Leaflet: Information for the User

Fenticerta®100 micrograms sublingual tablets EFG

Fenticerta®200 micrograms sublingual tablets EFG

Fenticerta®300 micrograms sublingual tablets EFG

Fenticerta®400 micrograms sublingual tablets EFG

Fenticerta®600 micrograms sublingual tablets EFG

Fenticerta®800 micrograms sublingual tablets EFG

fentanyl (as citrate)

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 you, 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 Fenticerta is and what it is used for

2.What you need to know before you start taking Fenticerta

3.How to take Fenticerta

4.Possible side effects

5.Storage of Fenticerta

6. Contents of the pack and additional information

Fenticerta is a treatment for adultswho are already regularly taking powerful pain medications (opioids)for their persistent cancer pain, but require treatment for breakthrough pain. If unsure, consult with 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 substance of Fenticerta is fentanyl. Fentanyl belongs to a group of powerful pain medications called opioids.

Do not take Fenticerta:

• if you are allergic to the active ingredient or to any of the other components of this medicine (listed in section 6),
• if you have severe breathing problems,
• if you are not regularly taking a prescribed opioid medication (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine) every day at the same time, for at least a week, to control persistent pain. If you have not been taking these medications,do not takefentanylsublingual tabletsbecause its use may increase the risk of your breathing becoming slower and/or shallower, and even stopping.
• if you have short-term pain other than breakthrough pain.

Warnings and precautions

Keep this medicine in a safe and protected place, out of reach of other people (see section 5 “Storage of Fenticerta”, for more information).

Consult your doctor or pharmacist or nurse before starting to take Fenticerta 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 Fenticerta may mask the extent of the damage
• breathing problems or myasthenia gravis (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 the dose with more caution
• brain tumor and/or elevated intracranial pressure (increased pressure in the brain that causes severe 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 “Other medicines and Fenticerta”.
• if you have ever had adrenal insufficiency or hormone deficiency (androgen deficiency) with the use of opioids.

When taking fentanylsublingual tablets, inform your doctor or dentist that you are taking this medicine if

• you are about to undergo surgery
• you feel pain or increased sensitivity to pain (hyperalgesia) that does not respond to the prescribed dose.
• you present a combination of the following symptoms: nausea, vomiting, anorexia, 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.

Consult your doctorDURINGthe use of Fenticerta:

• if you experience respiratory problems related to sleep: Fenticerta may cause sleep-related respiratory problems such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, nocturnal awakening due to difficulty breathing, difficulty maintaining sleep, or excessive daytime somnolence. If you or someone else observe these symptoms, contact your doctor. Your doctor may consider reducing the dose.

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 will become more sensitive to pain when using Fenticerta. This is known as hyperalgesia. Increasing the dose of Fenticerta may continue to reduce pain for a while, 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 Fenticerta.

Dependence and addiction

The repeated use of Fenticerta 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 a feeling of lack of control over the amount of medicine you should take or the frequency with which you should take 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 Fenticerta may be higher if:

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

If you notice any of the following symptoms while using Fenticerta, 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 take 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

If treatment is interrupted, withdrawal symptoms may appear. Inform your doctor or nurse if you believe this is happening (see also section 4. Possible side effects).

Use in athletes

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

Other medicines and Fenticerta

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 medications you take regularly for pain).

Some medicines may increase or decrease the effects of Fenticerta. 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 fentanyl 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 infections caused by viruses).
• Rifampicin or rifabutin (medicines used to treat bacterial infections)
• Carbamazepine, phenytoin, or phenobarbital (medicines used to treat seizures).
• Medicines based on plants 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 in the last two weeks
• Determined types of potent analgesics, called agonists/antagonists, such as buprenorphine, nalbuphine, and pentazocine (pain medications) and some analgesics for neuropathic pain (gabapentin and pregabalin). You may experience withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while using these medicines.

Fenticerta may increase the effect of medicines that make you feel sleepy, including:

• otherpotent pain medications(opioid pain medications, for pain and cough)
• general anesthetics (used to put you to sleep during operations)
• muscle relaxants
• sleeping pills
• medicines used to treat
• • depression
  • allergies
  • anxiety and psychosis
• medicines containing clonidine (used to treat high blood pressure)

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

Taking Fenticerta with food, drinks, and alcohol

Fenticerta 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 your treatment with Fenticerta as it may increase the adverse effects of Fenticerta.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, or think you may be pregnant, consult your doctor or pharmacist before using this medicine.

Do not take fentanyl during pregnancy unless your doctor has specifically indicated it.

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

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

Driving and operating machinery

Fenticerta may 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 Fenticerta, do not drive or operate machinery.

Before starting treatment and regularly during it, your doctor will also explain what you can expect from the use of Fenticerta, when and for how long you should use it, when you should contact your doctor and when you should suspend use (see also section 2).

Follow exactly the administration instructions for this medication indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

YOU should only use this medication according to your doctor's instructions. Do not use it on anyone else as it could cause SERIOUS risks to your health, especially in children.

