KAPTIC 800 micrograms SUBLINGUAL TABLETS

Introduction

Package 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 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 signs of illness are the same as yours.
• If you get 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

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

1. What is Kaptic and what is it used for

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

Breakthrough pain is a type of pain that happens suddenly, even though you have taken your usual opioid pain medicine.

The active substance in Kaptic 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 Kaptic

Do not take Kaptic

• 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, at the same time, for your persistent pain. If you have not been using these medicines, do not use Kaptic, as it may increase the risk of your breathing becoming slower and/or shallower, and even stopping.
• If you have short-term pain that is not breakthrough pain.

Warnings and precautions

Tell your doctor or pharmacist or nurse before you start taking Kaptic if you have or have had any of the following conditions, as your doctor will need to take this into account when prescribing your dose:

• A head injury, as Kaptic may hide the extent of the damage
• Breathing problems or severe muscle weakness (myasthenia gravis)
• If you have heart problems, especially a slow heart rate
• Low blood pressure
• Liver or kidney disease, as you may need your doctor to adjust your dose more carefully
• Brain tumour and/or increased pressure in the brain (which can cause 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 section “Other medicines and Kaptic”.
• If you are taking pain medicines for nerve pain (gabapentin and pregabalin).

When you are taking Kaptic, 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, where the adrenal glands do not produce enough hormones.
• you have ever had adrenal insufficiency or a lack of sex hormones (androgen deficiency) when using opioids.
• you have sleep-related breathing disorders: Kaptic may cause sleep-related breathing disorders such as sleep apnoea (pauses in breathing during sleep) and sleep-related hypoxemia (low oxygen levels in the blood). Symptoms may include pauses in breathing during sleep, waking up at night due to difficulty breathing, difficulty staying asleep, or excessive sleepiness during the day. If you or someone else notices these symptoms, contact your doctor. Your doctor may consider reducing the dose.
• repeated use of Kaptic can lead to dependence and abuse, which can cause a potentially life-threatening overdose. If you are concerned about becoming dependent on Kaptic, it is important that you talk to your doctor.

Your doctor may need to monitor you more closely:

• if you or a family member have ever abused or been dependent on alcohol, prescription medicines, or street drugs (“addiction”).
• if you are a smoker.
• if you have ever had problems related to your mood (depression, anxiety, or personality disorder) or have been treated by a psychiatrist for other mental health conditions.

Use in athletes

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

Other medicines and Kaptic

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

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

The following medicines may increase the effects of Kaptic:

• Certain types of antifungal medicines that contain substances like ketoconazole or itraconazole (used to treat fungal infections)
• Certain types of antibiotic medicines used to treat infections (called macrolides, which contain substances like erythromycin)
• Certain types of antiviral medicines called protease inhibitors, which contain, for example, ritonavir (used to treat viral infections).

The following medicines may reduce the effects of Kaptic:

• Rifampicin or rifabutin (medicines used to treat bacterial infections)
• Carbamazepine, phenytoin, or phenobarbital (medicines used to treat seizures).
• Herbal medicines that contain St. John's Wort (Hypericum perforatum)
• Certain types of strong painkillers called partial agonist/antagonists, such as buprenorphine, nalbuphine, and pentazocine (medicines for pain). You may experience withdrawal symptoms (nausea, vomiting, diarrhoea, anxiety, shivering, tremors, and sweating) when using these medicines.

Kaptic may increase the effect of medicines that make you feel sleepy, so using them at the same time increases the risk of drowsiness, difficulty breathing (respiratory depression), coma, and can be life-threatening. Therefore, using them at the same time should only be considered when there are no other possible treatment alternatives.

Some examples of sedative medicines are:

• other strong pain-relieving medicines(opioid-type medicines for pain and cough)
• general anaesthetics (used to put you to sleep during operations)
• muscle relaxants
• sleeping pills
• medicines used to treat
• • depression
  • allergies
  • anxiety
  • psychosis
• medicines that contain clonidine (used to treat high blood pressure)

However, if your doctor prescribes Kaptic and sedative medicines at the same time, the dose and duration of treatment will need to be limited by your doctor.

Tell your doctor about all sedative medicines you are taking and follow your doctor's dose recommendations strictly. It may be useful to inform your family or friends about the signs and symptoms mentioned above. Talk to your doctor if you experience any of these symptoms.

The risk of side effects increases if you are taking medicines such as certain antidepressants or antipsychotics. Kaptic 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 Kaptic is suitable for you.

It is not recommended to use Kaptic at the same time as 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.

Using Kaptic with food, drinks, and alcohol

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

Pregnancy and breastfeeding

Do not take Kaptic 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 Kaptic if you are breastfeeding. You should not start breastfeeding until at least 5 days after the last dose of Kaptic.

