems, falls, flushing, feeling very hot, diarrhoea, seizure (epileptic fit), swelling of arms or legs, seeing or hearing things that are not real (hallucinations), fever, reduced or loss of consciousness and itchy rash with delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that are not real, sleep disturbances, nightmares)
• pharmacological tolerance, drug dependence (addiction), drug abuse (see section 2).

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

Reporting suspected adverse reactions

If you experience any kind 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 Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Abstral

The pain relief provided by the medicine Abstral is very strong and could be extremely dangerous if accidentally taken by a child. Keep out of sight and reach of children.

Store this medicine in a safe and secure place, inaccessible to other people. This medicine may cause serious harm or even be fatal to individuals who take it accidentally or intentionally when it has not been prescribed for them.

It is recommended to store the medicine in a closed or locked place.

Do not use this medicine after the expiry date stated on the blister pack after "EXP". The expiry date refers to the last day of the month indicated.

Store below 25°C.

Keep in the original packaging to protect from moisture.

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 you are unsure, please ask your pharmacist how to properly dispose of unused medicines and their packaging. This will help protect the environment.

6. Contents of the pack and other information

Composition of Abstral

The active substance is fentanyl. One sublingual tablet contains:

100 micrograms of fentanyl (as citrate)

200 micrograms of fentanyl (as citrate)

300 micrograms of fentanyl (as citrate)

400 micrograms of fentanyl (as citrate)

600 micrograms of fentanyl (as citrate)

800 micrograms of fentanyl (as citrate)

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

Appearance of Abstral and contents of the pack

Abstral is a small white sublingual tablet that must be placed under the tongue. It is available in a wide variety 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 tablet in the shape of a "D"

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

Available in packs of 10 or 30 tablets.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Grünenthal Pharma, S.A.

Doctor Zamenhof, 36

28027 Madrid

Spain

Manufacturer

RECIPHARM LEGANES S.L.U.

Calle Severo Ochoa, 13

28914 Leganés (Madrid)

Spain

This medicinal product is authorized in the European Economic Area (EEA) member states and the United Kingdom (Northern Ireland) under the following names:

Abstral:

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

Lunaldin:

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

This leaflet has been reviewed on: February 2026

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