ABSTRAL 300 micrograms SUBLINGUAL TABLETS

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 regularly a prescribed opioid medicine every day for your persistent pain (e.g. codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine). 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 even stop.
• ? 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 children and in a safe place to prevent accidental intake. (See section 5, Storage of Abstral, for further information).

Before you take Abstral, tell your doctor or pharmacist if you have or have had any of the following conditions, as your doctor will need to consider this when prescribing your dose:

? a head injury, as Abstral may obscure the diagnosis of the extent of the injury.

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

? if you have heart problems, especially slow heart rate.

• Low blood pressure.

? liver or kidney disease, as you may need a dose adjustment with caution.

? brain tumour and/or increased intracranial pressure (increased pressure in the brain that can cause 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 lack of sex hormones (androgen deficiency) with opioid use.

When taking Abstral, 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 can be an indication of a potentially life-threatening condition called adrenal insufficiency, where 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 (the body gets used to it, 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 becomes less effective, talk to your doctor. Your doctor will decide whether it is best for you to increase the dose or to gradually reduce the 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 the feeling that you cannot control 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 relieves 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, prescribed medicines or illegal drugs (“addiction”).
• ? you smoke.
• ? you have had mood problems (depression, anxiety or personality disorders) or have been treated by a psychiatrist for other mental disorders.

If you notice any of the following signs 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 tried to reduce or stop using the medicine but find it difficult.
• ? 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 using 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 it safely.

Sleep-related breathing disorders

Abstral may cause sleep-related breathing disorders, including sleep apnoea (interrupted breathing during sleep) and sleep hypoxemia (low oxygen levels in the blood). Symptoms may include interrupted breathing during sleep, waking up during the night due to lack of air, difficulty staying asleep or excessive daytime sleepiness. If you or another person observes 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 effect of Abstral. Consequently, if you start, change the dose or stop treatment with the following medicines, inform your doctor as he/she 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, containing, 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 for the treatment of severe depression and Parkinson’s disease. Inform 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) while using these medicines.

Abstral may increase the effect of medicines that make you feel drowsy (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 containing 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. For this reason, using Abstral with sedative medicines should only be considered when other treatment options are not possible.

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

Tell your doctor about all sedative medicines you are taking and follow your doctor’s instructions 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 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 side effects of Abstral.

Pregnancy and breast-feeding

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

Fentanyl can pass into breast milk and may cause side effects in the breast-fed baby. Do not use Abstral if you are breast-feeding. You should not start breast-feeding 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 breast-feeding.

Driving and using machines

Abstral may affect your ability to drive or use machines as it may cause drowsiness, dizziness or blurred vision.

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 sodium (23 mg) per tablet, i.e. 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 instructions for administering this medication exactly. If you are unsure, 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 COULD CAUSE SERIOUS RISKS TO THEIR HEALTH, 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 DOSE OF ABSTRAL 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 treatment with Abstral 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 could suffer an 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 TOLD YOU TO.

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

Continuing Treatment – Once the Right Dose is Established

Once you and your doctor have established a dose of Abstral 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 episode of breakthrough pain with Abstral.

If you think the dose of the medication you are using does not control your breakthrough pain satisfactorily, tell your doctor because 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 of the units 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 you can 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

?You should 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 occasionally

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

The 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 emergency 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, blurred or altered vision, slow or fast heart rate, low blood pressure, memory loss
• depression, suspicious thoughts/fear, feeling confused, disoriented, anxious/unhappy/restless, feeling unusually happy/healthy, mood changes
• feeling of 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/easily distracted, 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 can manifest with 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

Rare side effects (frequency cannot be estimated from available data):

• tongue swelling, severe 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 include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that 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 can be potentially fatal (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. Storing Abstral

The pain relief from 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.

Store 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 store the medication in a locked cabinet or with a lock.

Do not use this medication after the expiration date shown 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 in 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 forms. 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 can be found on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/