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

Driving and using machines

Ask your doctor if you can drive or use machines while taking Kaptic. It is important that before driving or using machines, you see how this medicine affects you. Do not drive or use machines if you feel drowsy, dizzy, have blurred vision, or double vision, or have difficulty concentrating. Be particularly careful at the start of treatment, after a dose increase, after a change in formulation, and/or when taking it with other medicines.

3. How to take Kaptic

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

Follow the instructions for taking this medicine exactly as your doctor has told you. If you are unsure, ask your doctor or pharmacist again.

YOU SHOULD ONLY USE THIS MEDICINE AS DIRECTED BY YOUR DOCTOR.Do not use it for anyone else, as it could cause serious health risks, especially in children.

Kaptic is a different type of medicine from other pain medicines you may have used. ALWAYS TAKE THE DOSE OF KAPTIC AS DIRECTED BY YOUR DOCTOR;this may be a different dose from the one you used with other pain medicines for breakthrough pain.

Starting treatment – Finding the right dose

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

If you do not get adequate pain relief with a 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 overdose.

Your doctor may advise you to take a dose made up of more than one tablet at the same time. ONLY DO THIS IF YOUR DOCTOR TELLS YOU TO.

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

Continuing treatment – Once the right dose is established

Once you and your doctor have found a dose of Kaptic that controls your breakthrough pain, you should not take this dose more than four times a day. A DOSE OF KAPTIC 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 Kaptic.

If you think the dose of Kaptic you are using does not control your breakthrough pain well enough, tell your doctor, as you may need to have your dose adjusted.

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

Taking the medicine

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 starts to work to relieve pain.

When you have an episode of breakthrough pain, take the dose as directed by your doctor as follows:

• If your mouth is dry, take a sip of water to moisten it. Spit or swallow the water.
• Take the tablet(s) out of 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 top layer at the point indicated by the arrow and carefully remove the tablet. Do not try to push the Kaptic sublingual tablets through the top layer, as this will damage the tablets.
• Place the tablet under your tongue as far back as you can and let it dissolve completely.
• Kaptic 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 Kaptic than you should

• Remove any remaining tablets from your mouth
• Tell your carer or another person what has happened
• You must contact your doctor, pharmacist, or local hospital immediately and ask for advice
• While waiting for the doctor, keep the person awake by talking to them or shaking them from time to time

Symptoms of an overdose include:

• Extreme drowsiness
• Slow, shallow breathing

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 medicine and the amount taken.

If you stop taking Kaptic

You should stop using Kaptic when you no longer have breakthrough pain. However, you should continue taking your usual opioid medicines for persistent cancer pain as recommended by your doctor. You may experience withdrawal symptoms similar to the possible side effects of Kaptic when you stop treatment with Kaptic. If you have withdrawal symptoms or are concerned about pain relief, talk to your doctor, who will assess whether you need any medicine to reduce or prevent withdrawal symptoms.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Adverse Effects

Like all medicines, Kaptic can cause adverse effects, although not all people suffer from 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 Kaptic 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 drowsiness
• shortness of breath/difficulty breathing
• inflammation inside the mouth, vomiting, constipation, dry mouth
• sweating, fatigue/lack of energy

Uncommon adverse 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/fears 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 compression, 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 alterations, rash, itching, night sweating, decreased sensitivity to touch, ease of bruising
• joint pain or stiffness, muscle stiffness
• withdrawal syndrome (which can manifest with the following adverse effects: nausea, vomiting, diarrhea, anxiety, chills, tremors, and sweating), accidental overdose, in men inability to achieve or maintain an erection, general malaise

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

• tongue swelling, severe respiratory problems, falls, flushing, feeling of excessive heat, diarrhea, convulsion (epileptic seizure), inflammation of arms or legs, seeing or hearing things that are not real (hallucinations), pyrexia.
• drug dependence (addiction).
• drug abuse.
• 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).

Prolonged treatment with fentanyl during pregnancy can cause withdrawal symptoms in the newborn, which can be potentially fatal (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 that does not appear in this prospectus. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Kaptic

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

Do not use this medicine 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 thrown away through drains or into the trash. Deposit the packaging and medicines you no longer need at the SIGRE Point in the pharmacy. In case of doubt, ask your pharmacist how to dispose of the packaging and medicines you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Kaptic Composition

The active ingredient is fentanyl. Each 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 Package Contents

Kaptic 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 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 10x1 or 30x1 tablet blister packs.

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

The blisters are child-resistant.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Ferrer Internacional, S.A.

Gran Vía Carlos III, 94

08028 Barcelona

Spain

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

Date of the Last Revision of this Prospectus: April 2021

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/