Leaflet: information for the user

Kaptic100 micrograms sublingual tablets EFG

Kaptic200 micrograms sublingual tablets EFG

Kaptic300 micrograms sublingual tablets EFG

Kaptic400 micrograms sublingual tablets EFG

Kaptic600 micrograms sublingual tablets EFG

Kaptic800 micrograms sublingual tablets EFG

Fentanyl

Read this leaflet carefully before starting to take this medicine, as 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 you must not give it to other people 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 Kaptic is and what it is used for

2. What you need to know before starting to take Kaptic

3. How to take Kaptic

4. Possible side effects

5. Storage of Kaptic

6. Contents of the pack and additional information

Kaptic 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 ingredient in Kaptic sublingual tablets is fentanil. Fentanil belongs to a group of powerful pain medications called opioids.

Do not take Kaptic

• If you are allergic to fentanyl or any of the other components of this medication (listed in section 6)
• If you have severe breathing problems
• If you are not regularly taking an opioid medication prescribed by your doctor (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 those medications, do not use Kaptic, as 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

Consult your doctor, pharmacist, or nurse before starting to take Kaptic if you have or have had any of the conditions listed below, as your doctor will need to take this into account when prescribing your dose:

• A head injury, as Kaptic may mask the extent of the damage
• Respiratory 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 (increase in brain pressure that causes severe headache, nausea, vomiting, and blurred vision)
• Oral or mucositis (inflammation and redness of the inside of the mouth)
• If you are taking antidepressants or antipsychotics. See the section “Other medications and Kaptic”.
• If you are taking pain medications for neuropathic pain (gabapentin and pregabalin).

When taking Kaptic, inform your doctor or dentist that you are taking this medication if:

• You are about to undergo surgery
• You feel pain or increased sensitivity to pain (hyperalgesia) that does not respond to a higher dose of the medication as prescribed by your doctor.
• 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.
• You have ever had adrenal insufficiency or hormone deficiency (androgen deficiency) with the use of opioids.
• You have sleep-related respiratory problems: Kaptic 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.
• The repeated use of Kaptic may lead to dependence and abuse that may cause a potentially fatal overdose. If you are concerned about the possibility of becoming dependent on Kaptic, it is essential to consult your doctor.

Your doctor may need to monitor you more closely:

• If you or a family member have ever had abuse or dependence on alcohol, prescription medications, or drugs (“addiction”).
• If you are a smoker.
• If you have ever had mood-related problems (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

Use in athletes

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

Other medications and Kaptic

Inform your doctor or pharmacist that you are using or have recently used or may need to use any other medication (other than opioid pain medications you take regularly).

Some medications may increase or decrease the effects of Kaptic. Therefore, if you start, change the dose, or stop treatment with the following medications, inform your doctor, as it may be necessary to adjust your Kaptic dose.

The following medications may increase the effects of Kaptic:

• Certain types of antifungal medications containing substances such as ketoconazole or itraconazole (used to treat fungal infections)
• Certain types of antibiotics used to treat infections (called macrolides, which contain substances such as erythromycin)
• Certain types of antiviral medications called protease inhibitors, which contain, for example, ritonavir (used to treat infections caused by viruses).

The following medications may reduce the effects of Kaptic:

• Rifampicin or rifabutin (medications used to treat bacterial infections)
• Carbamazepine, phenytoin, or phenobarbital (medications used to treat seizures)
• Herbal medications containing St. John's Wort (Hypericum perforatum)
• Determined types of potent pain medications, called partial agonist/antagonists, such as buprenorphine, nalbuphine, and pentazocine (pain medications). You may experience withdrawal symptoms (nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating) while using these medications.

Kaptic may increase the effect of medications that make you feel sleepy, so the simultaneous use increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and may put your life at risk. Therefore, simultaneous use should only be considered when there are no other possible treatment alternatives.

Examples of sedative medications include:

• Otherpotent pain medications(opioid pain medications, for pain and cough)
• General anesthetics (used to put you to sleep during surgery)
• Muscle relaxants
• Sleeping pills
• Medications used to treat
• • depression
  • allergies
  • anxiety
  • psychosis
• Medications containing clonidine (used to treat high blood pressure)

However, if your doctor prescribes Kaptic and sedative medications simultaneously, the dose and duration of treatment should be limited by your doctor.

