Fenticerta 800 micrograms sublingual tablets EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Fenticerta® 100 microgram tablets sublingual EFG

Fenticerta® 200 microgram tablets sublingual EFG

Fenticerta® 300 microgram tablets sublingual EFG

Fenticerta® 400 microgram tablets sublingual EFG

Fenticerta® 600 microgram tablets sublingual EFG

Fenticerta® 800 microgram tablets sublingual EFG

fentanyl (as citrate)

Read all of 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, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if such effects are not listed in this leaflet. See section 4.

Leaflet contents:

1. What Fenticerta is and what it is used for
2. What you need to know before taking Fenticerta
3. How to take Fenticerta
4. Possible side effects
5. How to store Fenticerta
6. Contents of the pack and other information

1. What Fenticerta is and what it is used for

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

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

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

2. What you need to know before starting Fenticerta

Do not take Fenticerta:

• if you are allergic to the active substance or to any of the other components of this medicine (listed in section 6),
• if you have severe breathing problems,
• if you are not already regularly taking an opioid medicine prescribed by your doctor (e.g., codeine, fentanyl, hydromorphone, morphine, oxycodone, meperidine), every day at the same time, for at least one week, to manage persistent pain. If you have not been taking these medicines, do not take fentanyl sublingual tablets, as their use may increase the risk of slowed and/or shallow breathing, or even respiratory arrest,
• if you have short-term pain other than breakthrough pain,
• if you are being treated with medicines containing sodium oxybate (used to treat certain symptoms of narcolepsy).

Warnings and precautions

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

Talk to your doctor, pharmacist, or nurse before starting Fenticerta 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 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 you may require more cautious dose adjustments by your doctor,
• Brain tumor and/or increased intracranial pressure (elevated 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 “Other medicines and Fenticerta”,
• If you have ever experienced adrenal insufficiency or sex hormone deficiency (androgen deficiency) with opioid use.

While taking fentanyl sublingual tablets, inform your doctor or dentist that you are taking this medicine if:

• You are undergoing 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.

Consult your doctor DURING treatment with Fenticerta:

• if you develop sleep-related breathing disorders: Fenticerta may cause sleep-related breathing disorders such as sleep apnea (pauses in breathing during sleep) and sleep-related hypoxemia (low blood oxygen levels). Symptoms may include breathing pauses during sleep, waking up at night due to difficulty breathing, trouble staying asleep, or excessive daytime sleepiness. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing your dose.

Long-term use and tolerance

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

Dependence and addiction

Repeated use of Fenticerta may also lead to dependence, abuse, and addiction, which could result in 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 loss of control over the amount or frequency of medicine use. You may feel a need to continue using the medicine even if it no longer helps relieve pain.

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

• you or a family member have abused or been dependent on alcohol, prescription medicines, 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 Fenticerta, it could be a sign of dependence or addiction:

• You need to use the medicine for longer than prescribed by your doctor,
• You need to use a higher dose than recommended,
• You are using the medicine for reasons other than prescribed, for example, “to stay calm” or “to help you sleep”,
• You have made repeated unsuccessful attempts to stop using the medicine or control its use,
• You feel unwell when you stop taking the medicine (e.g., nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), and 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 stop the medicine, and how to do so safely.

If treatment is stopped, withdrawal symptoms may occur. Inform your doctor or nurse if you think this is happening to you (see also section 4. Possible side effects).

Use in athletes

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

Other medicines and Fenticerta

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines (other than the opioid medicines you regularly take for pain).

Some medicines may increase or decrease the effects of Fenticerta. Therefore, if you start, change the dose, or stop taking any of the following medicines, inform your doctor, as your dose of fentanyl sublingual tablets may need to be adjusted:

• Certain antifungal medicines containing substances such as ketoconazole or itraconazole (used to treat fungal infections),

• Certain antibiotic medicines used to treat infections (macrolides, containing substances such as erythromycin),

• Certain 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 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 for treating pain). You may experience withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while using these medicines.

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

• other strong painkillers (opioid-type medicines 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).

The risk of certain other 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 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 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 treatment with Fenticerta, as it may increase the adverse effects of Fenticerta.

Pregnancy and breastfeeding

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

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

Fentanyl may pass into breast milk and cause adverse effects in the infant. Do not use Fenticerta if you are breastfeeding. You should not start breastfeeding until at least 5 days have passed since your last dose of fentanyl sublingual tablets.

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

Driving and using machines

Fenticerta 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 Fenticerta, do not drive or operate machinery.