Fenticerta is a type of medication different from other medications you may have used to treat irruptive pain.You must always take the dose of Fenticerta as indicated by your doctor;this may be a different dose from what you have used with other medications for irruptive pain.

Starting treatment – Establishing the most suitable dose

To ensure the treatment with Fenticerta is successful, your doctor will need to identify the most suitable dose for the treatment of your irruptive pain. Fenticerta is available in a wide range of doses. You may need to try different doses of Fenticerta during different episodes of pain before finding the most suitable dose. Your doctor will help you with this task and find the most suitable dose for you.

If you do not get adequate relief from pain with a dose, your doctor may instruct you to take an additional dose to treat an episode of irruptive pain. Do not take a second doseunless your doctor instructs you to do so, as you may suffer a overdose.

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

After taking the last dose, wait at least two hours before treating another episode of irruptive pain with Fenticerta.

Continuing treatment – Once the most suitable dose has been established

Once you and your doctor have established a dose of Fenticerta that controls your pain peaks, you should not take this dose more than four times a day.A dose of Fenticerta may consist of more than one tablet.

After taking the last dose, wait at least two hours before treating another episode of irruptive pain with Fenticerta.

If you believe the dose of Fenticerta you are using does not control your pain peaks satisfactorily, inform your doctor as you may need your dose adjusted.

You should not change your dose of Fenticerta unless your doctor instructs you to do so.

Medication intake

Fenticerta should be used sublingually. This means you should place the tablet under your tongue, where it will dissolve quickly to allow the active ingredient to be absorbed through the lining of your mouth. Once absorbed, it will begin to act to relieve your pain.

When you have an episode of irruptive pain, 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 line of points / perforations (keep the remaining units of the blister pack together).
  • Peel the edge of the sheet where the arrow indicates and carefully remove the tablet. Do not try to press the Fenticerta sublingual tablets through the top sheet, as this will damage the tablets.
• Place the tablet under your tongue as far back as possible, and let it dissolve completely.
• Fenticerta will dissolve quickly under your tongue and be absorbed to provide you with pain relief. It is therefore essential that you do not 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 Fenticerta than you should

• Remove any remaining tablet 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 instructions
• While waiting for the doctor, keep the person awake by talking to them or shaking them occasionally

The symptoms of an overdose include:

• Extreme drowsiness
• Slow, shallow breathing

Seek immediate medical assistance if this occurs.

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

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

If you interrupt treatment with Fenticerta

You should stop using Fenticerta when you no longer have irruptive pain. However, you should continue taking your usual opioid medications to treat persistent cancer pain as recommended by your doctor. You may experience withdrawal symptoms similar to possible side effects ofFenticerta. If you experience withdrawal symptoms or are concerned about pain relief, consult your doctor, who will evaluate whether you need any medication to reduce or suppress withdrawal symptoms.

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

Like all medicines, this medicine may 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 to seek emergency help (see also section 3 “If you take more Fenticerta 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/anxiety, 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(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 (cannot be estimated from available data):

• swelling of the tongue,
• serious respiratory problems,
• falls,
• flushing,
• sensation of excessive heat,
• diarrhea,
• seizure (epileptic crisis),
• inflammation of arms or legs,
• seeing or hearing things that are not real (hallucinations),
• fever,
• pharmacological tolerance, drug dependence (addiction), drug abuse (see section 2),
• reduction or loss of consciousness,
• pruritic rash,

• delirium (symptoms may include a combination of agitation, restlessness, disorientation, confusion, fear, seeing or hearing things that do not exist, sleep disturbances, nightmares).

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

Reporting of side effects

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 prospectus. You can also report them directly through the Spanish System for the Vigilance of Medicinal Products 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 of this medication is very strong and can be extremely hazardous if a child accidentally takes it. Keep this medication out of the sight and reach of children.

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

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

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

No special storage conditions are required.

Medications should not be disposed of through drains or trash. Dispose of packaging and unused medications at the SIGRE collection point at the pharmacy.If in doubt, ask your pharmacist how to dispose of packaging and unused medications.By doing so, you will help protect the environment.

Composition of Fenticerta

-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, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the package

Fenticerta 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 circular 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.

The sublingual tablets are presented in child-resistant, single-dose blister packs (PA/AL/PVC//AL/PET) and inserted into a cardboard package.

Fenticerta is available in packages of 10x1 or 30x1 tablets.

Only some package sizes may be marketed.

Marketing authorization holder and manufacturer responsible

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid
Spain

Manufacturer responsible

Prasfarma S.L.

C/ Sant Joan 11-15

08560 Manlleu – Barcelona

Spain

or

KERN PHARMA, S.L.

Polígono Ind. Colón II

Venus, 72

08228 Terrassa – Barcelona

Spain

or

LEK PHARMACEUTICALS D.D.

Verovškova 57

1526 Ljubljana,

Slovenia

Last review date of this leaflet:April 2025

For detailed and updated information on this medicine, please visit the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/