ABSTRAL 400 micrograms SUBLINGUAL TABLETS

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 all of this leaflet carefully before you start taking this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
• If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack and other information

1. What is Abstral and what is it used for
2. What you need to know before you take Abstral
3. How to take Abstral
4. Possible side effects
   1. Storage of Abstral

1. Contents of the pack and other information

1. What is Abstral and what is it used for

Abstral is a treatment for adults who are already taking regular, potent pain medicines (opioids)for their persistent cancer pain, and who need treatment for breakthrough pain. If you are not sure, ask your doctor.

Breakthrough pain is a type of pain that occurs suddenly, even when you have taken your usual opioid pain medicine for your persistent pain.

The active substance in Abstral sublingual tablets is fentanyl. Fentanyl belongs to a group of strong pain-relieving medicines called opioids.

2. What you need to know before you take Abstral

Do not takeAbstral

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

? if you have severe breathing problems

• ? if you are not already using a prescribed opioid medicine every day for your persistent pain (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine), for at least one week. If you have not been using these medicines, do not use Abstral as its use can increase the risk that your breathing becomes slower and/or shallower and/or stops.
• ? if you have short-term pain which is not breakthrough pain.
• ? if you are taking medicines that contain sodium oxybate.

Warnings and precautions

Keep this medicine out of the sight and reach of other people, especially children (see section 5 Storage of Abstral for more information).

Before you take Abstral, tell your doctor or pharmacist 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 hide the extent of the damage.

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

? if you have heart problems, especially a low heart rate.

• low blood pressure.

? liver or kidney disease, as you may need your doctor to adjust your dose more carefully.

? a brain tumour and/or increased intracranial pressure (increased pressure in the brain that causes severe headache, nausea, vomiting and blurred vision).

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

• ? if you are taking antidepressants or antipsychotics; see section “Using Abstral with other medicines”.
• ? if you have ever had adrenal insufficiency or a lack of sex hormones (androgen deficiency) when using opioids.

When you are taking Abstral, tell 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 have a combination of the following symptoms: nausea, vomiting, loss of appetite, fatigue, weakness, dizziness and low blood pressure. Together, these symptoms can be a sign 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 pain-relievers can make the medicine less effective (your body gets used to it, which is known as pharmacological tolerance). You may also become more sensitive to pain when using Abstral. This is known as hyperalgesia. Increasing the dose of Abstral may continue to relieve pain for a time, but it can also be harmful. If you notice that the medicine is becoming less effective, talk to your doctor. Your doctor will decide whether it is better for you to increase the dose or to gradually reduce your use of Abstral.

Dependence and addiction

Repeated use of Abstral can also lead to dependence, abuse and addiction, which could result in a potentially life-threatening overdose. The risk of these side effects may be greater with higher doses and longer use. Dependence or addiction can lead to a feeling of a loss of control over the amount of medicine you need to use or how often you need to use it. You may feel a need to continue using the medicine even if it no longer helps to 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 a member of your family have abused alcohol or experienced dependence on it, or prescription or illicit drugs (“addiction”).
• you smoke.
• you have ever had mood problems (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental health diseases.

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 your doctor has instructed.
• you need to use a higher dose than recommended.
• you are using the medicine for reasons other than those prescribed, for example, “to feel calm” or “to help you sleep”.
• you have made repeated unsuccessful attempts to stop using the medicine or control your use of it.
• you feel unwell when you stop using the medicine (e.g. nausea, vomiting, diarrhoea, anxiety, shivering, shaking and sweating), and you feel better once you start taking it again (“withdrawal symptoms”).

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

Sleep-related breathing disorders

Abstral may cause sleep-related breathing disorders, including sleep apnoea (pauses in breathing while sleeping) and sleep hypoxemia (low levels of oxygen in the blood). Symptoms may include pauses in breathing while sleeping, waking up during the night due to lack of breath, difficulty staying asleep or excessive daytime sleepiness. If you or another person notice these symptoms, contact your doctor to assess the possibility of reducing the dose.