Inform your doctor of all sedative medications you are taking and follow your doctor's recommended dose strictly. It may be helpful to inform your family or friends of the mentioned symptoms. Talk to your doctor if you experience any of these symptoms.

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

It is not recommended to use Kaptic with medications called monoamine oxidase inhibitors (MAOIs), used to treat severe depression and Parkinson's disease. Inform your doctor if you have taken this type of medication in the last two weeks.

Use of Kaptic with food, drinks, and alcohol

Kaptic 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 Kaptic treatment, as it may increase the adverse effects of Kaptic.

Pregnancy and breastfeeding

You should not take Kaptic during pregnancy unless your doctor has explicitly indicated it.

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

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

Driving and operating machinery

Ask your doctor if you can drive or operate machinery during Kaptic treatment. It is essential to observe how this medication affects you before driving or operating machinery. Do not drive or operate machinery if you feel drowsy, dizzy, have blurred vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after increasing the dose, after changing the formulation, and/or when taking it with other medications.

Before taking Kaptic for the first time, your doctor will explain how to take it to effectively manage your pain episodes.

Follow exactly the administration instructions for this medication as indicated by your doctor. If in 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 health risks, especially in children.

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

Starting treatment – Establishing the most suitable dose

To ensure successful treatment with Kaptic, your doctor will need to identify the most suitable dose for your breakthrough pain treatment. Kaptic is available in a wide range of doses. You may need to try different doses of Kaptic during different pain episodes 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 pain relief with a dose, your doctor may instruct you to take an additional dose to treat a breakthrough pain episode. Do not take a second doseunless your doctor instructs you to do so,as you may suffer an overdose.

Your doctor may advise you to take a dose composed 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 another breakthrough pain episode with Kaptic.

Continuing treatment – Once the most suitable dose has been established

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

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

If you believe the Kaptic dose you are using does not adequately control your pain episodes, inform your doctor, as you may need to adjust your dose.

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

Medication intake

Kaptic 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 begins to act to relieve pain.

When you have a breakthrough pain episode, 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 perforation line (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 sublingual Kaptic 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.
• Kaptic will dissolve quickly under your tongue and be absorbed to provide you with pain relief. Therefore, it is essential not to 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 Kaptic than you should

• Remove any remaining tablet from your mouth
• Tell your caregiver or another person what has happened
• You must 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.

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 Kaptic

You should stop using Kaptic when you no longer have breakthrough 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 of Kaptic when you interrupt treatment with Kaptic. 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 using this medication, ask your doctor or pharmacist.

Like all medicines, Kaptic can cause side effects, although not everyone will experience them.

If you start to feel unusual or extreme drowsiness or if your breathing becomes shallow and slow, you or your caregiver should contact your doctor or local hospital for emergency assistance (see also section 3 “If you take more Kaptic 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

Rare 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/restlessness, 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(which 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 (frequency cannot be estimated from available data):

• swelling of the tongue, severe respiratory problems, falls, flushing, feeling of excessive heat, diarrhea, convulsion (seizure), inflammation of arms or legs, seeing or hearing things that are not real (hallucinations), pyrexia.
• drug dependence (addiction).
• drug abuse.
• 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 of Pharmacovigilance of Medicines 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 takes it accidentally. Keep out of the sight and reach of children.

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

No special storage conditions are required.

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

Medicines should not be disposed of through drains or in the trash. Deposit the containers and unused medicines at the SIGRE collection point of the pharmacy.in case of doubt, ask your pharmacist how to dispose of the containers and unused medicines. By doing so, you will help protect the environment.

Kaptic Composition

The active ingredient is fentanil. Each 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.

Product Appearance and Packaging Contents

Kaptic 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, 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

Kaptic 100, 200, 300, 400 micrograms is available in blister packs of 10x1 or 30x1 tablets.

Kaptic 600, 800 micrograms is available in blister packs of 30x1 tablets.

The blisters are child-resistant.

Only some package sizes may be commercially available.

Marketing Authorization Holder and Responsible Manufacturer

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

Responsible Manufacturer

Prasfarma, S.L.

C/ Sant Joan 11-15

08560 Manlleu - Barcelona

Spain

Local Representative

Ferrer Farma S.A.

Av. Diagonal 549, 5th floor

08029 Barcelona

Spain

Last Review Date of this Leaflet: April 2021

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