3. How to take Fenticerta

Before starting treatment and regularly during treatment, your doctor will also explain to you what to expect from using Fenticerta, 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 exactly the dosing instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

YOU SHOULD USE THIS MEDICINE ONLY AS DIRECTED BY YOUR DOCTOR. No one else should use this medicine, as it may cause SERIOUS risks to their health, especially in children.

Fenticerta is a different type of medicine compared to other medicines you may have used to treat breakthrough pain. You must always take the dose of Fenticerta exactly as prescribed by your doctor; this dose may differ from the one you have used with other breakthrough pain medicines.

Starting treatment – Determining the most appropriate dose

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

If you do not achieve adequate pain relief with one 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 you could experience 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 specifically instructed you to do so.

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

Continuing treatment – Once the most appropriate dose has been established

Once you and your doctor have established a Fenticerta dose that controls your pain episodes, you should not take this dose more than four times per day. A dose of Fenticerta 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 Fenticerta.

If you feel that the dose of Fenticerta you are taking does not satisfactorily control your pain episodes, inform your doctor, as your dose may need adjustment.

Do not change your dose of Fenticerta unless instructed by your doctor.

How to take the medicine

Fenticerta must be used sublingually. This means you should place the tablet under your tongue, where it will dissolve quickly, allowing the active ingredient to be absorbed through the lining of your mouth. Once absorbed, it begins to work to relieve 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 out 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 dotted line/perforations (keep the remaining units together).
  • Peel back the foil along the arrow and carefully remove the tablet. Do not press the Fenticerta sublingual tablets through the top foil, as this may damage them.
• Place the tablet as far back under your tongue as possible and let it dissolve completely.
• Fenticerta will dissolve quickly under the tongue and be absorbed to provide pain relief. It is therefore important not to 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 Fenticerta than you should

• Remove any remaining tablet from your mouth.
• Inform your caregiver or another person about what has happened.
• Contact your doctor, pharmacist, or local 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 an overdose include:

• Extreme drowsiness
• Slow, shallow breathing
• Coma

If this occurs, seek immediate medical assistance.

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

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 medicine and the amount ingested.

If you stop using Fenticerta

You should stop using Fenticerta when you no longer have breakthrough pain. However, you must continue taking your usual opioid medicines for persistent cancer pain as prescribed by your doctor. You may experience withdrawal symptoms similar to possible adverse effects of Fenticerta when stopping treatment with Fenticerta. 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

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

If you start 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 help (see also section 3 “If you take more Fenticerta 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
• swelling inside the mouth, vomiting, constipation, dry mouth
• sweating, tiredness / fatigue / lack of energy

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

• allergic reaction, tremors/shivering, blurred or altered vision, slow or rapid heartbeat, 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 reactions, rash, itching, night sweats, decreased sensitivity to touch, tendency to bruise easily
• joint pain or stiffness, muscle stiffness
• withdrawal syndrome (may present with the following adverse effects: nausea, vomiting, diarrhoea, anxiety, chills, tremor, and sweating), accidental overdose, in men inability to achieve or maintain an erection, general malaise

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

• swelling of the tongue

• serious 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

• pharmacological tolerance, drug dependence (addiction), drug abuse (see section 2)

• reduced or loss of consciousness

• itchy rash

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

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

Reporting of adverse effects

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

5. Storage of Fenticerta

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

Store this medicine in a safe and secure place, inaccessible to others. 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 Fenticerta in a closed or locked location.

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

No special storage conditions are required.

Medicines must not be disposed of via wastewater or household waste. Unused medicines and their containers should be returned to the SIGRE collection point at your pharmacy. If you are unsure, 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 Fenticerta

• 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 components are mannitol (E421), silicified microcrystalline cellulose, sodium croscarmellose, and magnesium stearate.

Appearance of the product and contents of the pack

Fenticerta is a small white sublingual tablet intended to be placed under the tongue. It is available in a wide range of strengths and forms. Your doctor will prescribe the appropriate dose (strength) 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 tablet shaped like a "D".

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

Sublingual tablets are supplied in single-dose, child-resistant perforated blisters (PA/AL/PVC//AL/PET), contained in a cardboard package.

Fenticerta is available in pack sizes of 10x1 or 30x1 tablets.

Some pack sizes may not be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Sandoz Farmacéutica, S.A.

Parque Norte Business Park

Roble Building

C/ Serrano Galvache, 56

28033 Madrid, Spain

Manufacturer

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

Date of the most recent revision of this leaflet: June 2025

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