Use in athletes

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

Using Abstral with other medicines

Tell your doctor or pharmacist that you are taking, have recently taken or might take any other medicines (apart from the opioid medicines you are taking regularly for pain).

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

? 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 that contain alcohol.

• Medicines called monoamine oxidase inhibitors (MAOIs), used to treat severe depression and Parkinson’s disease. Tell your doctor if you have taken this type of medicine in the last two weeks.
• Certain types of strong pain-relievers, called partial agonist/antagonists, such as buprenorphine, nalbuphine and pentazocine (medicines for pain relief). You may experience withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety, shivering, shaking and sweating) when using these medicines.

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

• other strong pain-relieving medicines(opioid-type medicines, e.g. for pain and cough)
• certain pain-relievers for nerve 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)

Using Abstral at the same time as sedative medicines, such as benzodiazepines, increases the risk of drowsiness, difficulty breathing (respiratory depression) and coma, and can be life-threatening. Therefore, using Abstral together with sedative medicines should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking and follow your doctor’s instructions strictly regarding the dose. It may be useful to inform friends or family members so they can recognise the signs and symptoms mentioned above. Contact your doctor if you experience these symptoms.

The risk of some other side effects increases if you are taking certain antidepressants or antipsychotics. Abstral may interact with these medicines, and you may experience changes in your mental status (e.g. agitation, hallucinations, coma) and other effects such as body temperature above 38°C, increased heart rate, unstable blood pressure and exaggerated reflexes, muscle stiffness, lack of coordination and/or gastrointestinal symptoms (e.g. nausea, vomiting, diarrhoea). Your doctor will tell you if Abstral is suitable for you.

Abstral with food, drinks and alcohol

Abstral may cause drowsiness in some people. Do not drink alcohol without talking to 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

Do not take Abstral during pregnancy unless your doctor has explicitly told you to do so.

Fentanyl can pass into breast milk and cause side effects in the breastfed baby. Do not use Abstral if you are breastfeeding. You should not start breastfeeding until at least 5 days after the last dose of Abstral.

Ask your doctor or pharmacist for advice before taking any medicine during pregnancy or breastfeeding.

Driving and using machines

Abstral may reduce your mental and/or physical ability to perform tasks that require attention, such as driving or using machines.

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

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 medication for the first time, your doctor will explain how you should take it to effectively treat your breakthrough pain.

Before starting treatment and on a regular basis during treatment, your doctor will also explain what you can expect from using this medication, 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).

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

YOU SHOULD ONLY USE THIS MEDICATION AS DIRECTED BY YOUR DOCTOR. DO NOT LET ANYONE ELSE USE IT, AS IT MAY CAUSE SERIOUS HEALTH RISKS, ESPECIALLY IN CHILDREN.

Abstral is a different type of medication from other medications you may have used to treat breakthrough pain. YOU SHOULD ALWAYS TAKE THE ABSTRAL DOSE AS DIRECTED BY YOUR DOCTOR;this may be a different dose from what you have used with other medications for breakthrough pain.

Starting treatment – Finding the right dose

For Abstral treatment to be successful, your doctor will need to identify the right dose for treating your breakthrough pain. This medication is available in a wide range of doses. You may need to try different doses of the medication during different episodes of pain before finding the right dose. Your doctor will help you with this task and find the right dose for you.

If you do not get adequate pain relief with one dose, your doctor may tell you to take an additional dose to treat a breakthrough pain episode.

Do not take a second dose unless your doctor tells you to,as you may experience an overdose.

Your doctor may advise you to take a dose consisting of more than one tablet at the same time. DO THIS ONLY IF YOUR DOCTOR HAS INSTRUCTED YOU TO DO SO.

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

Continuing treatment – Once the right dose has been established

Once you and your doctor have established an Abstral dose that controls your breakthrough pain, 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 the next breakthrough pain episode with Abstral.

If you think the dose of the medication you are using does not control your breakthrough pain satisfactorily, inform your doctor, as you may need to have your dose adjusted.

Do not change your dose of this medication unless your doctor tells you to.

Taking the medication

This medication should 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 lining of your mouth. Once absorbed, fentanyl starts to work to relieve pain.

When you have a breakthrough pain episode, take the dose directed 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 pack by tearing along the perforation (keep the remaining units in the blister pack together).
  • Peel off the edge of the foil where indicated by the arrow and carefully remove the tablet. Do not try to push the Abstral sublingual tablets through the foil, as this could damage the tablets.
• Place the tablet under your tongue as far back as possible, and let it dissolve completely.
• Abstral will dissolve quickly under your tongue and be absorbed to provide relief from your pain. It is therefore important that you do not suck, chew, or swallow the tablet.
• Do not drink or eat anything until the tablet has dissolved completely under your tongue.

If you take more of the medication than you should:

?Remove any remaining tablets from your mouth

?Tell your caregiver or another person what has happened

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

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

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

Symptoms of an overdose include:

?Extreme drowsiness

? Shallow, slow 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, phone 91 562 04 20, stating the medication and the amount taken.

If you stop taking Abstral

You should stop using this medication when you no longer have breakthrough pain. However, you should continue taking your usual opioid medications to treat persistent cancer pain as directed by your doctor. You may experience withdrawal symptoms similar to the possible side effects of Abstral when you stop treatment with Abstral. If you have 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 medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone 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 urgent help (see also 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/lack of energy

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

• allergic reaction, tremors/shaking, altered or blurred vision, slow or fast heart rate, low blood pressure, memory loss
• depression, suspicious thoughts/fears without reason, feeling confused, disoriented, anxious/unhappy/restless, feeling unusually happy/healthy, mood changes
• feeling of permanent fullness, stomach pain, indigestion
• mouth ulcers, tongue problems, mouth or throat pain, throat tightness, lip or gum ulcers
• loss of appetite, loss or alteration of sense of smell/taste
• dullness/drowsiness, difficulty sleeping or sleep disturbances, attention problems/easy distraction, lack of energy/weakness/loss of strength
• skin changes, rash, itching, night sweats, decreased sensitivity to touch, easy bruising
• joint pain or stiffness, muscle stiffness
• withdrawal syndrome (which may be manifested by the following side effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), accidental overdose, in men inability to achieve or maintain an erection, general malaise

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

• tongue swelling, serious breathing problems, falls, flushing, feeling of intense heat, diarrhea, seizure (epileptic fit), arm or leg inflammation, seeing or hearing things that are not real (hallucinations), fever, reduced or lost consciousness, and rash with itching and delirium (symptoms may consist of a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not really 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 can be potentially life-threatening (see section 2).

Reporting suspected adverse reactions

If you experience any side effects, consult your doctor or pharmacist, even if they are possible side effects not listed in this leaflet.

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Abstral

The pain relief provided by Abstral is very strong and can be extremely dangerous if a child were to take it accidentally.Keep out of sight and reach of children.

Keep this medication in a safe and secure place, where others cannot access it. This medication can cause serious harm and even be fatal if used accidentally or intentionally by someone who has not been prescribed it.

It is recommended to keep the medication in a locked or secure location.

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

Store below 25°C.

Keep in the original packaging to protect from moisture.

Medications should not be disposed of through wastewater or household waste. Deposit the packaging and any unused medication in the SIGRE collection point at your pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and any unused medication. This will help protect the environment.

6. Package contents and additional information

Composition of Abstral

The active ingredient 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 package contents

Abstral is a small white sublingual tablet that should be placed under the tongue. It is available in a wide range of doses and shapes. Your doctor will prescribe the right 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.

Not all 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 Leganes (Madrid)

Spain

This medication is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under 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, Slovakia, Romania.

This leaflet was last revised in:August 2024

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